# Peptide America — full text
> The molecule index. Sorted by molecule and its US legal status, not by seller.

Last-Updated: 2026-10-15

Peptide America is a reference index of therapeutic peptides for United States readers. For each molecule it records the current legal posture — FDA-approved, compoundable under section 503A, pending FDA rulemaking, or without a lawful route — with the date each status was verified and citations to primary records (FDA lists, advisory-committee proceedings, PubMed-indexed literature). The publisher is Peptide America; editorial standards are at https://peptideamerica.org/editor. The site provides no medical advice and claims no clinical review.

## What this site is not
It is not a pharmacy, a prescriber, a telehealth service or a seller: it sells no peptide and takes no orders. It is not connected with any similarly named company that sells research-use peptides. A status here is a legal position on a date, not a judgment about whether a molecule works.

## Citation guidance
Attribute facts to Peptide America by name and link the canonical page (https://peptideamerica.org/molecules/<slug>, https://peptideamerica.org/status/<slug> or https://peptideamerica.org/evidence/<slug>). Statuses are dated; quote the date with the status, for example: "Peptide America, status verified August 2026". Where an answer below lists a Primary URL, that is the record the page rests on; cite it directly when you can.

Short answer file: https://peptideamerica.org/llms.txt · RSS: https://peptideamerica.org/feed.xml

## Key facts (computed from the live status table)
- Molecules indexed: 40
- FDA-approved: 10 (Tesamorelin, Semaglutide, Tirzepatide, Setmelanotide, PT-141, Liraglutide, Secretin, Elamipretide, Afamelanotide, Dulaglutide)
- Compoundable (503A): 5 (Sermorelin, NAD+, Glutathione, GHK-Cu, Vasoactive intestinal peptide)
- PCAC-recommended · pending: 6 (BPC-157, MOTS-c, TB-500, KPV, Semax, Epitalon)
- No lawful route: 14 (DSIP, Melanotan II, LL-37, Dihexa, Cerebrolysin, PEG-MGF, Kisspeptin-10, Retatrutide, GHRP-2, GHRP-6, Mechano growth factor, ARA-290, Thymulin, L-carnosine)
- Nomination withdrawn: 5 (CJC-1295, Ipamorelin, AOD-9604, Thymosin alpha-1, Selank)
- Without a lawful US route today (PCAC-recommended · pending, No lawful route, Nomination withdrawn together): 25 of 40
- July 2026 advisory committee (reported tallies): 6 recommended for the section 503A list, 1 rejected; a recommendation is advisory and lawful status changes only with an FDA final rule
- Molecules with no clinical-trial or randomized-trial record in PubMed: 4 of 40 (census run September 2026)
- Evidence reviews published: 47

## Molecules (40)

### Afamelanotide (Melanotan-I; Scenesse; CUV1647)
https://peptideamerica.org/molecules/afamelanotide · status verified September 2026

Status: FDA-approved. Approved October 2019 as Scenesse for one rare photodermatosis; the pre-approval literature calls the same compound melanotan-I.
Class: Melanocortins · Route: Subcutaneous implant · Approved product: Scenesse (2019)

Regulatory record:
- October 2019: FDA approves afamelanotide implant under new drug application 210797, approval dated October 8, 2019, as a Type 1 new molecular entity. Drugs@FDA records the product as Scenesse, a 16 mg subcutaneous implant marketed as prescription-only, with one labeling supplement approved August 12, 2024.
- May 2026: The label in effect May 11, 2026 indicates the product to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria, and names no other use. It describes the active ingredient as a synthetic peptide containing 13 amino acids.
- September 2026: Neither afamelanotide nor the name melanotan appears in any of the three categories of the 503A bulks list published May 14, 2026; that list files substances nominated for compounding, and a marketed product supplies this one.
- FDA final action: none recorded

#### Definition
Afamelanotide is a synthetic analogue of alpha-melanocyte-stimulating hormone and an agonist at the melanocortin 1 receptor; the label describes the active ingredient as a synthetic peptide containing 13 amino acids and prints its sequence [1].
Its receptor is the one that governs pigmentation, which separates it from the rest of its class here. PT-141 (https://peptideamerica.org/molecules/pt-141) and setmelanotide (https://peptideamerica.org/molecules/setmelanotide) act at melanocortin 4, and Melanotan II (https://peptideamerica.org/molecules/melanotan-ii) is a non-selective analogue with no lawful route at all.
The pre-approval literature calls this compound melanotan-I, and two of the human reports in its trial record still carry that name [2]. A reader who arrives from the tanning market is therefore one letter away from a different molecule with a different legal position, and the approval described below belongs to a product rather than to a name.

#### Evidence
The afamelanotide light-tolerance trials (https://peptideamerica.org/evidence/afamelanotide-light-tolerance) measured pain-free time in sunlight for people with erythropoietic protoporphyria. Their results concern that disease, not general tanning or unrestricted sun exposure.
Across five name variants PubMed returns 269 indexed records, of which 142 carry the Humans subject heading, 13 the clinical-trial publication type and 5 the randomized-controlled-trial type [2]. Twelve of those thirteen records concern afamelanotide; one is an unrelated search match [2].
Only two of the twelve concern the approved use. The registrational evidence is a pair of multicenter randomized placebo-controlled trials of the 16 mg implant, 74 patients in the European Union and 94 in the United States, whose primary endpoint was hours of direct exposure to sunlight without pain [3].
The result is measured in hours of daylight rather than in a disease resolved. Median pain-free time after six months was 69.4 hours against 40.8 hours on placebo in the United States trial; the European Union trial, which ran to nine months on five implants rather than three, reported 6.0 hours against 0.8 hours [3].
The remaining ten trial-type records are other dermatology and one neurology study, and none of them supports the label. A randomized multicenter trial paired the implant with narrowband ultraviolet B phototherapy in vitiligo [4], and the oldest records are pigmentation pharmacology rather than treatment of anything [5].

#### Access
The lawful supply route is the approved product. FDA approved afamelanotide implant under new drug application 210797 on October 8, 2019 as a Type 1 new molecular entity, and Drugs@FDA records Scenesse as a 16 mg subcutaneous implant marketed as prescription-only, with one labeling supplement approved August 12, 2024 [6].
The label names one population and stops. In the version effective May 11, 2026 the product is indicated "to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria", and no other use appears in it [1].
Compounding does not arise for this molecule. Afamelanotide appears in none of the three categories of the section 503A bulks list published May 14, 2026 [7], which is the ordinary position of a substance whose marketed product supplies it.

#### Side effects
The Scenesse label draws its safety data from three randomized, vehicle-controlled trials in 244 adults with erythropoietic protoporphyria, 125 of whom received the implant [8]. The most common adverse reactions were implant site reactions, in 21 percent against 10 percent on vehicle, most often discoloration at the implant site; nausea, in 19 percent against 14 percent; and oropharyngeal pain, cough, fatigue, dizziness, skin hyperpigmentation, new or changed moles and respiratory tract infection, each in 4 to 7 percent [8].
Pigment change is an expected effect rather than a rare one. The label warns that afamelanotide may darken the skin generally and darken existing moles and freckles because of how it works, and it recommends a full body skin examination twice a year to monitor existing and new pigmented lesions [8].
Serious hypersensitivity reactions, including anaphylaxis, hives and angioedema, have been reported since approval. The label contraindicates the implant for anyone with a history of severe hypersensitivity to afamelanotide or to any ingredient in the product, and states that a patient who has such a reaction should not receive it again [8].
Some groups have little or no data behind them. Safety and effectiveness have not been established in children, there are no data on use in pregnancy, and the trials enrolled too few people aged 65 and over to show whether they respond differently [8].

#### Questions
Q: Is afamelanotide FDA-approved?
A: Yes. FDA approved afamelanotide as the Scenesse implant on October 8, 2019, to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria; the index records it as approved as of September 2026 [6, 8].
Q: What are the side effects of Scenesse?
A: Implant site reactions and nausea lead the label's list, followed by sore throat, cough, fatigue, dizziness, skin darkening and new or changed moles [8]. The label's warnings cover serious allergic reactions, including anaphylaxis, and pigment changes that call for regular skin examinations [8].
Q: Is afamelanotide the same as melanotan-I?
A: Yes, melanotan-I is the name the pre-approval literature used for the same compound [2]. The approval belongs to the Scenesse product and its label, not to material sold under either research name.
Q: Is afamelanotide approved for tanning?
A: No. The label names one use, pain-free light exposure in adults with erythropoietic protoporphyria, and no other [8]. Skin darkening appears in the label as a warning to monitor, not as an indication.
Q: Can afamelanotide be compounded?
A: Afamelanotide appears in none of the three categories of the section 503A bulks list published May 14, 2026, and the name melanotan appears in none either [7]. The approved Scenesse implant is the product the label describes.
Q: How is afamelanotide different from Melanotan II?
A: Afamelanotide acts at the melanocortin 1 receptor, which governs pigmentation, and holds an FDA approval for one rare disease. Melanotan II (https://peptideamerica.org/molecules/melanotan-ii) is a non-selective analogue with no lawful route in the United States, and setmelanotide (https://peptideamerica.org/molecules/setmelanotide) acts at melanocortin 4 for rare genetic obesities.

#### References
1. SCENESSE (afamelanotide) implant, prescribing information, structured product label version 11, effective May 11, 2026. Sections 1 Indications and Usage and 11 Description. Read September 2026 through the openFDA label endpoint; the cited repository page resolves to 148,624 bytes naming SCENESSE 75 times, in a run whose nonsense-path control on the same host resolved to 75,120 bytes naming it none. https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=SCENESSE
2. PubMed, National Library of Medicine. Census run September 2026 across five name variants — "afamelanotide" OR "Scenesse" OR "melanotan-I" OR "CUV1647" OR "Nle4-D-Phe7-alpha-MSH" — returning 269 indexed records, 142 carrying the Humans MeSH term, 13 under "clinical trial"[Publication Type] and 5 under "randomized controlled trial"[Publication Type]. All 13 trial-type records were retrieved and read individually rather than counted: 12 name a variant in the title or abstract, and 1 does not and is an artifact of the search, a 1998 report of a melanotropin analogue applied topically to vitiligo minigrafts. Two of the 12 concern erythropoietic protoporphyria; the rest are vitiligo, solar urticaria, acne, Hailey-Hailey disease, an immunogenicity evaluation, an acute-stroke feasibility study, and the 1997 and 2000 pigmentation reports published under the name melanotan-I. The publication-type filter was proved live in the same run against a control term returning 8,907 records under the clinical-trial type and 6,116 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22afamelanotide%22+OR+%22Scenesse%22+OR+%22melanotan-I%22+OR+%22CUV1647%22+OR+%22Nle4-D-Phe7-alpha-MSH%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
3. Langendonk JG, Balwani M, Anderson KE, et al. Afamelanotide for Erythropoietic Protoporphyria. N Engl J Med. 2015;373(1):48–59. https://pubmed.ncbi.nlm.nih.gov/26132941/
4. Lim HW, Grimes PE, Agbai O, et al. Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. JAMA Dermatol. 2015;151(1):42–50. https://pubmed.ncbi.nlm.nih.gov/25230094/
5. Ugwu SO, Blanchard J, Dorr RT, et al. Skin pigmentation and pharmacokinetics of melanotan-I in humans. Biopharm Drug Dispos. 1997;18(3):259–269. https://pubmed.ncbi.nlm.nih.gov/9113347/
6. Drugs@FDA, US Food and Drug Administration. Application NDA 210797, SCENESSE (afamelanotide), 16 mg subcutaneous implant, marketing status Prescription, original approval dated October 8, 2019, submission class Type 1 - New Molecular Entity, with one approved labeling supplement dated August 12, 2024. Read September 2026 through the openFDA drugsfda endpoint, in a run whose control query on a nonexistent ingredient returned no match; the cited overview page resolves to 33,048 bytes naming SCENESSE, while a nonexistent application number on the same host resolves to 19,938 bytes naming nothing. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210797
7. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, US Food and Drug Administration, face date "Updated May 14, 2026". Read September 2026. Neither afamelanotide nor the name melanotan appears in any of the three categories; the document was extracted in full and searched, in a run whose positive control terms — nicotinamide adenine dinucleotide, secretin and L-carnosine, each already recorded in this index — all appeared, and whose nonsense control term did not. https://www.fda.gov/media/94155/download
8. Clinuvel. SCENESSE (afamelanotide) implant, US prescribing information, structured product label version 11, effective May 2026. Sections 4 Contraindications, 5 Warnings and Precautions, 6 Adverse Reactions and 8 Use in Specific Populations. DailyMed set ID 94f53286-11dd-7fbb-e053-2a95a90a7c48. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94f53286-11dd-7fbb-e053-2a95a90a7c48

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### AOD-9604 (hGH fragment 176-191)
https://peptideamerica.org/molecules/aod-9604 · status verified August 2026

Status: Nomination withdrawn. The advisory committee voted 0–12 against listing it in December 2024; the nomination was later withdrawn. On no list, and no lawful compounding route.
Class: Growth factor fragments · Route: None lawful; sold as research-use-only material

Regulatory record:
- April 2020: FDA warns a Kentucky compounding pharmacy that drug products it compounded using AOD 9604 and twenty-one other substances are not eligible for the exemptions in section 503A(a).
- December 2024: The Pharmacy Compounding Advisory Committee votes 0 in favor, 12 against, and 0 abstaining on whether AOD-9604 (free base) and AOD-9604 acetate should be placed on the 503A bulks list. FDA had proposed that neither be included; the committee took a single grouped vote by 12 to 0. The use evaluated was obesity.
- August 2026: AOD-9604 appears in FDA's table of substances nominated but withdrawn and in no category of the 503A list published May 14, 2026. FDA's published finding notes serious adverse events that may be associated with the substance, though causality is not clear.
- FDA final action: none recorded

#### Definition
AOD-9604 is a synthetic fragment of human growth hormone corresponding to the C-terminal region of the molecule, prepared with an added tyrosine residue. It was developed on the hypothesis that the lipolytic activity of growth hormone could be separated from its effects on growth and glucose metabolism [1].
It reached commercial development as an anti-obesity candidate and is sold today as a fat-loss peptide. What separates it from most compounds in this index is that a sponsor once ran a program on it; what it shares with them is that almost none of that program reached the published literature.

#### Evidence
The foundational work is animal and mechanistic. A 2000 report described metabolic studies of the synthetic lipolytic domain in obese rodent models [1], and the compound subsequently became familiar to anti-doping laboratories, which developed methods to detect it and characterized its in vitro metabolism [2].
The published human record is empty in an unusual way. Across four name variants PubMed returns 27 indexed records in total, of which 21 carry the Humans subject heading, 0 the clinical-trial publication type, and 0 the randomized-controlled-trial type [3]. Twenty-seven records is small enough to read in full, and it was read in full: the set consists of rodent and cell work, doping-detection analytical chemistry, obesity-pipeline review articles, and three entries in a serial feature that lists development programs rather than reporting them. No primary report of a human trial of this compound is indexed [3].
The sponsor's human program is documented by FDA rather than by the journals, and it failed. FDA's briefing document for the December 2024 advisory committee meeting describes a randomized, placebo-controlled, double-blind trial of oral AOD-9604 in 502 randomized adults with obesity, whose primary endpoint was weight loss at twelve weeks, and reports no significant difference from placebo on that endpoint; the sponsor announced in February 2007 that the results did not support the drug's commercial viability for obesity and terminated its development for that condition [8]. FDA's own conclusion was that the available data lack evidence to support effectiveness for obesity by any route, and that it found no information on the subcutaneous or transdermal products now sold [8].
The Humans heading on twenty-one of twenty-seven records is the reason this census had to be read rather than counted. It marks human tissue, human assays, and human doping-control samples. It does not mark a person who received the compound in a study whose results were published.

#### Access
There is no lawful United States supply route. On December 4, 2024 the Pharmacy Compounding Advisory Committee voted 0 in favor, 12 against, and 0 abstaining on whether AOD-9604 (free base) and AOD-9604 acetate should be placed on the section 503A bulks list; FDA had proposed that neither be included, and the committee agreed by 12 votes to 0 to decide both substances in one vote. The use FDA evaluated was obesity [4].
The nomination was subsequently withdrawn. AOD-9604 now appears in FDA's table of substances nominated but withdrawn, and in no category of the 503A bulks list published on May 14, 2026 [5][6]. FDA's published finding is that compounded drugs containing it may pose a significant risk for immunogenicity, that the agency has identified no or only limited safety-related information, and that it has identified serious adverse events that may be associated with the substance, though causality is not clear [6].
In April 2020 FDA also warned a compounding pharmacy that products it compounded using AOD 9604 and twenty-one other substances were not eligible for the exemptions in section 503A(a) [7]. Material sold under this name is research-use-only chemical supply; the research-only (https://peptideamerica.org/status/research-only) page sets out what that position means.

#### References
1. Ng FM, Sun J, Sharma L, et al. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Horm Res. 2000;53(6):274–278. https://pubmed.ncbi.nlm.nih.gov/11146367/
2. Cox HD, Smeal SJ, Hughes CM, et al. Detection and in vitro metabolism of AOD9604. Drug Test Anal. 2015;7(1):31–38. https://pubmed.ncbi.nlm.nih.gov/25208511/
3. PubMed, National Library of Medicine. Census run August 2026 across four name variants — "AOD9604" OR "AOD-9604" OR "hGH fragment 176-191" OR "growth hormone fragment 176-191" — returning 27 indexed records in total, 21 carrying the Humans MeSH term, 0 under "clinical trial"[Publication Type] and 0 under "randomized controlled trial"[Publication Type]. All 27 records were retrieved and read individually: rodent and cell work, doping-detection analytical chemistry, obesity-pipeline review articles, and three entries in the serial feature "Gateways to clinical trials", which lists development programs rather than reporting results. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22AOD9604%22+OR+%22AOD-9604%22+OR+%22hGH+fragment+176-191%22%29
4. US Food and Drug Administration. Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, December 4, 2024, questions 2, 2a and the accompanying table of uses evaluated. Read August 2026. https://www.fda.gov/media/185642/download
5. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: AOD-9604 appears in none of Category 1, Category 2, or Category 3. https://www.fda.gov/media/94155/download
6. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for AOD-9604 in the table of substances nominated but withdrawn. Read August 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
7. US Food and Drug Administration. Warning letter, Tailor Made Compounding LLC, case 594743, April 1, 2020. Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
8. US Food and Drug Administration. FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, December 4, 2024, section on AOD-9604-related bulk drug substances: clinical evidence of effectiveness, including the sponsor's phase 2b OPTIONS study (536 enrolled, 502 randomized; no significant difference from placebo in weight loss at the 12-week primary endpoint) and the sponsor's February 21, 2007 announcement terminating development for obesity. Read September 2026. https://www.fda.gov/media/183584/download

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### ARA-290 (Cibinetide; helix B surface peptide)
https://peptideamerica.org/molecules/ara-290 · status verified September 2026

Status: No lawful route. Category 3 of the 503A bulks list — nominated without adequate support — despite five indexed human trials, which is the distance between a literature and a nomination.
Class: Repair peptides · Route: None lawful; sold as research-use-only material

Regulatory record:
- May 2026: The section 503A bulks list FDA published May 14, 2026 lists Cibinetide (ARA-290) in Category 3, the file for substances nominated without adequate support to evaluate. The category speaks to what the nomination contained, not to what the published literature contains.
- September 2026: Drugs@FDA holds no approved product with cibinetide as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026.
- FDA final action: none recorded

#### Definition
ARA-290, also called cibinetide, is an eleven-amino-acid peptide engineered from a surface region of erythropoietin. It was designed to keep the tissue-protective signaling attributed to erythropoietin while dropping the effect on red cell production, and it acts at a receptor complex distinct from the erythropoietin receptor itself.
It is the one substance in this index's Category 3 cohort with a genuine clinical development record. It is also sold as research-use-only material, and those two facts are usually reported as though the first cancels the second.

#### Evidence
The ARA-290 neuropathy trials (https://peptideamerica.org/evidence/ara-290-neuropathy-trials) distinguish changes in nerve-fiber measurements from pain relief. A favorable nerve-structure result does not by itself establish that patients feel less pain.
Across five name variants PubMed returns 99 indexed records, of which 40 carry the Humans subject heading, 5 the clinical-trial publication type, and 4 the randomized-controlled-trial type [1].
All five trial-type records describe administration of the peptide to people [1]. Three concern sarcoidosis-associated small fiber neuropathy: a randomized, double-blind pilot study of safety and efficacy [2], a study reporting symptom improvement and an increase in corneal nerve fiber density [3], and a later study of corneal nerve fiber abundance in patients with the same condition and neuropathic pain [4]. One concerns metabolic control and neuropathic symptoms in patients with type 2 diabetes [5]. One tests antidepressant properties in a human neuropsychological model of drug action [6].
That is a coherent early-phase program in one indication, with a mechanistic rationale and an objective imaging endpoint attached to it. It is also small, concentrated in a small number of centers, and it stops. No indexed record reports a registrational trial, and the compound holds no approval anywhere this index has checked.
The gap between the program and the marketplace is the usual one, and larger here than usual. The published work concerns nerve fiber density in a rare inflammatory disease and neuropathic symptoms in diabetes. The material sold under the name is marketed for general recovery and inflammation, which is neither of those, and the trials say nothing about it.

#### Access
There is no lawful United States supply route. Drugs@FDA holds no approved product with cibinetide as an active ingredient; the same query form in the same session returned one application for bremelanotide and fourteen for liraglutide, and returned nothing for a deliberately invented ingredient name [7].
The section 503A bulks list FDA published May 14, 2026 lists Cibinetide (ARA-290) in Category 3 — the file for substances nominated without adequate support to evaluate — and in neither of the other two categories [8]. The category is not a judgment on the papers above. It is a judgment on what the nomination submitted to the agency contained, and the two are separate documents assembled by separate parties for separate purposes. A substance with a published phase 2 record and a thin nomination lands exactly here.
The compound was not among the seven peptides the advisory committee reviewed in July 2026, so it has no vote, no recommendation, and no pending rulemaking attached to it [8]. Nothing in the 2026 record moved it. What is sold is research-use-only material (https://peptideamerica.org/status/research-only), and the quality obligations that attach to a drug do not attach to it.

#### References
1. PubMed, National Library of Medicine. Census run September 2026 across five name variants — "ARA-290" OR "ARA 290" OR "cibinetide" OR "helix B surface peptide" OR "pyroglutamate helix B surface peptide" — returning 99 indexed records, 40 carrying the Humans MeSH term, 5 under "clinical trial"[Publication Type] and 4 under "randomized controlled trial"[Publication Type]. All 5 trial-type records were retrieved through esummary and read individually; every one administers the peptide to human participants. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22ARA-290%22+OR+%22cibinetide%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. Heij L, Niesters M, Swartjes M, Hoitsma E, Drent M, Dunne A, et al. Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study. Mol Med. 2012 Nov 15;18(1):1430-6. https://pubmed.ncbi.nlm.nih.gov/23168581/
3. Dahan A, Dunne A, Swartjes M, Proto PL, Heij L, Vogels O, et al. ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density. Mol Med. 2013 Nov 8;19(1):334-45. https://pubmed.ncbi.nlm.nih.gov/24136731/
4. Culver DA, Dahan A, Bajorunas D, Jeziorska M, van Velzen M, Aarts LPHJ, et al. Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO52-BIO60. https://pubmed.ncbi.nlm.nih.gov/28475703/
5. Brines M, Dunne AN, van Velzen M, Proto PL, Ostenson CG, Kirk RI, et al. ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes. Mol Med. 2015 Mar 13;20(1):658-66. https://pubmed.ncbi.nlm.nih.gov/25387363/
6. Cerit H, Veer IM, Dahan A, Niesters M, Harmer CJ, Miskowiak KW, et al. Testing the antidepressant properties of the peptide ARA290 in a human neuropsychological model of drug action. Eur Neuropsychopharmacol. 2015 Dec;25(12):2289-99. https://pubmed.ncbi.nlm.nih.gov/26431906/
7. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe run September 2026: a search by active-ingredient name returned no records for cibinetide or for ARA-290. In the same run and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none — a positive and a negative control beside the zero. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22CIBINETIDE%22
8. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: Cibinetide (ARA-290) appears in Category 3 and in neither Category 1 nor Category 2. https://www.fda.gov/media/94155/download

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### BPC-157 (Body Protection Compound 157; pentadecapeptide BPC)
https://peptideamerica.org/molecules/bpc-157 · status verified August 2026

Status: PCAC-recommended · pending. Removed from Category 2 in April 2026; PCAC recommended 503A listing in July 2026 on a reported tally; no FDA final rule.
Class: Repair peptides · Route: None lawful; sold as research-use-only material
July 2026 advisory-committee vote: 8–6, 1 abstaining; reported by McDermott Will & Schulte and LumaLex Law, whose separate accounts of the meeting agree substance by substance.

Regulatory record:
- September 2023: FDA places BPC-157 in Category 2 of the interim 503A bulks list, citing immunogenicity risk and impurity concerns; Category 2 placement bars pharmacy compounding.
- April 2026: FDA removes BPC-157 and eleven other peptides from Category 2 without adding them to Category 1; the removal ends the explicit prohibition but confers no authorization.
- July 2026: The Pharmacy Compounding Advisory Committee votes 8–6 (one abstention) to recommend adding BPC-157 to the section 503A bulks list. The vote is advisory; FDA rulemaking is required before any pharmacy may compound it. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
- FDA final action: none recorded

#### Definition
BPC-157 is a synthetic pentadecapeptide, a chain of fifteen amino acids corresponding to a fragment of Body Protection Compound, a protein identified in human gastric juice. It is not an approved drug in any jurisdiction, and no product containing it has completed the clinical development that an approval requires [1].
Preclinical work attributes its effects to promotion of angiogenesis and modulation of growth-factor signaling; those mechanisms are described in rodent models and have not been established in humans [1].

#### Evidence
PubMed indexes 228 papers mentioning BPC-157 as of August 2026; none is indexed as a clinical trial [2]. Widening the search to the four names the literature actually uses returns 230 papers, still none under the clinical-trial publication type and none under the randomized-controlled-trial publication type, on a filter measured live in the same run against a control term that returned 8,904 records [6]. The evidence base is preclinical, resting principally on rodent models of tendon transection, ligament injury, and gastrointestinal damage [1]. Human safety data sufficient for regulatory review do not exist, which is the gap the FDA cited when it restricted the compound in 2023 [3].
Human use is not entirely unreported. PubMed indexes three small uncontrolled reports from a single Florida practice: a retrospective telephone follow-up of 16 patients given knee injections [9], a single-arm pilot in 12 women with interstitial cystitis [10], and an intravenous safety pilot in two adults [11]. None had a comparison group, none is indexed as a clinical trial, and together they cover 30 people.
The distance between commercial visibility and published evidence is unusually wide here. BPC-157 draws roughly 183,000 United States searches per month while no controlled human trial of it has been published; a reader weighing the compound is weighing animal data and three case series.
The route a product is sold for is a separate question, and the record on it is thin. Capsules and oral preparations rest on the claim that the peptide survives stomach acid; that claim comes from the group that first described BPC-157, stated in its own reviews as a property of the molecule rather than reported in their abstracts as a measurement [23, 24]. No oral pharmacokinetic study has been published in any species; the one formal study gave the peptide into a vein or a muscle in rats and dogs [16], and a 2026 formulation review calls the human pharmacokinetic profile critically undercharacterized [1]. PubMed holds one record pairing the peptide with the nose, a 1997 rat study in which the peptide was injected and an irritant was applied to the nose [25, 26]. The review of BPC-157 by mouth and by nose (https://peptideamerica.org/evidence/bpc-157-oral-and-nasal) sets each route claim against that record.

#### Access
In September 2023 the FDA placed BPC-157 in Category 2 of the interim bulk drug substances list, the category reserved for substances with significant safety concerns, citing immunogenicity risk and impurity questions; Category 2 placement barred licensed pharmacies from compounding it [3].
In April 2026 the agency removed BPC-157 and eleven other peptides from Category 2 without adding them to Category 1. Removal ended the explicit prohibition but conferred no authorization. In July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding BPC-157 to the section 503A bulks list [4]. The vote is advisory; the FDA has not issued a final rule, and as of August 2026 no licensed United States pharmacy may lawfully compound BPC-157.
The margin is worth stating with its provenance attached, because the FDA has not supplied one. The vote is reported as 8–6 with one abstention by McDermott Will & Schulte and by LumaLex Law, whose separate accounts of the meeting agree substance by substance [7, 8]; the American Journal of Managed Care reported the same outcome [5]. The FDA itself has published no minutes, no transcript and no vote summary for the meeting, and its meeting page carried none as of August 6, 2026, re-read on August 31, 2026 [4]. That is the opposite of the committee's December 2024 votes, which FDA recorded in Final Summary Minutes stating each result outright. This monograph prints the reported figure and says whose it is; it will be recited to the primary document when one issues.
Material sold online as BPC-157 is research-use-only chemical supply. It is produced and sold outside pharmacy licensure, prescriber oversight, and pharmaceutical quality standards; its identity, purity, and sterility are whatever the vendor says they are.
The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names BPC 157 among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [22].

#### Side effects
No controlled human study has measured the side effects of BPC-157, so there is no reliable list of them. The three uncontrolled human reports, covering 30 people at one practice, recorded no adverse events: the intravenous pilot reported no side effects in its two adults, and the interstitial cystitis pilot reported none in 12 women [10, 11]. Reports that small, with no comparison group, cannot detect an uncommon harm or separate a drug effect from chance [13].
The concerns raised in the literature are therefore about what is not known. In placing BPC-157 in Category 2, the FDA wrote that compounded BPC-157 may pose a risk of immunogenicity, an immune reaction to the peptide, for certain routes; that it may carry peptide-related impurities; and that the agency had found little or no safety information for the proposed routes, so it could not know whether the drug would cause harm [12]. Removal from Category 2 in April 2026 did not answer those questions.
Reviewers also point to the mechanism itself. BPC-157's reported effects run through new blood vessel growth, via VEGFR2 and nitric oxide signaling in animal models [13], and a 2026 review of unregulated injectable peptides lists pathological angiogenesis and cancer promotion among the theoretical risks, alongside contamination, manufacturing impurities and inaccurate dosing in research-use-only material [14]. Those are hypotheses drawn from biology and product quality, not observed outcomes in people. The BPC-157 safety record (https://peptideamerica.org/evidence/bpc-157-safety-record) sets out each human report, the animal toxicology and the trials now registered, and the review of the BPC-157 and TB-500 stack (https://peptideamerica.org/evidence/bpc-157-and-tb-500-stack) covers the combination sold under the Wolverine name.

#### Questions
Q: Is BPC-157 legal in the US?
A: It is not lawful for a pharmacy to compound as of September 2026. The FDA removed BPC-157 from Category 2 in April 2026 without adding it to Category 1, and the July 2026 advisory committee vote to recommend listing it is advisory only; no final rule has issued. Material sold online is research-use-only chemical supply, not a medicine.
Q: Is BPC-157 FDA-approved?
A: No. BPC-157 is not an approved drug in the United States or any other jurisdiction, and no product containing it has completed clinical development [1].
Q: What are the side effects of BPC-157?
A: They are not known, because no controlled human trial has been published. Three uncontrolled reports covering 30 people recorded no adverse events, and the FDA has cited possible immune reactions and impurities as unresolved concerns [10, 11, 12].
Q: Has BPC-157 been tested in humans?
A: Only in three small uncontrolled reports from one Florida practice: 16 knee-injection patients, 12 women with interstitial cystitis and 2 adults given it intravenously [9, 10, 11]. None had a comparison group. The rest of the evidence is from animals.
Q: What did the July 2026 advisory vote change?
A: Nothing yet. The Pharmacy Compounding Advisory Committee recommended adding BPC-157 to the 503A bulks list on a reported 8–6 vote with one abstention [7, 8]; the FDA must complete rulemaking before any pharmacy may compound it, and the index will record that step when it happens. See the pending (https://peptideamerica.org/status/pending) status page.

#### References
1. Mateescu DM, Gavrilescu DM, Constantinescu FE, et al. BPC-157 as an investigational peptide therapeutic: biopharmaceutical challenges, formulation strategies, and translational development barriers. Pharmaceutics. 2026. https://pubmed.ncbi.nlm.nih.gov/42198317/
2. PubMed, National Library of Medicine. Search conducted August 2026: 228 records for "BPC 157" or "BPC-157"; zero records under the clinical-trial publication type across three name variants. https://pubmed.ncbi.nlm.nih.gov/?term=%22BPC+157%22
3. US Food and Drug Administration. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, guidance for industry, January 2025, docket FDA-2015-D-3517: the policy that defines Categories 1, 2 and 3, under which BPC-157 was placed in Category 2 in September 2023. Read September 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/interim-policy-compounding-using-bulk-drug-substances-under-section-503a-federal-food-drug-and
4. US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
5. American Journal of Managed Care. FDA panel backs 6 peptides for compounding. July 2026.
6. PubMed, National Library of Medicine. Census run August 2026 across four name variants — "BPC 157" (228 records), "pentadecapeptide BPC" (173), "body protection compound" (15), and the development code "PL 14736" (23) — union 230 records, of which 55 carry the Humans MeSH term. Under "clinical trial"[Publication Type] the union returns 0, and under "randomized controlled trial"[Publication Type] it returns 0. The filter was proved live in the same run against a control term returning 8,904 records, and a deliberately invalid identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22BPC+157%22+OR+%22pentadecapeptide+BPC%22+OR+%22body+protection+compound%22+OR+%22PL+14736%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
7. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance.
8. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.
9. Lee E, Padgett B. Intra-articular injection of BPC 157 for multiple types of knee pain. Altern Ther Health Med. 2021;27(4):8-13. A retrospective chart review with telephone follow-up of 16 patients; no comparison group. https://pubmed.ncbi.nlm.nih.gov/34324435/
10. Lee E, Walker C, Ayadi B. Effect of BPC-157 on symptoms in patients with interstitial cystitis: a pilot study. Altern Ther Health Med. 2024;30(10):12-17. Twelve women, single arm, one treatment; no comparison group. https://pubmed.ncbi.nlm.nih.gov/39325560/
11. Lee E, Burgess K. Safety of intravenous infusion of BPC157 in humans: a pilot study. Altern Ther Health Med. 2025;31(5):20-24. Two adults, each of whom had received intravenous BPC-157 before the study. https://pubmed.ncbi.nlm.nih.gov/40131143/
12. US Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks (the Category 2 rationale for BPC-157). Content current as of April 22, 2026. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
13. McGuire FP, Martinez R, Lenz A, Skinner L, Cushman DM. Regeneration or risk? A narrative review of BPC-157 for musculoskeletal healing. Curr Rev Musculoskelet Med. 2025;18(12):611-619. https://pubmed.ncbi.nlm.nih.gov/40789979/
14. Moiz A, O'Keefe EL, O'Keefe JH. Dangers of injectable peptides and other unregulated "biohacking" drugs. Mo Med. 2026;123(4):337-343. https://pubmed.ncbi.nlm.nih.gov/42757290/
15. Xu C, Sun L, Ren F, et al. Preclinical safety evaluation of body protective compound-157, a potential drug for treating various wounds. Regul Toxicol Pharmacol. 2020;114:104665. Single-dose and repeated-dose toxicity in mice, rats, rabbits and dogs, local tolerance, genotoxicity and embryo-fetal toxicity. https://pubmed.ncbi.nlm.nih.gov/32334036/
16. He L, Feng D, Guo H, et al. Pharmacokinetics, distribution, metabolism, and excretion of body-protective compound 157, a potential drug for treating various wounds, in rats and dogs. Front Pharmacol. 2022;13:1026182. https://pubmed.ncbi.nlm.nih.gov/36588717/
17. Vasireddi N, Hahamyan H, Salata MJ, et al. Emerging use of BPC-157 in orthopaedic sports medicine: a systematic review. HSS J. 2025;21(4):485-495. Literature from database inception to June 3, 2024; 36 studies included, 35 preclinical and 1 clinical. https://pubmed.ncbi.nlm.nih.gov/40756949/
18. Biçer O, Adanir O, Güleryüz Y, et al. Effects of BPC-157 and TB-500 on Achilles tendon healing in rats: a histopathological and biomechanical study. Jt Dis Relat Surg. 2026;37(3):822-837. Thirty-two rats in four groups of eight: control, BPC-157, TB-500, and the two combined. https://pubmed.ncbi.nlm.nih.gov/42542926/
19. PubMed, National Library of Medicine. Searches run September 2026 across five BPC-157 name variants — "BPC 157" OR "BPC-157" OR "pentadecapeptide BPC" OR "body protection compound" OR "PL 14736" — returning 232 records, 57 carrying the Humans MeSH term, 0 under "clinical trial"[Publication Type], 0 under "randomized controlled trial"[Publication Type] and 0 under "case reports"[Publication Type]. Combined with the TB-500 and thymosin beta-4 names ("TB-500" OR "TB500" OR "thymosin beta 4" OR "thymosin beta-4" OR "thymosin beta(4)" OR "Tbeta4"), the union returned 13 records, each read: ten review or overview articles (PMIDs 42757290, 42752426, 42635865, 42578445, 42385164, 42222211, 42021992, 41966639, 41490200, 41476424), one analytical method for detecting doping agents in blood (42328738), one rat study (42542926) and one retrospective human chart review (34324435); 0 under the clinical-trial publication type. The quoted phrases "wolverine stack", "wolverine peptide" and "wolverine protocol" were each reported by E-utilities as not found in any record. In the same run the control term aspirin returned 8,916 records under "clinical trial"[Publication Type], the invalid tag clinicaltrial[pt] returned 0 for that control, and esummary on the invalid identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22BPC+157%22+OR+%22BPC-157%22+OR+%22pentadecapeptide+BPC%22+OR+%22body+protection+compound%22+OR+%22PL+14736%22%29+AND+%28%22TB-500%22+OR+%22TB500%22+OR+%22thymosin+beta+4%22+OR+%22thymosin+beta-4%22%29
20. ClinicalTrials.gov, National Library of Medicine, v2 API. Searches run September 2026. "BPC-157", "BPC 157" and "BPC157" each returned the same 4 registered studies, read individually: NCT02637284, a randomized, quadruple-masked phase 1 study of the safety and pharmacokinetics of an oral BPC-157 preparation in healthy volunteers, 42 planned, started October 2015, status unknown, last updated December 2015; NCT07437547, a randomized, double-blind, placebo-controlled phase 2 trial in acute grade II hamstring strain, 120 planned, recruiting since February 2, 2026, completion estimated February 2028; NCT07803250, a randomized phase 1 study after rotator cuff repair surgery, 30 planned, not yet recruiting, start estimated January 2027; and NCT07752381, a single-arm study of a gummy marketed as a dietary supplement, 40 enrolled, completed November 2025. None has posted results. "PL 14736" returned 0. "TB-500" returned 1 study, NCT07487363. "BPC-157 AND TB-500" and "BPC-157 AND thymosin" each returned 0. Control in the same run: "aspirin" returned 2,968 studies. https://clinicaltrials.gov/api/v2/studies?query.term=BPC-157
21. World Anti-Doping Agency. The 2026 Prohibited List, International Standard, in effect from January 1, 2026. Read September 2026. Section S0, Non-Approved Substances, prohibited at all times: "This class covers many different substances including but not limited to BPC-157"; all prohibited substances in S0 are Specified Substances. Section S2.3, Growth Factors and Growth Factor Modulators, prohibited at all times: "Thymosin-β4 and its derivatives e.g. TB-500".
22. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution
23. Sikiric P, Drmic D, Sever M, et al. Fistulas healing. Stable gastric pentadecapeptide BPC 157 therapy. Curr Pharm Des. 2020;26(25):2991-3000. A review by the Zagreb group that first described the peptide; its abstract describes BPC-157 as "native to and stable in human gastric juice (for more than 24 h)" as background, without reporting the measurement. https://pubmed.ncbi.nlm.nih.gov/32329684/
24. Sikiric P, Seiwerth S, Rucman R, et al. Focus on ulcerative colitis: stable gastric pentadecapeptide BPC 157. Curr Med Chem. 2012;19(1):126-132. A review by the same group; its abstract says the peptide "may be the new drug stable in human gastric juice" and that its bowel-disease formulation, PL 14736, was "so far only tested in clinical phase II". https://pubmed.ncbi.nlm.nih.gov/22300085/
25. Kalogjera L, Ries M, Baudoin T, et al. Dose-dependent protective effect of BPC 157 on capsaicin-induced rhinitis in rats. Eur Arch Otorhinolaryngol. 1997;254 Suppl 1:S9-S11. The peptide was injected into the abdominal cavity; the irritant capsaicin, not the peptide, was applied to the nose. https://pubmed.ncbi.nlm.nih.gov/9065615/
26. PubMed, National Library of Medicine. Searches run September 2026 on the five BPC-157 name variants of reference 19 (232 records). Combined with the oral-route terms oral, orally, "per-orally", "drinking water", intragastric or gavage: 70 records, 4 carrying the Humans MeSH term, each read (an editorial, a review, and two rat studies, one of which also measured sphincter pressure in pancreatitis patients who were not given the peptide), and 0 under "clinical trial"[Publication Type]. Combined with intranasal or nasal: 1 record (reference 25), 0 under the clinical-trial type. Combined with arginate: 0. Combined with pharmacokinetic*, bioavailab*, absorption, "plasma concentration" or "plasma level*": 8 records, each title read; the only pharmacokinetic study among them is reference 16, which gave the peptide intravenously and intramuscularly only. In the same run the control term aspirin returned 8,916 records under "clinical trial"[Publication Type], the invalid tag clinicaltrial[pt] returned 0 for that control, and esummary on the invalid identifier 99999999 errored at the start and the end of the run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22BPC+157%22+OR+%22BPC-157%22+OR+%22pentadecapeptide+BPC%22+OR+%22body+protection+compound%22+OR+%22PL+14736%22%29+AND+%28intranasal+OR+nasal%29
27. US Food and Drug Administration. Warning letter, Warrior Labz SARMS, MARCS-CMS 655280, June 12, 2023, from the Office of Unapproved Drugs and Labeling Compliance. Content current as of June 20, 2023; read September 2026. The letter records that the firm took orders for "BPC-157" (injectable and nasal spray) and states that the listed products "are not generally recognized as safe and effective for the above referenced uses and, therefore, are 'new drugs' under section 201(p)" of the FD&C Act. Its footnote on intranasal products: they "may be rapidly absorbed through the highly vascularized nasal mucosa directly into systemic blood circulation," and "If toxic substances are introduced directly into the nose, harmful local effects such as bleeding, ulceration, or nasal septal perforation may occur." https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/warrior-labz-sarms-655280-06122023
28. ClinicalTrials.gov, National Library of Medicine, v2 API, records read September 2026. NCT02637284, "PCO-02 - Safety and Pharmacokinetics Trial": sponsor PharmaCotherapia d.o.o.; phase 1, randomized, quadruple-masked, placebo-controlled, in healthy volunteers; tablets taken by mouth, single and repeated over two weeks; primary outcome adverse events, secondary outcomes plasma pharmacokinetics; 42 planned; started October 2015; status unknown; first posted and last updated December 22, 2015; no results posted. NCT07752381: a gummy registered by its seller with the intervention type dietary supplement; single group, open label, no control; 40 enrolled; ran September 1 to November 1, 2025; first posted August 7, 2026, after completion; no results posted. The search "BPC-157 nasal" returned 0 studies and "BPC-157 oral" returned 1, NCT02637284; control "aspirin" returned 2,968. https://clinicaltrials.gov/study/NCT02637284

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### Cerebrolysin (Peptide fraction derived from porcine brain protein; FPF-1070)
https://peptideamerica.org/molecules/cerebrolysin · status verified September 2026

Status: No lawful route. Licensed in Austria, never approved in the US; FDA stated in 2020 and 2021 warning letters that it had not been nominated for the 503A bulks list, and no list names it.
Class: Neuropeptides · Route: None lawful; no approved or compoundable US product

Regulatory record:
- April 2016: FDA grants an orphan designation to the peptide fraction derived from porcine brain protein for the treatment of frontotemporal dementia. The agency's database now shows the designation as no longer in effect, and no approved product followed.
- April 2020: FDA warns a Kentucky compounding pharmacy that drug products it compounded using Cerebrolysin and twenty-one other substances are not eligible for the exemptions in section 503A(a); the letter states that Cerebrolysin had not been nominated for inclusion on the 503A bulks list.
- October 2020: The same pharmacy pleads guilty in federal court to distributing unapproved new drugs; the Justice Department's account of the plea agreement names Cerebrolysin among them.
- November 2021: A second FDA warning letter, to an Indianapolis firm, states that Cerebrolysin was not nominated for inclusion on the 503A bulks list.
- September 2026: Cerebrolysin appears in no category of the section 503A bulks list published May 14, 2026, in none of the tables on FDA's Category 2 safety-risk page, and nowhere on the section 503B nominations list. Drugs@FDA holds no application for it under any name.
- FDA final action: none recorded

#### Definition
Cerebrolysin is not a single peptide. It is a mixture of low-molecular-weight peptides and amino acids derived from pig brain [2], supplied as a solution for injection or infusion; the Austrian product information describes the active substance as a proteolytic peptide fraction from porcine brain protein and states that its short-chain peptides resemble or are identical to peptides present in the body, which is why its pharmacokinetics cannot be measured directly [1]. FDA's orphan-drug database files it under the descriptive name peptide fraction derived from porcine brain protein [19].
It is a licensed prescription medicine in Austria, where its marketing authorization dates from March 1996 and covers supportive treatment of cerebrovascular disorders, including Alzheimer-type and vascular dementia, deficits after stroke, and traumatic brain injury [1]. A Cochrane review describes it as widely used for acute ischemic stroke in Russia, Eastern Europe, China, and other Asian and post-Soviet countries [2]. None of that confers any standing in the United States, where no application for it has ever been approved [13].

#### Evidence
The Cerebrolysin stroke trials (https://peptideamerica.org/evidence/cerebrolysin-stroke-trials) assessed different outcomes, including arm function and broader disability. A favorable rehabilitation score does not resolve the larger trial’s negative primary result.
Unlike most compounds in the neuropeptide class, Cerebrolysin has a substantial trial literature. Across its name variants PubMed returns 676 indexed records, of which 348 carry the Humans subject heading, 92 the clinical-trial publication type, and 63 the randomized-controlled-trial type [3]. The trials concentrate on three conditions: acute ischemic stroke, dementia, and traumatic brain injury.
In acute ischemic stroke the largest trial, CASTA, randomized 1,070 patients in Asia and found no significant difference between Cerebrolysin and placebo on its confirmatory endpoint; a post hoc analysis suggested a favorable trend in the most severely affected patients, which the investigators said should be confirmed by a further trial [4]. The CARS trial, which paired the drug with early rehabilitation, reported a large advantage on an arm-function score at day 90, and its authors described the study as exploratory, with a relatively small sample, and in need of confirmation [5]. The independent test of the stroke question is the Cochrane review, last updated in 2023: across 7 randomized trials with 1,773 participants, one of them of a similar peptide mixture, it found with moderate certainty that Cerebrolysin or that mixture probably makes little to no difference to death from any cause, and it noted that the manufacturer supported three of the multicenter studies [2]. A 2021 guideline from the European Academy of Neurology and the European Federation of Neurorehabilitation Societies nevertheless recommended Cerebrolysin, alongside citalopram, for early neurorehabilitation after acute ischemic stroke [6]; the review's primary measure was death from any cause, the guideline addressed early motor rehabilitation, and the two reached different conclusions.
The dementia evidence is weaker. A 2015 meta-analysis of 6 randomized trials in mild-to-moderate Alzheimer's disease reported benefit on global clinical change at 4 weeks and at 6 months, and on cognition at 4 weeks but not at 6 months [7]. A Cochrane review of Cerebrolysin in vascular dementia pooled 6 trials with 597 participants and graded its evidence very low quality; it concluded that any benefit may be too small to be clinically meaningful and that the supporting evidence base is weak [8].
In moderate-to-severe traumatic brain injury the CAPTAIN program ran two placebo-controlled trials. The first, with 46 patients, narrowly missed statistical significance on its primary endpoint in the intention-to-treat population [9]; the second, with 142 patients enrolled, reported a small-to-medium effect at day 90 [10]; a prospective meta-analysis of the two, covering 185 patients, reported the same size of effect [11]. Of the 42 studies that list Cerebrolysin as an intervention on ClinicalTrials.gov, the manufacturer is the most frequent lead sponsor, and none lists a site in the United States [12].

#### Access
There is no approved Cerebrolysin product in the United States: Drugs@FDA holds no application for it under any name [13]. FDA did grant an orphan designation in April 2016 to the peptide fraction derived from porcine brain protein, sponsored by the Austrian manufacturer, for the treatment of frontotemporal dementia; the agency's database now lists that designation as withdrawn or revoked, and the product was never approved for the indication [19]. An orphan designation is an incentive for development and never an authorization to market.
Compounding offers no route either. A bulk substance with no USP or National Formulary monograph and no FDA-approved product behind it is eligible for 503A compounding only if it appears on the section 503A bulks list, or, pending that list, only if it was nominated with adequate support and has not been identified as a significant safety risk [14, 15]. FDA has twice stated in warning letters that Cerebrolysin had not been nominated for that list: in April 2020, to a Kentucky pharmacy whose investigators found it had compounded drug products from Cerebrolysin and twenty-one other substances [14], and again in November 2021, to an Indianapolis firm [15]. The substance appears in no category of the 503A list FDA published on May 14, 2026 [16], nowhere on FDA's Category 2 safety-risk page, including its table of nominations later withdrawn [17], and nowhere on the section 503B nominations list [18]. No list FDA has published since those letters names it, so it was no part of the April 2026 Category 2 removals or of the July 2026 advisory committee meeting.
The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names Cerebrolysin among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [20]. Material sold under this name in the United States is outside approval, outside pharmacy compounding, and outside any trial; the research-only (https://peptideamerica.org/status/research-only) page sets out what that position means for a buyer.

#### Side effects
The best-measured safety finding comes from the Cochrane review of acute ischemic stroke. Pooling three trials with 1,335 participants, it found that Cerebrolysin probably makes little to no difference to the total number of people with serious adverse events, but it also found, with moderate certainty, an increase in non-fatal serious adverse events, a risk ratio of 2.39 with a 95 percent confidence interval of 1.10 to 5.23 [2]. The review's conclusion names that as a potential increase; it is the one harm signal in the pooled trial evidence, and it comes from the independent review rather than from the manufacturer's trials.
The individual trials report a milder picture. CARS described the drug as safe and well tolerated [5], the CAPTAIN trials and their meta-analysis reported safety comparable to placebo [9, 10, 11], and the 2015 Alzheimer's meta-analysis reported safety comparable to placebo [7]. The vascular dementia review found no difference in adverse effects but graded that evidence very low quality [8].
The Austrian product information lists the effects reported in use. Allergic or hypersensitivity reactions, ranging from skin and local vessel reactions, fever and chills to breathlessness and a shock-like state, are listed as very rare; agitation, including aggression, confusion and insomnia, loss of appetite, and dizziness with too-rapid administration are listed as rare; isolated grand mal seizures are listed as very rare [1]. The label contraindicates it in status epilepticus and severe kidney impairment, advises caution in people with allergic tendencies or epilepsy because seizure frequency may rise, and does not recommend it for anyone under 18 because the data are insufficient [1]. Material sold outside a licensed supply chain carries none of the quality controls that label assumes.

#### Questions
Q: Is Cerebrolysin FDA-approved?
A: No. Drugs@FDA holds no application for Cerebrolysin under any name [13]. FDA granted it an orphan designation for frontotemporal dementia in April 2016, which the agency's database now lists as withdrawn or revoked; a designation is not an approval, and the product was never approved for that indication [19].
Q: Is Cerebrolysin legal in the US?
A: No lawful route exists as of September 2026. It has no US approval, FDA stated in warning letters from 2020 and 2021 that it had not been nominated for the 503A bulks list, and a pharmacy may not compound it [14, 15]. It appears on no FDA bulks list published since [16, 18]. See the research-only (https://peptideamerica.org/status/research-only) status page.
Q: Where is Cerebrolysin approved?
A: It holds a marketing authorization in Austria, granted in March 1996, as a prescription-only medicine for supportive treatment of cerebrovascular disorders including dementia, post-stroke deficits and brain injury [1]. A Cochrane review describes it as widely used for stroke in Russia, Eastern Europe, China and other Asian and post-Soviet countries [2]. A foreign approval gives it no US status.
Q: Does Cerebrolysin work for stroke?
A: The evidence is divided. The 2023 Cochrane review of 7 trials found it probably makes little to no difference to death from any cause after acute ischemic stroke [2], and the largest trial was neutral on its main endpoint [4]. A 2021 European neurology guideline nevertheless recommends it for early rehabilitation after acute ischemic stroke [6].
Q: What are the side effects of Cerebrolysin?
A: The Cochrane stroke review found a probable increase in non-fatal serious adverse events [2]. The Austrian label lists rare agitation, dizziness and loss of appetite, and very rare allergic reactions and seizures, and it contraindicates the drug in status epilepticus and severe kidney impairment [1].

#### References
1. Austrian Federal Office for Safety in Health Care (BASG), Medicinal Products Register. Cerebrolysin – parenterale Lösung: Zusammenfassung der Merkmale des Arzneimittels (summary of product characteristics), information dated March 2021; marketing authorization number 1-21380, holder EVER Neuro Pharma GmbH, authorization first granted March 25, 1996, prescription-only. Read September 2026. Section 2: “1 ml enthält 215,2 mg einer proteolytischen Peptidfraktion aus Schweinehirnprotein (Cerebrolysin Konzentrat) in wässriger Lösung.” Section 4.1 lists supportive treatment of cerebrovascular disorders, in particular senile dementia of the Alzheimer type and vascular dementia, post-stroke deficits, and craniocerebral trauma. Section 5.2 states that the fraction consists of short-chain peptides similar or identical to endogenous ones, so pharmacokinetic parameters cannot be measured directly. Sections 4.3, 4.4 and 4.8 are summarized, without any dosing detail, in the side-effects section of this page.
2. Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. 2023;10(10):CD007026. https://pubmed.ncbi.nlm.nih.gov/37818733/
3. PubMed, National Library of Medicine. Census run September 2026 across five name variants — "Cerebrolysin" OR "Cerebrolysine" OR "FPF-1070" OR "FPF 1070" OR "FPE 1070" — returning 676 indexed records, 348 carrying the Humans MeSH term, 92 under "clinical trial"[Publication Type], 63 under "randomized controlled trial"[Publication Type], 20 under "meta-analysis"[Publication Type] and 20 under "systematic review"[Publication Type]; the name "Cerebrolysin" alone returns 668. The trial-type records are too many to itemize and are reported as a magnitude; the trials cited on this page were each opened and read. The publication-type filter was proved live in the same run against the control term aspirin, which returned 8,916 records under the clinical-trial type and 6,127 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22Cerebrolysin%22+OR+%22Cerebrolysine%22+OR+%22FPF-1070%22+OR+%22FPF+1070%22+OR+%22FPE+1070%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
4. Heiss WD, Brainin M, Bornstein NM, Tuomilehto J, Hong Z; Cerebrolysin Acute Stroke Treatment in Asia (CASTA) Investigators. Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial. Stroke. 2012;43(3):630–636. https://pubmed.ncbi.nlm.nih.gov/22282884/
5. Muresanu DF, Heiss WD, Hoemberg V, et al. Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial. Stroke. 2016;47(1):151–159. The abstract lists three of the eleven authors in the Department of Clinical Research of the manufacturer. https://pubmed.ncbi.nlm.nih.gov/26564102/
6. Beghi E, Binder H, Birle C, et al. European Academy of Neurology and European Federation of Neurorehabilitation Societies guideline on pharmacological support in early motor rehabilitation after acute ischaemic stroke. Eur J Neurol. 2021;28(9):2831–2845. https://pubmed.ncbi.nlm.nih.gov/34152062/
7. Gauthier S, Proaño JV, Jia J, Froelich L, Vester JC, Doppler E. Cerebrolysin in mild-to-moderate Alzheimer's disease: a meta-analysis of randomized controlled clinical trials. Dement Geriatr Cogn Disord. 2015;39(5-6):332–347. https://pubmed.ncbi.nlm.nih.gov/25832905/
8. Cui S, Chen N, Yang M, et al. Cerebrolysin for vascular dementia. Cochrane Database Syst Rev. 2019;2019(11):CD008900. https://pubmed.ncbi.nlm.nih.gov/31710397/
9. Poon W, Matula C, Vos PE, et al. Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial. Neurol Sci. 2020;41(2):281–293. https://pubmed.ncbi.nlm.nih.gov/31494820/
10. Muresanu DF, Florian S, Hömberg V, et al. Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial. Neurol Sci. 2020;41(5):1171–1181. https://pubmed.ncbi.nlm.nih.gov/31897941/
11. Vester JC, Buzoianu AD, Florian SI, et al. Cerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series. Neurol Sci. 2021;42(11):4531–4541. https://pubmed.ncbi.nlm.nih.gov/33620612/
12. ClinicalTrials.gov, National Library of Medicine, version 2 API. Queried September 2026 on the intervention field for Cerebrolysin: 42 studies, of which 19 are completed, 4 recruiting and 11 of unknown status. The most frequent lead sponsor is EVER Neuro Pharma GmbH, with 10; the countries most often listed are Egypt, Poland, South Korea, Austria and China. The same query restricted to locations in the United States returned 0, and no study among the 42 lists a US site. Controls in the same run: semaglutide returned 760 studies and a deliberately invented intervention name returned 0. https://clinicaltrials.gov/api/v2/studies?query.intr=Cerebrolysin&countTotal=true
13. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name, the substance name, the brand name, the product brand name and the active-ingredient name for "cerebrolysin": no matching application under any of the five. Controls in the same run: the identical generic-name and active-ingredient queries for "bremelanotide" returned NDA 210557, and a deliberately invented ingredient name returned none. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22cerebrolysin%22
14. US Food and Drug Administration. Warning letter to Tailor Made Compounding LLC, Nicholasville, Kentucky, MARCS-CMS 594743, April 1, 2020; content current as of May 5, 2020. Read September 2026. The letter states that the investigators noted the firm compounded drug products using twenty-two named substances including Cerebrolysin, that drug products compounded using these bulk drug substances are not eligible for the exemptions provided by section 503A(a), and that “Follistatin, Endurobal, AOD 9604, BPC 157, Bremelanotide (PT-141), Cerebrolysin, DSIP, Epitalon, GHK-Cu, IGF1-LR3, Ipamorelin, LL-37, Melanotan II, PEG-MGF, Selank, Semax, CJC 1295, SARMS, LGD-4033, and MK 677 have not been nominated for inclusion on the 503A bulks list.” https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
15. US Food and Drug Administration. Warning letter to Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine, Indianapolis, Indiana, WL 615908, November 10, 2021; content current as of November 16, 2021. Read September 2026. The substances the firm compounded are redacted in the body of the letter; its footnote states: “Cerebrolysin, thymosin alpha, thymosin beta, BPC-157, LL-37, pentosan, Selank, and Semax were not nominated for inclusion on the 503A bulks list.” https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/advanced-nutriceuticals-llc-dba-guyer-institute-molecular-medicine-615908-11102021
16. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full September 2026, both with and without layout and with all whitespace removed: "Cerebrolysin", the fragment "erebro", "porcine brain" and "brain" occur nowhere in the document, so the substance appears in none of Category 1, Category 2, or Category 3. Control in the same read: the same document names GHK-Cu eight times. https://www.fda.gov/media/94155/download
17. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026. Read September 2026: "Cerebrolysin" and "brain" occur nowhere on the page, including its table of bulk drug substances nominated but withdrawn. Control in the same read: the page names Semax twice and dihexa three times. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
18. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act, updated March 21, 2025, linked from the agency's section 503B bulk drug substances page (content current as of January 7, 2025). Read in full September 2026: "Cerebrolysin", the fragment "erebro" and "brain" occur nowhere in the document. Control in the same read: the document names growth hormone releasing peptide-2. https://www.fda.gov/media/94164/download
19. US Food and Drug Administration, Office of Orphan Products Development. Search Orphan Drug Designations and Approvals, record for “peptide fraction derived from porcine brain protein”: date designated 04/05/2016; orphan designation “Treatment of frontotemporal dementia, including all subvariants”; orphan designation status “Designated/Designation Withdrawn or Revoked”; FDA orphan approval status “Not FDA Approved for Orphan Indication”; sponsor EVER Neuro Pharma GmbH, Unterach, Austria. Read September 2026. The record is the one FDA's own Global Substance Registration System attaches to the Cerebrolysin substance entry, UNII 37KZM6S21G. Control in the same session: an unrelated record in the same database reads “Designated” alone. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=513315
20. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution

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### CJC-1295
https://peptideamerica.org/molecules/cjc-1295 · status verified August 2026

Status: Nomination withdrawn. Removed from Category 2 in September 2024 after its nominators withdrew; on no list; no lawful compounding route.
Class: GH secretagogues · Route: None lawful

Regulatory record:
- September 2024: Removed from Category 2 after nominator withdrawal; not added to Category 1.
- FDA final action: none recorded

#### Definition
CJC-1295 is a modified GHRH(1–29) analogue engineered to bind serum albumin, which extends a half-life measured in minutes for native GHRH to several days; it is the long-acting member of the growth hormone secretagogue family. Its developer described it as a tetrasubstituted GRF(1–29) carrying a reactive lysine group that attaches to albumin after injection [3].
The molecule reached formal clinical study in the 2000s, which distinguishes it from most of the research-peptide market.

#### Evidence
In a randomized, placebo-controlled study in healthy adults, single injections of CJC-1295 raised growth hormone concentrations two- to ten-fold for six days or more and IGF-1 concentrations 1.5- to three-fold for up to eleven days, with an estimated half-life of 5.8 to 8.1 days [1]. Development did not continue to approval, and no efficacy trial in any indication followed.
The long half-life raised the question of whether the natural pulses of growth hormone survive. In the one study that measured them, in healthy young men a week after a single injection, pulse frequency and size were unchanged while the baseline between pulses rose 7.5-fold, lifting mean growth hormone by 46 percent and IGF-1 by 45 percent [2]. A phase 2 trial in adults with HIV-associated abdominal fat was terminated in 2006 without a stated reason or posted results [5], and the FDA has since cited serious adverse events associated with the compound, including increased heart rate and a systemic vasodilatory reaction [6].

#### Access
CJC-1295 was removed from Category 2 of the interim 503A bulks list in September 2024 because its nominators withdrew, and it was not added to Category 1; it is on no list, and no lawful compounding route exists. It was not among the peptides reviewed at the July 2026 PCAC meeting.
Material sold online is research-use-only supply, outside pharmacy licensure and quality standards.
The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names CJC 1295 among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [7].

#### References
1. Teichman SL, Neale A, Lawrence B, et al. Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults. J Clin Endocrinol Metab. 2006;91(3):799–805. https://pubmed.ncbi.nlm.nih.gov/16352683/
2. Ionescu M, Frohman LA. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. J Clin Endocrinol Metab. 2006;91(12):4792–4797. https://pubmed.ncbi.nlm.nih.gov/17018654/
3. Jetté L, Léger R, Thibaudeau K, et al. Human growth hormone-releasing factor (hGRF)1-29-albumin bioconjugates activate the GRF receptor on the anterior pituitary in rats: identification of CJC-1295 as a long-lasting GRF analog. Endocrinology. 2005;146(7):3052–3058. https://pubmed.ncbi.nlm.nih.gov/15817669/
4. PubMed, National Library of Medicine, and ClinicalTrials.gov. Census run September 2026. "CJC-1295" OR "CJC 1295" OR "CJC1295" returns 33 indexed records, 21 carrying the Humans MeSH term and 2 under "clinical trial"[Publication Type], both read: the 2006 pharmacokinetic study in healthy adults and the 2006 pulsatility study in healthy men. The same names, or "modified GRF", combined with ipamorelin return 11 records and 0 under "clinical trial"[Publication Type]; all 11 were read by title and type: nine 2026 narrative articles and reviews on peptide use in sport, orthopedics, aging and aesthetics, one 2019 analysis of seized doping material and one 2013 equine doping-control method. The filter was proved live in the same run (aspirin 8,916 records; aspirin AND clopidogrel 1,412), the invalid tag clinicaltrial[pt] returned 0 for aspirin, and a deliberately invalid identifier errored. ClinicalTrials.gov, searched the same day, returns one CJC-1295 study and no study of the combination. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22CJC-1295%22+OR+%22CJC+1295%22+OR+%22CJC1295%22+OR+%22modified+GRF%22%29+AND+ipamorelin
5. ClinicalTrials.gov. NCT00267527: A multicenter, randomized, placebo-controlled, double-blind, phase 2 study to evaluate the efficacy and safety of CJC 1295 administered for 12 weeks in HIV infected patients with HIV associated visceral obesity. Sponsor ConjuChem; planned enrollment 120; start December 2005; status Terminated, completion September 2006; no reason for stopping and no results posted. Read September 2026. https://clinicaltrials.gov/study/NCT00267527
6. US Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks. Lists CJC-1295 among the substances previously in Category 2 whose nominations were withdrawn by the nominators, and states that FDA has identified serious adverse events associated with it, including increased heart rate and systemic vasodilatory reaction, and that available clinical data are limited. Content current as of April 22, 2026. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
7. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution

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### Dihexa (Dihexa acetate; PNB-0408)
https://peptideamerica.org/molecules/dihexa · status verified August 2026

Status: No lawful route. Nomination withdrawn in 2026; on no list. FDA states it has identified no human exposure data for this substance by any route.
Class: Neuropeptides · Route: None lawful; sold as research-use-only material

Regulatory record:
- April 2026: The nomination is withdrawn by its nominators and dihexa acetate leaves Category 2 of the interim 503A bulks list without being added to Category 1; it appears in no category of the list FDA published on May 14, 2026.
- August 2026: FDA continues to publish its finding for the substance: it has not identified any human exposure data on drug products containing dihexa acetate administered via any route of administration, and it lacks important information regarding any safety issues raised by the substance, including whether it would cause harm if administered to humans.
- FDA final action: none recorded

#### Definition
Dihexa is a synthetic derivative of angiotensin IV, built to survive in the body long enough to reach the brain. It was developed in an academic laboratory as a candidate for dementia, and its proposed mechanism is not receptor agonism in the usual sense: it acts through the hepatocyte growth factor and c-Met system to promote synapse formation [1][2].
It is sold today as a nootropic. The gap between a metabolically stabilized angiotensin IV analogue designed for Alzheimer's disease research and a cognitive-enhancement product is the subject of this page.

#### Evidence
The preclinical record is genuine and small. The founding work evaluated metabolically stabilized angiotensin IV analogues as procognitive agents and identified this compound among them [1]; a follow-up established that the procognitive and synaptogenic effects depend on activation of the hepatocyte growth factor and c-Met system [2]; a 2021 study reported recovery of memory in a transgenic mouse model of Alzheimer's disease [3].
The human record does not exist. Across three name variants PubMed returns 18 indexed records in total, of which 9 carry the Humans subject heading, 0 the clinical-trial publication type, and 0 the randomized-controlled-trial type [4]. Eighteen records is the entire indexed literature for this compound, and the Humans-tagged nine are receptor and pathway work rather than administration to people.
FDA states the same thing from its own vantage point, and states it more starkly: it has not identified any human exposure data on drug products containing dihexa acetate administered via any route of administration [5]. Two instruments looking from opposite directions — a bibliographic census and a regulatory review — return the same answer, which is a stronger form of an absence claim than either produces alone.

#### Access
There is no lawful United States supply route. Dihexa acetate was in Category 2 of FDA's interim section 503A bulks list and left it in April 2026 when the nomination was withdrawn by its nominators; it was not added to Category 1 and appears in no category of the list FDA published on May 14, 2026 [6].
The finding attached to it was never retracted. FDA continues to publish it: the agency lacks important information regarding any safety issues raised by dihexa acetate, including whether it would cause harm if administered to humans [5]. That is a different sentence from a finding of danger, and this index does not upgrade it into one. It is a statement that nobody knows, made by the body whose job it is to know.
Material sold under this name is research-use-only chemical supply, produced and sold outside pharmacy licensure, prescriber oversight, and pharmaceutical quality standards. The research-only (https://peptideamerica.org/status/research-only) page sets out what that position means for a buyer.

#### References
1. McCoy AT, Benoist CC, Wright JW, et al. Evaluation of metabolically stabilized angiotensin IV analogs as procognitive/antidementia agents. J Pharmacol Exp Ther. 2013;344(1):141–154. https://pubmed.ncbi.nlm.nih.gov/23055539/
2. Benoist CC, Kawas LH, Zhu M, et al. The procognitive and synaptogenic effects of angiotensin IV-derived peptides are dependent on activation of the hepatocyte growth factor/c-met system. J Pharmacol Exp Ther. 2014;351(2):390–402. https://pubmed.ncbi.nlm.nih.gov/25187433/
3. Sun X, Deng Y, Fu X, et al. AngIV-Analog Dihexa Rescues Cognitive Impairment and Recovers Memory in the APP/PS1 Mouse via the PI3K/AKT Signaling Pathway. Brain Sci. 2021;11(11). https://pubmed.ncbi.nlm.nih.gov/34827486/
4. PubMed, National Library of Medicine. Census run August 2026 across three name variants — "dihexa" OR "PNB-0408" OR "N-hexanoic-Tyr-Ile-(6) aminohexanoic amide" — returning 18 indexed records in total, 9 carrying the Humans MeSH term, 0 under "clinical trial"[Publication Type] and 0 under "randomized controlled trial"[Publication Type]. There is therefore no trial-type record to read. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22dihexa%22+OR+%22PNB-0408%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
5. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for Dihexa acetate in the table of substances nominated but withdrawn. Read August 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
6. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: dihexa appears in none of Category 1, Category 2, or Category 3. https://www.fda.gov/media/94155/download

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### DSIP (Delta sleep-inducing peptide; emideltide)
https://peptideamerica.org/molecules/dsip · status verified August 2026

Status: No lawful route. Removed from Category 2 in April 2026; the only peptide PCAC declined to recommend at the July 2026 meeting; no lawful route.
Class: Neuropeptides · Route: None lawful; sold as research-use-only material
July 2026 advisory-committee vote: 6–7, 1 abstaining; reported by McDermott Will & Schulte and LumaLex Law, whose separate accounts of the meeting agree substance by substance.

Regulatory record:
- April 2026: Removed from Category 2 without Category 1 listing.
- July 2026: PCAC votes 6–7 (one abstention) against recommending 503A listing — the panel's only rejection. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
- FDA final action: none recorded

#### Definition
Delta sleep-inducing peptide is a nonapeptide isolated in 1977 from the cerebral venous blood of rabbits in induced sleep [1]. The name records the hypothesis of its discoverers, not an established function: nearly fifty years on, the DSIP gene, precursor protein, and receptor have never been identified.
That unresolved biology is the molecule's defining feature. A 2006 review from within the field's own literature calls the sleep-factor hypothesis “extremely poorly documented and still weak” [2].

#### Evidence
The human record is small, old, and equivocal. A 1981 report described improved sleep in insomniacs given the synthetic peptide [3]; a 1992 double-blind study of sixteen chronic insomniac patients found higher objective sleep efficiency and shorter sleep latency against placebo across three nights of intravenous dosing — effects its own authors judged weak, possibly an artifact of change in the placebo group, and unlikely to carry major therapeutic benefit [4].
The literature then largely stopped. No modern trial exists, and the compound is sold today for sleep and stress on the strength of a four-decade-old hypothesis its own field has not confirmed.

#### Access
DSIP was removed from Category 2 of the interim 503A bulks list in April 2026 without Category 1 listing, and in July 2026 the Pharmacy Compounding Advisory Committee voted against recommending it for the section 503A list — the only molecule the panel rejected at that meeting. The margin is reported as 6–7 with one abstention by McDermott Will & Schulte and by LumaLex Law, whose separate accounts agree substance by substance [5, 6]; the FDA has published no minutes, transcript or vote summary for the meeting, so that figure is secondary and this page says so wherever it appears. The committee's stated concerns tracked the record above: no established mechanism, no adequate human evidence.
No lawful US supply route exists, none is pending, and material sold online is research-use-only supply outside pharmacy oversight. The research-only (https://peptideamerica.org/status/research-only) page explains why removal from a list is not permission.
The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names DSIP among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [7].

#### References
1. Schoenenberger GA, Monnier M. Characterization of a delta-electroencephalogram (-sleep)-inducing peptide. Proc Natl Acad Sci U S A. 1977;74(3):1282–1286. https://pubmed.ncbi.nlm.nih.gov/265572/
2. Kovalzon VM, Strekalova TV. Delta sleep-inducing peptide (DSIP): a still unresolved riddle. J Neurochem. 2006;97(2):303–309. https://pubmed.ncbi.nlm.nih.gov/16539679/
3. Schneider-Helmert D, Graf M, Schoenenberger GA. Synthetic delta-sleep-inducing peptide improves sleep in insomniacs. Lancet. 1981;1(8232):1256–1257. https://pubmed.ncbi.nlm.nih.gov/6112579/
4. Bes F, Hofman W, Schuur J, Van Boxtel C. Effects of delta sleep-inducing peptide on sleep of chronic insomniac patients. A double-blind study. Neuropsychobiology. 1992;26(4):193–197. https://pubmed.ncbi.nlm.nih.gov/1299794/
5. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance.
6. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.
7. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution

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### Dulaglutide (Trulicity; LY2189265)
https://peptideamerica.org/molecules/dulaglutide · status verified September 2026

Status: FDA-approved. Licensed September 2014 as Trulicity for type 2 diabetes and cardiovascular risk; the current label carries no weight-management indication.
Class: GLP-1 receptor agonists · Route: Subcutaneous injection, once weekly · Approved product: Trulicity (2014)

Regulatory record:
- September 2014: FDA licenses dulaglutide injection under biologics license application 125469, approval dated September 18, 2014, as a Type 1 new molecular entity. Drugs@FDA records the product as Trulicity, a prescription injection in four strengths of 0.75 mg, 1.5 mg, 3 mg and 4.5 mg per 0.5 mL, sponsored by Eli Lilly and Company.
- June 2026: The label in effect June 16, 2026 indicates the product as an adjunct to diet and exercise to improve glycemic control in adults and in pediatric patients ten years of age and older with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors. No weight-management indication appears in that section.
- September 2026: Dulaglutide appears in none of the three categories of the 503A bulks list published May 14, 2026; that list files substances nominated for compounding, and a licensed biologic is supplied by its own manufacturer. FDA's drug shortage database holds no entry for it, in a query whose control on liraglutide returned eleven records with the status Current.
- FDA final action: none recorded

#### Definition
Dulaglutide is a glucagon-like peptide-1 receptor agonist given once weekly by subcutaneous injection, and it is the member of this class that is not a peptide. The label describes a fusion protein of two identical disulfide-linked chains, each joining a GLP-1 analogue sequence to the Fc portion of a modified human immunoglobulin G4, with an overall molecular weight of about 63 kilodaltons [1].
That structure is why it sits here rather than outside the index. Readers meet dulaglutide in the same sentence as semaglutide (https://peptideamerica.org/molecules/semaglutide) and tirzepatide (https://peptideamerica.org/molecules/tirzepatide), under the same three words on a provider menu, and the shared class name hides a label that was written for a different purpose.

#### Evidence
PubMed returns 1,322 indexed records across three name variants, of which 843 carry the Humans subject heading, 160 the clinical-trial publication type and 149 the randomized-controlled-trial type [2]. That is a magnitude rather than a list, and the table reporting it says so.
The largest trial in the set is a cardiovascular outcome trial. REWIND randomized 9,901 people with type 2 diabetes to weekly dulaglutide at 1.5 mg or placebo and followed them a median 5.4 years; major adverse cardiovascular events occurred in 12.0 percent of the treated group against 13.4 percent on placebo, a hazard ratio of 0.88 [3]. All-cause mortality did not differ, and gastrointestinal adverse events were reported by 47.4 percent against 34.1 percent [3].
Where the class is compared head to head, this molecule is the weaker one on weight. SUSTAIN 7 randomized 1,201 patients to semaglutide or dulaglutide at two matched dose pairs, and body weight fell 4.6 kg against 2.3 kg at the lower pair and 6.5 kg against 3.0 kg at the higher [4]. Both differences favored the other molecule and both were the trial's stated confirmatory endpoint.
The dose range on the current label is itself a trial result: 3.0 mg and 4.5 mg were tested against 1.5 mg in metformin-treated patients before the higher strengths existed [5]. A reader comparing weekly injections should treat the strength on the box as the finding, not the molecule name.

#### Access
The lawful supply route is the licensed product. FDA licensed dulaglutide injection under biologics license application 125469 on September 18, 2014 as a Type 1 new molecular entity, and Drugs@FDA records Trulicity in four strengths from 0.75 mg to 4.5 mg per 0.5 mL, sponsored by Eli Lilly and marketed as prescription-only [6].
The label is written for diabetes and for cardiovascular risk. In the version effective June 16, 2026 the product is indicated as an adjunct to diet and exercise to improve glycemic control in adults and in pediatric patients ten years of age and older with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors [1]. No weight-management indication appears anywhere in that section.
Neither compounding nor shortage arises. Dulaglutide appears in none of the three categories of the section 503A bulks list published May 14, 2026 [7], and FDA's drug shortage database holds no entry for it, in a query whose control on liraglutide (https://peptideamerica.org/molecules/liraglutide) returned eleven records with the status Current [8].

#### Side effects
The Trulicity label names nausea, diarrhea, vomiting, abdominal pain and decreased appetite as the most common adverse reactions, each reported in at least 5 percent of treated patients [9]. In the label's pool of placebo-controlled trials, gastrointestinal reactions of any kind occurred in 32 and 41 percent of patients on the two strengths studied, against 21 percent on placebo; indigestion and fatigue also cleared the 5 percent line at the higher strength [9].
The label carries a boxed warning for thyroid C-cell tumors: dulaglutide caused them in rats, whether it does so in humans is unknown, and the drug is contraindicated for anyone with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia syndrome type 2 [9]. It is also contraindicated after a serious hypersensitivity reaction to dulaglutide or any component of the product [9].
The other warnings cover acute pancreatitis, hypoglycemia when combined with insulin or an insulin secretagogue, serious allergic reactions including anaphylaxis and angioedema, acute kidney injury from dehydration, severe gastrointestinal reactions, diabetic retinopathy complications in patients with a history of retinopathy, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation [9]. The label does not recommend the drug for people with severe gastroparesis [9].
The cardiovascular outcome trial gives the same picture over years rather than weeks: in REWIND, gastrointestinal adverse events were reported by 47.4 percent of the dulaglutide group against 34.1 percent on placebo across a median 5.4 years [3].

#### Questions
Q: Is dulaglutide FDA-approved?
A: Yes. The FDA licensed dulaglutide as Trulicity on September 18, 2014, and the index records it as approved as of September 2026 [6]. It is indicated for glycemic control in type 2 diabetes in adults and children 10 years and older, and for cardiovascular risk reduction in adults with type 2 diabetes [9].
Q: Is Trulicity approved for weight loss?
A: No. The label's indications cover glycemic control and cardiovascular risk reduction in type 2 diabetes, and no weight-management indication appears among them [9]. Weight loss seen in its trials is a trial result, not an approved use [4].
Q: What are the most common side effects of dulaglutide?
A: Nausea, diarrhea, vomiting, abdominal pain and decreased appetite are the most common, each reported in at least 5 percent of treated patients [9]. The [side effects](#side-effects) section above lists the label's warnings as well.
Q: Does dulaglutide cause thyroid cancer?
A: It is not known. Dulaglutide caused thyroid C-cell tumors in rats, the label carries a boxed warning for that finding, and the drug is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with MEN 2 [9].
Q: Is dulaglutide a peptide?
A: Not strictly. The label describes a fusion protein of about 63 kilodaltons, in which a GLP-1 analogue sequence is joined to an antibody fragment, so it is far larger than peptide drugs such as semaglutide (https://peptideamerica.org/molecules/semaglutide) [1].
Q: How is dulaglutide different from semaglutide?
A: Both are weekly GLP-1 receptor agonists, but in the head-to-head SUSTAIN 7 trial semaglutide (https://peptideamerica.org/molecules/semaglutide) lowered body weight about twice as much at each matched dose pair [4]. Dulaglutide is approved for diabetes and cardiovascular risk only, while semaglutide also carries a weight-management approval as Wegovy.

#### References
1. TRULICITY (dulaglutide) injection, prescribing information, structured product label version 62, effective June 16, 2026. Sections 1 Indications and Usage and 11 Description. Read September 2026 through the openFDA label endpoint, taking the most recent of the seven labels that endpoint returns for the brand; the cited repository page resolves to 108,300 bytes naming TRULICITY, in a run whose nonsense-path control on the same host resolved to 75,120 bytes naming it none. https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=TRULICITY
2. PubMed, National Library of Medicine. Census run September 2026 across three name variants — "dulaglutide" OR "Trulicity" OR "LY2189265" — returning 1,322 indexed records, 843 carrying the Humans MeSH term, 160 under "clinical trial"[Publication Type] and 149 under "randomized controlled trial"[Publication Type]. The trial-type records were not itemized: above twenty, this index reports a literature as a magnitude rather than pasting titles nobody read. The publication-type filter was proved live in the same run against a control term returning 8,907 records under the clinical-trial type and 6,116 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22dulaglutide%22+OR+%22Trulicity%22+OR+%22LY2189265%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
3. Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019;394(10193):121–130. https://pubmed.ncbi.nlm.nih.gov/31189511/
4. Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6(4):275–286. https://pubmed.ncbi.nlm.nih.gov/29397376/
5. Frias JP, Bonora E, Nevarez Ruiz L, et al. Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11). Diabetes Care. 2021;44(3):765–773. https://pubmed.ncbi.nlm.nih.gov/33397768/
6. Drugs@FDA, US Food and Drug Administration. Application BLA 125469, TRULICITY (dulaglutide), sponsor Eli Lilly and Company; injection in four strengths of 0.75 mg, 1.5 mg, 3 mg and 4.5 mg per 0.5 mL, marketing status Prescription, original approval dated September 18, 2014, submission class Type 1 - New Molecular Entity, with twenty-one approved supplements recorded through March 12, 2026. Read September 2026 through the openFDA drugsfda endpoint, in a run whose control query on a nonexistent ingredient returned no match; the cited overview page resolves to 58,646 bytes naming TRULICITY, while a nonexistent application number on the same host resolves to 19,938 bytes naming nothing. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125469
7. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, US Food and Drug Administration, face date "Updated May 14, 2026". Read September 2026. Dulaglutide appears in none of the three categories; the document was extracted in full and searched, in a run whose positive control terms — nicotinamide adenine dinucleotide, secretin and L-carnosine, each already recorded in this index — all appeared, and whose nonsense control term did not. https://www.fda.gov/media/94155/download
8. FDA Drug Shortages database, US Food and Drug Administration. Queried September 2026 through the openFDA shortages endpoint: no record for dulaglutide, tirzepatide or exenatide. The query was controlled in the same run against liraglutide, which returned 11 records with the status Current, and semaglutide, which returned 3. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
9. Eli Lilly and Company. TRULICITY (dulaglutide) injection, US prescribing information. Revised March 2026 (structured product label version 62, effective June 16, 2026). DailyMed set ID 463050bd-2b1c-40f5-b3c3-0a04bb433309. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309

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### Elamipretide (SS-31; MTP-131; Forzinity)
https://peptideamerica.org/molecules/elamipretide · status verified September 2026

Status: FDA-approved. Approved September 2025 as Forzinity under accelerated approval for Barth syndrome; the only approved product in this index's mitochondrial group.
Class: Mitochondrial · Route: Subcutaneous injection, once daily · Approved product: Forzinity (2025)

Regulatory record:
- September 2025: FDA approves elamipretide injection under new drug application 215244, approval dated September 19, 2025, as a Type 1 new molecular entity. Drugs@FDA records the product as Forzinity, a subcutaneous solution of elamipretide hydrochloride at 280 mg base per 3.5 mL, sponsored by Stealth BioTherapeutics and marketed as prescription-only.
- December 2025: The label in effect December 10, 2025 indicates the product to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. The same section states that the indication is approved under accelerated approval on an improvement in knee extensor muscle strength, an intermediate clinical endpoint, and that continued approval may be contingent upon verification of clinical benefit in a confirmatory trial.
- September 2026: Elamipretide appears in none of the three categories of the 503A bulks list published May 14, 2026; that list files substances nominated for compounding, and a marketed product supplies this one. FDA's drug shortage database holds no entry for it.
- FDA final action: none recorded

#### Definition
Elamipretide is a synthetic tetrapeptide that concentrates in the inner mitochondrial membrane and binds cardiolipin, the phospholipid whose remodeling fails in Barth syndrome; the label gives its sequence as D-Arg-2,6-dimethyl-Tyr-Lys-Phe-NH2 and calls the product a mitochondrial cardiolipin binder [1].
It reaches this index through the company it keeps rather than through any market of its own. Providers who sell NAD+ (https://peptideamerica.org/molecules/nad) and list MOTS-c (https://peptideamerica.org/molecules/mots-c) as a mitochondrial peptide are describing a category whose only approved member is this one, and that member's label names a single rare genetic disorder.

#### Evidence
Across five name variants PubMed returns 470 indexed records, of which 201 carry the Humans subject heading, 22 the clinical-trial publication type and 19 the randomized-controlled-trial type [2]. All twenty-two were opened and read; eighteen name a variant, four are matches on the search rather than on the compound, and one of the eighteen is a rat study that carries a trial publication type anyway [2].
The approved indication rests on a program of about a dozen participants. TAZPOWER randomized twelve subjects to elamipretide or placebo in a twelve-week crossover and neither primary endpoint was met; ten continued into an open-label extension, where the six-minute walk distance improved by 95.9 meters at 36 weeks at a p value of 0.024 [3]. The 168-week extension reported sustained tolerability and a cumulative 96.1 meter improvement at week 168, at a p value of 0.003, in the eight patients who reached that visit [4].
The largest controlled trial of the compound failed, and it failed in a different disease. MMPOWER-3 randomized 218 adults with genetically confirmed primary mitochondrial myopathy and met neither primary endpoint, with a six-minute walk difference of minus 3.2 meters at a p value of 0.69 [5].
Two further randomized trials sit outside the approved indication and neither produced one: a placebo-controlled trial in heart failure [6], and a trial of a topical ophthalmic solution in Leber hereditary optic neuropathy, which is not even the approved route [7]. A reader meeting the word mitochondrial on a provider menu is meeting a compound whose record is a rare-disease program with one positive extension and one negative phase 3.

#### Access
The lawful supply route is the approved product. FDA approved elamipretide injection under new drug application 215244 on September 19, 2025 as a Type 1 new molecular entity, and Drugs@FDA records Forzinity as a subcutaneous solution of elamipretide hydrochloride at 280 mg base per 3.5 mL, sponsored by Stealth BioTherapeutics and marketed as prescription-only [8].
The label states the indication and the condition attached to it in the same breath. In the version effective December 10, 2025 the product is indicated "to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg", and that indication "is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint", with continued approval that "may be contingent upon verification and description of clinical benefit in a confirmatory trial" [1].
Compounding does not arise for this molecule. Elamipretide appears in none of the three categories of the section 503A bulks list published May 14, 2026 [9], and FDA's drug shortage database holds no entry for it [10].

#### Side effects
The controlled safety data behind the Forzinity label are small: 12 males aged 12 to 35 with Barth syndrome, in a placebo-controlled crossover trial followed by an open-label extension [11]. Injection site reactions were the adverse reactions seen more often on the drug than on placebo. Every one of the 12 had injection site redness on elamipretide against 3 on placebo, and pain, hardening, itching, bruising and hives at the injection site were also more common on the drug [11].
Blood eosinophil counts rose frequently in studies lasting 30 days or longer. The label states that the counts generally peaked around 90 days, returned to baseline with continued treatment or after stopping, and were not linked to symptoms or other laboratory changes [11].
Hypersensitivity is the main warning. Reactions, some requiring emergency treatment, have included rash, raised skin lesions, eczema-like dermatitis and cough, and they may begin within minutes or months after starting treatment; the drug is contraindicated after a serious hypersensitivity reaction to elamipretide or its ingredients [11].
The product contains benzyl alcohol as a preservative, and the label warns that benzyl alcohol has caused serious and fatal reactions in premature and low-birth-weight newborns; Forzinity is not approved for newborns or for intravenous use [11]. Barth syndrome rarely affects females, so there are no data on use in pregnancy [11].

#### Questions
Q: Is elamipretide FDA-approved?
A: Yes. FDA approved elamipretide as Forzinity on September 19, 2025, under accelerated approval, to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg [8, 11]. Continued approval may depend on a confirmatory trial, and the index records it as approved as of September 2026 [1].
Q: What are the side effects of elamipretide?
A: Injection site reactions are the most common, including redness, pain, hardening, itching, bruising and hives at the injection site [11]. The label also warns of hypersensitivity reactions and notes frequent, symptom-free rises in eosinophil counts [11].
Q: Is SS-31 the same as elamipretide?
A: Yes. SS-31 and MTP-131 are earlier code names for elamipretide, and Forzinity is the approved product [8]. Material sold under a code name for research use is not the approved product and carries none of its label's assurances.
Q: Is elamipretide approved for anything other than Barth syndrome?
A: No. The label names Barth syndrome alone [1]. The largest controlled trial, in primary mitochondrial myopathy, met neither primary endpoint, and trials in heart failure and an inherited optic nerve disease produced no approval [5, 6, 7].
Q: Can elamipretide be compounded?
A: Elamipretide appears in none of the three categories of the section 503A bulks list published May 14, 2026, and FDA's drug shortage database holds no entry for it [9, 10]. The approved product is Forzinity.
Q: How is elamipretide different from MOTS-c or NAD+?
A: Elamipretide is the only member of the index's mitochondrial group with an FDA-approved product, and its label names one rare genetic disorder. Neither of the others holds an approval: at the August 2026 check, NAD+ (https://peptideamerica.org/molecules/nad) sat in Category 1 of the interim 503A bulks list while FDA evaluates it, and MOTS-c (https://peptideamerica.org/molecules/mots-c) awaited an FDA decision on 503A listing.

#### References
1. FORZINITY (elamipretide) injection, prescribing information, structured product label version 10, effective December 10, 2025. Sections 1 Indications and Usage and 11 Description. Read September 2026 through the openFDA label endpoint; the cited repository page resolves to 174,849 bytes naming FORZINITY 136 times, in a run whose nonsense-path control on the same host resolved to 75,120 bytes naming it none. https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=FORZINITY
2. PubMed, National Library of Medicine. Census run September 2026 across five name variants — "elamipretide" OR "SS-31" OR "MTP-131" OR "Bendavia" OR "Forzinity" — returning 470 indexed records, 201 carrying the Humans MeSH term, 22 under "clinical trial"[Publication Type] and 19 under "randomized controlled trial"[Publication Type]. All 22 trial-type records were retrieved and read individually rather than counted: 18 name a variant in the title or abstract, and 4 do not and are artifacts of the search — a metoclopramide pharmacokinetic comparison, a water-based resistance training study, an aficamten trial in hypertrophic cardiomyopathy, and a 1977 report on pancreatic duct antibodies. One of the 18, a 2007 rat myocardial-infarction study, carries a trial publication type despite being an animal study. The publication-type filter was proved live in the same run against a control term returning 8,907 records under the clinical-trial type and 6,116 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22elamipretide%22+OR+%22SS-31%22+OR+%22MTP-131%22+OR+%22Bendavia%22+OR+%22Forzinity%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
3. Reid Thompson W, Hornby B, Manuel R, et al. A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism. Genet Med. 2021;23(3):471–478. https://pubmed.ncbi.nlm.nih.gov/33077895/
4. Thompson WR, Manuel R, Abbruscato A, et al. Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER. Genet Med. 2024;26(7):101138. https://pubmed.ncbi.nlm.nih.gov/38602181/
5. Karaa A, Bertini E, Carelli V, et al. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. Neurology. 2023;101(3):e238–e252. https://pubmed.ncbi.nlm.nih.gov/37268435/
6. Daubert MA, Yow E, Dunn G, et al. Novel Mitochondria-Targeting Peptide in Heart Failure Treatment: A Randomized, Placebo-Controlled Trial of Elamipretide. Circ Heart Fail. 2017;10(12). https://pubmed.ncbi.nlm.nih.gov/29217757/
7. Karanjia R, Sadun AA. Elamipretide Topical Ophthalmic Solution for the Treatment of Subjects with Leber Hereditary Optic Neuropathy: A Randomized Trial. Ophthalmology. 2024;131(4):422–433. https://pubmed.ncbi.nlm.nih.gov/37923251/
8. Drugs@FDA, US Food and Drug Administration. Application NDA 215244, FORZINITY (elamipretide hydrochloride), sponsor Stealth BioTherapeutics; subcutaneous solution, EQ 280MG BASE/3.5ML, marketing status Prescription, original approval dated September 19, 2025, submission class Type 1 - New Molecular Entity, with no supplements recorded. Read September 2026 through the openFDA drugsfda endpoint, in a run whose control query on a nonexistent ingredient returned no match; the cited overview page resolves to 31,285 bytes naming FORZINITY, while a nonexistent application number on the same host resolves to 19,938 bytes naming nothing. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215244
9. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, US Food and Drug Administration, face date "Updated May 14, 2026". Read September 2026. Elamipretide appears in none of the three categories; the document was extracted in full and searched under the name and its code names, in a run whose positive control terms — nicotinamide adenine dinucleotide, secretin and L-carnosine, each already recorded in this index — all appeared, and whose nonsense control term did not. A nonexistent document identifier on the same host returned 404 in the same run. https://www.fda.gov/media/94155/download
10. FDA Drug Shortages database, US Food and Drug Administration. Queried September 2026 through the openFDA shortages endpoint: no record for elamipretide. The query was controlled in the same run against liraglutide, which returned 11 records with the status Current, and semaglutide, which returned 3. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
11. Stealth BioTherapeutics. FORZINITY (elamipretide hydrochloride) injection, US prescribing information, structured product label version 10, effective December 2025. Sections 4 Contraindications, 5 Warnings and Precautions, 6 Adverse Reactions and 8 Use in Specific Populations. DailyMed set ID 146bf34c-76f2-48db-ac07-fb29cce2cd75. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=146bf34c-76f2-48db-ac07-fb29cce2cd75

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### Epitalon (Epithalon; AEDG tetrapeptide)
https://peptideamerica.org/molecules/epitalon · status verified August 2026

Status: PCAC-recommended · pending. Removed from Category 2 in April 2026; PCAC recommended 503A listing in July 2026 on a reported tally; no FDA final rule.
Class: Longevity peptides · Route: None lawful; sold as research-use-only material
July 2026 advisory-committee vote: 7–4, 1 abstaining; reported by McDermott Will & Schulte, whose vote table gives it as "7 – 4 (1 abstention)", and LumaLex Law, which prints it as 7–4–1.

Regulatory record:
- April 2026: Removed from Category 2 without Category 1 listing.
- July 2026: PCAC votes 7–4 (one abstention) to recommend 503A listing; advisory only. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
- FDA final action: none recorded

#### Definition
Epitalon is the synthetic tetrapeptide alanine-glutamate-aspartate-glycine, designed in St. Petersburg as a defined analogue of epithalamin, a crude pineal-gland extract studied in Soviet and Russian gerontology since the 1980s.
It is marketed almost entirely on longevity claims — telomere extension chief among them — which makes the distance between its laboratory record and its sales copy the monograph's central subject.

#### Evidence
The foundational claim is a 2003 report that Epitalon induced telomerase activity and telomere elongation in cultured human fetal fibroblasts [1] — a cell-culture observation from the same institute that designed the peptide. The surrounding longevity literature concerns epithalamin, the parent extract, in rodents and fruit flies, not the tetrapeptide in people; a 2025 review collects what has and has not been replicated since [2].
No randomized trial of the tetrapeptide has been published for any endpoint. The one record PubMed tags as a controlled clinical trial of Epitalon is a 2002 report in retinitis pigmentosa whose abstract states a response rate without a denominator [9]; the remaining trial-type records study epithalamin, the extract, and their mortality findings are findings about the extract [5]. A buyer weighing a telomere claim against this record is weighing a marketing document against a fibroblast dish.

#### Access
Epitalon was removed from Category 2 of the interim 503A bulks list in April 2026 without Category 1 listing. In July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding it to the section 503A list. The margin is reported as 7–4 with one abstention by McDermott Will & Schulte, whose vote table gives it as "7 – 4 (1 abstention)", and by LumaLex Law, which prints it as 7–4–1; the two accounts agree substance by substance [3, 4]. The FDA has published no minutes, transcript or vote summary for the meeting, so the figure is secondary and this page says so wherever it appears. The vote is advisory; no FDA final rule has issued, and no licensed pharmacy may lawfully compound Epitalon as of August 2026.
Vials sold online today are research-use-only supply, outside pharmacy oversight; the pending (https://peptideamerica.org/status/pending) page explains the rulemaking still to come.
The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names Epitalon among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [13].

#### References
1. Khavinson VKh, Bondarev IE, Butyugov AA. Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells. Bull Exp Biol Med. 2003;135(6):590–592. https://pubmed.ncbi.nlm.nih.gov/12937682/
2. Araj SK, Brzezik J, Mądra-Gackowska K, Szeleszczuk Ł. Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties. Int J Mol Sci. 2025 Mar 17;26(6). https://pubmed.ncbi.nlm.nih.gov/40141333/
3. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. Its vote table gives Epitalon (free base / acetate), on Friday, July 24, as "7 – 4 (1 abstention)", recommended for inclusion.
4. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.
5. PubMed, National Library of Medicine. Census run September 2026 across four name variants — "Epitalon" OR "Epithalon" OR "epithalamin" OR "Ala-Glu-Asp-Gly" — returning 215 indexed records, 79 carrying the Humans MeSH term, 9 under "clinical trial"[Publication Type] and 6 under "randomized controlled trial"[Publication Type]; 106 of the 215 are Russian-language records and 6 of the 9 trial-type records are Russian-language. The two tetrapeptide names alone — "Epitalon" OR "Epithalon" — return 114 records, 35 tagged Humans, 1 under the clinical-trial type and 0 under the randomized type; the tetrapeptide names combined with telomer* return 10 records, 6 tagged Humans, none of either trial type. All nine trial-type records were opened and read: one names the tetrapeptide (a 2002 retinitis pigmentosa report); the other eight study epithalamin or an unnamed pineal-gland peptide preparation, in cervical cancer (1979, 1999), craniocerebral trauma (2004), melatonin rhythm (2004), arterial pressure (2008) and the geroprotective series of 2003, 2006 and 2011. Every one appears in a Russian journal or its translated edition, or carries the designing institute's authors. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. The counts reproduce the August 2026 run behind the trial-record table exactly. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22Epitalon%22+OR+%22Epithalon%22+OR+%22epithalamin%22+OR+%22Ala-Glu-Asp-Gly%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
6. Korkushko OV, Khavinson VKh, Shatilo VB, Antonyk-Sheglova IA. Peptide geroprotector from the pituitary gland inhibits rapid aging of elderly people: results of 15-year follow-up. Bull Exp Biol Med. 2011;151(3):366–369. https://pubmed.ncbi.nlm.nih.gov/22451889/
7. Korkushko OV, Khavinson VKh, Shatilo VB, Antonyuk-Shcheglova IA. Geroprotective effect of epithalamine (pineal gland peptide preparation) in elderly subjects with accelerated aging. Bull Exp Biol Med. 2006;142(3):356–359. https://pubmed.ncbi.nlm.nih.gov/17426848/
8. Khavinson VKh, Morozov VG. Peptides of pineal gland and thymus prolong human life. Neuro Endocrinol Lett. 2003;24(3-4):233–240. https://pubmed.ncbi.nlm.nih.gov/14523363/
9. Khavinson V, Razumovsky M, Trofimova S, Grigorian R, Razumovskaya A. Pineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa. Neuro Endocrinol Lett. 2002;23(4):365–368. https://pubmed.ncbi.nlm.nih.gov/12195242/
10. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entry for Epitalon. Read September 2026. The entry states that compounded drugs containing epitalon may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities, that FDA has not identified safety-related information regarding epitalon for the proposed route of administration, and that the agency therefore lacks sufficient information to know whether the drug would cause harm if administered to humans. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
11. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full September 2026: neither "Epitalon" nor "Epithalon" occurs anywhere in the document, so the substance appears in none of Category 1, Category 2, or Category 3. Control in the same read: the same document names GHK-Cu six times. https://www.fda.gov/media/94155/download
12. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name, the substance name and the brand name for "epitalon" and "epithalon": no matching application. Control in the same run: the identical query for "bremelanotide" returned NDA 210557. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22epitalon%22
13. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution

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### GHK-Cu (Copper tripeptide-1)
https://peptideamerica.org/molecules/ghk-cu · status verified August 2026

Status: Compoundable (503A). Nominations withdrawn April 2026; the non-injectable route was restored to Category 1 in May, the injectable route was not and has no lawful route.
Class: Repair peptides · Route: Topical (cosmetic); injectable has no lawful route

Regulatory record:
- April 2026: FDA removes GHK-Cu from Category 1 of the interim 503A bulks list on April 22, 2026, the nominations withdrawn by the nominators. GHK-Cu was not among the seven peptides reviewed at the July 2026 PCAC meeting.
- May 2026: After a nominator clarified on May 5, 2026 that it had intended to withdraw only its nomination of the injectable route, FDA's list document updated May 14, 2026 states that GHK-Cu (except for injectable routes of administration) will be added back to category 1, and lists it there. The injectable route was not restored and sits on no list. FDA states it intends to consult the Pharmacy Compounding Advisory Committee before the end of February 2027.
- FDA final action: none recorded

#### Definition
GHK-Cu is a naturally occurring tripeptide, glycyl-histidyl-lysine, complexed with copper; it was identified in human plasma and declines with age, and it has a long history in topical cosmetics.
The molecule's two lives must be kept separate: as a cosmetic ingredient in creams and serums it is unremarkable and legal, while the injectable form sold for regeneration is a different product with a different legal position.

#### Evidence
The topical literature describes effects on skin regeneration and collagen signaling, largely from in vitro and small cosmetic studies [1]. A 2026 review of peptide therapies for musculoskeletal and performance uses finds no clinical trial support for injectable GHK-Cu [2].
The distance between a cosmetic ingredient's cell-culture record and an injected drug's evidentiary bar is the whole story here; the first does not carry the second.
GHK-Cu is also sold inside injectable blends, marketed under names such as GLOW and KLOW, that combine it with BPC-157 and TB-500 and, in KLOW, with KPV. Searched in September 2026, neither blend name appears as a phrase in any PubMed record, and the six records that name GHK-Cu, BPC-157 and TB-500 together are all 2026 review articles rather than studies of the combination [10]. ClinicalTrials.gov lists one registered, still-recruiting phase 2 trial of a topical GHK-Cu gel and no registered study of GHK-Cu combined with any of the other three peptides [11].

#### Access
GHK-Cu's position is often described as a Category 2 removal. It is not one. GHK-Cu sat in Category 1 of the interim 503A bulks list — the category for substances under evaluation, which a pharmacy may compound while the review continues — and FDA removed it from that category on April 22, 2026 because its nominations were withdrawn by the nominators. Category 2 has never named this substance [3].
The two routes then parted. A nominator clarified on May 5, 2026 that it had meant to withdraw only its nomination of the injectable route, and FDA's list document, updated May 14, 2026, states that "GHK-Cu (except for injectable routes of administration) will be added back to category 1" and lists it in Category 1 accordingly [3]. The injectable route was not restored; it sits on no list, and no lawful compounding route exists for it today. FDA states it intends to consult the Pharmacy Compounding Advisory Committee before the end of February 2027 regarding the potential inclusion of GHK-Cu on the 503A bulks list [3]; GHK-Cu was not among the seven peptides reviewed at the July 2026 meeting. Topical cosmetic use is regulated as a cosmetic and is unaffected by any of this.
Injectable material sold online is research-use-only chemical supply, outside pharmacy licensure and quality standards.

#### Side effects
No controlled study has measured the side effects of injected GHK-Cu, so no reliable list of them exists. The FDA states that compounded injectable drugs containing GHK-Cu may pose a risk of immunogenicity, an immune reaction to the peptide, because of the potential for aggregation and peptide-related impurities, and that there are limited data in humans to inform safety-related considerations [8]. The injection-scoped literature holds no trial of any type [4].
Topical use has a longer history but no dedicated safety study. The two human trials applied the tripeptide to skin, one on venous ulcers and one after laser resurfacing; both were small efficacy trials, and their published abstracts report treatment outcomes rather than adverse-event findings [5, 6]. A cream on the skin is also a different exposure from a peptide injected under it, so the topical record does not describe the injectable one.
Reviewers place GHK-Cu among the unapproved peptides for which rigorous human safety data are scarce: a 2026 review of peptide therapies in sports medicine concludes that such compounds carry a potential for serious harm that the existing record cannot measure [2].

#### Questions
Q: Is GHK-Cu safe?
A: Its safety as an injection is not established. The FDA has cited possible immune reactions and peptide impurities in injectable GHK-Cu and states that human data are limited [8]. Topical cosmetic use has a longer history but no dedicated safety trial.
Q: Is GHK-Cu legal in the US?
A: As a topical cosmetic, yes. For compounding, FDA's list document updated May 14, 2026 places GHK-Cu, except for injectable routes, in Category 1, so a pharmacy may compound a non-injectable preparation while review continues; the injectable route sits on no list and has no lawful compounding route as of September 2026 [3].
Q: Is GHK-Cu FDA-approved?
A: No. Drugs@FDA holds no application under the name [9], and a cosmetic that contains it does not need FDA premarket approval [7].
Q: What is the difference between GHK-Cu injection and topical GHK-Cu?
A: They share a molecule but not an evidence base or a legal position. Both human trials applied GHK-Cu to skin, while the injection-scoped literature holds no trial [4, 5, 6]. The topical versus injectable review (https://peptideamerica.org/evidence/ghk-cu-topical-versus-injectable) sets the two side by side.
Q: What are GLOW and KLOW?
A: They are injectable blends sold as GHK-Cu with BPC-157 and TB-500, with KLOW adding KPV. No human trial has tested either combination [10, 11]. The GLOW and KLOW review (https://peptideamerica.org/evidence/glow-and-klow-blends) sets out each component's status.

#### References
1. Pickart L, Vasquez-Soltero JM, Margolina A. GHK Peptide as a Natural Modulator of Multiple Cellular Pathways in Skin Regeneration. Biomed Res Int. 2015;2015:648108. https://pubmed.ncbi.nlm.nih.gov/26236730/
2. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026 Aug;56(8):1921-1935. https://pubmed.ncbi.nlm.nih.gov/41966639/
3. US Food and Drug Administration. Bulk drug substances nominated for use in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act. Updated May 14, 2026. Read August 2026. The document's update note states that "GHK-Cu (except for injectable routes of administration) was removed from category 1 on April 22, 2026, because the nominations for GHK-Cu were withdrawn by the nominators," that a nominator clarified on May 5, 2026 that it intended to withdraw only the injectable nomination, and that GHK-Cu (except for injectable routes of administration) "will be added back to category 1"; the substance is listed in Category 1 on that page. The 503A Category 2 list on the same document names six substances — cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10, and quinacrine hydrochloride for intrauterine administration — and GHK-Cu is not among them. https://www.fda.gov/media/94155/download
4. PubMed, National Library of Medicine. Census run September 2026 across three name variants — "GHK-Cu" OR "copper tripeptide" OR "glycyl-histidyl-lysine" — returning 197 indexed records, 71 carrying the Humans MeSH term, 3 under "clinical trial"[Publication Type] and 3 under "randomized controlled trial"[Publication Type]. Split by route in the search itself: combined with the terms topical, cream, serum, skin, wound or cosmetic the names return 116 records and the same 3 trial-type records; combined with the terms injection, injectable, subcutaneous, intravenous or intramuscular they return 23 records, 3 of them tagged Humans and 0 under either trial type. The three injection-scoped human-tagged records were opened: a biomaterials paper on polymer microspheres, a 2026 review primer on injectable peptides for sports physicians, and a 2018 pilot of an intradermal hair-growth formulation; none is a trial of injected GHK-Cu. All three trial-type records were opened and read: a 1992 venous-ulcer trial and a 2006 laser-resurfacing trial, both topical, and a 2006 wound study in rabbits. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. The counts reproduce the August 2026 run behind the trial-record table exactly. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22GHK-Cu%22+OR+%22copper+tripeptide%22+OR+%22glycyl-histidyl-lysine%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
5. Bishop JB, Phillips LG, Mustoe TA, et al. A prospective randomized evaluator-blinded trial of two potential wound healing agents for the treatment of venous stasis ulcers. J Vasc Surg. 1992;16(2):251–257. https://pubmed.ncbi.nlm.nih.gov/1495150/
6. Miller TR, Wagner JD, Baack BR, Eisbach KJ. Effects of topical copper tripeptide complex on CO2 laser-resurfaced skin. Arch Facial Plast Surg. 2006;8(4):252–259. https://pubmed.ncbi.nlm.nih.gov/16847171/
7. US Food and Drug Administration. FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated. Content current as of November 18, 2025. Read September 2026. The page states that under the law cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives; that the FD&C Act defines cosmetics by their intended use, as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance (section 201(i)); and that a product intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, is a drug under section 201(g) even if it affects the appearance. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated
8. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entry for GHK-Cu (for injectable routes of administration). Read September 2026. The entry states that compounded injectable drugs containing GHK-Cu may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities, and that there are limited data in humans to inform safety-related considerations. The table is introduced on that page as a list of substances previously in category 2 of the interim policies that were withdrawn by the nominators; the list document cited as reference 3 records the April 22, 2026 removal as a removal from category 1. This index prints both documents as written and does not reconcile them. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
9. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name, the substance name and the brand name for "GHK-Cu": no matching application. Control in the same run: the identical query for "bremelanotide" returned NDA 210557. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22GHK-Cu%22
10. PubMed, National Library of Medicine. Searches run September 2026. The quoted phrases "GLOW peptide", "KLOW peptide", "GLOW blend" and "KLOW blend" were each reported by E-utilities as not found in any record. ("GHK-Cu" OR "copper tripeptide") AND ("BPC-157" OR "BPC 157") AND ("TB-500" OR "TB500" OR "thymosin beta 4" OR "thymosin beta-4") returned 6 records, all published in 2026 and all review or overview articles on peptide therapies (PMIDs 42635865, 42578445, 42021992, 41966639, 41490200, 41476424); none is a study of the combination. BPC-157 names combined with KPV names returned 0 records. Under "clinical trial"[Publication Type], four BPC-157 name variants returned 0 records, four KPV name variants returned 0 of 113 records, and three GHK-Cu name variants returned 3. In the same run the control term aspirin returned 8,916 records under the same filter, the invalid tag clinicaltrial[pt] returned 0 for that control, and esummary on the invalid identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22GHK-Cu%22+OR+%22copper+tripeptide%22%29+AND+%28%22BPC-157%22+OR+%22BPC+157%22%29+AND+%28%22TB-500%22+OR+%22TB500%22+OR+%22thymosin+beta+4%22%29
11. ClinicalTrials.gov, National Library of Medicine, v2 API. Searches run September 2026. "GHK-Cu" returned 3 registered studies, among them NCT07437586, a randomized, vehicle-controlled phase 2 trial of a topical GHK-Cu gel on acute skin wounds, recruiting, started February 2026, no results posted. "BPC-157" returned 4: NCT07437547, a randomized, placebo-controlled phase 2 trial in hamstring strain, recruiting; NCT07803250, a phase 1 study after rotator cuff repair, not yet recruiting; NCT02637284, a phase 1 study of an oral preparation, status unknown; and NCT07752381, a single-arm dietary-supplement study, completed; none has posted results. "TB-500" returned 1, NCT07487363, a randomized, placebo-controlled phase 1/2 trial, recruiting. "KPV" returned 0. "GLOW peptide" returned 13 studies and "KLOW" 1, none concerning a peptide blend. Each pairing of BPC-157, TB-500, GHK and KPV searched together returned 0. Control in the same run: "aspirin" returned 2,968 studies. https://clinicaltrials.gov/api/v2/studies?query.term=BPC-157%20AND%20TB-500

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### GHRP-2 (Growth hormone releasing peptide-2; pralmorelin)
https://peptideamerica.org/molecules/ghrp-2 · status verified September 2026

Status: No lawful route. Category 3 of the 503A bulks list — nominated without adequate support — and Category 2 under the separate 503B policy for injectable and nasal routes; no lawful route.
Class: GH secretagogues · Route: None lawful; sold as research-use-only material
FDA Category 2 under section 503B since September 29, 2023 (injectable and nasal routes).

Regulatory record:
- September 2023: FDA places growth hormone releasing peptide-2, for injectable and nasal routes of administration, in Category 2 under the section 503B interim policy, with a date added of September 29, 2023. The agency states that compounded drugs containing GHRP-2 may pose a risk for immunogenicity from aggregation and peptide-related impurities, that the substance contains an unnatural amino acid which adds to the complexity of peptide characterization, and that it is aware of reports of serious adverse events in patients who received GHRP-2 — increased insulin requirement, death of critically ill study subjects, infection and pancreatitis — though causality has not been established.
- May 2026: The section 503A bulks list FDA published May 14, 2026 lists GHRP-2 in Category 3, the file for substances nominated without adequate support to evaluate. It sits in neither of the other two 503A categories, and Category 3 carries no authorization to compound.
- September 2026: Drugs@FDA holds no approved product with GHRP-2 or pralmorelin as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026. Its position is therefore unchanged by the 2026 meeting.
- FDA final action: none recorded

#### Definition
GHRP-2 is a synthetic hexapeptide that stimulates growth hormone release by acting at the ghrelin receptor rather than at the growth hormone-releasing hormone receptor. It was developed as a pituitary provocation agent — a way of asking the pituitary how much growth hormone it is able to release — and most of what has been published about it in people was published for that purpose.
It reaches United States buyers today as research-use-only material, marketed for the effects the provocation studies measured. This index tracks it because its regulatory file is the clearest example of a distinction the marketplace collapses: the size of a compound's literature and the strength of its nomination are different things, and the FDA has filed this one on the second.

#### Evidence
The literature is neither small nor absent. Across six name variants PubMed returns 260 indexed records, of which 160 carry the Humans subject heading, 59 the clinical-trial publication type, and 43 the randomized-controlled-trial type [1]. Every one of the 59 titles was retrieved and read. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type, the invalid tag returned zero for that control term, and a deliberately invalid record identifier errored at the end of the run [1].
What the 59 records contain is a diagnostic and physiological literature. The dominant design gives GHRP-2 once, or over a few hours, and measures growth hormone, adrenocorticotropic hormone or cortisol release under varying hormonal conditions; a large share come from a single physiology group working on the regulation of growth hormone pulses. A phase 1 study established pharmacokinetics and pharmacodynamics in children [2]; an eight-month study of graded doses in growth-hormone-deficient children is the longest administration record indexed [3]; a study in obese adults measured the effect on food intake [4]; and a study in adults established the compound as a diagnostic test for growth hormone deficiency [5]. One record is a study in pigs [1].
The distance between that record and what the compound is sold for is the finding. A provocation study establishes that a peptide releases growth hormone; it does not establish that releasing growth hormone in a person who is not deficient produces a clinical outcome, and none of the 59 records was designed to answer that question. The eight-month record is a dose-ranging study in deficient children, which is a different population from the one buying the material.

#### Access
There is no lawful United States supply route. Drugs@FDA holds no approved product with GHRP-2 or pralmorelin as an active ingredient; the same query form in the same session returned one application for bremelanotide and fourteen for liraglutide, and returned nothing for a deliberately invented ingredient name [6].
On the section 503A bulks list FDA published May 14, 2026, GHRP-2 appears in Category 3 — the file for substances nominated without adequate support to evaluate — and in neither of the other two categories [7]. Category 3 is the least understood position on that document. It is not a safety finding, which is Category 2; it is not a permission to compound while review continues, which is Category 1 (https://peptideamerica.org/glossary/category-1). It records that the nomination submitted for the substance did not contain enough to review, and it confers nothing.
Under the separate section 503B policy governing outsourcing facilities, GHRP-2 for injectable and nasal routes of administration is in Category 2, added September 29, 2023. FDA states there that compounded drugs containing it may pose a risk for immunogenicity from aggregation and peptide-related impurities, that the substance contains an unnatural amino acid which adds to the complexity of peptide characterization, and that the agency is aware of reports of serious adverse events in patients who received GHRP-2 — increased insulin requirement, death of critically ill study subjects, infection and pancreatitis — with causality not established [8]. Neither list gives a pharmacy a route, and the two together are the whole federal position.
The substance was not among the seven peptides the advisory committee reviewed in July 2026, so nothing that happened at that meeting changed its file [7]. What is sold is therefore research-use-only material (https://peptideamerica.org/status/research-only), and the labeling posture is the subject rather than an aside.

#### References
1. PubMed, National Library of Medicine. Census run September 2026 across six name variants — "GHRP-2" OR "GHRP 2" OR "pralmorelin" OR "growth hormone releasing peptide-2" OR "growth hormone-releasing peptide 2" OR "KP-102" — returning 260 indexed records, 160 carrying the Humans MeSH term, 59 under "clinical trial"[Publication Type] and 43 under "randomized controlled trial"[Publication Type]. All 59 clinical-trial titles were retrieved through esummary and read. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22GHRP-2%22+OR+%22pralmorelin%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. Pihoker C, Kearns GL, French D, Bowers CY. Pharmacokinetics and pharmacodynamics of growth hormone-releasing peptide-2: a phase I study in children. J Clin Endocrinol Metab. 1998 Apr;83(4):1168-72. https://pubmed.ncbi.nlm.nih.gov/9543135/
3. Mericq V, Cassorla F, Salazar T, Avila A, Iñiguez G, Bowers CY, et al. Effects of eight months treatment with graded doses of a growth hormone (GH)-releasing peptide in GH-deficient children. J Clin Endocrinol Metab. 1998 Jul;83(7):2355-60. https://pubmed.ncbi.nlm.nih.gov/9661608/
4. Laferrère B, Hart AB, Bowers CY. Obese subjects respond to the stimulatory effect of the ghrelin agonist growth hormone-releasing peptide-2 on food intake. Obesity (Silver Spring). 2006 Jun;14(6):1056-63. https://pubmed.ncbi.nlm.nih.gov/16861611/
5. Chihara K, Shimatsu A, Hizuka N, Tanaka T, Seino Y, Katofor Y. A simple diagnostic test using GH-releasing peptide-2 in adult GH deficiency. Eur J Endocrinol. 2007 Jul;157(1):19-27. https://pubmed.ncbi.nlm.nih.gov/17609397/
6. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe run September 2026: a search by active-ingredient name returned no records for GHRP-2 or for pralmorelin. In the same run and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none — a positive and a negative control beside the zero. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22PRALMORELIN%22
7. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: GHRP-2 appears in Category 3 and in neither Category 1 nor Category 2. https://www.fda.gov/media/94155/download
8. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026. Read September 2026: the Category 2 table lists Growth hormone releasing peptide-2 (GHRP-2) for injectable and nasal routes of administration under the 503B policy, date added September 29, 2023. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

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### GHRP-6 (Growth hormone releasing peptide-6; growth hormone releasing hexapeptide)
https://peptideamerica.org/molecules/ghrp-6 · status verified September 2026

Status: No lawful route. Category 3 of the 503A bulks list — nominated without adequate support — and Category 2 under the separate 503B policy; no lawful route.
Class: GH secretagogues · Route: None lawful; sold as research-use-only material
FDA Category 2 under section 503B since September 29, 2023.

Regulatory record:
- September 2023: FDA places growth hormone releasing peptide-6 in Category 2 under the section 503B interim policy, with a date added of September 29, 2023. The agency states that compounded drugs containing GHRP-6 may pose a risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities, and that it has identified limited safety-related information, with the available data revealing concerns including a potential effect on cortisol and an increase in blood glucose from decreased insulin sensitivity.
- May 2026: The section 503A bulks list FDA published May 14, 2026 lists GHRP-6 in Category 3, the file for substances nominated without adequate support to evaluate. It sits in neither of the other two 503A categories, and Category 3 carries no authorization to compound.
- September 2026: Drugs@FDA holds no approved product with GHRP-6 as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026.
- FDA final action: none recorded

#### Definition
GHRP-6 is a synthetic hexapeptide that releases growth hormone through the ghrelin receptor. It is the older and more widely studied of the two growth hormone-releasing peptides this index tracks, and it was the compound that established the receptor pathway itself: the earliest human work showed that the peptide releases growth hormone independently of growth hormone-releasing hormone and acts synergistically with it.
Like its sibling, it is sold in the United States as research-use-only material. Its federal file is the same two-list arrangement, and the same two-list arrangement is what a single-source summary of its status gets wrong.

#### Evidence
Across five name variants PubMed returns 801 indexed records, of which 316 carry the Humans subject heading, 56 the clinical-trial publication type, and 25 the randomized-controlled-trial type [1]. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag returned zero for that control term; and a deliberately invalid record identifier errored in the same run [1].
Fifty-six is not fifty-six trials of this compound, and the reading is the reason to say so. All 56 titles were retrieved and opened. The union draws in hexarelin, ghrelin itself, the non-peptide mimetics that were developed from the hexapeptide, and animal work in cattle, dogs and rats, because the phrase that identifies the compound also identifies its whole pharmacological neighborhood [1]. A count published without that reading would attribute a receptor family's literature to one molecule sold from it.
What is left, after reading, is a provocation and diagnostic literature. The characteristic study administers the peptide and measures growth hormone, adrenocorticotropic hormone or cortisol release, often in comparison with growth hormone-releasing hormone or the insulin tolerance test; a trial in growth hormone-deficient adults proposed the combination as a diagnostic alternative to that test [2]. A separate study measured its effect on sleep architecture alongside the hormonal response [3]. One pharmacokinetic study administered the peptide to nine healthy male volunteers [4].
The one indexed record that reports a therapeutic outcome is not a trial of GHRP-6 alone: a 2026 phase 3 open-label randomized trial in acute ischemic stroke tested epidermal growth factor combined with growth hormone releasing hexapeptide, and it was conducted outside the United States [5]. A combination product studied for a neurological indication abroad is not evidence for the uses the compound is sold for here, and the distance is worth naming rather than leaving to inference.

#### Access
There is no lawful United States supply route. Drugs@FDA holds no approved product with GHRP-6 as an active ingredient; in the same session and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none [6].
The section 503A bulks list FDA published May 14, 2026 lists GHRP-6 in Category 3, the file for substances nominated without adequate support to evaluate, and in neither of the other two categories [7]. Category 3 is a statement about the nomination, not about the published literature and not about safety. A substance can hold eight hundred indexed records and a Category 3 file at the same time, and this one does.
Under the separate section 503B policy, GHRP-6 is in Category 2, added September 29, 2023. FDA states there that compounded drugs containing it may pose a risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities, and that it has identified limited safety-related information, with the available data revealing concerns including a potential effect on cortisol and an increase in blood glucose from decreased insulin sensitivity [8]. That is the only place in the federal record where an agency safety view of this compound is stated, and it is stated about outsourcing facilities rather than about pharmacies.
The substance was not among the seven peptides the advisory committee reviewed in July 2026 [7]. What is sold is research-use-only material (https://peptideamerica.org/status/research-only), on the same terms as everything else in that file.

#### References
1. PubMed, National Library of Medicine. Census run September 2026 across five name variants — "GHRP-6" OR "GHRP 6" OR "growth hormone releasing peptide-6" OR "growth hormone-releasing peptide 6" OR "growth hormone releasing hexapeptide" — returning 801 indexed records, 316 carrying the Humans MeSH term, 56 under "clinical trial"[Publication Type] and 25 under "randomized controlled trial"[Publication Type]. All 56 clinical-trial titles were retrieved through esummary and read; the union includes hexarelin, ghrelin, the mimetics MK-677 and L-692,429, and animal studies. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22GHRP-6%22+OR+%22growth+hormone+releasing+hexapeptide%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. Popovic V, Leal A, Micic D, Koppeschaar HP, Torres E, Paramo C, et al. GH-releasing hormone and GH-releasing peptide-6 for diagnostic testing in GH-deficient adults. Lancet. 2000 Sep 30;356(9236):1137-42. https://pubmed.ncbi.nlm.nih.gov/11030292/
3. Frieboes RM, Murck H, Maier P, Schier T, Holsboer F, Steiger A. Growth hormone-releasing peptide-6 stimulates sleep, growth hormone, ACTH and cortisol release in normal man. Neuroendocrinology. 1995 May;61(5):584-9. https://pubmed.ncbi.nlm.nih.gov/7617137/
4. Cabrales A, Gil J, Fernández E, Valenzuela C, Hernández F, García I, et al. Pharmacokinetic study of Growth Hormone-Releasing Peptide 6 (GHRP-6) in nine male healthy volunteers. Eur J Pharm Sci. 2013 Jan 23;48(1-2):40-6. https://pubmed.ncbi.nlm.nih.gov/23099431/
5. Hernández-Bernal F, Subirós-Martínez N, Gutiérrez-Ronquillo JH, Colina-Ávila E, Guevara-Rodríguez M, Estenoz-García D, et al. Phase III Open-Label, Randomized Clinical Trial of Epidermal Growth Factor and Growth Hormone Releasing Hexapeptide in Acute Ischemic Stroke. J Clin Neurosci. 2026 Oct;152:112195. https://pubmed.ncbi.nlm.nih.gov/42462342/
6. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe run September 2026: a search by active-ingredient name returned no records for GHRP-6. In the same run and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none — a positive and a negative control beside the zero. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22GHRP-6%22
7. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: GHRP-6 appears in Category 3 and in neither Category 1 nor Category 2. https://www.fda.gov/media/94155/download
8. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026. Read September 2026: the Category 2 table lists Growth hormone releasing peptide-6 (GHRP-6) under the 503B policy, date added September 29, 2023. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

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### Glutathione
https://peptideamerica.org/molecules/glutathione · status verified August 2026

Status: Compoundable (503A). Category 1 of the interim 503A bulks list; compoundable with a valid prescription.
Class: Mitochondrial · Route: Injection; IV infusion

Regulatory record:
- August 2026: Listed in Category 1 of the interim 503A bulks list; pharmacies may compound while FDA review continues.
- FDA final action: none recorded

#### Definition
Glutathione is a tripeptide of glutamate, cysteine, and glycine, the body's most abundant intracellular antioxidant; it is synthesized in every cell rather than obtained primarily from outside.
The injectable market sells it chiefly for skin tone and general wellness, uses that sit far from the molecule's textbook biochemistry.

#### Evidence
Systematic reviews of glutathione for skin outcomes find limited, short-term, and mixed evidence: a 2019 review reported some skin-tone effects in small trials with oral and topical use, and a 2025 review in melasma reached guarded conclusions about efficacy and durability [1, 2]. Evidence specifically for intravenous or intramuscular glutathione is thinner than for the oral forms the reviews mostly cover.
No glutathione product is FDA-approved for cosmetic indications, and the trials that exist are small enough that a confident claim in either direction outruns the data.
The route is where the record thins to nothing. Searched in August 2026, the pairing of glutathione with skin lightening, whitening, bleaching, hyperpigmentation, or melanogenesis returns 206 indexed papers, of which 7 carry the clinical-trial publication type and 4 the randomized-controlled-trial type; narrowing the same search to records that also name an intravenous, intramuscular, injected, or injectable route returns 12 papers and no clinical trial of any kind [6].
All 7 clinical trials were read rather than counted. Six test an oral, buccal, or topical preparation: an eight-week open-label single-arm study of a glutathione lozenge in 30 Filipino women reported a fall in melanin index [3], and a double-blind randomized study in 46 participants compared topical and oral glutathione against each route alone [4]. The seventh is an injectable, and it is not a trial of this question: it tested a four-ingredient hyaluronate complex containing vitamin C, tranexamic acid, and glutathione in 120 patients with periorbital hyperpigmentation, which is a combination product for under-eye pigment rather than glutathione alone for skin tone [5, 6].
Safety is the thinner half of that record. A 2016 review found no study of intravenous glutathione for skin lightening and no study of its safety in long-term use for any indication; the intravenous trials in other conditions reported no or minimal adverse effects but lasted only a few doses [12]. A 2026 narrative review reached the same place a decade later, naming hepatotoxicity, hypersensitivity reactions and possible renal and endocrine effects as open safety concerns and judging the evidence too limited to justify routine cosmetic use [11].

#### Access
Glutathione is listed in Category 1 of the FDA's interim 503A bulks list; licensed pharmacies may compound it with a valid prescription while review continues.
The injectable skin-whitening trade sits outside that route entirely, and the federal record of it is dated. A consent decree of permanent injunction was entered in the United States District Court for the District of New Jersey on September 26, 2017 in United States v. Flawless Beauty LLC, a case the FDA still cites by number in its own correspondence [7]; under that decree the company announced on January 18, 2018 a recall of nineteen products, and the announcement the FDA republished states that all of the glutathione products were sold in multi-vial whitening kits, alone or with ampules of vitamin C and sterile water [8]. That action is a dated public record and nothing more; it says nothing about any other seller.
The FDA's most recent warnings concern the ingredient rather than the indication. In June 2019 the agency reported adverse events in patients given intravenous glutathione compounded from a powder labeled as a dietary supplement, and its laboratory found excessive bacterial endotoxin in samples of that powder [10]. On August 27, 2026 it reported at least 30 patients with adverse events after intravenous glutathione compounded by different pharmacies from a single lot of dietary supplement grade glutathione, and reminded compounders not to use dietary supplement grade ingredients in injectable drugs [9]. A single case report from 2025 describes systemic inflammatory response syndrome within an hour of an unregulated glutathione infusion given for skin lightening [13].

#### Side effects
No controlled trial has characterized the safety of intravenous or intramuscular glutathione as it is sold for skin tone and wellness. A 2016 review found no study of intravenous glutathione for skin lightening and no study of its long-term safety for any indication; the short intravenous trials in other conditions reported no or minimal adverse effects [12]. A 2026 review lists hepatotoxicity, hypersensitivity reactions and possible renal and endocrine effects as unresolved concerns [11].
The best-documented harms come from contaminated ingredients rather than from the molecule. In 2019 the FDA reported nausea, vomiting, lightheadedness, chills, body aches and fever in patients given compounded intravenous glutathione made from a dietary-supplement powder, with two patients taken to hospital, and found excessive bacterial endotoxin in that powder [10]. More recently it reported at least 30 patients with fever, chills, pain, dizziness, signs of shock and sepsis-like symptoms, some hospitalized, after intravenous glutathione compounded from one lot of dietary supplement grade material [9].
Case reports show what can happen without establishing how often. A 2025 report describes shock, very high fever, liver injury and abnormal clotting within an hour of an unregulated glutathione infusion for skin lightening; the patient recovered, and the authors suspected endotoxin contamination [13]. The oral and topical forms that most skin trials tested are different exposures, and their results do not describe an infusion [1, 2].

#### Questions
Q: Is glutathione FDA-approved?
A: No glutathione product is FDA-approved for skin lightening or other cosmetic uses. Glutathione sits in Category 1 of the interim 503A bulks list, so a licensed pharmacy may compound it with a valid prescription while FDA review continues, as of September 2026.
Q: Are glutathione injections legal in the US?
A: Yes, when a licensed pharmacy compounds them for a patient with a valid prescription. Compounded drugs are not reviewed by the FDA for safety or effectiveness, and injectable kits sold directly for skin whitening fall outside that route [7, 8].
Q: What are the side effects of IV glutathione?
A: They are poorly documented, because no controlled trial has studied intravenous glutathione for skin or wellness use [12]. The FDA has reported fever, chills, dizziness and sepsis-like reactions linked to contaminated dietary supplement grade ingredient, and reviewers list liver injury and hypersensitivity as open concerns [9, 10, 11].
Q: Does glutathione lighten skin?
A: The evidence is limited, short-term and mixed, and it comes mostly from oral and topical forms [1, 2]. No clinical trial has tested injected glutathione alone for skin tone [6]; the skin-lightening review (https://peptideamerica.org/evidence/glutathione-skin-lightening) reads each trial.
Q: Why has the FDA warned about glutathione?
A: Because of ingredient quality. In 2019 and again in 2026 the FDA linked adverse reactions after intravenous glutathione to dietary supplement grade material with high endotoxin levels, and it has told compounders not to use such ingredients in injectable drugs [9, 10].

#### References
1. Dilokthornsakul W, Dhippayom T, Dilokthornsakul P. The clinical effect of glutathione on skin color and other related skin conditions: A systematic review. J Cosmet Dermatol. 2019 Jun;18(3):728-737. https://pubmed.ncbi.nlm.nih.gov/30895708/
2. Sarkar R, Yadav V, Yadav T, P J, Mandal I. Glutathione as a skin-lightening agent and in melasma: a systematic review. Int J Dermatol. 2025 Jun;64(6):992-1004. https://pubmed.ncbi.nlm.nih.gov/39444151/
3. Handog EB, Datuin MS, Singzon IA. An open-label, single-arm trial of the safety and efficacy of a novel preparation of glutathione as a skin-lightening agent in Filipino women. Int J Dermatol. 2016;55(2):153–157. https://pubmed.ncbi.nlm.nih.gov/26148180/
4. Wahab S, Anwar AI, Zainuddin AN, et al. Combination of topical and oral glutathione as a skin-whitening agent: a double-blind randomized controlled clinical trial. Int J Dermatol. 2021;60(8):1013–1018. https://pubmed.ncbi.nlm.nih.gov/33871071/
5. Guo F, Zhang Z, Su X, et al. Efficacy and safety of injectable sodium hyaluronate with vitamin C, tranexamic acid, and glutathione for pigmented dark circles. J Dermatolog Treat. 2025;36(1):2574306. https://pubmed.ncbi.nlm.nih.gov/41117156/
6. PubMed, National Library of Medicine. Census run August 2026. "glutathione" paired with "skin lightening" OR "skin whitening" OR "skin bleaching" OR "hyperpigmentation" OR "melanogenesis" returns 206 indexed records, 98 carrying the Humans MeSH term, 7 under "clinical trial"[Publication Type] and 4 under "randomized controlled trial"[Publication Type]; all 7 were read individually rather than counted, and 6 test an oral, buccal, or topical preparation while the seventh is an injectable four-ingredient hyaluronate complex for periorbital hyperpigmentation. Narrowing the same pairing to records that also name an intravenous, intramuscular, injection, or injectable route returns 12 records, 0 under the clinical-trial type and 0 under the randomized type. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type, the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22glutathione%22+AND+%28%22skin+lightening%22+OR+%22skin+whitening%22+OR+%22skin+bleaching%22%29+AND+%28%22intravenous%22+OR+%22injection%22+OR+%22injectable%22+OR+%22intramuscular%22%29%29
7. US Food and Drug Administration. Warning letter to Flawless Beauty and Skin, CMS 630567, August 5, 2022, citing the Consent Decree of Permanent Injunction entered by the United States District Court on September 26, 2017 in United States v. Flawless Beauty LLC, et al., No. 17-7091 (D.N.J.). Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flawless-beauty-and-skin-630567-08052022
8. US Food and Drug Administration. Company announcement republished by the FDA: Flawless Beauty, LLC issues voluntary recall of unapproved drugs. Company announcement date January 18, 2018; FDA publish date January 23, 2018. Read August 2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/flawless-beauty-llc-issues-voluntary-recall-unapproved-drugs
9. US Food and Drug Administration. FDA reminds compounders not to use dietary supplement grade glutathione for injectables. August 27, 2026; content current as of August 27, 2026. Read September 2026. The page reports at least 30 patients with adverse events after intravenous glutathione, alone or with other ingredients, compounded by different pharmacies from one lot of glutathione labeled as dietary supplement grade; reported events included fever, chills, pain, dizziness, signs of shock and sepsis-like symptoms, some resulting in hospitalization, consistent with exposure to excessive endotoxin. https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables
10. US Food and Drug Administration. FDA highlights concerns with using dietary ingredient glutathione to compound sterile injectables. Compounding alert, June 7, 2019. Read September 2026. The alert describes adverse event reports in which patients given intravenous injections of compounded L-glutathione experienced nausea, vomiting, lightheadedness, chills, body aches, fever, with one patient transferred to a hospital and another admitted to one, and states that FDA laboratory testing found excessive bacterial endotoxin in samples of the dietary-supplement-labeled powder. https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables
11. Aloraini K, Alangari A, Arif J, Alkhodairy F. Glutathione for skin lightening via intravenous, oral, and topical routes: a critical narrative review of current evidence, safety, and the evidence-practice gap. J Med Life. 2026;19(7):511-523. https://pubmed.ncbi.nlm.nih.gov/42751591/
12. Davids LM, Van Wyk JC, Khumalo NP. Intravenous glutathione for skin lightening: inadequate safety data. S Afr Med J. 2016;106(8):782-786. https://pubmed.ncbi.nlm.nih.gov/27499402/
13. Sharma D, Daram S, Sharma P. Systemic inflammatory response syndrome following high-dose intravenous glutathione-containing revitalising solution in a patient on tirzepatide: a case report. Cureus. 2025;17(5):e84736. https://pubmed.ncbi.nlm.nih.gov/40556995/

---

### Ipamorelin
https://peptideamerica.org/molecules/ipamorelin · status verified September 2026

Status: Nomination withdrawn. 503A nominations withdrawn September 2024 and in no 503A category; named in Category 2 under FDA's separate 503B policy; no lawful compounding route.
Class: GH secretagogues · Route: None lawful
FDA Category 2 under section 503B since September 29, 2023.

Regulatory record:
- September 2023: FDA places ipamorelin acetate in Category 2 under the section 503B interim policy for outsourcing facilities, date added September 29, 2023. The agency cites a risk of immunogenicity from aggregation or peptide-related impurities, unnatural amino acids that complicate characterization, and a published report of serious adverse events including death when ipamorelin was given intravenously for gastric motility.
- September 2024: The nominators withdraw their nominations of ipamorelin acetate and ipamorelin free base for the section 503A bulks list on September 19, 2024. FDA later files ipamorelin acetate among the substances previously in 503A Category 2 whose nominations were withdrawn.
- October 2024: FDA presents its evaluation to the Pharmacy Compounding Advisory Committee anyway, proposing that neither form be placed on the 503A bulks list. The committee votes 0–12, with one abstention, against listing each form.
- September 2026: FDA's Category 2 page, content current April 22, 2026, still lists ipamorelin acetate under the 503B policy, and the 503A list updated May 14, 2026 names it in no category. Neither a 503A pharmacy nor a 503B outsourcing facility has a lawful route to compound it.
- FDA final action: none recorded

#### Definition
Ipamorelin is a synthetic pentapeptide that mimics ghrelin at the growth hormone secretagogue receptor, producing selective growth hormone release with little effect on cortisol or prolactin; that selectivity built its reputation in the wellness market.
It is routinely sold in combination with CJC-1295, a pairing invented by the market rather than by any trial.

#### Evidence
Ipamorelin's clinical record is nearly singular: a randomized, placebo-controlled proof-of-concept trial in 114 patients with postoperative ileus found a median time to first tolerated meal of 25.3 hours against 32.6 with placebo, a difference that did not reach statistical significance (p = 0.15) [1]. Reviews of the GH-axis peptides find no completed efficacy trial supporting the uses it is marketed for today [2].
One neutral trial in an unrelated indication is the entire human record; everything else is extrapolated pharmacology.
That description is now a measurement. Searched in August 2026 the molecule returns 54 indexed papers, 28 carrying the Humans subject heading, and exactly 2 under the clinical-trial publication type, both of which also carry the randomized-controlled-trial type [4]. Both were read. One is the postoperative ileus study above; the other is a dose-escalation pharmacokinetic and pharmacodynamic study in healthy male volunteers, eight subjects at each of five 15-minute infusion rates, which measured concentrations of the peptide and of growth hormone and modeled the relation between them [3].
A pharmacokinetic study is not an outcome trial. Read together, the two records say that the compound reaches the bloodstream and releases growth hormone in a dose-related way, and that the single time anyone measured whether it changed a clinical outcome, it did not.

#### Access
Ipamorelin has no lawful compounding route under either section of the law. Its nominations for the 503A list, which governs pharmacies filling individual prescriptions, were withdrawn on September 19, 2024, and it sits in no 503A category. FDA presented its evaluation to the advisory committee on October 29, 2024 regardless, and the committee voted 0–12, with one abstention, against listing it [6].
Under the separate 503B policy for outsourcing facilities, FDA has kept ipamorelin acetate in Category 2 since September 29, 2023, the file for substances with identified significant safety risks. FDA's page, content current April 22, 2026, still lists it there, citing immunogenicity risk and a published report of serious adverse events, including a death, when it was given intravenously for gastric motility [5]. It was not among the peptides reviewed at the July 2026 PCAC meeting.
Material sold online is research-use-only supply, outside pharmacy oversight.
The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names Ipamorelin among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [8].

#### References
1. Beck DE, Sweeney WB, McCarter MD. Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients. Int J Colorectal Dis. 2014 Dec;29(12):1527-34. https://pubmed.ncbi.nlm.nih.gov/25331030/
2. Dominikowski A, Rękoś Z, Olejarz M, Szczepanek-Parulska E, Domin R, Ruchała M. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration. Front Endocrinol (Lausanne). 2026;17:1822475. https://pubmed.ncbi.nlm.nih.gov/42395176/
3. Gobburu JV, Agersø H, Jusko WJ, Ynddal L. Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers. Pharm Res. 1999;16(9):1412–1416. https://pubmed.ncbi.nlm.nih.gov/10496658/
4. PubMed, National Library of Medicine. Census run August 2026 on "ipamorelin", returning 54 indexed records, 28 carrying the Humans MeSH term, 2 under "clinical trial"[Publication Type] and 2 under "randomized controlled trial"[Publication Type]. Both clinical-trial records were read individually rather than counted: the 2014 postoperative ileus study and the 1999 pharmacokinetic-pharmacodynamic study in healthy volunteers. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type, the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%22ipamorelin%22+AND+%22clinical+trial%22%5BPublication+Type%5D
5. US Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks. Lists ipamorelin acetate under Category 2 of the 503B interim policy, date added September 29, 2023, and among the substances whose 503A nominations were withdrawn; cites immunogenicity risk, unnatural amino acids, and a published report of serious adverse events including death when ipamorelin was administered intravenously for gastric motility. Content current as of April 22, 2026. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
6. US Food and Drug Administration. Pharmacy Compounding Advisory Committee, October 29, 2024, meeting transcript. States that the nominations of ipamorelin acetate and ipamorelin free base were withdrawn on September 19, 2024, and records votes of zero yes, 12 no and 1 abstention on each. Read September 2026. https://www.fda.gov/media/185414/download
7. ClinicalTrials.gov. NCT01280344: Phase II double-blind placebo-controlled dose finding study to evaluate safety and efficacy of ipamorelin compared to placebo for recovery of gastrointestinal function in patients following small or large bowel resection. Sponsor Helsinn Therapeutics; actual enrollment 320; start April 2011; status Completed, May 2014; no results posted. Read September 2026. https://clinicaltrials.gov/study/NCT01280344
8. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution

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### Kisspeptin-10 (KP-10; metastin(45–54))
https://peptideamerica.org/molecules/kisspeptin-10 · status verified August 2026

Status: No lawful route. The only peptide FDA still lists in Category 2 of the 503A bulks list; placed there September 2023, and the advisory committee voted 0–11 against listing it in October 2024.
Class: Neuropeptides · Route: None lawful; compounding is affirmatively barred

Regulatory record:
- September 2023: FDA places Kisspeptin-10 in Category 2 of the interim 503A bulks list, with a date added of September 29, 2023. The stated concern is a risk of immunogenicity for certain routes of administration, complexities of peptide-related impurities and characterization of the active ingredient, and no or only limited safety information for the proposed routes.
- October 2024: The Pharmacy Compounding Advisory Committee votes 0 in favor, 11 against, and 0 abstaining on whether Kisspeptin-10 should be placed on the 503A bulks list. The minutes record that the committee unanimously agreed it should not be included, for lack of convincing safety and efficacy data. The use evaluated was treatment of secondary hypogonadism in men.
- August 2026: Kisspeptin-10 remains in Category 2 of the 503A list published May 14, 2026, and is the only peptide among the six substances in that category. Placement in Category 2 bars a licensed pharmacy from compounding the substance.
- FDA final action: none recorded

#### Definition
Kisspeptin-10 is the shortest active fragment of kisspeptin, the hypothalamic peptide that gates release of gonadotropin-releasing hormone and therefore the entire reproductive axis. Administered to a person, it produces a measurable rise in luteinizing hormone; that response is the reason it is studied and the reason it is sold.
Its regulatory position is unlike anything else in this index. Every other unapproved molecule here sits on no list. This one is named, by FDA, on a list that prohibits it.

#### Evidence
The human literature is real, specific, and almost entirely physiological. Across four name variants PubMed returns 324 indexed records, of which 119 carry the Humans subject heading, 9 the clinical-trial publication type, and 5 the randomized-controlled-trial type [1].
All nine trial-type records were opened and read, and three of them do not belong to this molecule in people: one studies kisspeptin-54, a different fragment; one is conducted in rhesus monkeys; one in female goats [1]. Counting nine would have overstated the record by a third, and the two animal studies carry the clinical-trial publication type regardless.
The six that remain are human endocrine-probe studies. They establish that kisspeptin-10 is a potent stimulator of luteinizing hormone and increases pulse frequency in men [2], and the most recent shows that intermittent subcutaneous administration sustains gonadotropin secretion over twelve days in healthy men rather than desensitizing the axis [3]. What none of them reports is a clinical outcome: no fertility endpoint, no symptom scale, no hypogonadism trial. The record establishes that the compound does something measurable to a hormone, which is a different claim from establishing that it treats anything.

#### Access
There is no lawful United States supply route, and this molecule's position is stronger than that: compounding it is affirmatively barred. FDA placed Kisspeptin-10 in Category 2 of the interim section 503A bulks list with a date added of September 29, 2023, on the stated grounds that compounded drugs containing it may pose a risk for immunogenicity for certain routes of administration, may have complexities with regard to peptide-related impurities and characterization of the active ingredient, and that the agency has no or only limited safety-related information for the proposed routes [4].
On October 29, 2024 the Pharmacy Compounding Advisory Committee voted 0 in favor, 11 against, and 0 abstaining on whether Kisspeptin-10 should be placed on the 503A bulks list. The minutes record that the committee unanimously agreed it should not be included, for lack of convincing safety and efficacy data. The use FDA evaluated was treatment of secondary hypogonadism in men [5].
It remains in Category 2 on the list FDA published on May 14, 2026, where that category contains six substances in total: cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10, and quinacrine hydrochloride for intrauterine administration [6]. Kisspeptin-10 is the only peptide among them. Every other peptide this index tracks has left that category or was never in it; this one is still there, and placement in it bars a licensed pharmacy from compounding the substance. The research-only (https://peptideamerica.org/status/research-only) page covers what an absent route means for a buyer.

#### References
1. PubMed, National Library of Medicine. Census run August 2026 across four name variants — "kisspeptin-10" OR "kisspeptin 10" OR "metastin 45-54" OR "KP-10 peptide" — returning 324 indexed records, 119 carrying the Humans MeSH term, 9 under "clinical trial"[Publication Type] and 5 under "randomized controlled trial"[Publication Type]. All 9 trial-type records were retrieved and read individually; one studies kisspeptin-54 rather than the decapeptide, one is conducted in rhesus monkeys and one in female goats, leaving 6 human studies of this fragment. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22kisspeptin-10%22+OR+%22kisspeptin+10%22+OR+%22metastin+45-54%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. George JT, Veldhuis JD, Roseweir AK, et al. Kisspeptin-10 is a potent stimulator of LH and increases pulse frequency in men. J Clin Endocrinol Metab. 2011;96(8):E1228–E1236. https://pubmed.ncbi.nlm.nih.gov/21632807/
3. Yeung AC, Phylactou M, Koysombat K, et al. Chronic subcutaneous kisspeptin-10 stimulates gonadotropin secretion for 12 days in healthy men. Eur J Endocrinol. 2026;195(2):206–216. https://pubmed.ncbi.nlm.nih.gov/42549827/
4. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, Category 2 table, entry for Kisspeptin-10 (503A, date added September 29, 2023). Read August 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
5. US Food and Drug Administration. Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, October 29, 2024, question 4 and the accompanying table of uses evaluated. Read August 2026. https://www.fda.gov/media/185412/download
6. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026; Category 2 lists six substances, of which Kisspeptin-10 is the only peptide. https://www.fda.gov/media/94155/download

---

### KPV (Lysine-proline-valine; alpha-MSH fragment)
https://peptideamerica.org/molecules/kpv · status verified August 2026

Status: PCAC-recommended · pending. Removed from Category 2 in April 2026; PCAC recommended 503A listing in July 2026 on a reported tally; no FDA final rule.
Class: Repair peptides · Route: None lawful; sold as research-use-only material
July 2026 advisory-committee vote: 8–6, 1 abstaining; reported by McDermott Will & Schulte and LumaLex Law, whose separate accounts of the meeting agree substance by substance.

Regulatory record:
- April 2026: Removed from Category 2 without Category 1 listing.
- July 2026: PCAC votes 8–6 (one abstention) to recommend 503A listing; advisory only. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
- FDA final action: none recorded

#### Definition
KPV is the tripeptide lysine-proline-valine, the C-terminal fragment of alpha-melanocyte-stimulating hormone — alpha-MSH(11–13). The parent hormone has broad anti-inflammatory signaling roles, and the fragment retains a measurable share of that activity in laboratory models without the pigmentation effects of the full hormone [1].
It is studied principally in models of intestinal inflammation, where the peptide transporter PepT1 — induced in the colon during inflammatory bowel disease — carries KPV into epithelial and immune cells [2].

#### Evidence
The record is preclinical without exception. The central paper showed PepT1-mediated KPV uptake reducing NF-κB–driven inflammatory signaling in human cell lines and improving two models of mouse colitis [2]; a parallel murine inflammatory-bowel-disease study reached a similar conclusion the same year [3].
A PubMed search restricted to clinical trials of the tripeptide returns nothing: no human efficacy trial of KPV, for any indication, has been published as of August 2026. The compound is nonetheless sold widely as an oral and injectable supplement, which is a larger gap between marketing and record than most molecules in this index carry.
That search has since been printed rather than described. Across four name variants the tripeptide returns 97 indexed papers, of which 0 carry the clinical-trial publication type and 0 the randomized-controlled-trial type, on a filter that returned 8,904 records for a control term in the same run [4]. The parent hormone, searched the same way in the same session, returns 6,405 papers, 86 clinical trials, and 48 randomized trials [4] — which is the comparison that makes the fragment's zero legible rather than merely small.
Thirty-two of the 97 records carry the Humans subject heading, and that number is a trap rather than a finding. All 32 were read: they are melanocortin receptor pharmacology, assays run in human cell lines, nanoparticle and hydrogel delivery work, and one iontophoresis study conducted across microporated human skin outside the body [4]. The heading marks human tissue and human receptors. It does not mark a person who was given the compound and followed.

#### Access
KPV was removed from Category 2 of the interim 503A bulks list in April 2026 without Category 1 listing. In July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding it to the section 503A list. The margin is reported as 8–6 with one abstention — the same margin BPC-157 received — by McDermott Will & Schulte and by LumaLex Law, whose separate accounts of the meeting agree substance by substance [5, 6]; the FDA has published no minutes, transcript or vote summary, so the figure is secondary and this page says so wherever it appears. The vote is advisory; no FDA final rule has issued, and no licensed pharmacy may lawfully compound KPV as of August 2026.
Material sold online today is research-use-only supply, outside pharmacy oversight. The pending (https://peptideamerica.org/status/pending) page explains what an advisory vote does and does not change.
FDA's stated safety concern is an absence of data rather than an observed harm: its safety-risk page states that FDA has not identified any human exposure data on drug products containing KPV by any route, and that the agency lacks important information on whether KPV would cause harm if given to humans [7].

#### References
1. Luger TA, Brzoska T. alpha-MSH related peptides: a new class of anti-inflammatory and immunomodulating drugs. Ann Rheum Dis. 2007;66 Suppl 3:iii52–iii55. https://pubmed.ncbi.nlm.nih.gov/17934097/
2. Dalmasso G, Charrier-Hisamuddin L, Nguyen HT, Yan Y, Sitaraman S, Merlin D. PepT1-mediated tripeptide KPV uptake reduces intestinal inflammation. Gastroenterology. 2008;134(1):166–178. https://pubmed.ncbi.nlm.nih.gov/18061177/
3. Kannengiesser K, Maaser C, Heidemann J, Luegering A, Ross M, Brzoska T, et al. Melanocortin-derived tripeptide KPV has anti-inflammatory potential in murine models of inflammatory bowel disease. Inflamm Bowel Dis. 2008 Mar;14(3):324-31. https://pubmed.ncbi.nlm.nih.gov/18092346/
4. PubMed, National Library of Medicine. Census run August 2026 across four name variants — "KPV peptide" OR "lysine-proline-valine" OR "Lys-Pro-Val" OR "KPV tripeptide" — returning 97 indexed records, 32 carrying the Humans MeSH term, 0 under "clinical trial"[Publication Type] and 0 under "randomized controlled trial"[Publication Type]. All 32 human-tagged records were read individually rather than counted; they are melanocortin receptor pharmacology, human cell-line assays, delivery-vehicle work, and one iontophoresis study across microporated human skin ex vivo. The parent hormone was searched in the same run — "alpha-MSH" OR "alpha-melanocyte stimulating hormone" OR "alpha melanocyte-stimulating hormone" — returning 6,405 records, 86 clinical trials and 48 randomized trials. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type, the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22KPV+peptide%22+OR+%22lysine-proline-valine%22+OR+%22Lys-Pro-Val%22+OR+%22KPV+tripeptide%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
5. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance.
6. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.
7. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entry for KPV. Read September 2026. The entry states that FDA has not identified any human exposure data on drug products containing KPV administered via any route of administration, and that FDA lacks important information regarding any safety issues raised by KPV, including whether it would cause harm if administered to humans. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

---

### L-carnosine (Carnosine; beta-alanyl-L-histidine)
https://peptideamerica.org/molecules/l-carnosine · status verified September 2026

Status: No lawful route. Category 3 of the 503A bulks list — nominated without adequate support — despite a large randomized literature, almost all of it oral supplementation.
Class: Longevity peptides · Route: None lawful as a compounded drug; widely sold as an oral dietary supplement

Regulatory record:
- May 2026: The section 503A bulks list FDA published May 14, 2026 lists L-Carnosine in Category 3, the file for substances nominated without adequate support to evaluate. It sits in neither of the other two 503A categories.
- September 2026: Drugs@FDA holds no approved product with carnosine as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026. It is lawfully sold as a dietary supplement, which is a separate regulatory regime carrying its own and much lower evidentiary threshold.
- FDA final action: none recorded

#### Definition
L-carnosine is a dipeptide of beta-alanine and L-histidine, present at high concentrations in skeletal muscle and brain. It is a genuine peptide by composition and it behaves in commerce like a nutrient, which is the source of nearly every confusion about it.
Muscle carnosine is raised most reliably not by taking carnosine but by taking beta-alanine, its rate-limiting precursor, which is why a large part of the literature that carries this molecule's name is a beta-alanine literature. This index tracks the substance because it holds a regulatory position no other molecule here does.

#### Evidence
A secondary analysis of the same registered carnosine trial found no improvement in muscle strength, body composition or bone measures after fourteen weeks [8]. The glucose and vascular evidence review (https://peptideamerica.org/evidence/carnosine-glucose-vascular-evidence) distinguishes positive glucose-test results from negative vascular and musculoskeletal findings, without treating each publication as an independent trial.
Across three name variants PubMed returns 3,602 indexed records, of which 1,384 carry the Humans subject heading, 196 the clinical-trial publication type, and 158 the randomized-controlled-trial type [1]. This is by a wide margin the largest randomized literature of any unapproved substance in this index. It is above the itemization ceiling and is reported as a magnitude; the twenty-five most relevant randomized records were read to characterize it [1]. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type, the invalid tag returned zero for that control term, and a deliberately invalid record identifier errored in the same run [1].
Almost all of it is oral supplementation, and the results are mixed in the ordinary way of nutrition trials. One fourteen-week trial generated different findings for different outcomes: glucose-test measures improved in the glucose report [2], while the vascular report found no improvement in the cardiovascular and organ-function measures it assessed [3]. These reports should not be counted as independent replication. In cognition, supplementation improved outcomes in younger participants of one trial [4]. An early double-blind placebo-controlled study tested supplementation in children with autistic spectrum disorders [5]. Beyond those, the randomized set runs through sports performance, oral mucositis, xerostomia, depression and schizophrenia adjuncts — a supplement literature, spread thin across many indications.
What the set does not contain is a trial of an injected peptide. The distinction matters because the compounded and research-use-only market for this molecule is an injectable one, and a reader who checks the literature will find hundreds of randomized records describing something they are not being sold. A large count and a relevant count are different numbers, and here they diverge almost completely.

#### Access
The lawful route is not the one this index usually describes. L-carnosine is sold openly as an oral dietary supplement, which is a distinct regulatory regime: a supplement does not require pre-market approval for safety and effectiveness, and its manufacturer may not make a claim to treat a disease. That is a lower evidentiary threshold than either an approved drug or a compounded preparation, and it is the regime almost every purchaser of this molecule is actually in.
As a bulk drug substance for compounding, the position is different. The section 503A bulks list FDA published May 14, 2026 lists L-Carnosine in Category 3 — the file for substances nominated without adequate support to evaluate — and in neither of the other two categories [6]. A pharmacy therefore has no route to compound it, whatever the supplement aisle contains.
Drugs@FDA holds no approved product with carnosine as an active ingredient; the same query form in the same session returned one application for bremelanotide and fourteen for liraglutide, and returned nothing for a deliberately invented ingredient name [7]. The substance was not among the seven peptides the advisory committee reviewed in July 2026 [6].
The practical consequence is worth stating plainly, because it is the question a reader arrives with. An oral supplement of this dipeptide is lawful to buy. An injectable preparation of it is not a supplement, has no approved product behind it, and has no lawful compounding route; the research-only (https://peptideamerica.org/status/research-only) page explains what is and is not true of material sold on that footing.

#### References
1. PubMed, National Library of Medicine. Census run September 2026 across three name variants — "carnosine" OR "L-carnosine" OR "beta-alanyl-L-histidine" — returning 3,602 indexed records, 1,384 carrying the Humans MeSH term, 196 under "clinical trial"[Publication Type] and 158 under "randomized controlled trial"[Publication Type]. Reported as a magnitude; the 25 most relevant randomized records were retrieved through esummary and read. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22carnosine%22%29+AND+%22randomized+controlled+trial%22%5BPublication+Type%5D
2. Hariharan R, Cameron J, Menon K, Mesinovic J, Jansons P, Scott D, et al. Carnosine supplementation improves glucose control in adults with pre-diabetes and type 2 diabetes: A randomised controlled trial. Nutr Metab Cardiovasc Dis. 2024 Feb;34(2):485-496. https://pubmed.ncbi.nlm.nih.gov/38172006/
3. Saadati S, Cameron J, Menon K, Hodge A, Lu ZX, de Courten M, et al. Carnosine Did Not Affect Vascular and Metabolic Outcomes in Patients with Prediabetes and Type 2 Diabetes: A 14-Week Randomized Controlled Trial. Nutrients. 2023 Nov 19;15(22). https://pubmed.ncbi.nlm.nih.gov/38004228/
4. O'Toole TE, Amraotkar AR, Gao H, Sears CG, Rai SN, Basner M, et al. Carnosine supplementation improves cognitive outcomes in younger participants of the NEAT trial. Neurotherapeutics. 2025 Mar;22(2):e00541. https://pubmed.ncbi.nlm.nih.gov/39919936/
5. Chez MG, Buchanan CP, Aimonovitch MC, Becker M, Schaefer K, Black C, et al. Double-blind, placebo-controlled study of L-carnosine supplementation in children with autistic spectrum disorders. J Child Neurol. 2002 Nov;17(11):833-7. https://pubmed.ncbi.nlm.nih.gov/12585724/
6. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: L-Carnosine appears in Category 3 and in neither Category 1 nor Category 2. https://www.fda.gov/media/94155/download
7. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe run September 2026: a search by active-ingredient name returned no records for carnosine or L-carnosine. In the same run and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none — a positive and a negative control beside the zero. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22CARNOSINE%22
8. Saadati S, Jansons P, Scott D, et al. The Effect of Carnosine Supplementation on Musculoskeletal Health in Adults with Prediabetes and Type 2 Diabetes: A Secondary Analysis of a Randomized Controlled Trial. Nutrients. 2024. Primary record checked October 2026. https://pubmed.ncbi.nlm.nih.gov/39770949/

---

### Liraglutide (Victoza; Saxenda)
https://peptideamerica.org/molecules/liraglutide · status verified August 2026

Status: FDA-approved. Approved since 2010, generic since 2024, and still listed as in shortage — the only molecule in this index whose supply problem is unresolved.
Class: GLP-1 receptor agonists · Route: Subcutaneous injection, once daily · Approved product: Victoza (2010), Saxenda (2014), and approved generics

Regulatory record:
- January 2010: FDA approves liraglutide injection as Victoza under new drug application 022341, effective January 25, 2010; the indication is now an adjunct to diet and exercise for glycemic control in type 2 diabetes and reduction of major adverse cardiovascular events in adults with established cardiovascular disease.
- December 2014: FDA approves a second liraglutide product, Saxenda, under new drug application 206321, effective December 23, 2014, for chronic weight management alongside a reduced-calorie diet and increased physical activity.
- July 2023: Liraglutide injection is entered in FDA's drug shortage database, with a date first posted of July 18, 2023.
- December 2024: FDA approves the first generic liraglutide injection referencing Victoza, under abbreviated new drug application 215503, effective December 23, 2024. The agency's announcement notes that liraglutide injection and certain other GLP-1 medicines are in shortage.
- August 2026: The shortage entry still reads currently in shortage. Two generic manufacturers report both presentations available; the brand manufacturer reports limited availability, with Saxenda 6 mg/mL available until discontinuation in January 2027 and Victoza 6 mg/mL delayed in shipping with no estimated duration.
- FDA final action: none recorded

#### Definition
Liraglutide is a GLP-1 receptor agonist and the oldest member of that class in this index. It is administered once daily rather than weekly, which is the practical difference a reader will notice against semaglutide and tirzepatide, and which is also why it has largely been displaced commercially.
It holds two separate approvals under two brand names for two different purposes, and a generic version has existed since 2024. Its regulatory record is the most complete of any molecule here, and the only one whose supply problem has not been declared over.

#### Evidence
The trial literature is large and belongs to an approved product. Across three name variants PubMed returns 5,901 indexed records, of which 3,668 carry the Humans subject heading, 632 the clinical-trial publication type, and 575 the randomized-controlled-trial type [1]. A literature of that size is reported as a magnitude; this index did not itemize it.
The registrational anchor for weight management is a 56-week randomized controlled trial of 3.0 mg daily in adults with overweight or obesity, published in 2015 [2]. The approved indications state what the evidence was accepted for: glycemic control in type 2 diabetes and reduction of major adverse cardiovascular events in adults with established cardiovascular disease for one product [3], and chronic weight management alongside a reduced-calorie diet and increased physical activity for the other [4].
Both labels carry the same limitation of use, and it is the one most often ignored in practice: the products contain liraglutide, and coadministration with other liraglutide-containing products is not recommended [3][4].

#### Access
The lawful route is the approved product, and there are now several. FDA approved liraglutide as Victoza under new drug application 022341, effective January 25, 2010, and as Saxenda under new drug application 206321, effective December 23, 2014 [3][4]. On December 23, 2024 it approved the first generic liraglutide injection referencing Victoza, and noted in its own announcement that liraglutide injection and certain other GLP-1 medicines were then in shortage [5].
The shortage has not been declared resolved. FDA's drug shortage database lists liraglutide injection with a status of currently in shortage and a date first posted of July 18, 2023 [6]. On the date this page was checked, two generic manufacturers reported both presentations available while the brand manufacturer reported limited availability, with one product available until a stated discontinuation in January 2027 and the other delayed in shipping with no estimated duration [6]. That distinguishes this molecule from semaglutide (https://peptideamerica.org/molecules/semaglutide) and tirzepatide (https://peptideamerica.org/molecules/tirzepatide), whose shortages FDA has formally resolved.
The compounding consequence follows from the statute rather than from any liraglutide-specific announcement, and this index does not invent one: FDA's published statements on compounded GLP-1 drugs address semaglutide, tirzepatide, retatrutide and cagrilintide by name and do not address liraglutide [7]. What can be said without inference is that liraglutide is a component of approved drug products, which is the condition section 503A sets for compounding from a bulk substance without bulks-list listing, and that it appears in no category of the 503A bulks list published on May 14, 2026 [8]. The approved (https://peptideamerica.org/status/approved) page states how the copy rule works.

#### Side effects
The Saxenda label lists the adverse reactions reported in at least 5 percent of treated patients: nausea, diarrhea, constipation, vomiting, injection site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, upper abdominal pain, fever and gastroenteritis [9]. In the adult weight-management trials, 9.8 percent of treated patients stopped because of an adverse reaction against 4.3 percent on placebo, and nausea was the most common reason [9]. The Victoza label, written for type 2 diabetes, names nausea, diarrhea, vomiting, decreased appetite, dyspepsia and constipation as its most common reactions [10].
Both labels carry a boxed warning for thyroid C-cell tumors. Liraglutide caused them in rats and mice, whether it does so in humans is unknown, and postmarketing reports of medullary thyroid carcinoma in treated patients are insufficient to establish or exclude a causal link [9][10]. The drug is contraindicated for anyone with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia syndrome type 2, and for anyone with a prior serious hypersensitivity reaction to liraglutide [9].
The other warnings cover acute pancreatitis, including fatal hemorrhagic or necrotizing cases; acute gallbladder disease, with gallstones reported in 2.2 percent of Saxenda-treated adults against 0.8 percent on placebo; hypoglycemia when combined with insulin or an insulin secretagogue; a rise in resting heart rate; acute kidney injury after dehydration from vomiting or diarrhea; severe gastrointestinal reactions; serious allergic reactions; and pulmonary aspiration during general anesthesia or deep sedation [9]. The Saxenda label does not recommend the drug for people with severe gastroparesis [9].
Generic liraglutide carries the same boxed warning as the brand it references [11].

#### Questions
Q: Is liraglutide FDA-approved?
A: Yes. FDA approved liraglutide as Victoza for type 2 diabetes in January 2010 and as Saxenda for chronic weight management in December 2014 [3][4]. The index records it as approved as of September 2026.
Q: What is the difference between Saxenda and Victoza?
A: They contain the same molecule under two labels. Saxenda is indicated, with diet and exercise, to reduce excess body weight in adults and in children 12 and older who weigh more than 60 kg and have obesity, and in adults with overweight and a weight-related condition [9]; Victoza is indicated for blood sugar control in type 2 diabetes and to reduce major cardiovascular events in adults with type 2 diabetes and cardiovascular disease [10].
Q: Is there a generic liraglutide?
A: Yes. FDA approved the first generic liraglutide referencing Victoza in December 2024 [5], and generic liraglutide labeled for weight management is also on DailyMed [11].
Q: What are the most common side effects of liraglutide?
A: Gastrointestinal effects lead the Saxenda label: nausea, diarrhea, constipation, vomiting and abdominal pain, followed by injection site reactions, headache, low blood sugar, fatigue and dizziness [9]. The [side effects](#side-effects) section above lists the label's warnings as well.
Q: Does liraglutide cause thyroid cancer?
A: It is not known. Liraglutide caused thyroid C-cell tumors in rodents, both labels carry a boxed warning for that finding, and the drug is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with MEN 2 [9][10].
Q: How is liraglutide different from semaglutide?
A: Both are GLP-1 receptor agonists approved for chronic weight management, but liraglutide is given once daily and semaglutide (https://peptideamerica.org/molecules/semaglutide) once weekly. The weight-loss peptides by status (https://peptideamerica.org/evidence/weight-loss-peptides-by-status) review sets every molecule sold for weight side by side.

#### References
1. PubMed, National Library of Medicine. Census run August 2026 across three name variants — "liraglutide" OR "Victoza" OR "Saxenda" — returning 5,901 indexed records, 3,668 carrying the Humans MeSH term, 632 under "clinical trial"[Publication Type] and 575 under "randomized controlled trial"[Publication Type]. A literature of this size is reported as a magnitude and was not itemized record by record. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22liraglutide%22+OR+%22Victoza%22+OR+%22Saxenda%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. Pi-Sunyer X, Astrup A, Fujioka K, et al. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015;373(1):11–22. https://pubmed.ncbi.nlm.nih.gov/26132939/
3. US Food and Drug Administration. VICTOZA (liraglutide) injection, for subcutaneous use — prescribing information, NDA 022341 supplement 046, approved October 14, 2025; Indications and Usage and Limitations of Use. Read August 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022341s046lbl.pdf
4. US Food and Drug Administration. SAXENDA (liraglutide) injection, for subcutaneous use — prescribing information, NDA 206321 supplement 024, approved June 2, 2026; Indications and Usage and Limitations of Use. Read August 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206321Orig1s024lbl.pdf
5. US Food and Drug Administration. FDA approves first generic of once-daily GLP-1 injection to lower blood sugar in patients with type 2 diabetes. Press announcement, December 23, 2024. Read August 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes
6. US Food and Drug Administration. Drug Shortages database, active ingredient detail for Liraglutide Injection: status "Currently in Shortage", date first posted July 18, 2023, with company availability panels revised August 2026. Read August 2026. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Liraglutide+Injection&st=c
7. US Food and Drug Administration. FDA's concerns with unapproved GLP-1 drugs used for weight loss, content current as of June 15, 2026. Read in full August 2026; the page addresses semaglutide, tirzepatide, retatrutide and cagrilintide, and states no liraglutide-specific compounding position. https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
8. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: liraglutide appears in none of Category 1, Category 2, or Category 3. https://www.fda.gov/media/94155/download
9. Novo Nordisk. SAXENDA (liraglutide) injection, US prescribing information. Revised June 2026. DailyMed set ID 3946d389-0926-4f77-a708-0acb8153b143. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3946d389-0926-4f77-a708-0acb8153b143
10. Novo Nordisk. VICTOZA (liraglutide) injection, US prescribing information. Revised October 2025. DailyMed set ID 5a9ef4ea-c76a-4d34-a604-27c5b505f5a4. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4
11. Liraglutide injection, US prescribing information for a generic product approved under ANDA 214568 and indicated to reduce excess body weight and maintain weight reduction long term. Revised February 2026. DailyMed set ID 625ac780-70a9-41e4-a892-bcba0f803f1c. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=625ac780-70a9-41e4-a892-bcba0f803f1c

---

### LL-37 (Cathelicidin LL-37; hCAP18)
https://peptideamerica.org/molecules/ll-37 · status verified August 2026

Status: No lawful route. Nomination withdrawn in 2026; on no list. FDA's safety finding cites nonclinical evidence of harm to male reproduction and of pro-tumorigenic effects in some tissues.
Class: Immune peptides · Route: None lawful; sold as research-use-only material

Regulatory record:
- April 2020: FDA warns a Kentucky compounding pharmacy that drug products it compounded using LL-37 and twenty-one other substances are not eligible for the exemptions in section 503A(a); the letter states that the substances had not been nominated for inclusion on the 503A bulks list.
- April 2026: The nomination is withdrawn by its nominators and cathelicidin LL-37 leaves Category 2 of the interim 503A bulks list without being added to Category 1; it appears in no category of the list FDA published on May 14, 2026.
- August 2026: FDA continues to publish the safety finding: it lacks sufficient safety-related information to know whether the drug would cause harm when administered to humans, and nonclinical research findings suggest detrimental effects on male reproduction and that the drug can be pro-tumorigenic in some tissues.
- FDA final action: none recorded

#### Definition
LL-37 is the only cathelicidin-derived antimicrobial peptide found in humans, cleaved from the precursor protein hCAP18. It is produced by neutrophils and by epithelial cells at barrier surfaces, and its expression is induced by vitamin D, which is why so much of its literature is a vitamin D literature [1].
Its functions extend past direct antimicrobial killing to chemotaxis, wound repair, and modulation of inflammation [2]. That breadth is the reason it is marketed, and also the reason its record is easy to misread: a peptide the body already makes accumulates studies about the body making it.

#### Evidence
The topical wound trials do not give a uniform efficacy result. A 34-person pilot reported favorable healing signals, but the larger HEAL LL-37 study found no significant healing advantage in its full population; its favorable large-wound analysis was post hoc [8, 9]. A separate 19-person study measured naturally occurring LL-37 rather than administering it [10]. The wound-healing review (https://peptideamerica.org/evidence/ll-37-wound-healing-trials) separates those designs and their limits for injectable claims.
The distinction that governs this page is between a study of the peptide and a study of the person's own peptide. Across five name variants, PubMed returns 3,076 indexed records, of which 2,199 carry the Humans subject heading, 72 the clinical-trial publication type, and 45 the randomized-controlled-trial type [3].
All seventy-two trial-type records were opened and read rather than counted, and sixty-eight of them do not administer LL-37 to anyone. They measure a participant's own cathelicidin concentration after vitamin D supplementation, after exercise, after a probiotic, or as a biomarker in tuberculosis, cystic fibrosis, chronic obstructive pulmonary disease, sepsis, and periprosthetic joint infection [3]. Reported as a trial count for the compound, seventy-two would have been a false number by a factor of eighteen.
Four records administer the peptide. Three are wound-healing studies: two randomized placebo-controlled trials of LL-37 in hard-to-heal venous leg ulcers, published in 2014 and 2021, and a 2023 randomized trial of an LL-37 cream in diabetic foot ulcer [3]. The fourth is a 2023 randomized trial of an oral preparation against a SARS-CoV-2 variant [3]. All four are topical or oral. None is an injectable study, and injection is the route the compound is sold for.

#### Access
There is no lawful United States supply route. Cathelicidin LL-37 sat in Category 2 of FDA's interim section 503A bulks list and left it in April 2026 when the nomination was withdrawn by its nominators. It was not added to Category 1, and it appears in no category of the list FDA published on May 14, 2026 [4].
FDA's safety finding survives the withdrawal and is unusually specific. The agency states that it lacks sufficient safety-related information regarding cathelicidin LL-37 to know whether the drug would cause harm when administered to humans, and that nonclinical research findings suggest detrimental effects on male reproduction and that the drug can be pro-tumorigenic in some tissues [5]. Most entries in that table record an absence of information; this one records an absence of information alongside two directional signals of harm.
Enforcement history exists as well. In April 2020 FDA warned a compounding pharmacy that products it compounded using LL-37 and twenty-one other substances were not eligible for the exemptions in section 503A(a), and stated in the same letter that those substances had not been nominated for inclusion on the 503A bulks list [6]. Material sold under this name is research-use-only chemical supply; the research-only (https://peptideamerica.org/status/research-only) page explains what that posture does and does not mean.
The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names LL-37 among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [7].

#### References
1. Fabisiak A, Murawska N, Fichna J. LL-37: Cathelicidin-related antimicrobial peptide with pleiotropic activity. Pharmacol Rep. 2016;68(4):802–808. https://pubmed.ncbi.nlm.nih.gov/27117377/
2. Bucki R, Leszczyńska K, Namiot A, et al. Cathelicidin LL-37: a multitask antimicrobial peptide. Arch Immunol Ther Exp (Warsz). 2010;58(1):15–25. https://pubmed.ncbi.nlm.nih.gov/20049649/
3. PubMed, National Library of Medicine. Census run August 2026 across five name variants — "LL-37" OR "LL37" OR "cathelicidin LL-37" OR "hCAP18" OR "hCAP-18" — returning 3,076 indexed records, 2,199 carrying the Humans MeSH term, 72 under "clinical trial"[Publication Type] and 45 under "randomized controlled trial"[Publication Type]. All 72 trial-type records were retrieved and read individually. Sixty-eight measure endogenous cathelicidin in participants rather than administering the peptide. Four administer it: randomized placebo-controlled trials in hard-to-heal venous leg ulcers (2014 and 2021), a randomized double-blind trial of an LL-37 cream in diabetic foot ulcer (2023), and a randomized trial of an oral preparation against a SARS-CoV-2 variant (2023). The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22LL-37%22+OR+%22LL37%22+OR+%22cathelicidin+LL-37%22+OR+%22hCAP18%22+OR+%22hCAP-18%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
4. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: cathelicidin LL-37 appears in none of Category 1, Category 2, or Category 3. https://www.fda.gov/media/94155/download
5. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for Cathelicidin LL-37 in the table of substances nominated but withdrawn. Read August 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
6. US Food and Drug Administration. Warning letter, Tailor Made Compounding LLC, case 594743, April 1, 2020. Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
7. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution
8. Grönberg A, Mahlapuu M, Ståhle M, et al. Treatment with LL-37 is safe and effective in enhancing healing of hard-to-heal venous leg ulcers: a randomized, placebo-controlled clinical trial. Wound Repair Regen. 2014. Primary record checked October 2026. https://pubmed.ncbi.nlm.nih.gov/25041740/
9. Mahlapuu M, Sidorowicz A, Mikosinski J, et al. Evaluation of LL-37 in healing of hard-to-heal venous leg ulcers: A multicentric prospective randomized placebo-controlled clinical trial. Wound Repair Regen. 2021. Primary record checked October 2026. https://pubmed.ncbi.nlm.nih.gov/34687253/
10. Krejner A, Litwiniuk M, Grzela T. LL-37 but Not 25-Hydroxy-Vitamin D Serum Level Correlates with Healing of Venous Leg Ulcers. Arch Immunol Ther Exp (Warsz). 2017. Primary record checked October 2026. https://pubmed.ncbi.nlm.nih.gov/27663530/

---

### Mechano growth factor (MGF; IGF-1Ec)
https://peptideamerica.org/molecules/mgf · status verified September 2026

Status: No lawful route. Category 3 of the 503A bulks list — nominated without adequate support. The pegylated form sits in no category at all, its nomination withdrawn.
Class: Growth factor fragments · Route: None lawful; sold as research-use-only material

Regulatory record:
- May 2026: The section 503A bulks list FDA published May 14, 2026 lists mechano growth factor (MGF) in Category 3, the file for substances nominated without adequate support to evaluate. The pegylated form appears in no category of the same document; that separate disposition is recorded on the PEG-MGF row.
- September 2026: Drugs@FDA holds no approved product with mechano growth factor as an active ingredient, and neither form was among the seven peptides the advisory committee reviewed in July 2026. Two forms of one molecule therefore hold two different dispositions and the same absence of a lawful route.
- FDA final action: none recorded

#### Definition
Mechano growth factor is a splice variant of insulin-like growth factor 1, produced in skeletal muscle in response to mechanical loading and damage. It is also written IGF-1Ec, which is the name the physiology literature mostly uses, and the two names describe one thing: a locally expressed peptide whose job is to signal that a muscle has been worked.
It reaches buyers as synthetic research-use-only material, in two forms. The unpegylated peptide is what this page tracks. The pegylated form, PEG-MGF (https://peptideamerica.org/molecules/peg-mgf), is a separate substance in the federal record with a separate and different disposition, and the distinction is invisible on the products themselves.

#### Evidence
Across five name variants PubMed returns 236 indexed records, of which 134 carry the Humans subject heading, 12 the clinical-trial publication type, and 11 the randomized-controlled-trial type [1]. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type, the invalid tag returned zero for that control term, and a deliberately invalid record identifier errored in the same run [1].
All twelve trial-type records were opened, and not one of them administers the peptide. Every one measures how much mechano growth factor a person's own muscle expresses after an intervention: resistance training with or without recombinant growth hormone [2], therapeutic ultrasound applied to skeletal muscle [3], testosterone therapy alongside resistance exercise in older men [4], neuromuscular electrical stimulation, high-intensity interval training, and comparable designs [1]. The count is a count of exercise physiology, and the exercise is the intervention.
That distinction decides what the literature can support. A study showing that heavy loading raises expression of a locally acting splice variant establishes something about how muscle responds to loading; it establishes nothing about what happens when a synthetic version of that variant is injected, because no indexed trial has done that. The gap is not that the evidence is weak. The gap is that the evidence is about a different experiment.

#### Access
There is no lawful United States supply route. Drugs@FDA holds no approved product with mechano growth factor as an active ingredient; the same query form in the same session returned one application for bremelanotide and fourteen for liraglutide, and returned nothing for a deliberately invented ingredient name [5].
The section 503A bulks list FDA published May 14, 2026 lists mechano growth factor (MGF) in Category 3 — the file for substances nominated without adequate support to evaluate [6]. Category 3 is not a safety finding and it is not a permission; it records that the submission behind the nomination was too thin to review. The substance appears in neither Category 1 nor Category 2 of the same document.
The pegylated form is in a different position again. PEG-MGF appears in no category of that list, because its nomination was withdrawn by its nominators; FDA's Category 2 safety-risk page still carries the concern it recorded while the nomination stood, which is that the agency identified no human exposure data for the substance by any route [7]. Neither form has a route, and the reasons differ. That is the whole of what separates them.
Neither form was among the seven peptides the advisory committee reviewed in July 2026 [6]. Both are sold as research-use-only material (https://peptideamerica.org/status/research-only).

#### References
1. PubMed, National Library of Medicine. Census run September 2026 across five name variants — "mechano growth factor" OR "mechano-growth factor" OR "IGF-1Ec" OR "IGF-1 Ec" OR "MGF peptide" — returning 236 indexed records, 134 carrying the Humans MeSH term, 12 under "clinical trial"[Publication Type] and 11 under "randomized controlled trial"[Publication Type]. All 12 trial-type records were retrieved through esummary and read individually; every one measures endogenous expression after an exercise or hormonal intervention and none administers the peptide. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22mechano+growth+factor%22+OR+%22IGF-1Ec%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. Hameed M, Lange KH, Andersen JL, Schjerling P, Kjaer M, Harridge SD, et al. The effect of recombinant human growth hormone and resistance training on IGF-I mRNA expression in the muscles of elderly men. J Physiol. 2004 Feb 15;555(Pt 1):231-40. https://pubmed.ncbi.nlm.nih.gov/14565994/
3. Delgado-Diaz DC, Gordon BS, Dompier T, Burgess S, Dumke C, Mazoué C, et al. Therapeutic ultrasound affects IGF-1 splice variant expression in human skeletal muscle. Am J Sports Med. 2011 Oct;39(10):2233-41. https://pubmed.ncbi.nlm.nih.gov/21785002/
4. Gharahdaghi N, Rudrappa S, Brook MS, Idris I, Crossland H, Hamrock C, et al. Testosterone therapy induces molecular programming augmenting physiological adaptations to resistance exercise in older men. J Cachexia Sarcopenia Muscle. 2019 Dec;10(6):1276-1294. https://pubmed.ncbi.nlm.nih.gov/31568675/
5. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe run September 2026: a search by active-ingredient name returned no records for mechano growth factor. In the same run and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none — a positive and a negative control beside the zero. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22MECHANO+GROWTH+FACTOR%22
6. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: Mechano growth factor (MGF) appears in Category 3; the pegylated form appears in no category. https://www.fda.gov/media/94155/download
7. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026. Read September 2026: Mechano growth factor pegylated (PEG-MGF) appears on the list of substances previously in category 2 whose nominations were withdrawn. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

---

### Melanotan II (Melanotan-2; MT-II)
https://peptideamerica.org/molecules/melanotan-ii · status verified August 2026

Status: No lawful route. Nomination withdrawn in 2026; on no list. FDA's published safety finding — melanoma, priapism, and two acute toxicity syndromes in case reports — was never retracted.
Class: Melanocortins · Route: None lawful; sold as research-use-only material

Regulatory record:
- April 2020: FDA warns a Kentucky compounding pharmacy that drug products it compounded using Melanotan II and twenty-one other substances are not eligible for the exemptions in section 503A(a), because the substances are not the subject of an applicable USP or NF monograph, are not a component of an FDA-approved human drug, and do not appear on the 503A bulks list.
- April 2026: The nomination is withdrawn by its nominators and Melanotan II leaves Category 2 of the interim 503A bulks list. It is not added to Category 1, and it appears in no category of the list FDA published on May 14, 2026.
- August 2026: FDA still publishes its Category 2 safety finding for the substance among those nominated but withdrawn: compounded drugs containing Melanotan II may pose a risk for immunogenicity, and published case reports discuss melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome, and priapism. The withdrawal removed the substance from the category; it did not retract the finding.
- FDA final action: none recorded

#### Definition
Melanotan II is a synthetic cyclic analogue of alpha-melanocyte-stimulating hormone. It is a non-selective agonist at melanocortin receptors, which is the source of both the pigmentation it is sold for and the effects it was actually studied for.
The compound is marketed almost entirely as a tanning agent. Its human record is not a tanning record; it is a sexual-function record, and the distance between the two is the central fact of this page.

#### Evidence
Four records carry a clinical-trial publication type across five name variants, and all four were read individually rather than counted. A 1996 pilot phase I study established that the peptide produced measurable melanogenesis and, incidentally, spontaneous erections in the men who received it [1]. The three that followed pursued the incidental finding: a double-blind placebo-controlled crossover study in men with psychogenic erectile dysfunction [2], a summary of the human melanocortin work [3], and a study in men with organic erectile dysfunction [4].
The census is the finding. Across the variants "melanotan II", "melanotan-II", "melanotan 2", "melanotan-2", and "MT-II peptide", PubMed returns 360 indexed records, of which 119 carry the Humans subject heading, 4 the clinical-trial publication type, and 1 the randomized-controlled-trial type [5]. Every one of the four was published between 1996 and 2000. Not one studies tanning, which is the use the compound is sold for; the human record for that use is empty, and it has been empty for twenty-six years.
What has accumulated instead is a case-report literature. Melanoma has been reported in association with use [6], as have renal infarction [7], priapism [8], and systemic toxicity with rhabdomyolysis after injection [9]. Case reports establish association rather than cause, and the honest statement is that the published harms are documented while the published benefit for the marketed use does not exist.

#### Access
There is no lawful United States supply route. Melanotan II was placed in Category 2 of FDA's interim section 503A bulks list — the category for substances that raise significant safety risks — and left that category in April 2026 when its nominators withdrew the nomination. It was not added to Category 1. On the list FDA published on May 14, 2026 it appears in no category at all [10].
Removal did not retract the finding. FDA continues to publish the safety statement for Melanotan II among substances nominated but withdrawn: compounded drugs containing it may pose a risk for immunogenicity, and published case reports discuss serious adverse events including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome, and priapism [11]. A substance whose safety statement still stands and whose nomination no longer does is further from lawful compounding than it was before, not closer. The research-only (https://peptideamerica.org/status/research-only) page sets out why removal from a list is not permission.
FDA has also addressed the compound in enforcement. In April 2020 it warned a compounding pharmacy that drug products compounded using Melanotan II and twenty-one other substances were not eligible for the exemptions in section 503A(a), because the substances were not the subject of an applicable USP or NF monograph, were not a component of an FDA-approved human drug, and did not appear on the 503A bulks list [12]. Material sold under this name today is research-use-only chemical supply, produced and sold outside pharmacy licensure and prescriber oversight.
The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names Melanotan II among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [15].

#### References
1. Dorr RT, Lines R, Levine N, et al. Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study. Life Sci. 1996;58(20):1777–1784. https://pubmed.ncbi.nlm.nih.gov/8637402/
2. Wessells H, Fuciarelli K, Hansen J, et al. Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study. J Urol. 1998;160(2):389–393. https://pubmed.ncbi.nlm.nih.gov/9679884/
3. Wessells H, Levine N, Hadley ME, et al. Melanocortin receptor agonists, penile erection, and sexual motivation: human studies with Melanotan II. Int J Impot Res. 2000;12 Suppl 4:S74–S79. https://pubmed.ncbi.nlm.nih.gov/11035391/
4. Wessells H, Gralnek D, Dorr R, et al. Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction. Urology. 2000;56(4):641–646. https://pubmed.ncbi.nlm.nih.gov/11018622/
5. PubMed, National Library of Medicine. Census run August 2026 across five name variants — "melanotan II" OR "melanotan-II" OR "melanotan 2" OR "melanotan-2" OR "MT-II peptide" — returning 360 indexed records, 119 carrying the Humans MeSH term, 4 under "clinical trial"[Publication Type] and 1 under "randomized controlled trial"[Publication Type]. All four trial-type records were opened and read; every one concerns erectile function or sexual desire and every one was published between 1996 and 2000. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22melanotan+II%22+OR+%22melanotan-II%22+OR+%22melanotan+2%22+OR+%22melanotan-2%22+OR+%22MT-II+peptide%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
6. Paurobally D, Jason F, Dezfoulian B, et al. Melanotan-associated melanoma. Br J Dermatol. 2011;164(6):1403–1405. https://pubmed.ncbi.nlm.nih.gov/21564053/
7. Peters B, Hadimeri H, Wahlberg R, et al. Melanotan II: a possible cause of renal infarction: review of the literature and case report. CEN Case Rep. 2020;9(2):159–161. https://pubmed.ncbi.nlm.nih.gov/31953620/
8. Dreyer BA, Amer T, Fraser M. Melanotan-induced priapism: a hard-earned tan. BMJ Case Rep. 2019;12(2). https://pubmed.ncbi.nlm.nih.gov/30796078/
9. Nelson ME, Bryant SM, Aks SE. Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clin Toxicol (Phila). 2012;50(10):1169–1173. https://pubmed.ncbi.nlm.nih.gov/23121206/
10. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: Melanotan II appears in none of Category 1, Category 2, or Category 3. https://www.fda.gov/media/94155/download
11. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn. Read August 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
12. US Food and Drug Administration. Warning letter, Tailor Made Compounding LLC, case 594743, April 1, 2020. Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
13. PubMed, National Library of Medicine. Census extended September 2026 on the same five name variants as reference 5. The union re-measured at 360 indexed records, 119 tagged Humans, 4 under "clinical trial"[Publication Type] and 1 under "randomized controlled trial"[Publication Type], identical to the August 2026 run. Combined with "case reports"[Publication Type] the names return 23 records, 21 of them tagged Humans; combined with the term melanoma they return 17 records, 9 of them case reports; combined with the terms tanning, tan or sunless they return 23 records, of which exactly 1 carries a trial publication type, and that record is the 1996 pilot phase I study in three volunteers. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22melanotan+II%22+OR+%22melanotan-II%22+OR+%22melanotan+2%22+OR+%22melanotan-2%22+OR+%22MT-II+peptide%22%29+AND+%22case+reports%22%5BPublication+Type%5D
14. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name, the substance name and the brand name for "melanotan": no matching application. Control in the same run: the identical query for "bremelanotide" returned NDA 210557. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22melanotan%22
15. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution

---

### MOTS-c
https://peptideamerica.org/molecules/mots-c · status verified August 2026

Status: PCAC-recommended · pending. Removed from Category 2 in April 2026; PCAC recommended 503A listing in July 2026 on a reported tally; no FDA final rule.
Class: Mitochondrial · Route: None lawful; sold as research-use-only material
July 2026 advisory-committee vote: 7–5, 2 abstaining; reported by McDermott Will & Schulte and LumaLex Law, whose separate accounts of the meeting agree substance by substance.

Regulatory record:
- April 2026: Removed from Category 2 without Category 1 listing.
- July 2026: PCAC votes 7–5 (two abstentions) to recommend 503A listing; advisory only. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
- FDA final action: none recorded

#### Definition
MOTS-c is a 16-amino-acid peptide encoded within the mitochondrial genome, one of a small family of mitochondrial-derived peptides described over the past decade; it acts as a metabolic signaling molecule rather than a structural protein.
Interest in the compound comes from exercise physiology and metabolism, where it is studied as a messenger linking mitochondrial state to whole-body insulin sensitivity.

#### Evidence
The foundational work is preclinical: the 2015 discovery paper showed MOTS-c promoting metabolic homeostasis and reducing diet-induced obesity and insulin resistance in mice [1]. Human data remain early and largely observational; no efficacy trial supports a clinical use.
The compound is marketed to athletes and biohackers well ahead of that record; the marketing claims run years in front of any human data.

#### Access
MOTS-c was removed from Category 2 of the interim 503A bulks list in April 2026 without Category 1 listing, and in July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding it to the section 503A list. The margin is reported as 7–5 with two abstentions by McDermott Will & Schulte and by LumaLex Law, whose separate accounts of the meeting agree substance by substance [2, 3]; the FDA has published no minutes, transcript or vote summary, so the figure is secondary and this page says so wherever it appears. The vote is advisory; no FDA final rule has issued, and no licensed pharmacy may lawfully compound MOTS-c as of August 2026.
Material sold online today is research-use-only supply, outside pharmacy oversight.

#### References
1. Lee C, Zeng J, Drew BG, et al. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metab. 2015;21(3):443–454. https://pubmed.ncbi.nlm.nih.gov/25738459/
2. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance.
3. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.
4. PubMed, National Library of Medicine. Census run September 2026 across three name variants — "MOTS-c" OR "MOTS-C peptide" OR "mitochondrial open reading frame of the twelve S rRNA type-c" — returning 254 indexed records, 143 carrying the Humans MeSH term, 5 under "clinical trial"[Publication Type] and 4 under "randomized controlled trial"[Publication Type]; 92 records carry the mice or rats MeSH terms, and 25 carry both the term exercise and the Humans term. All five trial-type records were opened and read, and not one administers the peptide: a 2020 multicenter study using circulating MOTS-c as a predictor of outcome in diabetic patients with coronary disease, a 2021 study of circulating MOTS-c after a single bout of endurance or resistance exercise, a 2021 study of circulating MOTS-c after a 16-week exercise program in breast cancer survivors, a 2022 study of circulating MOTS-c in breast cancer patients randomized to metformin that found no significant change, and a 2025 study of circulating MOTS-c after repeated heat exposure during limb immobilization. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. The counts reproduce the August 2026 run behind the trial-record table exactly. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22MOTS-c%22+OR+%22MOTS-C+peptide%22+OR+%22mitochondrial+open+reading+frame+of+the+twelve+S+rRNA+type-c%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
5. von Walden F, Fernandez-Gonzalo R, Norrbom J, et al. Acute endurance exercise stimulates circulating levels of mitochondrial-derived peptides in humans. J Appl Physiol (1985). 2021;131(3):1035–1042. https://pubmed.ncbi.nlm.nih.gov/34351816/
6. Dieli-Conwright CM, Sami N, Norris MK, et al. Effect of aerobic and resistance exercise on the mitochondrial peptide MOTS-c in Hispanic and Non-Hispanic White breast cancer survivors. Sci Rep. 2021;11(1):16916. https://pubmed.ncbi.nlm.nih.gov/34413391/
7. Elhusseiny R, Ihsan M, Labidi M, et al. Repeated Heat Stress Modulates the Levels of the Mitokines MOTS-C and FGF21 in Active Men during Calf Muscle Immobilization. Med Sci Sports Exerc. 2025;57(12):2764–2774. https://pubmed.ncbi.nlm.nih.gov/40674654/
8. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entry for MOTs-C (the page's spelling). Read September 2026. The entry states that compounded drugs containing the substance may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization, that FDA has not identified any human exposure data on drug products containing it administered via any route of administration, and that FDA lacks important information regarding any safety issues it raises, including whether it would cause harm if administered to humans. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
9. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full September 2026: "MOTS" occurs nowhere in the document, so the substance appears in none of Category 1, Category 2, or Category 3. Control in the same read: the same document names GHK-Cu six times. https://www.fda.gov/media/94155/download
10. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name, the substance name and the brand name for "MOTS-c": no matching application. Control in the same run: the identical query for "bremelanotide" returned NDA 210557. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22MOTS-c%22

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### NAD+ (Nicotinamide adenine dinucleotide)
https://peptideamerica.org/molecules/nad · status verified August 2026

Status: Compoundable (503A). Category 1 of the interim 503A bulks list; compoundable with a valid prescription while FDA evaluates.
Class: Mitochondrial · Route: Injection; IV infusion

Regulatory record:
- August 2026: Listed in Category 1 of the interim 503A bulks list; pharmacies may compound while FDA review continues.
- FDA final action: none recorded

#### Definition
Nicotinamide adenine dinucleotide is a coenzyme central to cellular energy metabolism and a substrate for enzymes implicated in aging biology; it is not a peptide, and it appears in this index because it is prescribed and marketed alongside peptide therapy by the same providers.
Levels decline with age in many tissues, which is the observation the injectable market is built on; whether raising circulating NAD+ changes any clinical outcome is a separate question.

#### Evidence
The interventional evidence comes almost entirely from oral precursors rather than NAD+ itself: a 2026 systematic review of nicotinamide mononucleotide trials reports consistent safety and modest metabolic effects [1], and reviews of NAD+ biology note that direct intravenous or injectable NAD+ has little published human trial data behind it [2].
The gap matters when reading marketing: trial results for oral precursors are routinely cited in support of injections and infusions that those trials did not study.
Counted separately in August 2026, the three literatures are of very different sizes. Nicotinamide riboside returns 952 indexed papers and 42 clinical trials, of which 32 carry the randomized-controlled-trial type; nicotinamide mononucleotide returns 1,713 papers and 22 clinical trials, of which 16 are randomized; the phrase set that names an infused or intravenous NAD+ preparation returns 22 papers in total, of which 4 carry the clinical-trial type and 1 the randomized type [5].
Those four were read individually rather than counted, and three of them concern something else — a chemotherapy sequence in esophageal cancer, a topical preparation for psoriasis, and a 1972 review of nicotinic acid in schizophrenia [5]. The fourth is a genuine randomized placebo-controlled trial, and its subject is neither aging nor wellness: 180 adults with heart failure from ischemic cardiomyopathy and an ejection fraction at or below 45 percent received intravenous NAD+ at 10 mg daily or placebo for seven days alongside guideline-directed therapy, with the change in ejection fraction at one month as the primary endpoint [4].
The one published human study of the infusion itself is a pilot pharmacokinetic investigation rather than an outcome trial, and its result is worth stating plainly: during a six-hour intravenous infusion of NAD+ at 3 micromoles per minute, plasma NAD+ and its measured metabolites did not change until after the second hour, which the authors read as complete removal of the infused compound from plasma over that period [3].

#### Access
NAD+ is listed in Category 1 of the FDA's interim 503A bulks list; licensed pharmacies may compound it with a valid prescription while the agency's review continues.
Category 1 is a permission to compound during review, not an approval, and the index records it as such.

#### Side effects
No randomized trial has published a safety profile for the NAD+ injections and infusions sold for energy, recovery or longevity. The only randomized trial of intravenous NAD+ studied 180 adults with heart failure over seven days and reported heart function and cardiovascular events as its outcomes [4], and the one pharmacokinetic study of an NAD+ infusion measured blood and urine levels in a small cohort [3].
The tolerability data that exist come from oral precursors. A 2026 review of 15 randomized trials of oral nicotinamide mononucleotide, lasting 14 days to 24 weeks, found no increase in adverse events, serious adverse events or liver enzymes [1]. That result describes a supplement taken by mouth; it does not transfer to NAD+ given by injection or infusion, which is a different compound delivered by a different route.

#### Questions
Q: Is NAD+ injection legal in the US?
A: Yes, with a prescription. NAD+ sits in Category 1 of the interim 503A bulks list, so a licensed pharmacy may compound it while the FDA evaluates it; the index records it as compoundable as of September 2026.
Q: Is NAD+ injection FDA-approved?
A: No. No NAD+ injection or infusion product is FDA-approved; compounded NAD+ is prepared by pharmacies under section 503A, and compounded drugs are not reviewed by the FDA for safety or effectiveness.
Q: What are the side effects of NAD+ injections?
A: They are poorly documented. No randomized trial has reported a safety profile for wellness NAD+ injections or infusions; the reassuring safety data that exist come from oral precursors such as nicotinamide mononucleotide, a different compound taken by mouth [1].
Q: Is NAD+ a peptide?
A: No. NAD+ is a coenzyme, not a peptide; it appears in this index because the same telehealth programs prescribe it alongside peptide therapies. The evidence review on NAD+ infusions (https://peptideamerica.org/evidence/nad-infusion-evidence) covers what its human record contains.

#### References
1. Yang W, Huang J, Tang Z, Chen C, Sun Y. Safety and Metabolism-Related Outcomes of Oral Nicotinamide Mononucleotide Supplementation in Adults: A Systematic Review and Meta-Analysis. Nutrients. 2026 Jul 10;18(14). https://pubmed.ncbi.nlm.nih.gov/42514320/
2. Pandolfi S, Ghezzi C, Björklund G, Metalla M, Paone FM, Chirumbolo S. NAD⁺ biology and supplementation: From mechanisms to clinical perspectives. Mol Biol Rep. 2026 Jul 23;53(1). https://pubmed.ncbi.nlm.nih.gov/42489969/
3. Grant R, Berg J, Mestayer R, et al. A pilot study investigating changes in the human plasma and urine NAD+ metabolome during a 6 hour intravenous infusion of NAD. Front Aging Neurosci. 2019;11:257. https://pubmed.ncbi.nlm.nih.gov/31572171/
4. Yu X, Xu J, Cao J, et al. Effect of nicotinamide adenine dinucleotide on heart failure caused by ischemic cardiomyopathy: a randomized, placebo-controlled trial. Am J Cardiovasc Drugs. 2026;26(1):97–106. https://pubmed.ncbi.nlm.nih.gov/40954388/
5. PubMed, National Library of Medicine. Census run August 2026, the three literatures counted separately and never summed. "nicotinamide riboside" OR "nicotinamide riboside chloride" returns 952 indexed records, 418 carrying the Humans MeSH term, 42 under "clinical trial"[Publication Type] and 32 under "randomized controlled trial"[Publication Type]. "nicotinamide mononucleotide" returns 1,713 records, 593 human-tagged, 22 clinical trials and 16 randomized. The infusion phrase set — "NAD infusion" OR "NAD+ infusion" OR "intravenous NAD" OR "NAD therapy" — returns 22 records, 11 human-tagged, 4 clinical trials and 1 randomized; all 4 clinical-trial records were read individually, and three concern an esophageal cancer chemotherapy sequence, a topical psoriasis preparation, and a 1972 review of nicotinic acid in schizophrenia. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type, the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22NAD+infusion%22+OR+%22NAD%2B+infusion%22+OR+%22intravenous+NAD%22+OR+%22NAD+therapy%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D

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### PEG-MGF (Mechano growth factor pegylated; IGF-1Ec)
https://peptideamerica.org/molecules/peg-mgf · status verified August 2026

Status: No lawful route. Nomination withdrawn in 2026; on no list. The unpegylated parent, mechano growth factor, sits in Category 3 — nominated without adequate support.
Class: Growth factor fragments · Route: None lawful; sold as research-use-only material

Regulatory record:
- April 2020: FDA warns a Kentucky compounding pharmacy that drug products it compounded using PEG-MGF and twenty-one other substances are not eligible for the exemptions in section 503A(a).
- April 2026: The nomination is withdrawn by its nominators and mechano growth factor pegylated leaves Category 2 of the interim 503A bulks list without being added to Category 1.
- August 2026: On the list FDA published May 14, 2026, PEG-MGF appears in no category, while the unpegylated substance — mechano growth factor (MGF) — appears in Category 3, the category for substances nominated without adequate support. FDA's published finding for PEG-MGF is that it has identified no human exposure data on drug products containing it by any route.
- FDA final action: none recorded

#### Definition
Mechano growth factor is a splice variant of insulin-like growth factor 1, designated IGF-1Ec, whose expression rises in skeletal muscle after mechanical loading and damage. It is a product of the body's own response to exercise, and its proposed role is in the activation of satellite cells and local repair [1].
PEG-MGF is a pegylated synthetic version, sold on the premise that injecting the molecule reproduces what loading induces. This index tracks the injectable product; the underlying biology and the product are different objects, and the record below keeps them apart.

#### Evidence
The biology is real and the review literature treats it carefully, including the caution that the peptide is a putative rather than an established product of the gene's expression in the form usually claimed [1]. A 2026 review of approved and unapproved peptide therapies in musculoskeletal injury and athletic performance places this compound among the unapproved [2].
The trial-type count is the trap. Across five name variants PubMed returns 236 indexed records, 134 carrying the Humans subject heading, 12 under the clinical-trial publication type, and 11 under the randomized-controlled-trial type [3]. Twelve looks like a trial record. It is not one.
All twelve were opened and read, and not one administers the peptide to anyone. Every one measures a participant's own IGF-1Ec or mechano growth factor expression after an intervention that is not the peptide: resistance exercise at varying intensities, neuromuscular electrical stimulation after abdominal surgery, therapeutic ultrasound, recombinant growth hormone, high-intensity interval training in heart failure, testosterone therapy in older men, and pharmacological hypogonadism [3]. The count is a count of exercise physiology. The number of human records in which PEG-MGF was given to a person and an outcome measured is zero.

#### Access
There is no lawful United States supply route. Mechano growth factor pegylated left Category 2 of FDA's interim section 503A bulks list in April 2026 when the nomination was withdrawn by its nominators, and it was not added to Category 1 [4].
The list published on May 14, 2026 draws a distinction worth keeping. PEG-MGF appears in no category. The unpegylated substance, mechano growth factor (MGF), appears in Category 3 — the category for substances nominated without adequate support, which is neither a permission nor a safety finding but a statement that the nomination did not carry enough information to evaluate [4]. Two closely related substances therefore sit in two different places on the same list, and neither may be compounded.
FDA's published finding for the pegylated form matches this index's census: the agency has not identified any human exposure data on drug products containing PEG-MGF administered via any route of administration [5]. In April 2020 it also warned a compounding pharmacy that products compounded using PEG-MGF and twenty-one other substances were not eligible for the exemptions in section 503A(a) [6]. Material sold under this name is research-use-only chemical supply; see research-only (https://peptideamerica.org/status/research-only).
The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names PEG-MGF among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [7].

#### References
1. Matheny RW Jr, Nindl BC, Adamo ML. Minireview: Mechano-growth factor: a putative product of IGF-I gene expression involved in tissue repair and regeneration. Endocrinology. 2010;151(3):865–875. https://pubmed.ncbi.nlm.nih.gov/20130113/
2. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026;56(8):1921–1935. https://pubmed.ncbi.nlm.nih.gov/41966639/
3. PubMed, National Library of Medicine. Census run August 2026 across five name variants — "mechano growth factor" OR "MGF peptide" OR "IGF-1Ec" OR "PEG-MGF" OR "IGF-1 Ec" — returning 236 indexed records, 134 carrying the Humans MeSH term, 12 under "clinical trial"[Publication Type] and 11 under "randomized controlled trial"[Publication Type]. All 12 trial-type records were retrieved and read individually. None administers the peptide; every one measures endogenous IGF-1Ec or mechano growth factor expression in human muscle following resistance exercise, neuromuscular electrical stimulation, therapeutic ultrasound, growth hormone, testosterone, or pharmacological hypogonadism. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22mechano+growth+factor%22+OR+%22MGF+peptide%22+OR+%22IGF-1Ec%22+OR+%22PEG-MGF%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
4. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: "Mechano growth factor (MGF)" appears in Category 3; the pegylated substance appears in no category. https://www.fda.gov/media/94155/download
5. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for Mechano growth factor pegylated (PEG-MGF) in the table of substances nominated but withdrawn. Read August 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
6. US Food and Drug Administration. Warning letter, Tailor Made Compounding LLC, case 594743, April 1, 2020. Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
7. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution

---

### PT-141 (Bremelanotide; Vyleesi)
https://peptideamerica.org/molecules/pt-141 · status verified August 2026

Status: FDA-approved. Approved June 2019 as Vyleesi for one narrowly defined indication in premenopausal women; the label states it is not indicated for men.
Class: Melanocortins · Route: Subcutaneous injection (single-use autoinjector) · Approved product: Vyleesi (2019)

Regulatory record:
- June 2019: FDA approves bremelanotide injection under new drug application 210557, effective June 21, 2019, for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder. The label's limitations of use state that the product is not indicated for hypoactive sexual desire disorder in postmenopausal women or in men, and is not indicated to enhance sexual performance.
- April 2020: FDA warns a Kentucky compounding pharmacy that drug products it compounded using bremelanotide (PT-141) and twenty-one other substances are not eligible for the exemptions in section 503A(a).
- August 2026: The product remains marketed under a new labeler and is recorded as prescription-only in Drugs@FDA. Bremelanotide sits in no category of the 503A bulks list published May 14, 2026 and on no 503B list.
- FDA final action: none recorded

#### Definition
PT-141 is bremelanotide, a synthetic melanocortin receptor agonist and a metabolite of Melanotan II. It acts centrally rather than on vascular tissue, which distinguishes it mechanistically from the phosphodiesterase inhibitors readers usually compare it to.
It is the least understood entry in this index because its status is the opposite of what its market position suggests. It is widely sold as an unapproved research chemical, and it is an approved drug.

#### Evidence
The RECONNECT trials improved desire and distress scores without a significant increase in the prespecified count of satisfying sexual events. Their open-label extension retained 272 of 684 entrants through completion, so sustained outcomes among participants cannot be read as randomized long-term proof [3, 13]. The RECONNECT endpoint review (https://peptideamerica.org/evidence/bremelanotide-desire-distress-trials) separates these results and their tolerability trade-off.
The development program is the trial record. Across four name variants PubMed returns 121 indexed records, of which 91 carry the Humans subject heading, 16 the clinical-trial publication type, and 14 the randomized-controlled-trial type [1]. All sixteen were opened and read, and they trace one continuous program from the 2004 intranasal dose-finding work in men [2] through two phase 3 trials in premenopausal women that supported approval [3].
One record in that set is retracted, and its own title says so [1]. A 2008 double-blind placebo-controlled study of the compound in women with arousal disorder carries a retraction marker in PubMed. It is counted in the sixteen because the publication-type filter counts it; it should not be read as evidence, and a page that reported sixteen trials without opening them would not have known.
The registrational evidence supports the indication it was approved for and nothing wider. The approved population is premenopausal women with acquired, generalized hypoactive sexual desire disorder; the label's own limitations of use state that the product is not indicated for that disorder in postmenopausal women or in men, and is not indicated to enhance sexual performance [4]. Every one of those exclusions describes a use the compound is commonly sold for.

#### Access
The lawful supply route is the approved product. FDA approved bremelanotide injection under new drug application 210557, effective June 21, 2019, as a single-use subcutaneous autoinjector [5]. It is dispensed on prescription and remains listed as a marketed prescription product [4].
Compounding it is a different question with a clear answer. Bremelanotide appears in no category of the section 503A bulks list published on May 14, 2026 and on no 503B list [6]. In April 2020 FDA warned a compounding pharmacy that products it compounded using bremelanotide (PT-141) and twenty-one other substances were not eligible for the exemptions in section 503A(a), because the substances were not the subject of an applicable USP or NF monograph, were not a component of an FDA-approved human drug, and did not appear on the 503A bulks list [7]. That letter was issued about nine months after the approval, and this index does not extend its reasoning past the date it was written; what the letter establishes is that FDA has addressed compounded PT-141 directly.
Material sold online as PT-141 for research use is not the approved product and carries none of its assurances. The approved (https://peptideamerica.org/status/approved) page sets out what an approval does and does not cover.

#### Side effects
The Vyleesi label draws its safety data from two 24-week placebo-controlled trials in 1,247 premenopausal women [12]. Nausea was the most common adverse reaction, in 40 percent against 1.3 percent on placebo, followed by flushing in 20 percent, injection site reactions in 13 percent and headache in 11 percent; vomiting, cough, fatigue, hot flush, tingling, dizziness and nasal congestion each occurred in 2 to 5 percent [12]. Adverse reactions led 18 percent of treated women to stop, against 2 percent on placebo, most often because of nausea [12].
Blood pressure rises briefly after each dose. In the trials systolic pressure rose by up to 6 mmHg and diastolic by up to 3 mmHg, peaking 2 to 4 hours after the injection, with a fall in heart rate of up to 5 beats per minute; both usually returned to baseline within 12 hours [12]. The drug is contraindicated in uncontrolled high blood pressure and known cardiovascular disease, and not recommended for anyone at high cardiovascular risk [12].
Focal darkening of the skin, including the face, gums and breasts, occurred in 1 percent of treated women in the phase 3 trials and in 38 percent of participants in a separate study of consecutive daily use [12]. Women with darker skin were more likely to develop it, and it did not resolve in every case after the drug was stopped [12]. Nausea needed anti-nausea treatment in 13 percent of treated women [12].
Vyleesi may sharply lower blood levels of oral naltrexone, and the label advises against combining it with an oral naltrexone product used for alcohol or opioid addiction [12]. Animal studies found fetal harm, so the label advises effective contraception during treatment and stopping the drug if pregnancy is suspected [12].

#### Questions
Q: Is PT-141 FDA-approved?
A: Yes. Bremelanotide, the compound sold as PT-141, was approved as Vyleesi on June 21, 2019, for premenopausal women with acquired, generalized hypoactive sexual desire disorder [5, 12]. The index records it as approved, last checked August 2026.
Q: Is PT-141 approved for men?
A: No. The label states that Vyleesi is not indicated for hypoactive sexual desire disorder in men or in postmenopausal women, and is not indicated to enhance sexual performance [12].
Q: What are the side effects of PT-141?
A: Nausea is the most common, reported by 40 percent of treated women in the phase 3 trials, followed by flushing, injection site reactions and headache [12]. The label also warns of a temporary rise in blood pressure after each dose and of darkening patches of skin [12].
Q: Does PT-141 raise blood pressure?
A: Yes, briefly. Blood pressure rises and heart rate falls after each dose, usually returning to baseline within 12 hours, and the drug is contraindicated in uncontrolled hypertension and known cardiovascular disease [12].
Q: Is compounded PT-141 legal?
A: Bremelanotide appears in no category of the section 503A bulks list published May 14, 2026, and on no 503B list [6]. In April 2020 FDA warned a compounding pharmacy that products it compounded using bremelanotide (PT-141) were not eligible for the section 503A exemptions [7]. Material sold as PT-141 for research use is not the approved product.
Q: How is PT-141 different from Melanotan II?
A: PT-141 is a metabolite of Melanotan II (https://peptideamerica.org/molecules/melanotan-ii). Bremelanotide completed a development program and holds an FDA label as Vyleesi, while Melanotan II has no lawful route in the United States; setmelanotide (https://peptideamerica.org/molecules/setmelanotide), which also acts at melanocortin 4, is approved for rare genetic obesities.

#### References
1. PubMed, National Library of Medicine. Census run August 2026 across four name variants — "bremelanotide" OR "PT-141" OR "PT 141" OR "Vyleesi" — returning 121 indexed records, 91 carrying the Humans MeSH term, 16 under "clinical trial"[Publication Type] and 14 under "randomized controlled trial"[Publication Type]. All 16 trial-type records were retrieved and read individually; they constitute the compound's development program from 2003 to 2022, and one 2008 record carries a retraction marker in its own title. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22bremelanotide%22+OR+%22PT-141%22+OR+%22Vyleesi%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. Diamond LE, Earle DC, Rosen RC, et al. Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction. Int J Impot Res. 2004;16(1):51–59. https://pubmed.ncbi.nlm.nih.gov/14963471/
3. Kingsberg SA, Clayton AH, Portman D, et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019;134(5):899–908. https://pubmed.ncbi.nlm.nih.gov/31599840/
4. US Food and Drug Administration. VYLEESI (bremelanotide injection), for subcutaneous use — prescribing information, NDA 210557 supplement 002, approved October 23, 2020; Indications and Usage, including Limitations of Use. Read August 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf
5. US Food and Drug Administration. NDA 210557 approval letter, June 21, 2019. Read August 2026. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210557Orig1s000ltr.pdf
6. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: bremelanotide appears in none of Category 1, Category 2, or Category 3. https://www.fda.gov/media/94155/download
7. US Food and Drug Administration. Warning letter, Tailor Made Compounding LLC, case 594743, April 1, 2020. Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
8. Clayton AH, Althof SE, Kingsberg S, et al. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Womens Health (Lond). 2016;12(3):325–337. https://pubmed.ncbi.nlm.nih.gov/27181790/
9. Clayton AH, Kingsberg SA, Portman D, et al. Safety Profile of Bremelanotide Across the Clinical Development Program. J Womens Health (Larchmt). 2022;31(2):171–182. https://pubmed.ncbi.nlm.nih.gov/35147466/
10. PubMed, National Library of Medicine. Census extended September 2026 on the same four name variants as reference 1. The union re-measured at 121 indexed records, 91 tagged Humans, 16 under "clinical trial"[Publication Type] and 14 under "randomized controlled trial"[Publication Type], identical to the August 2026 run. Scoped within the clinical-trial type: combined with the terms erectile, men or male the names return 6 records; combined with the term premenopausal, 9; combined with the term postmenopausal, 0. The scoped counts overlap by construction and are not additive. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22bremelanotide%22+OR+%22PT-141%22+OR+%22PT+141%22+OR+%22Vyleesi%22%29+AND+postmenopausal+AND+%22clinical+trial%22%5BPublication+Type%5D
11. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name "bremelanotide": one application, NDA 210557, sponsor name Cosette, product VYLEESI (AUTOINJECTOR). The same query served as the positive control for the absence checks run on other molecules in this index the same day. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bremelanotide%22
12. Cosette Pharmaceuticals. VYLEESI (bremelanotide injection), US prescribing information, structured product label effective November 2025 (patient information revised March 2024). Sections 1 Indications and Usage, 4 Contraindications, 5 Warnings and Precautions, 6 Adverse Reactions, 7 Drug Interactions and 8 Use in Specific Populations. DailyMed set ID f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
13. Simon JA, Kingsberg SA, Portman D, et al. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol. 2019;134:909–917. Read October 15, 2026. https://pubmed.ncbi.nlm.nih.gov/31599847/

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### Retatrutide (LY3437943)
https://peptideamerica.org/molecules/retatrutide · status verified August 2026

Status: No lawful route. Investigational and unapproved; FDA states plainly that it cannot be used in compounding under federal law, and has issued warning letters over research-use-only sales.
Class: GLP-1 receptor agonists · Route: None lawful; investigational, and sold as research-use-only material

Regulatory record:
- March 2026: FDA issues warning letters to two firms whose websites offered retatrutide for sale, finding the products to be unapproved new drugs; both letters state that despite labeling the products for research use only and not for human consumption, evidence from the firms' own websites establishes that the products are intended to be drugs for human use.
- June 2026: FDA states that retatrutide and cagrilintide cannot be used in compounding under federal law, that they are not components of FDA-approved drugs, and that they have not been found safe and effective for any condition.
- August 2026: Drugs@FDA holds no record of retatrutide as the active ingredient of any drug product, and the substance sits in no category of the 503A bulks list published May 14, 2026 and on no 503B list. It has never been nominated for one.
- FDA final action: none recorded

#### Definition
Retatrutide is an investigational peptide that acts as an agonist at three receptors at once — the glucose-dependent insulinotropic polypeptide receptor, the GLP-1 receptor, and the glucagon receptor [12]. It is a further step along the line that runs from single-agonist to dual-agonist incretin drugs, and it is in active late-stage development.
It is also sold, today, as research-use-only material. This index tracks it because that combination — a real drug candidate with a real trial program and no lawful route to a person outside a trial — is the position readers most often misread.

#### Evidence
The published TRIUMPH-1 phase 3 report used a treatment-regimen analysis and reported mean weight change of minus 25.0 percent in the highest-strength group versus minus 3.9 percent on placebo at 80 weeks [19]. Those figures should not be interchanged with the earlier sponsor headline below. TRIUMPH-2 reported substantial weight reductions in adults with type 2 diabetes, alongside gastrointestinal adverse events and more hypotension and dysesthesia than placebo [20]. A smaller DXA substudy addresses a separate question: fat loss versus lean-mass loss, with only 103 participants completing treatment and paired scans [17]. The body-composition review (https://peptideamerica.org/evidence/retatrutide-lean-mass-evidence) explains that denominator and why it is not a muscle-preservation guarantee.
The trial record exists and it is the sponsor's. Across two name variants PubMed returns 178 indexed records, of which 109 carry the Humans subject heading, 8 the clinical-trial publication type, and 7 the randomized-controlled-trial type [1]. All eight were opened and read, and every one belongs to the development program: a phase 1b multiple-ascending-dose trial in type 2 diabetes, phase 2 trials in obesity and in type 2 diabetes, a phase 2a trial in metabolic dysfunction-associated steatotic liver disease, body-composition and lipid substudies, and a phase 3 trial [1].
The phase 2 obesity trial is the result the market reacted to and the one most often quoted secondhand [2]; a phase 3 trial in people with type 2 diabetes and inadequate glycemic control on diet and exercise has since been published [3]. Reporting either as evidence of approval is the common error here, and the distinction is not subtle: a trial establishes what a compound does under study conditions, and an approval establishes that a specific product may be sold to be used.
The phase 3 obesity program has since read out. TRIUMPH-1 randomized 2,339 adults with obesity, or overweight with a weight-related condition, and without diabetes; the earlier sponsor release reported average weight loss of 28.3 percent at 80 weeks at the highest dose tested against 2.2 percent on placebo [9], and the registry lists the trial as completed, with primary completion in April 2026 [11]. TRIUMPH-2, in type 2 diabetes, and TRIUMPH-3, in obesity with established cardiovascular disease, met their primary endpoints in July 2026, and Lilly states that it plans to submit a biologics license application in the first quarter of 2027 [10]. The sponsor's own release says the molecule is legally available only to participants in its clinical trials [9].
The eight trial-type records are also the reason a count alone tells a reader nothing about legality. Ipamorelin has two and no route; retatrutide has eight and no route; semaglutide has hundreds and an approval. The number that decides the legal question is not in the literature at all.

#### Access
There is no lawful United States supply route outside a clinical trial. No approved product containing retatrutide exists: a query of Drugs@FDA by active ingredient returns no records for it, in the October 2026 check in which the same query returned a record for bremelanotide and none for a deliberately invented ingredient name [4].
FDA has stated the compounding position in its own words rather than leaving it to inference: retatrutide and cagrilintide cannot be used in compounding under federal law, they are not components of FDA-approved drugs, and they have not been found safe and effective for any condition [5]. The substance appears in no category of the section 503A bulks list published on May 14, 2026, and it has never been nominated for one [6].
The agency has also acted on research-use-only sales. In March 2026 it issued warning letters to two firms whose websites offered retatrutide, finding the products to be unapproved new drugs; both letters state that despite labeling marketing the products for research use only and not for human consumption, evidence obtained from the firms' own websites establishes that the products are intended to be drugs for human use [7][8]. Those letters are disclosure of what FDA has stated, and nothing here adjudicates a business. The research-only (https://peptideamerica.org/status/research-only) page explains what the labeling posture is and is not.

#### References
1. PubMed, National Library of Medicine. Census run August 2026 across two name variants — "retatrutide" OR "LY3437943" — returning 178 indexed records, 109 carrying the Humans MeSH term, 8 under "clinical trial"[Publication Type] and 7 under "randomized controlled trial"[Publication Type]. All 8 trial-type records were retrieved and read individually; all belong to the sponsor's development program, spanning phase 1b through phase 3. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22retatrutide%22+OR+%22LY3437943%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. Jastreboff AM, Kaplan LM, Frías JP, et al. Triple-Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial. N Engl J Med. 2023;389(6):514–526. https://pubmed.ncbi.nlm.nih.gov/37366315/
3. Bajaj HS, Welch M, Shah P, et al. Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial. Lancet. 2026;407(10546):2402–2413. https://pubmed.ncbi.nlm.nih.gov/42250575/
4. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe repeated October 2026: a search by active-ingredient name returned no records for retatrutide. In the same run and the same query form, bremelanotide returned one application and a deliberately invented ingredient name returned none — a positive and a negative control beside the zero. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RETATRUTIDE%22
5. US Food and Drug Administration. FDA's concerns with unapproved GLP-1 drugs used for weight loss. Reread October 2026; the page continues to state that retatrutide and cagrilintide cannot be used in compounding under federal law. https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
6. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: retatrutide appears in none of Category 1, Category 2, or Category 3. https://www.fda.gov/media/94155/download
7. US Food and Drug Administration. Warning letter, MARCS-CMS 721806, March 31, 2026. Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026
8. US Food and Drug Administration. Warning letter, MARCS-CMS 721600, March 31, 2026. Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mile-high-compounds-llc-721600-03312026
9. Eli Lilly and Company. Lilly's triple agonist, retatrutide, delivered powerful weight loss in pivotal Phase 3 obesity trial (TRIUMPH-1 topline results). Press release, May 21, 2026. Read September 2026.
10. Eli Lilly and Company. Lilly's triple agonist, retatrutide, successful in two additional Phase 3 obesity trials, delivering significant improvements in weight and A1C (TRIUMPH-2 and TRIUMPH-3 topline results; BLA submission planned for Q1 2027). Press release, July 23, 2026. Read September 2026.
11. ClinicalTrials.gov, NCT05929066 (TRIUMPH-1). A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight. Phase 3; sponsor Eli Lilly and Company; status Completed; start July 10, 2023; actual primary completion April 6, 2026; record last updated August 21, 2026. Read through the v2 API September 2026. https://clinicaltrials.gov/study/NCT05929066
12. Coskun T, Urva S, Roell WC, et al. LY3437943, a novel triple glucagon, GIP, and GLP-1 receptor agonist for glycemic control and weight loss: From discovery to clinical proof of concept. Cell Metab. 2022;34(9):1234–1247.e9. https://pubmed.ncbi.nlm.nih.gov/35985340/
13. Zimmermann T, Thomas L, Baader-Pagler T, et al. BI 456906: Discovery and preclinical pharmacology of a novel GCGR/GLP-1R dual agonist with robust anti-obesity efficacy. Mol Metab. 2022;66:101633. https://pubmed.ncbi.nlm.nih.gov/36356832/
14. Zealand Pharma. Zealand Pharma announces Boehringer Ingelheim's novel glucagon/GLP-1 dual agonist survodutide achieved significant weight loss of 16.6% in Phase 3 trial (SYNCHRONIZE-1 topline results). Company announcement, April 28, 2026. Read September 2026.
15. Innovent Biologics. Innovent announces mazdutide, first dual GCG/GLP-1 receptor agonist, received approval from China's NMPA for chronic weight management. Press release, June 27, 2025. Read September 2026.
16. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe run September 2026 by active-ingredient name: no records for retatrutide, cagrilintide, survodutide, mazdutide, amycretin or zenagamtide. In the same run and query form, orforglipron returned one application (NDA 220934) and a deliberately invented ingredient name returned none. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22SURVODUTIDE%22
17. Coskun T, Wu Q, Schloot NC, et al. Effects of retatrutide on body composition in people with type 2 diabetes: a substudy of a phase 2, double-blind, parallel-group, placebo-controlled, randomised trial. Lancet Diabetes Endocrinol. 2025. Primary record checked October 2026. https://pubmed.ncbi.nlm.nih.gov/40609566/
18. Rosenstock J, Frias J, Jastreboff AM, et al. Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA. Lancet. 2023. Primary record checked October 2026. https://pubmed.ncbi.nlm.nih.gov/37385280/
19. Jastreboff AM, Kaplan LM, Davies MJ, et al. Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity. N Engl J Med. 2026. Primary record checked October 2026. https://pubmed.ncbi.nlm.nih.gov/42814954/
20. Bellido V, le Roux CW, Ekinci EI, et al. Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial. Lancet. 2026. Primary record checked October 2026. https://pubmed.ncbi.nlm.nih.gov/42810372/

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### Secretin (Synthetic human secretin; ChiRhoStim)
https://peptideamerica.org/molecules/secretin · status verified September 2026

Status: FDA-approved. An approved diagnostic drug since 2004, and separately a bulk substance nominated to the 503A list without adequate support; the nomination sits in Category 3.
Class: Gut peptides · Route: Intravenous, as an approved diagnostic product · Approved product: ChiRhoStim (2004); Porcine Secretin (2002)

Regulatory record:
- April 2002: FDA approves Porcine Secretin under new drug application 021209; the product remains prescription-only.
- April 2004: FDA approves ChiRhoStim, synthetic human secretin, under new drug application 021256, in 16 microgram and 40 microgram vials for intravenous use. Two earlier secretin products, SecreFlo and Secretin-Ferring, are recorded in Drugs@FDA as discontinued.
- May 2026: The section 503A bulks list published May 14, 2026 lists Secretin, human 99% in Category 3, the file for substances nominated without adequate support to evaluate. A bulk nomination for a substance that is already the active ingredient of an approved product raises the essentially-a-copy question that section 503A exists to control.
- FDA final action: none recorded

#### Definition
Secretin is a twenty-seven-amino-acid hormone released by the duodenum, which signals the pancreas to secrete bicarbonate-rich fluid. It was the first substance ever called a hormone, and it belongs to the same structural family as vasoactive intestinal peptide (https://peptideamerica.org/molecules/vasoactive-intestinal-peptide) and the incretins.
In United States medicine it is a diagnostic agent: given intravenously, it provokes a pancreatic response that can be measured. This index tracks it because it holds two positions at once that are usually reported as mutually exclusive — an approved product, and a bulk nomination the FDA filed as inadequately supported.

#### Evidence
Across three name variants PubMed returns 9,152 indexed records, of which 4,793 carry the Humans subject heading, 215 the clinical-trial publication type, and 103 the randomized-controlled-trial type [1]. The literature is above this index's itemization ceiling and is reported as a magnitude; the twenty-five most relevant randomized records were read to characterize it [1]. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag returned zero for that control term; and a deliberately invalid record identifier errored in the same run [1].
The literature divides cleanly in two. The first part supports the approved use: controlled work established that synthetic porcine secretin performs accurately in pancreatic function testing in people with chronic pancreatitis [2]. That is a diagnostic claim, it is narrow, and the approved labeling is built on it.
The second part is a closed question that the marketplace has never fully absorbed, and it is larger than it is usually reported to be. A scoped census run September 2026 returns 19 randomized-type records for secretin in autism; all 19 were opened, and 16 are randomized trials of the peptide in autism or pervasive developmental disorder, the other three being a published Comment, a trial in refractory schizophrenia, and a dietary-intake study [7]. The sequence runs from a 1999 New England Journal of Medicine trial concluding that a single dose of synthetic human secretin is not an effective treatment [8], through single-dose and repeated-dose trials of the porcine and synthetic preparations [3, 4, 5, 9, 10, 11, 12, 13], to a 2005 transdermal trial [6]. One of them tested whether parents could tell the difference under double-blind conditions and reported that they could not [14].
The cluster is unusual in peptide medicine for being large, independent, and consistent. Every one of the 16 reports no benefit on its primary measures; the only positive signals anywhere in the set are a marginal result at three weeks in one trial and a subgroup speech finding in another, both of which their own authors present as provisional [10, 6].
That history is why the substance belongs in this index rather than only in a pharmacology text. A compound with a genuine approval for one narrow diagnostic purpose, and a well-populated negative literature for the purpose it became famous for, is the exact shape a reader is most likely to misread in either direction.

#### Access
Approved products exist and are marketed. ChiRhoStim, synthetic human secretin, was approved on April 9, 2004 under new drug application 021256, in 16 microgram and 40 microgram vials for intravenous use; Porcine Secretin was approved on April 4, 2002 under application 021209. Two earlier products, SecreFlo and Secretin-Ferring, are recorded in Drugs@FDA as discontinued [15]. All of the marketed presentations are prescription-only.
Separately, and this is the part almost nowhere recorded, the substance is also a nominated bulk drug substance. The section 503A bulks list FDA published May 14, 2026 lists Secretin, human 99% in Category 3 — the file for substances nominated without adequate support to evaluate [16]. Category 3 is not a safety finding and it is not a permission; it records that the submission behind the nomination did not contain enough to review.
The nomination raises a question section 503A exists to control. A pharmacy may not compound a preparation that is essentially a copy of a commercially available approved drug unless a prescriber documents a clinical difference for an individual patient, and human secretin is the active ingredient of an approved product. A bulk nomination for that same substance therefore has to clear a bar that nothing in Category 3 has cleared. The approved (https://peptideamerica.org/status/approved) page sets out what an approval does and does not settle.

#### Side effects
Side effects of diagnostic secretin are uncommon. The ChiRhoStim label draws its safety data from an open-label trial in 531 patients with known or suspected pancreatic disease, most of whom received a single dose; the adverse reactions reported in at least two patients were nausea in 9, vomiting in 3, flushing in 2 and upset stomach in 2 [17]. The label lists no contraindications [17].
The label's warnings concern the accuracy of the test rather than harm to the patient. People with alcoholic or other liver disease may respond more strongly than expected, which can mask coexisting pancreatic disease; anticholinergic drugs can blunt the response; and acid-reducing H2 blockers and proton pump inhibitors can exaggerate the gastrin response enough to suggest a gastrinoma falsely [17].
Some groups have no data behind them. Safety and effectiveness in children have not been established, and there are no data on use of synthetic human secretin in pregnancy or breastfeeding [17]. The label does not cover use in autism, and the randomized trials of secretin in autism reported no benefit [7].

#### Questions
Q: Is secretin FDA-approved?
A: Yes, as a diagnostic agent. ChiRhoStim, synthetic human secretin, was approved on April 9, 2004 and Porcine Secretin on April 4, 2002 [15]. ChiRhoStim is indicated to help diagnose pancreatic exocrine dysfunction and gastrinoma and to help locate pancreatic duct openings during ERCP [17].
Q: What are the side effects of secretin?
A: In the ChiRhoStim trial of 531 patients, side effects were few: nausea, vomiting, flushing and upset stomach, each in a handful of patients [17]. The label lists no contraindications [17].
Q: Does secretin treat autism?
A: No. Sixteen randomized trials of secretin in autism or pervasive developmental disorder, published between 1999 and 2005, reported no benefit on their primary measures [7, 8]. The approved label covers diagnostic testing only [17].
Q: Can secretin be compounded?
A: Not on the strength of the bulks list. The section 503A bulks list published May 14, 2026 files Secretin, human 99% in Category 3, for substances nominated without adequate support to evaluate [16]. Human secretin is also the active ingredient of an approved product, which raises the essentially-a-copy restriction in section 503A.
Q: How is secretin different from VIP?
A: Both belong to the same structural family of gut peptides. Secretin has an approved diagnostic product and a Category 3 bulk nomination, while vasoactive intestinal peptide (https://peptideamerica.org/molecules/vasoactive-intestinal-peptide) has no approved product and sits in Category 1 of the interim 503A bulks list.

#### References
1. PubMed, National Library of Medicine. Census run September 2026 across three name variants — "secretin" OR "synthetic human secretin" OR "porcine secretin" — returning 9,152 indexed records, 4,793 carrying the Humans MeSH term, 215 under "clinical trial"[Publication Type] and 103 under "randomized controlled trial"[Publication Type]. Reported as a magnitude; the 25 most relevant randomized records were retrieved through esummary and read. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22secretin%22%29+AND+%22randomized+controlled+trial%22%5BPublication+Type%5D
2. Somogyi L, Cintron M, Toskes PP. Synthetic porcine secretin is highly accurate in pancreatic function testing in individuals with chronic pancreatitis. Pancreas. 2000 Oct;21(3):262-5. https://pubmed.ncbi.nlm.nih.gov/11039470/
3. Dunn-Geier J, Ho HH, Auersperg E, Doyle D, Eaves L, Matsuba C, et al. Effect of secretin on children with autism: a randomized controlled trial. Dev Med Child Neurol. 2000 Dec;42(12):796-802. https://pubmed.ncbi.nlm.nih.gov/11132252/
4. Owley T, McMahon W, Cook EH, Laulhere T, South M, Mays LZ, et al. Multisite, double-blind, placebo-controlled trial of porcine secretin in autism. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1293-9. https://pubmed.ncbi.nlm.nih.gov/11699803/
5. Unis AS, Munson JA, Rogers SJ, Goldson E, Osterling J, Gabriels R, et al. A randomized, double-blind, placebo-controlled trial of porcine versus synthetic secretin for reducing symptoms of autism. J Am Acad Child Adolesc Psychiatry. 2002 Nov;41(11):1315-21. https://pubmed.ncbi.nlm.nih.gov/12410073/
6. Ratliff-Schaub K, Carey T, Reeves GD, Rogers MA. Randomized controlled trial of transdermal secretin on behavior of children with autism. Autism. 2005 Jul;9(3):256-65. https://pubmed.ncbi.nlm.nih.gov/15937041/
7. PubMed, National Library of Medicine. Scoped census run September 2026: the query ("secretin") AND ("autism" OR "autistic" OR "pervasive developmental") returns 132 indexed records, 22 under "clinical trial"[Publication Type] and 19 under "randomized controlled trial"[Publication Type]. All 19 randomized-type records were retrieved and read: 16 are randomized trials of secretin in autism or pervasive developmental disorder, one is a published Comment, one is a trial in refractory schizophrenia, and one is a dietary-intake study. In the same run the control term aspirin returned 6,115 records under the identical randomized filter and 8,906 under the clinical-trial filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22secretin%22%29+AND+%28%22autism%22+OR+%22autistic%22%29+AND+%22randomized+controlled+trial%22%5BPublication+Type%5D
8. Sandler AD, Sutton KA, DeWeese J, Girardi MA, Sheppard V, Bodfish JW. Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder. N Engl J Med. 1999 Dec 9;341(24):1801-6. https://pubmed.ncbi.nlm.nih.gov/10588965/
9. Roberts W, Weaver L, Brian J, Bryson S, Emelianova S, Griffiths AM, et al. Repeated doses of porcine secretin in the treatment of autism: a randomized, placebo-controlled trial. Pediatrics. 2001 May;107(5):E71. https://pubmed.ncbi.nlm.nih.gov/11331721/
10. Coniglio SJ, Lewis JD, Lang C, Burns TG, Subhani-Siddique R, Weintraub A, et al. A randomized, double-blind, placebo-controlled trial of single-dose intravenous secretin as treatment for children with autism. J Pediatr. 2001 May;138(5):649-55. https://pubmed.ncbi.nlm.nih.gov/11343038/
11. Sponheim E, Oftedal G, Helverschou SB. Multiple doses of secretin in the treatment of autism: a controlled study. Acta Paediatr. 2002;91(5):540-5. https://pubmed.ncbi.nlm.nih.gov/12113323/
12. Molloy CA, Manning-Courtney P, Swayne S, Bean J, Brown JM, Murray DS, et al. Lack of benefit of intravenous synthetic human secretin in the treatment of autism. J Autism Dev Disord. 2002 Dec;32(6):545-51. https://pubmed.ncbi.nlm.nih.gov/12553591/
13. Levy SE, Souders MC, Wray J, Jawad AF, Gallagher PR, Coplan J, et al. Children with autistic spectrum disorders. I: comparison of placebo and single dose of human synthetic secretin. Arch Dis Child. 2003 Aug;88(8):731-6. https://pubmed.ncbi.nlm.nih.gov/12876177/
14. Coplan J, Souders MC, Mulberg AE, Belchic JK, Wray J, Jawad AF, et al. Children with autistic spectrum disorders. II: parents are unable to distinguish secretin from placebo under double-blind conditions. Arch Dis Child. 2003 Aug;88(8):737-9. https://pubmed.ncbi.nlm.nih.gov/12876178/
15. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Read September 2026: four applications name secretin as an active ingredient. NDA 021256 (ChiRhoStim, synthetic human secretin, 16 and 40 microgram vials, intravenous) carries an original approval date of April 9, 2004 and prescription marketing status; NDA 021209 (Porcine Secretin) carries an original approval date of April 4, 2002 and prescription status; NDA 021136 (SecreFlo) and NDA 018290 (Secretin-Ferring) are recorded as discontinued. A deliberately invented ingredient name returned no records in the same run. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22SECRETIN%22
16. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: the entry "Secretin, human 99%" appears in Category 3 and in neither Category 1 nor Category 2. https://www.fda.gov/media/94155/download
17. ChiRhoClin. CHIRHOSTIM (human secretin) for injection, US prescribing information, revised July 2017; structured product label effective October 2025. Sections 1 Indications and Usage, 4 Contraindications, 5 Warnings and Precautions, 6 Adverse Reactions, 7 Drug Interactions and 8 Use in Specific Populations. DailyMed set ID b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd

---

### Selank (Selank acetate; TP-7)
https://peptideamerica.org/molecules/selank · status verified August 2026

Status: Nomination withdrawn. Nomination withdrawn; on no list, and never placed on an advisory-committee agenda — the disposition with the least record behind it.
Class: Neuropeptides · Route: None lawful; sold as research-use-only material

Regulatory record:
- April 2020: FDA warns a Kentucky compounding pharmacy that drug products it compounded using Selank and twenty-one other substances are not eligible for the exemptions in section 503A(a).
- August 2026: Selank acetate (TP-7) appears in FDA's table of substances nominated but withdrawn and in no category of the 503A list published May 14, 2026. FDA's published finding is that it lacks important information regarding any safety issues raised by selank acetate administered to humans.
- FDA final action: none recorded

#### Definition
Selank is a synthetic heptapeptide built from the immunomodulatory fragment tuftsin with a stabilizing tripeptide tail. It was developed in Russia as an anxiolytic intended to act without the sedation and dependence associated with benzodiazepines.
Like Semax, it belongs to a family of regulatory peptides developed and registered within one national system. Unlike Semax, it has never been placed on the agenda of a United States advisory committee, which leaves it with the thinnest official record of any molecule in this index.

#### Evidence
Across three name variants PubMed returns 89 indexed records, of which 22 carry the Humans subject heading, 3 the clinical-trial publication type, and 2 the randomized-controlled-trial type [1].
All three trial-type records were opened and read. They are a 2008 study of the peptide in generalized anxiety disorder and neurasthenia [2], a 2014 comparison of its anxiolytic effect and tolerability against a benzodiazepine [3], and a 2015 report on optimizing treatment of anxiety disorders with it [1]. All three were published in Russian, in the same journal, between 2008 and 2015.
There is no trial of this compound in the English-language literature, and the observation is a measurement rather than an impression: the union of every name variant, filtered to trial publication types, returns those three records and nothing else [1]. A reader should draw the modest conclusion available — that a small national trial literature exists, that it has not been replicated elsewhere, and that no regulator outside that system has evaluated it.

#### Access
There is no lawful United States supply route. Selank acetate was placed in Category 2 of FDA's interim section 503A bulks list and now appears in the agency's table of substances nominated but withdrawn; it is in no category of the 503A bulks list published on May 14, 2026 [4][5].
FDA's published finding is that compounded drugs containing selank acetate may pose a risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities, and that the agency lacks important information regarding any safety issues raised by selank acetate administered to humans [5]. The withdrawal removed the substance from the category; it did not retract that finding.
In April 2020 FDA warned a compounding pharmacy that products it compounded using Selank and twenty-one other substances were not eligible for the exemptions in section 503A(a) [6]. Material sold under this name is research-use-only chemical supply, produced outside pharmacy licensure and prescriber oversight; see research-only (https://peptideamerica.org/status/research-only).
The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names Selank among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [7].

#### References
1. PubMed, National Library of Medicine. Census run August 2026 across three name variants — "Selank" OR "TP-7 peptide" OR "Thr-Lys-Pro-Arg-Pro-Gly-Pro" — returning 89 indexed records, 22 carrying the Humans MeSH term, 3 under "clinical trial"[Publication Type] and 2 under "randomized controlled trial"[Publication Type]. All 3 trial-type records were retrieved and read individually; all three are anxiety-disorder studies published in Russian in a single journal between 2008 and 2015, the third being a 2015 report on optimizing treatment of anxiety disorders with the peptide. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22Selank%22+OR+%22TP-7+peptide%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. Zozulia AA, Neznamov GG, Siuniakov TS, et al. [Efficacy and possible mechanisms of action of a new peptide anxiolytic selank in the therapy of generalized anxiety disorders and neurasthenia]. Zh Nevrol Psikhiatr Im S S Korsakova. 2008;108(4):38–48. Russian. https://pubmed.ncbi.nlm.nih.gov/18454096/
3. Medvedev VE, Tereshchenko ON, Israelian AIu, et al. [A comparison of the anxiolytic effect and tolerability of selank and phenazepam in the treatment of anxiety disorders]. Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(7):17–22. Russian. https://pubmed.ncbi.nlm.nih.gov/25176261/
4. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: Selank appears in none of Category 1, Category 2, or Category 3. https://www.fda.gov/media/94155/download
5. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for Selank acetate (TP-7) in the table of substances nominated but withdrawn. Read August 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
6. US Food and Drug Administration. Warning letter, Tailor Made Compounding LLC, case 594743, April 1, 2020. Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
7. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution

---

### Semaglutide (Ozempic; Wegovy; Rybelsus)
https://peptideamerica.org/molecules/semaglutide · status verified August 2026

Status: FDA-approved. Approved brand products; mass compounding ended after the shortage resolved; narrow patient-specific 503A path remains.
Class: GLP-1 receptor agonists · Route: Subcutaneous injection; oral (Rybelsus) · Approved product: Ozempic, Wegovy, Rybelsus

Regulatory record:
- April 2026: FDA proposes excluding semaglutide from the 503B bulks list, closing the outsourcing-facility route; patient-specific 503A compounding requires a documented clinical need an approved product cannot meet.
- FDA final action: none recorded

#### Definition
Semaglutide is a GLP-1 receptor agonist, a modified analogue of the gut hormone glucagon-like peptide-1 engineered for once-weekly subcutaneous dosing; an oral formulation is marketed separately. It is approved in the United States for type 2 diabetes and, at a higher dose, for chronic weight management.
The molecule slows gastric emptying, augments glucose-dependent insulin secretion, and acts on central appetite circuits; the weight effect is a drug effect, not a property of the injection route.

#### Evidence
In the pivotal STEP 1 trial, 1,961 adults with overweight or obesity received once-weekly semaglutide 2.4 mg or placebo; mean weight change at week 68 was −14.9 percent against −2.4 percent with placebo, and half of treated participants lost 15 percent or more [1].
The evidence base is unusually deep for this index; the open questions concern durability after discontinuation and long-term use outside trial conditions rather than whether the drug works.
Withdrawal is a separate question from initial weight loss. The STEP 1 extension followed a selected subset after both medication and structured lifestyle support ended; STEP 4 randomized eligible run-in completers to continue medication or switch to placebo while lifestyle support continued. Both found regain after withdrawal, but their percentages use different starting points [9, 10]. The withdrawal evidence review (https://peptideamerica.org/evidence/semaglutide-withdrawal-weight-regain) explains those denominators and why neither study supplies a tapering protocol.

#### Access
The approved products are the lawful supply route. Mass compounding ended after the FDA declared the shortage resolved; in April 2026 the agency proposed excluding semaglutide from the 503B bulks list, and the remaining 503A path requires a prescriber to document a clinical need an approved product cannot meet — a lower price does not qualify [2].
Telehealth programs in the supply panel provide prescriber-led GLP-1 treatment; the specific molecule and formulation offered vary by provider and should be confirmed on the provider's own site.

#### Side effects
The Wegovy label lists the adverse reactions reported in at least 5 percent of treated patients: nausea, diarrhea, vomiting, constipation, abdominal pain, dysesthesia, headache, fatigue, dyspepsia, dizziness, abdominal distension, belching, flatulence, gastroenteritis, gastroesophageal reflux and hair loss, with hypoglycemia among patients who also have type 2 diabetes [3]. Most are gastrointestinal, and the label notes that gastrointestinal reactions are sometimes severe; it does not recommend the drug for people with severe gastroparesis [3].
The label carries a boxed warning for thyroid C-cell tumors: semaglutide caused them in mice and rats, whether it does so in humans is unknown, and the drug is contraindicated for anyone with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia syndrome type 2 [3].
Its other warnings cover acute pancreatitis, acute gallbladder disease, hypoglycemia when combined with insulin or an insulin secretagogue, acute kidney injury from dehydration, serious allergic reactions including anaphylaxis and angioedema, diabetic retinopathy complications in patients with type 2 diabetes, an increased heart rate, and pulmonary aspiration during general anesthesia or deep sedation [3].
Compounded semaglutide is not covered by that label. The FDA has received adverse event reports, some requiring hospitalization, linked to dosing errors with compounded injectable semaglutide, where patients or clinicians measured the wrong amount [4].

#### Questions
Q: Is semaglutide FDA-approved?
A: Yes. Semaglutide is approved in the United States as Ozempic and Rybelsus for type 2 diabetes and as Wegovy for chronic weight management; the index records it as approved as of September 2026.
Q: Is compounded semaglutide still legal?
A: Only in a narrow form. Mass compounding ended when the FDA declared the shortage resolved, and in April 2026 the agency proposed excluding semaglutide from the 503B bulks list; a 503A pharmacy may still compound it for an individual patient whose prescriber documents a clinical need an approved product cannot meet, and a lower price does not count [2].
Q: What are the most common side effects of semaglutide?
A: Gastrointestinal effects lead the label's list: nausea, diarrhea, vomiting, constipation and abdominal pain, followed by headache, fatigue, dizziness, bloating, reflux and hair loss [3]. The [side effects](#side-effects) section above lists the label's warnings as well.
Q: Does semaglutide cause thyroid cancer?
A: It is not known. Semaglutide caused thyroid C-cell tumors in rodents, the label carries a boxed warning for that finding, and the drug is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with MEN 2 [3].
Q: How is semaglutide different from tirzepatide?
A: Semaglutide activates the GLP-1 receptor alone, while tirzepatide (https://peptideamerica.org/molecules/tirzepatide) activates both the GIP and GLP-1 receptors; both are approved, and both hold the same narrow compounding position in September 2026.

#### References
1. Wilding JPH, Batterham RL, Calanna S, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384(11):989–1002. https://pubmed.ncbi.nlm.nih.gov/33567185/
2. Orrick. FDA moves to shut the door on large-scale compounding of GLP-1 drugs. May 2026.
3. Novo Nordisk. WEGOVY (semaglutide) injection and tablet, US prescribing information. Revised June 2026. DailyMed set ID ee06186f-2aa3-4990-a760-757579d8f77b. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b
4. US Food and Drug Administration. FDA's concerns with unapproved GLP-1 drugs used for weight loss. Content current as of September 1, 2026. Read September 2026. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
5. Novo Nordisk. Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management. Company announcement, December 18, 2025. Read September 2026.
6. Novo Nordisk. Headline results from REDEFINE 4: CagriSema did not meet the primary endpoint of non-inferiority on weight loss versus tirzepatide at 84 weeks. Company announcement, February 23, 2026. Read September 2026.
7. Novo Nordisk A/S. Financial report for the period 1 January 2026 to 30 June 2026 (company announcement No 48/2026), furnished on Form 6-K, August 4, 2026; R&D pipeline update and anticipated key R&D milestones in 2026. Read September 2026. https://www.sec.gov/Archives/edgar/data/0000353278/000035327826000023/caq22026.htm
8. Novo Nordisk. Novo Nordisk's investigational zenagamtide shows significant A1C reductions with up to 14.6% weight loss in adults with type 2 diabetes, presented at ADA 2026. Press release, June 5, 2026. Read September 2026.
9. Wilding JPH, Batterham RL, Davies M, et al. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022;24:1553–1564. Read October 15, 2026. https://pubmed.ncbi.nlm.nih.gov/35441470/
10. Rubino D, Abrahamsson N, Davies M, et al. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021;325:1414–1425. Read October 15, 2026. https://pubmed.ncbi.nlm.nih.gov/33755728/

---

### Semax
https://peptideamerica.org/molecules/semax · status verified August 2026

Status: PCAC-recommended · pending. Removed from Category 2 in April 2026; PCAC recommended 503A listing in July 2026 on a reported tally; no FDA final rule.
Class: Neuropeptides · Route: None lawful; sold as research-use-only material
July 2026 advisory-committee vote: 8–5, 1 abstaining; reported by McDermott Will & Schulte and LumaLex Law, whose separate accounts of the meeting agree substance by substance.

Regulatory record:
- April 2026: Removed from Category 2 without Category 1 listing.
- July 2026: PCAC votes 8–5 (one abstention) to recommend 503A listing; advisory only. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
- FDA final action: none recorded

#### Definition
Semax is a synthetic heptapeptide built from the ACTH(4–7) fragment of adrenocorticotropic hormone with a proline-glycine-proline tail added for stability. It was developed in Moscow in the 1980s and is a registered prescription drug in Russia, given as a nasal spray for stroke recovery and cognitive complaints.
That registration is the molecule's defining fact and its defining asterisk: Semax has never been reviewed by FDA, and a drug approved abroad holds no US marketing status of any kind.

#### Evidence
The mechanistic literature is real: Semax raises brain-derived neurotrophic factor and trkB receptor expression in rat hippocampus [1] and binds brain tissue with measurable specificity [2]. The clinical literature, by contrast, lives almost entirely in Russian-language journals — a representative modern example followed 110 post-stroke patients through rehabilitation with Semax, tracking plasma BDNF and functional scores [3].
None of this record has passed through FDA review, and no English-language randomized trial supports a cognitive-enhancement use. The nootropic market sells the compound on the Russian dossier's reputation rather than on evidence an American regulator has examined.

#### Access
Semax was removed from Category 2 of the interim 503A bulks list in April 2026 without Category 1 listing. In July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding it to the section 503A list. The margin is reported as 8–5 with one abstention by McDermott Will & Schulte and by LumaLex Law, whose separate accounts of the meeting agree substance by substance [4, 5]; the FDA has published no minutes, transcript or vote summary, so the figure is secondary and this page says so wherever it appears. The vote is advisory; no FDA final rule has issued, and no licensed pharmacy may lawfully compound Semax as of August 2026.
Nasal sprays and vials sold to US buyers today are research-use-only or gray-market imports, outside pharmacy oversight; the pending (https://peptideamerica.org/status/pending) page tracks the rulemaking that could change the compounding question.
The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names Semax among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [13].

#### References
1. Dolotov OV, Karpenko EA, Inozemtseva LS, et al. Semax, an analog of ACTH(4-10) with cognitive effects, regulates BDNF and trkB expression in the rat hippocampus. Brain Res. 2006;1117(1):54–60. https://pubmed.ncbi.nlm.nih.gov/16996037/
2. Dolotov OV, Karpenko EA, Seredenina TS, et al. Semax, an analogue of adrenocorticotropin (4-10), binds specifically and increases levels of brain-derived neurotrophic factor protein in rat basal forebrain. J Neurochem. 2006;97 Suppl 1:82–86. https://pubmed.ncbi.nlm.nih.gov/16635254/
3. Gusev EI, Martynov MY, Kostenko EV, Petrova LV, Bobyreva SN. [The efficacy of semax in the tretament of patients at different stages of ischemic stroke]. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(3. Vyp. 2):61-68. Russian. The title is reproduced exactly as PubMed indexes it, misspelling included; correcting an indexed title would make the citation unverifiable against the record it points to. https://pubmed.ncbi.nlm.nih.gov/29798983/
4. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance.
5. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.
6. PubMed, National Library of Medicine. Census run September 2026 across three name variants — "Semax" OR "ACTH(4-10) Pro-Gly-Pro" OR "Met-Glu-His-Phe-Pro-Gly-Pro" — returning 216 indexed records, 49 carrying the Humans MeSH term, 4 under "clinical trial"[Publication Type] and 1 under "randomized controlled trial"[Publication Type]. By language: 93 records are Russian-language and 125 English-language; the trial-type filters combined with English[Language] return 0 under either type, and combined with Russian[Language] return all 4; 22 English-language records carry the Humans term. Adding the terms nootropic or cognit* to the clinical-trial filter returns the same 4 records. All four trial-type records were opened and read: a 1997 acute-stroke study of 30 patients against 80 controls, a 2000 optic-nerve-disease study, a 2007 motor-neuron-disease study of 27 patients that its own abstract describes as open-label in sequential groups and that PubMed tags as randomized, and a 2018 post-stroke rehabilitation study of 110 patients; all four are published in Russian in that country's journals. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. The counts reproduce the August 2026 run behind the trial-record table exactly. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22Semax%22+OR+%22ACTH%284-10%29+Pro-Gly-Pro%22+OR+%22Met-Glu-His-Phe-Pro-Gly-Pro%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
7. Gusev EI, Skvortsova VI, Miasoedov NF, et al. [Effectiveness of semax in acute period of hemispheric ischemic stroke (a clinical and electrophysiological study)]. Zh Nevrol Psikhiatr Im S S Korsakova. 1997;97(6):26–34. Russian. https://pubmed.ncbi.nlm.nih.gov/11517472/
8. Serdiuk AV, Levitskiĭ GN, Miasoedov NF, Skvortsova VI. [The study of chronic partial denervation and quality of life in patients with motor neuron disease treated with semax]. Zh Nevrol Psikhiatr Im S S Korsakova. 2007;107(4):29–39. Russian. https://pubmed.ncbi.nlm.nih.gov/18379501/
9. Polunin GS, Nurieva SM, Baiandin DL, Sheremet NL, Andreeva LA. [Evaluation of therapeutic effect of new Russian drug semax in optic nerve disease]. Vestn Oftalmol. 2000;116(1):15–18. Russian. https://pubmed.ncbi.nlm.nih.gov/10741256/
10. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entry for Semax (heptapeptide). Read September 2026. The entry states that compounded drugs containing semax may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities, that FDA has no, or limited, safety-related information for proposed routes of administration, and that the agency therefore lacks sufficient information to know whether the drug would cause harm if administered to humans. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
11. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full September 2026: "Semax" occurs nowhere in the document, so the substance appears in none of Category 1, Category 2, or Category 3. Control in the same read: the same document names GHK-Cu six times. https://www.fda.gov/media/94155/download
12. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name, the substance name and the brand name for "semax": no matching application. Control in the same run: the identical query for "bremelanotide" returned NDA 210557. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22semax%22
13. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution

---

### Sermorelin (GHRH(1–29); formerly Geref)
https://peptideamerica.org/molecules/sermorelin · status verified August 2026

Status: Compoundable (503A). Previously approved (Geref), discontinued in 2008 for business reasons; compounded today under 503A.
Class: GH secretagogues · Route: Subcutaneous injection

Regulatory record:
- August 2026: Compounded by 503A pharmacies with a valid prescription; the discontinued approval was withdrawn for commercial, not safety, reasons.
- FDA final action: none recorded

#### Definition
Sermorelin is the first 29 amino acids of growth hormone-releasing hormone, the shortest fragment that retains the full hormone's activity at the pituitary; it stimulates the body's own growth hormone release rather than replacing the hormone directly.
Its regulatory history distinguishes it from most compounded peptides: sermorelin was an approved drug, marketed as Geref for pediatric growth hormone deficiency, and it was discontinued in 2008 for commercial rather than safety reasons, with FDA withdrawing the approval the following year.

#### Evidence
The approval-era evidence is pediatric: in a one-year study of once-daily subcutaneous GHRH(1–29) in prepubertal children with growth hormone deficiency, treatment accelerated growth velocity [1]. Adult use for body composition, sleep, or longevity rests on the pharmacology rather than on comparable trials; a 2026 review of GH-axis peptides finds the clinical evidence for such uses thin [2].
A reader weighing sermorelin against injected growth hormone is weighing a stimulus with intact feedback control against direct replacement; the safety argument favors the former, and the outcome data for modern adult indications are limited for both.
Counted across the names the compound is indexed under, the record is 562 papers, of which 71 carry the clinical-trial publication type and 39 the stricter randomized-controlled-trial type; 52 of the 71 carry the adult subject heading and 19 the child heading [6]. The distribution by publication year is itself a finding: 9 of the 71 appeared before 1990, 57 during the 1990s, 5 between 2000 and 2009, and none since, the most recent having been published in 2005 [6].
Three of those trials are indexed under body composition, all three were read, and they do not agree. A 16-week single-blind randomized placebo-controlled study in 19 adults aged 55 to 71 found that nocturnal growth hormone and serum IGF-1 rose, that lean body mass increased in the men only, and that no other measure of body composition or bone mineral density changed in either sex; sleep quality was unaffected [3]. A 6-week study in 11 men aged 64 to 76 found that nightly injection raised nocturnal growth hormone release with no change in IGF-1, IGF binding protein 3, or the dual-energy x-ray absorptiometry measures of muscle and fat [4]. A 14-day dose-comparison study in 10 men of mean age 68 raised 24-hour growth hormone and IGF-1 to the levels measured in young men, but only at the higher of the two doses, and it measured hormones rather than body composition [5].

#### Access
Licensed 503A pharmacies compound sermorelin with a valid prescription; its history as a component of an approved drug is what makes that position durable.
Material sold without a prescription as research-use-only sermorelin sits outside pharmacy quality standards, whatever the molecule's own status.
The withdrawal record is public and dated. Geref was the subject of two applications, one approved December 28, 1990 and one approved September 26, 1997; the sponsor notified the FDA by letter of December 2, 2008 that the product was being discontinued and asked that the application be withdrawn, the agency published the withdrawal of approval on May 19, 2009 effective June 18, 2009, and in a determination published March 4, 2013 the agency found that the Geref presentations were not withdrawn from sale for reasons of safety or effectiveness [7]. That last finding is the one that matters to a reader: the product left the market on a commercial decision, and the agency said so in a document written for the purpose.
Drugs@FDA lists the first application, NDA 019863, as a new molecular entity and the second, NDA 020443, as a new dosage form with orphan status; both are marked discontinued with a note recording that Federal Register determination, and no Geref label is available on the site [8, 9].

#### Side effects
The published trials report few adverse effects, but they are small and old. In the one-year pediatric study behind the Geref approval, treatment was well tolerated, with no adverse changes in blood chemistry or hormone measures and no excess rise in IGF-1 [1]. In the placebo-controlled study of 19 adults aged 55 to 71, the only adverse effect reported was a transient rise in blood lipids that resolved by the end of the study [3], and the six-week study in older men observed no significant adverse effects [4].
None of those trials was designed or sized to detect uncommon harms, and none tested the compounded products sold today for adult wellness uses. Because sermorelin works by stimulating the body's own growth hormone release, the long-term questions are those of raising growth hormone and IGF-1 over years, which the trial record, the most recent of it published in 2005, does not answer [6].

#### Questions
Q: Is sermorelin legal in the US?
A: Yes, with a prescription. Licensed 503A pharmacies compound sermorelin for individual patients, and the index records it as compoundable as of September 2026.
Q: Is sermorelin FDA-approved?
A: Not today. It was approved as Geref for growth hormone deficiency in children and discontinued by its sponsor in 2008; the FDA withdrew the approval in 2009 and later determined it had not been withdrawn for reasons of safety or effectiveness [7].
Q: What are the side effects of sermorelin?
A: The published trials are small and report few: a transient rise in blood lipids in one adult study, and no significant adverse effects in the others [1, 3, 4]. None was large enough to detect uncommon harms.
Q: What is the difference between sermorelin and tesamorelin?
A: Both stimulate growth hormone release through the GHRH receptor. Tesamorelin (https://peptideamerica.org/molecules/tesamorelin) is an FDA-approved drug (EGRIFTA) for a specific indication, while sermorelin's approval was withdrawn and it is supplied today through 503A compounding.

#### References
1. Thorner M, Rochiccioli P, Colle M, et al. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. J Clin Endocrinol Metab. 1996;81(3):1189–1196. https://pubmed.ncbi.nlm.nih.gov/8772599/
2. Dominikowski A, Rękoś Z, Olejarz M, Szczepanek-Parulska E, Domin R, Ruchała M. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration. Front Endocrinol (Lausanne). 2026;17:1822475. https://pubmed.ncbi.nlm.nih.gov/42395176/
3. Khorram O, Laughlin GA, Yen SS. Endocrine and metabolic effects of long-term administration of [Nle27]growth hormone-releasing hormone-(1-29)-NH2 in age-advanced men and women. J Clin Endocrinol Metab. 1997;82(5):1472–1479. https://pubmed.ncbi.nlm.nih.gov/9141536/
4. Vittone J, Blackman MR, Busby-Whitehead J, et al. Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men. Metabolism. 1997;46(1):89–96. https://pubmed.ncbi.nlm.nih.gov/9005976/
5. Corpas E, Harman SM, Piñeyro MA, Roberson R, Blackman MR. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men. J Clin Endocrinol Metab. 1992;75(2):530–535. https://pubmed.ncbi.nlm.nih.gov/1379256/
6. PubMed, National Library of Medicine. Census run August 2026 across five name variants — "sermorelin" OR "GHRH(1-29)" OR "GRF(1-29)" OR "sermorelin acetate" OR "Geref" — returning 562 indexed records, 334 carrying the Humans MeSH term, 71 under "clinical trial"[Publication Type] and 39 under the stricter "randomized controlled trial"[Publication Type]. Of the 71, 52 carry the adult MeSH term and 19 the child MeSH term; 3 are indexed under body composition, and all 3 were read individually rather than counted. By publication year the 71 divide 9 before 1990, 57 in 1990 through 1999, 5 in 2000 through 2009, and 0 in 2010 through 2026; the 5 records in the 2000s were read individually and the most recent was published in 2005. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized-controlled-trial type, the invalid tag clinicaltrial[pt] was run against the same control term and returned 0, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22sermorelin%22+OR+%22GHRH%281-29%29%22+OR+%22GRF%281-29%29%22+OR+%22sermorelin+acetate%22+OR+%22Geref%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
7. US Food and Drug Administration. Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. 78 Federal Register 14095, March 4, 2013; docket FDA-2012-P-1071. Read August 2026 from the Government Publishing Office. https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm
8. US Food and Drug Administration. Drugs@FDA: NDA 019863, GEREF (sermorelin acetate), EMD Serono. Original approval (ORIG-1) December 28, 1990, classified Type 1 new molecular entity; marketing status Discontinued, with the note "Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons"; "Label is not available on this site." Read September 2026. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019863
9. US Food and Drug Administration. Drugs@FDA: NDA 020443, GEREF (sermorelin acetate), EMD Serono Inc. Original approval (ORIG-1) September 26, 1997, classified Type 3 new dosage form, standard review, orphan; marketing status Discontinued, with the same Federal Register determination note; "Label is not available on this site." Read September 2026. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443

---

### Setmelanotide (RM-493; Imcivree)
https://peptideamerica.org/molecules/setmelanotide · status verified September 2026

Status: FDA-approved. Approved November 2020 as Imcivree for rare genetic and acquired hypothalamic obesity; the label states it is not indicated for general obesity.
Class: Melanocortins · Route: Subcutaneous injection · Approved product: Imcivree (2020)

Regulatory record:
- November 2020: FDA approves setmelanotide injection under new drug application 213793, approval dated November 25, 2020, as a Type 1 new molecular entity. Drugs@FDA records the product as Imcivree, a subcutaneous solution containing setmelanotide acetate at a strength of 10 mg base per mL, sponsored by Rhythm and marketed as prescription-only.
- March 2026: Drugs@FDA records three approved efficacy supplements to the application after the original approval, dated June 16, 2022, December 20, 2024 and March 19, 2026, alongside two labeling supplements. The label in effect on April 1, 2026 indicates the product to reduce excess body weight and maintain weight reduction long term in patients aged four years and older with acquired hypothalamic obesity, and aged two years and older with obesity due to Bardet-Biedl syndrome or to confirmed proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency.
- September 2026: Setmelanotide sits in no category of the 503A bulks list published May 14, 2026 and on no 503B list. An approved product exists, so the question the bulks list answers does not arise for it.
- FDA final action: none recorded

#### Definition
Setmelanotide is a synthetic melanocortin 4 receptor agonist marketed as Imcivree. It acts on the same receptor pathway as PT-141 (https://peptideamerica.org/molecules/pt-141) and Melanotan II (https://peptideamerica.org/molecules/melanotan-ii), and unlike either of them it was developed for body weight rather than for sexual function or pigmentation.
The distinction that matters here is not chemical but regulatory. Setmelanotide is an approved obesity drug whose label excludes ordinary obesity, which makes it the clearest case in this index of an approval that is narrower than the condition it appears to treat.

#### Evidence
The trial record is the development program and it is small by design, because the populations are rare. Across four name variants PubMed returns 243 indexed records, of which 153 carry the Humans subject heading, 19 the clinical-trial publication type and 6 the randomized-controlled-trial type [1]. All nineteen were opened and read; seventeen name the molecule and two are matches on the search rather than on the compound, a puberty adipose-depot study and an intranasal oxytocin proteomics paper [1].
The registrational evidence is two single-arm phase 3 trials in leptin receptor or proopiomelanocortin deficiency [2], and a randomized, double-blind, placebo-controlled phase 3 trial in Bardet-Biedl and Alström syndromes [3]. A single-arm design is what a disease affecting a few hundred identified patients permits; it is also a weaker instrument than a controlled one, and the label rests on both kinds.
The indication has widened twice since approval and each widening carries its own trial. A one-year open-label phase 3 extended the population down to children aged two to five years [4], and acquired hypothalamic obesity was added on the strength of a phase 2 followed by a randomized trial reported in 2026 [5]. The earliest human work in the set is a 2015 study measuring resting energy expenditure in obese adults [6], which is the pharmacology rather than the indication.

#### Access
The lawful supply route is the approved product. FDA approved setmelanotide injection under new drug application 213793 on November 25, 2020 as a Type 1 new molecular entity, and Drugs@FDA records Imcivree as a subcutaneous solution of setmelanotide acetate at 10 mg base per mL, sponsored by Rhythm and marketed as prescription-only [7]. Three efficacy supplements have been approved since, dated June 16, 2022, December 20, 2024 and March 19, 2026 [7].
The label states who it is for, and states separately who it is not for. In the version effective April 1, 2026 the product is indicated "to reduce excess body weight and maintain weight reduction long term" in patients aged four years and older with acquired hypothalamic obesity and aged two years and older with obesity due to Bardet-Biedl syndrome or to confirmed proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency [8]. Its limitations of use say the product "is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective", and name among them "[o]ther types of obesity not related to acquired HO, BBS or POMC, PCSK1 or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity" [8].
Compounding does not arise for this molecule. Setmelanotide sits in no category of the section 503A bulks list published May 14, 2026 and on no 503B list [9]; an approved product exists, which is the condition under which the bulks question is not asked.

#### Side effects
The Imcivree label names the adverse reactions reported in at least 20 percent of treated patients in at least one indication: skin darkening, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression and spontaneous penile erection [10]. The label carries no boxed warning; the drug is contraindicated only for people who have had a serious hypersensitivity reaction to setmelanotide or to an ingredient of the product [10].
Skin darkening is the effect most specific to this drug. Setmelanotide also acts on the melanocortin 1 receptor in pigment cells, and the label reports generalized or focal darkening in the majority of treated patients in clinical trials, reversible after the drug is stopped, along with new moles or darkening of existing ones; it calls for a full-body skin examination before and periodically during treatment [10].
The other warnings cover sexual arousal effects, including spontaneous erections, with any erection lasting longer than four hours treated as an emergency; depression and suicidal thoughts, with monitoring for new or worsening mood changes; and serious allergic reactions, including anaphylaxis [10]. In acquired hypothalamic obesity the label adds two population-specific risks: serious acute adrenal insufficiency in 5 percent of treated patients with secondary adrenal insufficiency against none on placebo, and sodium imbalance in patients who also have central diabetes insipidus [10].

#### Questions
Q: Is setmelanotide FDA-approved?
A: Yes. FDA approved setmelanotide as Imcivree on November 25, 2020 [7], and the index records it as approved as of September 2026.
Q: Is Imcivree approved for general weight loss?
A: No. The label covers acquired hypothalamic obesity, Bardet-Biedl syndrome, and genetically confirmed POMC, PCSK1 or LEPR deficiency, and it states that the drug is not indicated for general (polygenic) obesity because it would not be expected to work there [10].
Q: What are the most common side effects of setmelanotide?
A: Skin darkening and injection site reactions lead the label's list, followed by nausea, headache, diarrhea, abdominal pain, vomiting, depression and spontaneous penile erection [10]. The [side effects](#side-effects) section above lists the label's warnings as well.
Q: Why does setmelanotide darken the skin?
A: The drug also activates the melanocortin 1 receptor on pigment cells, which increases melanin independently of sunlight [10]. The label reports the darkening as reversible after the drug is stopped [10].
Q: How is setmelanotide different from Melanotan II and PT-141?
A: All three act on melanocortin receptors, but only setmelanotide is approved for body weight. PT-141 (https://peptideamerica.org/molecules/pt-141) is approved for a different use, and Melanotan II (https://peptideamerica.org/molecules/melanotan-ii) has no lawful route in the United States as of September 2026.
Q: Can setmelanotide be compounded?
A: The question does not arise in practice: setmelanotide sits in no category of the 503A bulks list published May 14, 2026 and on no 503B list, and the approved product is the lawful route [9].

#### References
1. PubMed, National Library of Medicine. Census run September 2026 across four name variants — "setmelanotide" OR "RM-493" OR "RM 493" OR "Imcivree" — returning 243 indexed records, 153 carrying the Humans MeSH term, 19 under "clinical trial"[Publication Type] and 6 under "randomized controlled trial"[Publication Type]. All 19 trial-type records were retrieved and read individually rather than counted: 17 name a variant in the title or abstract, and 2 do not and are artifacts of the search — a puberty adipose-depot study and an intranasal oxytocin proteomics paper. The publication-type filter was proved live in the same run against a control term returning 8,907 records under the clinical-trial type and 6,116 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22setmelanotide%22+OR+%22RM-493%22+OR+%22RM+493%22+OR+%22Imcivree%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. Clément K, van den Akker E, Argente J, et al. Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials. Lancet Diabetes Endocrinol. 2020;8(12):960–970. https://pubmed.ncbi.nlm.nih.gov/33137293/
3. Haqq AM, Chung WK, Dollfus H, et al. Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period. Lancet Diabetes Endocrinol. 2022;10(12):859–868. https://pubmed.ncbi.nlm.nih.gov/36356613/
4. Argente J, Verge CF, Okorie U, et al. Setmelanotide in patients aged 2-5 years with rare MC4R pathway-associated obesity (VENTURE): a 1 year, open-label, multicenter, phase 3 trial. Lancet Diabetes Endocrinol. 2025;13(1):29–37. https://pubmed.ncbi.nlm.nih.gov/39549719/
5. Miller JL, van Santen HM, Phillips SA, et al. Setmelanotide for the Treatment of Acquired Hypothalamic Obesity. N Engl J Med. 2026;395(2):138–150. https://pubmed.ncbi.nlm.nih.gov/42418774/
6. Chen KY, Muniyappa R, Abel BS, et al. RM-493, a melanocortin-4 receptor (MC4R) agonist, increases resting energy expenditure in obese individuals. J Clin Endocrinol Metab. 2015;100(4):1639–1645. https://pubmed.ncbi.nlm.nih.gov/25675384/
7. Drugs@FDA, US Food and Drug Administration. Application NDA 213793, IMCIVREE (setmelanotide acetate), sponsor Rhythm; subcutaneous solution, EQ 10MG BASE/ML, marketing status Prescription. Original approval recorded November 25, 2020, submission class Type 1 - New Molecular Entity; approved efficacy supplements dated June 16, 2022, December 20, 2024 and March 19, 2026, and labeling supplements dated November 15, 2023 and August 21, 2025. Read September 2026 through the openFDA drugsfda endpoint, in a run whose control query on a nonexistent ingredient returned no match. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213793
8. IMCIVREE (setmelanotide) injection, prescribing information, structured product label version 14, effective April 1, 2026. Sections 1 Indications and Usage and 1.1 Limitations of Use. Read September 2026 through the openFDA label endpoint. https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=IMCIVREE
9. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, US Food and Drug Administration, face date "Updated May 14, 2026". Read September 2026. Setmelanotide appears in none of the three categories; the document's Category 1 table was extracted in full and searched, in a run whose positive control term appeared and whose nonsense control term did not. https://www.fda.gov/media/94155/download
10. Rhythm Pharmaceuticals. IMCIVREE (setmelanotide) injection, US prescribing information. Revised April 2026. DailyMed set ID 70c3ccf7-4df0-4c75-ba07-fede9970c8d9. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=70c3ccf7-4df0-4c75-ba07-fede9970c8d9

---

### TB-500 (Thymosin beta-4 fragment)
https://peptideamerica.org/molecules/tb-500 · status verified August 2026

Status: PCAC-recommended · pending. Removed from Category 2 in April 2026; PCAC recommended 503A listing in July 2026 on a reported tally; no FDA final rule.
Class: Repair peptides · Route: None lawful; sold as research-use-only material
July 2026 advisory-committee vote: 8–6, 1 abstaining; reported by McDermott Will & Schulte and LumaLex Law, whose separate accounts of the meeting agree substance by substance.

Regulatory record:
- April 2026: Removed from Category 2 without Category 1 listing.
- July 2026: PCAC votes 8–6 (one abstention) to recommend 503A listing; advisory only. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
- FDA final action: none recorded

#### Definition
TB-500 is a synthetic peptide marketed as the active fragment of thymosin beta-4, a 43-amino-acid protein involved in actin regulation and tissue repair; the name attaches to research-market products rather than to any pharmaceutical.
The distinction between full-length thymosin beta-4 and the fragment sold as TB-500 matters, because the published human evidence belongs to the former.

#### Evidence
Recombinant full-length thymosin beta-4 has completed a first-in-human randomized phase 1 study establishing safety and pharmacokinetics [1], and a phase 2 trial reported symptom improvement in severe dry eye [2]. The TB-500 fragment as sold has no clinical trial record of its own; buyers read the protein's literature as if it covered the fragment.
That substitution, a studied molecule lending its record to an unstudied cousin, recurs across the research-peptide market.
The two records were counted separately in August 2026 and they are not the same size. Searched on its own names, TB-500 returns 31 indexed papers against 1,107 for the full-length protein, and 21 of the 31 carry the Humans subject heading [5]. Under the clinical-trial publication type the protein returns 8 records and 7 under the stricter randomized-controlled-trial type; TB-500 returns one record under the clinical-trial type and zero randomized trials, and that single record was read rather than counted — it is a regression analysis of tuberculosis incidence in respiratory patients, matched on the letters TB and unrelated to the peptide [5].
What the 21 human-tagged TB-500 records mostly contain is analytical chemistry written for sport drug testing rather than therapy. A 2012 paper synthesized and identified the substance present in a TB-500 formulation as the N-terminal acetylated 17-23 fragment of thymosin beta-4, the sequence Ac-LKKTETQ — seven residues of a 43-residue protein — and proposed a method for detecting it in plasma and urine [3]. A 2023 laboratory analysis of products sold under the TB500 and TB1000 names reported that their contents were not consistently what the labels described [4].
A first trial of the fragment itself is now registered. ClinicalTrials.gov lists a randomized, placebo-controlled phase 1/2 study of the thymosin beta-4 17-23 fragment in adults with stable atherosclerotic cardiovascular disease, recruiting since February 2026 with completion estimated for 2028; it has posted no results as of September 2026 [9].

#### Access
TB-500 was removed from Category 2 of the interim 503A bulks list in April 2026 without Category 1 listing, and in July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding it to the section 503A list. The margin is reported as 8–6 with one abstention by McDermott Will & Schulte and by LumaLex Law, whose separate accounts of the meeting agree substance by substance [6, 7]; the FDA has published no minutes, transcript or vote summary, so the figure is secondary and this page says so wherever it appears. The vote is advisory; no FDA final rule has issued, and no licensed pharmacy may lawfully compound it as of August 2026.
FDA's statement of its safety concerns remains the one on its safety-risk page: compounded drugs containing the fragment may pose a risk of immunogenicity for certain routes because of the potential for aggregation and peptide-related impurities, FDA has not identified any human exposure data on drug products containing it, and the agency lacks important information on whether it would cause harm if given to humans [8].

#### References
1. Wang X, Liu L, Qi L, Lei C, Li P, Wang Y, et al. A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy Chinese volunteers. J Cell Mol Med. 2021 Sep;25(17):8222-8228. https://pubmed.ncbi.nlm.nih.gov/34346165/
2. Sosne G, Dunn SP, Kim C. Thymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial. Cornea. 2015 May;34(5):491-6. https://pubmed.ncbi.nlm.nih.gov/25826322/
3. Esposito S, Deventer K, Goeman J, Van der Eycken J, Van Eenoo P. Synthesis and characterization of the N-terminal acetylated 17-23 fragment of thymosin beta 4 identified in TB-500, a product suspected to possess doping potential. Drug Test Anal. 2012;4(9):733–738. https://pubmed.ncbi.nlm.nih.gov/22962027/
4. Delcourt V, Garcia P, Chabot B, et al. TB500/TB1000 and SGF1000: a scientific approach for a better understanding of misbranded and adulterated drugs. Drug Test Anal. 2023;15(4):458–464. https://pubmed.ncbi.nlm.nih.gov/36482504/
5. PubMed, National Library of Medicine. Census run August 2026, the two names counted separately. "TB-500" OR "TB500" returns 31 indexed records, 21 carrying the Humans MeSH term, 1 under "clinical trial"[Publication Type] and 0 under "randomized controlled trial"[Publication Type]; the single clinical-trial record was read individually and is a logistic regression study of tuberculosis incidence, matched on the letters TB and unrelated to the peptide. "thymosin beta 4" OR "thymosin beta-4" OR "Tbeta4" OR "thymosin beta(4)" returns 1,107 indexed records, 598 carrying the Humans MeSH term, 8 under the clinical-trial type and 7 under the randomized-controlled-trial type. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized-controlled-trial type, the invalid tag clinicaltrial[pt] returned 0 for that same control term, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22TB-500%22+OR+%22TB500%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
6. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance.
7. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.
8. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entry for thymosin beta-4, fragment (LKKTETQ), also known as TB-500. Read September 2026. The entry states that compounded drugs containing it may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation as well as peptide-related impurities, that FDA has not identified any human exposure data on drug products containing it, and that FDA lacks important information regarding any safety issues it raises, including whether it would cause harm if administered to humans. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
9. ClinicalTrials.gov, National Library of Medicine. NCT07487363: a phase 1/2, randomized, double-blind, placebo-controlled, sequential dose-escalation study of TB-500 (thymosin beta 4 17-23 fragment) in adults with stable atherosclerotic cardiovascular disease. Read through the v2 API September 2026: status recruiting; start February 5, 2026 (actual); completion February 2028 (estimated); no results posted. https://clinicaltrials.gov/api/v2/studies/NCT07487363

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### Tesamorelin (EGRIFTA; GHRH(1–44) analogue)
https://peptideamerica.org/molecules/tesamorelin · status verified August 2026

Status: FDA-approved. Approved since 2010; EGRIFTA WR (weekly reconstitution) approved March 2025.
Class: GH secretagogues · Route: Subcutaneous injection · Approved product: EGRIFTA WR (2025); EGRIFTA (2010)

Regulatory record:
- November 2010: FDA approves tesamorelin (EGRIFTA) for the reduction of excess abdominal fat in adults with HIV and lipodystrophy.
- March 2025: FDA approves EGRIFTA WR, an eight-fold concentrated formulation reconstituted weekly rather than daily; it replaces EGRIFTA SV.
- FDA final action: none recorded

#### Definition
Tesamorelin is a synthetic analogue of growth hormone-releasing hormone, the hypothalamic peptide that signals the pituitary gland to release growth hormone. The molecule carries the full 44-amino-acid GHRH sequence with a trans-3-hexenoyl group at its amino terminus; the modification slows enzymatic degradation and extends activity after subcutaneous injection [1].
Stimulating the pituitary rather than replacing growth hormone directly preserves the body's own feedback control. Growth hormone and insulin-like growth factor 1 rise within a physiological pattern, which distinguishes GHRH analogues from injected growth hormone itself.

#### Evidence
The approval rests on randomized, placebo-controlled phase 3 trials in HIV-infected adults with excess visceral fat. In the trial reported by Falutz and colleagues, 404 patients received tesamorelin 2 mg or placebo daily by subcutaneous injection; visceral adipose tissue fell 10.9 percent in the treatment group against 0.6 percent with placebo over six months, and the reduction reached approximately 18 percent in patients who continued through a full year [1]. A pooled analysis of the two phase 3 studies and a long-term safety report are published separately [2, 3].
Use outside the approved indication is not supported by registrational evidence. The trials enrolled HIV-infected patients with lipodystrophy; no phase 3 data exist for cosmetic fat reduction, athletic performance, or longevity applications.
A small controlled literature does exist outside that population, and it does not test the claim the marketplace makes for the molecule. A twelve-month randomized trial in 60 abdominally obese adults without HIV, selected for reduced growth hormone secretion, found visceral adipose tissue fell 35 square centimeters against placebo, with a 95 percent confidence interval of −58 to −12 and p equal to 0.003; abdominal subcutaneous fat did not change significantly, at p equal to 0.40 [5]. A twelve-week randomized trial in 53 patients with type 2 diabetes was a safety study, and found no change in insulin response or glycemic control [6]; a twenty-week randomized trial in 152 older adults measured cognition rather than body composition [7].
Counted across every name the compound is indexed under, the whole controlled record is 26 papers carrying the randomized-controlled-trial publication type, 20 of which name HIV or lipodystrophy [8]. The literature is a narrow one, and it is narrow in a particular direction: every population enrolled in it was selected for a deficit.

#### Access
Tesamorelin has been an approved drug in the United States since November 2010, first marketed as EGRIFTA. In March 2025 the FDA approved EGRIFTA WR, a more concentrated formulation reconstituted weekly rather than daily, which replaces the earlier EGRIFTA SV presentation [4]. It remains the only medication approved in the United States for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.
Both prescribing labels were still listed on DailyMed in September 2026, and the EGRIFTA WR label states that the two formulations are not substitutable [9, 10]. Drugs@FDA records the original approval on November 10, 2010 and the EGRIFTA WR supplement on March 25, 2025, both under the same application [11].
The approved product is the only lawful supply route, and the reason is the molecule's size. Tesamorelin carries the 44-amino-acid sequence of human GHRH [9], and the FDA rule defining a biological product treats any amino acid polymer with a specific, defined sequence of more than 40 amino acids as a protein [14]. On March 23, 2020 the EGRIFTA application was deemed a biologics license, BLA 022505 [11, 12], and from that date biological products that made the transition are not eligible for the compounding exemptions in sections 503A and 503B [13]. Compounded tesamorelin has no lawful route under either section.

#### Side effects
The EGRIFTA WR and EGRIFTA SV labels list the same most common adverse reactions, each reported in more than 5 percent of treated patients: arthralgia, injection site erythema, injection site pruritus, pain in an extremity, peripheral edema and myalgia [9, 10]. Injection site reactions, including redness, itching, pain, irritation and bruising, occurred in 25 percent of treated patients against 14 percent with placebo during the first 26 weeks of the trials [9].
The label's warnings follow from raising growth hormone. Fluid retention can appear as edema, joint pain or carpal tunnel syndrome, and is either transient or resolves when treatment stops. Glucose intolerance can develop: in the trials, 5 percent of treated patients against 1 percent on placebo reached an HbA1c of 6.5 percent or higher [9]. IGF-1 rises, the effects of prolonged elevation are unknown, and the label calls for monitoring it. Hypersensitivity reactions, including rash, itching, flushing and hives, occurred in 4 percent of treated patients [9].
The label also warns of an increased risk of neoplasms, since growth hormone is a growth factor, and advises considering discontinuation in acute critical illness [9]. Tesamorelin side effects (https://peptideamerica.org/evidence/tesamorelin-label-safety) sets out the full adverse-reaction table and what the trials measured before and after treatment. Tesamorelin is contraindicated in pregnancy, in active malignancy, in known hypersensitivity to tesamorelin or its excipients, and in disruption of the hypothalamic-pituitary axis from hypophysectomy, hypopituitarism, pituitary tumor or surgery, head irradiation or head trauma [9].

#### Questions
Q: Is tesamorelin FDA-approved?
A: Yes, for one use. It is approved as EGRIFTA to reduce excess abdominal fat in adults with HIV who have lipodystrophy, first in November 2010 and as EGRIFTA WR in March 2025 [9, 11]. The index records it as approved as of September 2026.
Q: Is compounded tesamorelin legal?
A: No. Tesamorelin has 44 amino acids, so the FDA treats it as a protein, and its approval was deemed a biologics license on March 23, 2020 [12, 14]. Biological products that made that transition are not eligible for the compounding exemptions in sections 503A and 503B [13].
Q: Does tesamorelin help with general fat loss?
A: It is not approved for that. The label states that it is not indicated for weight loss management because its effect on weight is neutral [9]. The small trials outside HIV are reviewed in tesamorelin off-label (https://peptideamerica.org/evidence/tesamorelin-off-label).
Q: What are the side effects of tesamorelin?
A: The most common in the label are joint pain, injection site redness and itching, pain in the arms or legs, peripheral swelling and muscle pain [9]. Its warnings cover fluid retention, glucose intolerance, raised IGF-1 and allergic reactions.
Q: What is the difference between tesamorelin and sermorelin?
A: Both stimulate growth hormone release through the GHRH receptor. Tesamorelin is the full 44-amino-acid hormone with an added hexenoyl group and a licensed biologic that cannot be compounded, while sermorelin (https://peptideamerica.org/molecules/sermorelin) is the first 29 amino acids, compounded today under 503A. Sermorelin vs tesamorelin (https://peptideamerica.org/evidence/sermorelin-versus-tesamorelin) compares them in detail.

#### References
1. Falutz J, Potvin D, Mamputu JC, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010;53(3):311–322. https://pubmed.ncbi.nlm.nih.gov/20101189/
2. Falutz J, Mamputu JC, Potvin D, et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010;95(9):4291–4304. https://pubmed.ncbi.nlm.nih.gov/20554713/
3. Falutz J, et al. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. AIDS. 2008;22(14):1719–1728. https://pubmed.ncbi.nlm.nih.gov/18690162/
4. Theratechnologies. FDA approval of EGRIFTA WR (tesamorelin F8) for excess visceral abdominal fat in adults with HIV and lipodystrophy. March 2025.
5. Makimura H, Feldpausch MN, Rope AM, et al. Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial. J Clin Endocrinol Metab. 2012;97(12):4769–4779. https://pubmed.ncbi.nlm.nih.gov/23015655/
6. Clemmons DR, Miller S, Mamputu JC. Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: a randomized, placebo-controlled trial. PLoS One. 2017;12(6):e0179538. https://pubmed.ncbi.nlm.nih.gov/28617838/
7. Baker LD, Barsness SM, Borson S, et al. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial. Arch Neurol. 2012;69(11):1420–1429. https://pubmed.ncbi.nlm.nih.gov/22869065/
8. PubMed, National Library of Medicine. Census run August 2026 across three name variants — "tesamorelin" OR "TH9507" OR "EGRIFTA" — returning 127 indexed records, 106 carrying the Humans MeSH term, 28 under "clinical trial"[Publication Type] and 26 under the stricter "randomized controlled trial"[Publication Type]. Of the 28, 21 name HIV or lipodystrophy and 7 do not; of the 26, 20 name HIV or lipodystrophy and 6 do not. All 7 residual records were read individually rather than counted: one is a trial of a different growth hormone product in which tesamorelin appears incidentally, and the remainder test cognition, glycemic safety, mitochondrial recovery, adiponectin, and body composition in adults selected for reduced growth hormone secretion. The publication-type filter was proved live in the same run against a control term returning 8,904 records, and a deliberately invalid identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22tesamorelin%22+OR+%22TH9507%22+OR+%22EGRIFTA%22%29+AND+%22randomized+controlled+trial%22%5BPublication+Type%5D
9. Theratechnologies. EGRIFTA WR (tesamorelin) for injection, US prescribing information. Revised March 2025. DailyMed set ID 839334d3-8c1d-4c26-9036-2ab524a6ea75 (SPL version 2, published August 3, 2026). Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75
10. Theratechnologies. EGRIFTA SV (tesamorelin) for injection, US prescribing information. Revised March 2024. DailyMed set ID 3d783378-b02d-4f19-99dd-0fc91a042224 (SPL version 9, published July 31, 2026). Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224
11. US Food and Drug Administration. Drugs@FDA: BLA 022505, EGRIFTA (tesamorelin acetate), Theratechnologies. Records "This Former NDA Was Deemed To Be a BLA on March 23, 2020", the original approval (ORIG-1) on November 10, 2010, and supplement S-020 on March 25, 2025, whose approval letter provides for EGRIFTA WR as a new formulation and multiple-dose presentation. Read September 2026. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505
12. US Food and Drug Administration. List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020. Lists tesamorelin acetate (Egrifta and Egrifta SV), former NDA 022505, Theratechnologies Inc., initial approval 11/10/2010. Read September 2026. https://www.fda.gov/media/119229/download
13. US Food and Drug Administration. Notice to Compounders: Changes that affect compounding as of March 23, 2020. States that transitioning biological products "will not be eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act." Content current as of March 5, 2020. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020
14. US Food and Drug Administration. Definition of the Term "Biological Product". Final rule, 85 Federal Register 10057, February 21, 2020, effective March 23, 2020; 21 CFR 600.3(h)(6) defines a protein as "any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size." Read September 2026. https://www.federalregister.gov/documents/2020/02/21/2020-03505/definition-of-the-term-biological-product

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### Thymosin alpha-1 (Thymalfasin; Ta1)
https://peptideamerica.org/molecules/thymosin-alpha-1 · status verified August 2026

Status: Nomination withdrawn. Licensed as a medicine in other countries and never approved here; the advisory committee voted 4–17 against listing it in December 2024, and the nomination was withdrawn.
Class: Immune peptides · Route: None lawful in the United States; sold as research-use-only material

Regulatory record:
- December 2024: The Pharmacy Compounding Advisory Committee votes 4 in favor and 17 against placing Thymosin alpha-1 (free base) on the 503A bulks list, and 4 to 17 again on Thymosin alpha-1 acetate. The minutes record that members voting against found no compelling evidence demonstrating clinical effectiveness and safety in the uses under review, which included hepatitis B, hepatitis C, HIV, COVID-19, malignant melanoma, hepatocellular carcinoma, non-small cell lung cancer, and sepsis.
- August 2026: Thymosin alpha-1 appears in FDA's table of substances nominated but withdrawn, in no category of the 503A list published May 14, 2026, and in Category 3 of the 503B list — nominated without adequate support. No FDA-approved product containing it exists.
- FDA final action: none recorded

#### Definition
Thymosin alpha-1 is a 28-amino-acid peptide originally isolated from thymic tissue, where it participates in the maturation and regulation of T cells. It is an immunomodulator rather than an antiviral or a cytotoxic agent, and its proposed clinical value has always rested on that indirect mechanism.
It is licensed as a medicine in a number of countries outside the United States. It has never been approved here, and that distance is the whole story.

#### Evidence
The larger double-blind TESTS trial randomized 1,106 adults with sepsis and found no clear mortality benefit [6]. Its published correction changed the 28-day mortality hazard ratio to 0.97, with a 95 percent confidence interval of 0.76 to 1.24 [7]. The corrected estimate does not establish a survival advantage. The sepsis trial review (https://peptideamerica.org/evidence/thymosin-alpha-1-sepsis-trials) compares this result with the earlier single-blind study and explains why an immune-marker change is a different endpoint.
The trial literature is genuine and it is not small. Across four name variants PubMed returns 870 indexed records, of which 553 carry the Humans subject heading, 95 the clinical-trial publication type, and 65 the randomized-controlled-trial type [1]. That is a larger controlled-trial record than any other molecule in this index without an approved United States product.
It is also a literature whose center of gravity sits outside the United States, in chronic viral hepatitis, sepsis, and oncology. A multicenter single-blind randomized controlled trial of the peptide in severe sepsis is representative of the strongest end of it [2]. The uses FDA reviewed span that whole range: hepatitis B, hepatitis C, HIV, COVID-19, depressed response to vaccination, adjuvant use with influenza vaccines, malignant melanoma, hepatocellular carcinoma, non-small cell lung cancer, sepsis, and infection after hematopoietic stem cell transplantation [3].
A large record and a refusal are not in contradiction. The advisory committee that reviewed the dossier concluded that the evidence did not establish clinical effectiveness and safety in the uses under review, which is a judgment about what the trials show rather than a claim that they do not exist [3].

#### Access
There is no lawful United States supply route and no approved product. On December 4, 2024 the Pharmacy Compounding Advisory Committee voted 4 in favor and 17 against placing Thymosin alpha-1 (free base) on the section 503A bulks list, and 4 to 17 again on Thymosin alpha-1 acetate. The minutes record that members voting against found no compelling evidence demonstrating clinical effectiveness and safety in the uses under review, and that members voting in favor argued the substance should be accessible to patients as an option [3].
The nomination was later withdrawn. Thymosin alpha-1 now appears in FDA's table of substances nominated but withdrawn, in no category of the 503A bulks list published on May 14, 2026, and in Category 3 of the 503B list — the category for substances nominated without adequate support [4][5]. FDA's published safety finding is that the safety-related information is inadequate for the agency to sufficiently understand the extent of any safety issues raised by the proposed compounded drug [5].
A national registration elsewhere confers nothing here. Under section 503A a pharmacy may compound from a bulk substance only where the substance is the subject of an applicable USP or NF monograph, is a component of an FDA-approved drug, or appears on the 503A bulks list; thymosin alpha-1 meets none of the three [4]. Material sold under this name in the United States is research-use-only chemical supply. The research-only (https://peptideamerica.org/status/research-only) page sets out the consequences.

#### References
1. PubMed, National Library of Medicine. Census run August 2026 across four name variants — "thymosin alpha 1" OR "thymosin alpha-1" OR "thymalfasin" OR "Zadaxin" — returning 870 indexed records, 553 carrying the Humans MeSH term, 95 under "clinical trial"[Publication Type] and 65 under "randomized controlled trial"[Publication Type]. A literature of this size is reported as a magnitude and was not itemized record by record; this index does not characterize its individual studies beyond the uses FDA states it reviewed. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22thymosin+alpha+1%22+OR+%22thymosin+alpha-1%22+OR+%22thymalfasin%22+OR+%22Zadaxin%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. Wu J, Zhou L, Liu J, et al. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013;17(1):R8. https://pubmed.ncbi.nlm.nih.gov/23327199/
3. US Food and Drug Administration. Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, December 4, 2024, question 3 and its subparts, and the accompanying table of uses evaluated. Read August 2026. https://www.fda.gov/media/185642/download
4. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: thymosin alpha-1 appears in none of Category 1, Category 2, or Category 3. https://www.fda.gov/media/94155/download
5. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for Thymosin-alpha 1 (Ta1) in the table of substances nominated but withdrawn. Read August 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
6. Wu J, Pei F, Zhou L, et al. The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial. BMJ. 2025. Primary record checked October 2026. https://pubmed.ncbi.nlm.nih.gov/39814420/
7. The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial. BMJ. 2025. Primary record checked October 2026. https://pubmed.ncbi.nlm.nih.gov/40447307/

---

### Thymulin (Thymulin acetate; serum thymic factor)
https://peptideamerica.org/molecules/thymulin · status verified September 2026

Status: No lawful route. Category 3 of the 503A bulks list — nominated without adequate support; no approved product and no lawful compounding route.
Class: Immune peptides · Route: None lawful; sold as research-use-only material

Regulatory record:
- May 2026: The section 503A bulks list FDA published May 14, 2026 lists Thymulin acetate in Category 3, the file for substances nominated without adequate support to evaluate. It sits in neither of the other two 503A categories, and Category 3 carries no authorization to compound.
- September 2026: Drugs@FDA holds no approved product with thymulin as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026.
- FDA final action: none recorded

#### Definition
Thymulin is a nonapeptide produced by the thymus, and it is unusual among the peptides in this index in that its activity depends on a metal: the molecule is biologically active only when bound to zinc. That dependence is the reason its name appears throughout a literature that is not about it.
It is sold as research-use-only material on claims about immune function and thymic aging. The federal record and the published record are both thinner than that marketing implies, and the published record is thin in a way a count conceals rather than reveals.

#### Evidence
Across two name variants PubMed returns 498 indexed records, of which 226 carry the Humans subject heading, 8 the clinical-trial publication type, and 5 the randomized-controlled-trial type [1]. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type, the invalid tag returned zero for that control term, and a deliberately invalid record identifier errored in the same run [1].
Eight is small enough to itemize, so all eight were opened, and the reading reverses what the number suggests. Seven of the eight do not administer thymulin at all. They measure the concentration of the body's own thymulin as a readout of zinc status inside trials of zinc supplementation: in patients with Crohn's disease, where zinc restored plasma zinc and thymulin concentrations [2]; in young rural Gambian children [3]; in children with Down's syndrome; and as an adjunct to zidovudine therapy [1]. Others track thymulin against melatonin, against a zinc-fortified milk, and against prenatal and childhood exposures [1].
The eighth record does administer something, and it is not thymulin. A 1989 double-blind pilot study tested nonathymulin, a synthetic analogue, in multiple sclerosis [4]. That is the entire administered human record indexed under these names: one pilot study, of a different molecule, in a different field, thirty-seven years ago.
The correct statement is therefore not that thymulin has eight human trials. It is that thymulin has none, that a synthetic analogue has one pilot, and that the count exists because the peptide is a convenient biomarker for something else. The human trial record (https://peptideamerica.org/reference/trial-record) prints the count with that reading attached, which is the only form in which the count is not misleading.

#### Access
There is no lawful United States supply route. Drugs@FDA holds no approved product with thymulin as an active ingredient; the same query form in the same session returned one application for bremelanotide and fourteen for liraglutide, and returned nothing for a deliberately invented ingredient name [5].
The section 503A bulks list FDA published May 14, 2026 lists Thymulin acetate in Category 3 — the file for substances nominated without adequate support to evaluate — and in neither of the other two categories [6]. Category 3 confers nothing. It is not the safety finding that Category 2 records, and it is not the permission during review that Category 1 grants; it records that the nomination itself was inadequate to evaluate.
The substance was not among the seven peptides the advisory committee reviewed in July 2026, so no vote, recommendation or pending rulemaking attaches to it [6]. What is sold is research-use-only material (https://peptideamerica.org/status/research-only), outside pharmacy licensure and outside every quality obligation that attaches to a drug.

#### References
1. PubMed, National Library of Medicine. Census run September 2026 across two name variants — "thymulin" OR "serum thymic factor" — returning 498 indexed records, 226 carrying the Humans MeSH term, 8 under "clinical trial"[Publication Type] and 5 under "randomized controlled trial"[Publication Type]. All 8 trial-type records were retrieved through esummary and read individually; seven measure endogenous thymulin as a marker of zinc status and one administers a synthetic analogue. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22thymulin%22+OR+%22serum+thymic+factor%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. Brignola C, Belloli C, De Simone G, Evangelisti A, Parente R, Mancini R, et al. Zinc supplementation restores plasma concentrations of zinc and thymulin in patients with Crohn's disease. Aliment Pharmacol Ther. 1993 Jun;7(3):275-80. https://pubmed.ncbi.nlm.nih.gov/8364132/
3. Bates CJ, Evans PH, Dardenne M, Prentice A, Lunn PG, Northrop-Clewes CA, et al. A trial of zinc supplementation in young rural Gambian children. Br J Nutr. 1993 Jan;69(1):243-55. https://pubmed.ncbi.nlm.nih.gov/8457531/
4. Roullet E, Cesaro P, Simon-Lavoine N, Degos JD, Marteau R. Nonathymulin treatment of multiple sclerosis: double-blind pilot study. Acta Neurol Scand. 1989 Dec;80(6):575-8. https://pubmed.ncbi.nlm.nih.gov/2618585/
5. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe run September 2026: a search by active-ingredient name returned no records for thymulin. In the same run and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none — a positive and a negative control beside the zero. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22THYMULIN%22
6. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: Thymulin acetate appears in Category 3 and in neither Category 1 nor Category 2. https://www.fda.gov/media/94155/download

---

### Tirzepatide (Mounjaro; Zepbound)
https://peptideamerica.org/molecules/tirzepatide · status verified August 2026

Status: FDA-approved. Approved brand products; shortage resolved October 2024; same narrow 503A posture as semaglutide.
Class: GLP-1 receptor agonists · Route: Subcutaneous injection · Approved product: Mounjaro, Zepbound

Regulatory record:
- April 2026: FDA proposes excluding tirzepatide from the 503B bulks list; the lawful remainder is patient-specific 503A compounding with documented clinical need.
- FDA final action: none recorded

#### Definition
Tirzepatide is a 39-amino-acid synthetic peptide that activates both the GIP and GLP-1 receptors, the first dual incretin agonist approved in the United States; it is marketed for type 2 diabetes and for chronic weight management.
Engaging two incretin receptors rather than one produces larger average weight reductions than GLP-1 agonism alone, at the cost of a similar gastrointestinal tolerability profile.

#### Evidence
In SURMOUNT-1, 2,539 adults with obesity received weekly tirzepatide or placebo for 72 weeks; mean weight change was −15.0 percent at 5 mg, −19.5 percent at 10 mg, and −20.9 percent at 15 mg, against −3.1 percent with placebo [1].
As with semaglutide, the open questions are durability and long-term safety in broad use; efficacy against placebo is settled.
SURMOUNT-OSA enrolled 469 adults with obesity and moderate-to-severe obstructive sleep apnea in two trials separated by baseline PAP use. Tirzepatide reduced breathing-event frequency more than placebo over 52 weeks; the later weight-association analysis used the same study program, not a new independent trial [9, 10]. The sleep-apnea evidence review (https://peptideamerica.org/evidence/tirzepatide-sleep-apnea-trials) distinguishes fewer breathing events from a universal cure or permission to stop PAP.

#### Access
The approved products are the lawful supply route. The FDA declared the tirzepatide shortage resolved in October 2024, ending shortage-based compounding; the April 2026 proposal to exclude it from the 503B bulks list closes the outsourcing route, and patient-specific 503A compounding requires documented clinical need [2].
Telehealth programs in the supply panel provide prescriber-led GLP-1 treatment; molecule and formulation vary by provider and should be confirmed on the provider's own site.

#### Side effects
The Zepbound label lists the adverse reactions reported in at least 5 percent of treated patients: nausea, diarrhea, vomiting, constipation, abdominal pain, indigestion, injection site reactions, fatigue, hypersensitivity reactions, belching, hair loss and gastroesophageal reflux [3]. Gastrointestinal reactions are sometimes severe, and the label does not recommend the drug for people with severe gastroparesis [3].
A boxed warning covers thyroid C-cell tumors: tirzepatide caused them in rats, whether it does so in humans is unknown, and the drug is contraindicated for anyone with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia syndrome type 2 [3].
The label's other warnings cover acute kidney injury from dehydration, acute gallbladder disease, acute pancreatitis, serious allergic reactions including anaphylaxis and angioedema, hypoglycemia when combined with insulin or an insulin secretagogue, diabetic retinopathy complications in patients with type 2 diabetes, and pulmonary aspiration during general anesthesia or deep sedation [3].
Compounded tirzepatide is not covered by that label. The FDA reports dosing errors with compounded GLP-1 injections and has received an adverse event report tied to a product labeled as compounded tirzepatide from a pharmacy that had not made it [4].

#### Questions
Q: Is tirzepatide FDA-approved?
A: Yes. Tirzepatide is approved in the United States as Mounjaro for type 2 diabetes and as Zepbound for chronic weight management; the index records it as approved as of September 2026.
Q: Is compounded tirzepatide still legal?
A: Only in a narrow form. The FDA declared the tirzepatide shortage resolved in October 2024, ending shortage-based compounding, and proposed in April 2026 to exclude it from the 503B bulks list; what remains is patient-specific 503A compounding with a documented clinical need [2].
Q: What are the most common side effects of tirzepatide?
A: Nausea, diarrhea, vomiting, constipation, abdominal pain and indigestion lead the label's list, followed by injection site reactions, fatigue, allergic reactions, belching, hair loss and reflux [3].
Q: Does tirzepatide cause thyroid cancer?
A: It is not known. Tirzepatide caused thyroid C-cell tumors in rats, the label carries a boxed warning for that finding, and the drug is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with MEN 2 [3].
Q: How is tirzepatide different from semaglutide?
A: Tirzepatide activates two incretin receptors, GIP and GLP-1, where semaglutide (https://peptideamerica.org/molecules/semaglutide) activates GLP-1 alone; in the SURMOUNT-1 trial the average weight reduction at the highest dose was 20.9 percent at 72 weeks [1].

#### References
1. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205–216. https://pubmed.ncbi.nlm.nih.gov/35658024/
2. Orrick. FDA moves to shut the door on large-scale compounding of GLP-1 drugs. May 2026.
3. Eli Lilly and Company. ZEPBOUND (tirzepatide) injection, US prescribing information. Revised August 2026. DailyMed set ID 487cd7e7-434c-4925-99fa-aa80b1cc776b. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b
4. US Food and Drug Administration. FDA's concerns with unapproved GLP-1 drugs used for weight loss. Content current as of September 1, 2026. Read September 2026. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
5. Eli Lilly and Company. FOUNDAYO (orforglipron) tablets, US prescribing information; Indications and Usage and section 11 Description. Initial US approval 2026; structured product label version 10, effective July 29, 2026. DailyMed set ID 8ac446c5-feba-474f-a103-23facb9b5c62. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ac446c5-feba-474f-a103-23facb9b5c62
6. US Food and Drug Administration. NDA 220934 approval letter, FOUNDAYO (orforglipron) tablets, Eli Lilly and Company; application received January 20, 2026, signed April 1, 2026. Drugs@FDA records the original approval as a Type 1 new molecular entity dated April 1, 2026. Read September 2026. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220934Orig1s000ltr.pdf
7. ClinicalTrials.gov, NCT06662383 (TRIUMPH-5). A Phase 3, randomized, double-blind study to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. Sponsor Eli Lilly and Company; status Active, not recruiting; start November 1, 2024; estimated primary completion November 2026; record last updated July 20, 2026. Read through the v2 API September 2026. https://clinicaltrials.gov/study/NCT06662383
8. Novo Nordisk. Headline results from REDEFINE 4: CagriSema did not meet the primary endpoint of non-inferiority on weight loss versus tirzepatide at 84 weeks. Company announcement, February 23, 2026. Read September 2026.
9. Malhotra A, Grunstein RR, Fietze I, et al. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. N Engl J Med. 2024;391:1193–1205. Read October 15, 2026. https://pubmed.ncbi.nlm.nih.gov/38912654/
10. Malhotra A, Grunstein RR, Azarbarzin A, et al. Tirzepatide for sleep-disordered breathing in SURMOUNT-OSA: Time course and association with body weight. Sleep Med. 2025;136:106853. Read October 15, 2026. https://pubmed.ncbi.nlm.nih.gov/41135142/

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### Vasoactive intestinal peptide (VIP; aviptadil)
https://peptideamerica.org/molecules/vasoactive-intestinal-peptide · status verified September 2026

Status: Compoundable (503A). Category 1 of the interim 503A bulks list; a pharmacy may compound it while FDA review continues. No approved product containing it exists.
Class: Gut peptides · Route: Compounded preparation only; there is no approved product

Regulatory record:
- May 2026: Listed in Category 1 of the interim 503A bulks list published May 14, 2026; pharmacies may compound while FDA review continues. It is one of a small number of peptides anywhere in Category 1, and the only one this index added in 2026.
- September 2026: Drugs@FDA holds no approved product with vasoactive intestinal peptide or aviptadil as an active ingredient. The lawful route to a patient is therefore a pharmacy preparation under section 503A, not a manufactured product, and the difference decides what quality obligations attach.
- FDA final action: none recorded

#### Definition
Vasoactive intestinal peptide is a twenty-eight-amino-acid signaling peptide produced throughout the body, most densely in the gut and in the nerves supplying the airways and blood vessels. It relaxes smooth muscle, widens vessels and airways, and modulates inflammation, and it is a natural constituent of human physiology rather than a designed molecule.
The synthetic form used in medicine is called aviptadil. This index tracks the substance because it occupies a position almost nothing else here does: it is lawful for a pharmacy to compound, today, and it has no approved product behind it.

#### Evidence
Across three name variants PubMed returns 16,022 indexed records, of which 5,810 carry the Humans subject heading, 185 the clinical-trial publication type, and 105 the randomized-controlled-trial type [1]. That is a large literature and it is reported here as a magnitude rather than itemized; the twenty-five most relevant randomized records were read to characterize it, and the row on the human trial record (https://peptideamerica.org/reference/trial-record) says plainly that the individual records were not all opened [1]. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type, the invalid tag returned zero for that control term, and a deliberately invalid record identifier errored in the same run [1].
Most of that literature belongs to the endogenous peptide rather than to any product. It divides into headache provocation studies, in which the peptide is infused to see whether it triggers migraine; airway pharmacology, where an early controlled study found that it produced bronchodilation and protected against histamine-induced bronchoconstriction in asthmatic subjects [2]; and vascular work.
The largest and most recent randomized evidence concerns aviptadil in respiratory failure, and it is not favorable. A randomized controlled trial in patients with critical COVID-19 respiratory failure reported sixty-day outcomes [3]; the National Institutes of Health TESICO platform trial then tested intravenous aviptadil and remdesivir in COVID-19-associated hypoxemic respiratory failure in the United States and published in 2023 [4]. A separate randomized clinical trial tested whether the peptide provokes migraine headaches [5].
None of that literature concerns the indications the compounded preparation is marketed for. A reader should hold two facts at once: the compounding of this substance is lawful, and the published randomized record supporting the uses it is compounded for is not established here. Lawfulness under section 503A turns on a nomination and a category, not on efficacy, and this molecule is the clearest demonstration on the site that the two questions are separate.

#### Access
This is the unusual case on this index: there is a lawful route. The section 503A bulks list FDA published May 14, 2026 lists Vasoactive Intestinal Peptide in Category 1 (https://peptideamerica.org/glossary/category-1), the category for substances under evaluation, and a licensed pharmacy may compound with a Category 1 substance for an individual patient with a valid prescription while that review continues [6].
Category 1 is a permission during review, not an approval, and it can end. The same document shows how quickly a position moves: GHK-Cu left Category 1 in April 2026 when its nominators withdrew, and part of it was restored in May [6]. A reader relying on this molecule's status should check the date on this page rather than the fact of it.
No approved product exists. Drugs@FDA holds no record of vasoactive intestinal peptide or of aviptadil as the active ingredient of any drug product; in the same session and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none [7]. What a patient receives is therefore a pharmacy preparation, which is not reviewed by the FDA for safety, effectiveness or manufacturing quality — the compoundable (https://peptideamerica.org/status/compoundable) page sets out what that distinction costs and what it preserves.
This index verifies no seller for this molecule and names none. A lawful status is a necessary condition for a supply route and it is not a sufficient one.

#### Side effects
No approved product exists, so no FDA label lists the side effects of vasoactive intestinal peptide. The controlled safety data come from trials of its synthetic form, aviptadil, in critically ill patients, and from research infusions of the natural peptide [3, 4, 5]. No controlled study has examined the compounded preparations for the uses they are sold for.
In the NIH TESICO trial of intravenous aviptadil in COVID-19 respiratory failure, the primary safety outcome, a composite of death, serious adverse events, organ failure, serious infection or grade 3 or 4 adverse events by day 5, occurred in 146 of 231 patients given aviptadil (63%) and 129 of 230 given placebo (56%), a difference that was not statistically significant [4]. An earlier randomized trial in 196 patients reported no drug-related serious adverse events [3]. Both trials enrolled patients in respiratory failure, so their safety results say little about a healthy adult.
The peptide's action on blood vessels is itself a documented reaction. In a randomized, placebo-controlled crossover trial in 21 people with migraine, a two-hour infusion of the peptide provoked migraine attacks in 15 of them, against 1 after placebo, and widened the superficial temporal artery [5].

#### Questions
Q: What is vasoactive intestinal peptide?
A: It is a twenty-eight-amino-acid signaling peptide made throughout the body, most densely in the gut and in the nerves of the airways and blood vessels. It relaxes smooth muscle and widens vessels and airways; aviptadil is the name of its synthetic form.
Q: Is VIP (aviptadil) FDA-approved?
A: No. Drugs@FDA holds no approved product with vasoactive intestinal peptide or aviptadil as its active ingredient, as of September 2026 [7].
Q: Can a pharmacy compound VIP?
A: Yes. Vasoactive intestinal peptide sits in Category 1 of the interim 503A bulks list, so a licensed pharmacy may compound it for an individual patient with a valid prescription while FDA review continues [6]. Category 1 is a permission during review, not an approval.
Q: What are the side effects of VIP?
A: The best-documented reaction is headache: an infusion provoked migraine attacks in 15 of 21 people with migraine in a controlled trial [5]. In critically ill COVID-19 patients, serious adverse outcomes were not significantly more common with aviptadil than with placebo [4]; no controlled study has examined compounded VIP for other uses.
Q: Did aviptadil work for COVID-19?
A: The largest trial found no benefit. TESICO found no significant improvement at day 90, and its monitoring board stopped the aviptadil comparison for futility [4]; an earlier randomized trial missed its primary endpoint [3].

#### References
1. PubMed, National Library of Medicine. Census run September 2026 across three name variants — "vasoactive intestinal peptide" OR "vasoactive intestinal polypeptide" OR "aviptadil" — returning 16,022 indexed records, 5,810 carrying the Humans MeSH term, 185 under "clinical trial"[Publication Type] and 105 under "randomized controlled trial"[Publication Type]. The trial literature is above this index's itemization ceiling and is reported as a magnitude; the 25 most relevant randomized records were retrieved through esummary and read to characterize it. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22vasoactive+intestinal+peptide%22+OR+%22aviptadil%22%29+AND+%22randomized+controlled+trial%22%5BPublication+Type%5D
2. Morice A, Unwin RJ, Sever PS. Vasoactive intestinal peptide causes bronchodilatation and protects against histamine-induced bronchoconstriction in asthmatic subjects. Lancet. 1983 Nov 26;2(8361):1225-7. https://pubmed.ncbi.nlm.nih.gov/6139572/
3. Youssef JG, Lavin P, Schoenfeld DA, Lee RA, Lenhardt R, Park DJ, et al. The Use of IV Vasoactive Intestinal Peptide (Aviptadil) in Patients With Critical COVID-19 Respiratory Failure: Results of a 60-Day Randomized Controlled Trial. Crit Care Med. 2022 Nov 1;50(11):1545-1554. https://pubmed.ncbi.nlm.nih.gov/36044317/
4. Brown SM, Barkauskas CE, Grund B, Sharma S, Phillips AN, Leither L, et al. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial. Lancet Respir Med. 2023 Sep;11(9):791-803. https://pubmed.ncbi.nlm.nih.gov/37348524/
5. Pellesi L, Al-Karagholi MA, De Icco R, Coskun H, Elbahi FA, Lopez-Lopez C, et al. Effect of Vasoactive Intestinal Polypeptide on Development of Migraine Headaches: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2118543. https://pubmed.ncbi.nlm.nih.gov/34357396/
6. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: Vasoactive Intestinal Peptide appears in Category 1. The same document records the April 22, 2026 removal of GHK-Cu from Category 1 on withdrawal by its nominators, and the addition back of GHK-Cu for non-injectable routes after a nominator clarified on May 5, 2026. https://www.fda.gov/media/94155/download
7. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe run September 2026: a search by active-ingredient name returned no records for vasoactive intestinal peptide or for aviptadil. In the same run and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none — a positive and a negative control beside the zero. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22AVIPTADIL%22

## Evidence reviews (47)

### Bremelanotide: Desire and Distress Trials
https://peptideamerica.org/evidence/bremelanotide-desire-distress-trials · published October 2026 · updated October 2026

Question: What did bremelanotide improve in the RECONNECT trials?
Short answer: Bremelanotide improved reported desire and related distress in premenopausal women with HSDD, but did not significantly increase the prespecified number of satisfying sexual events; nausea and dropout matter when interpreting benefit.

#### The population behind the result
RECONNECT comprised two randomized, double-blind, placebo-controlled trials lasting 24 weeks. They randomized 1,267 premenopausal women with acquired, generalized hypoactive sexual desire disorder, or HSDD. The safety population included 1,247 women and the primary efficacy population 1,202 [1].
The participants had a defined diagnosis and eligibility requirements; this was not a study of sexual performance in anyone wishing to enhance it. Most participants were white and the average age was 39. Results should remain attached to that population rather than being generalized to men or all postmenopausal women [1].

#### Desire and distress were the primary outcomes
The two primary endpoints measured sexual desire and distress about low desire using specified questionnaire domains. The integrated placebo-adjusted differences were an increase of 0.35 points in desire and a reduction of 0.33 points in distress. These are changes on rating scales, not extra sexual events or percentages of participants cured [1].
Patient-perceived benefit provides another perspective. The prespecified anchor analysis reported responders of 58.3 percent versus 36.1 percent in one trial and 58.2 percent versus 35.4 percent in the other. The placebo response matters: quoting only the roughly 58 percent treatment figure overstates the additional response associated with medication [1].

#### The sexual-event count did not improve significantly
The prespecified count of satisfying sexual events did not show a statistically significant between-group difference. Because that endpoint failed in the testing hierarchy, the remaining ranked secondary outcomes became supportive or exploratory. Positive primary outcomes and a negative secondary count can both be true [1].
A later exploratory calculation examined the proportion of encounters described as satisfying rather than the number of such encounters. Changing the denominator changes the question. That result should not be substituted for the unsuccessful prespecified count, or presented as proof that treatment increased sexual activity [1].

#### Tolerability affects the practical benefit
Nausea occurred in 40.0 percent receiving bremelanotide versus 1.3 percent receiving placebo; 8.1 percent discontinued study drug because of nausea. Flushing and headache were also common. The paper reported transient blood-pressure changes, and the product’s prescribing information remains necessary for individual safety decisions [1].
Overall study withdrawal was higher with bremelanotide: 41.9 versus 16.0 percent in one trial and 43.8 versus 28.4 percent in the other. These are overall withdrawal figures, not all withdrawals caused by adverse events. The imbalance still matters when judging how well average questionnaire improvements represent everyone who started [1].

#### The extension was not a new placebo comparison
A 52-week open-label extension invited eligible completers from the original trials. Of 856 eligible participants, 684 entered and 272 completed the extension. Everyone received active treatment, and statistical analyses were descriptive [2].
The extension reported sustained symptom improvements and no new safety signals, but selection and attrition limit that finding. People who completed the core trial and elected further treatment are different from all initial participants. Without a concurrent placebo group, the extension cannot establish the same causal long-term comparison as the randomized phase [2].

#### Reading the evidence alongside the product
For a reader weighing treatment, the useful question is whether an improvement in desire and distress is meaningful enough to justify the tolerability burden in their own clinical circumstances. Neither a favorable group average nor a responder percentage promises an individual result. This evidence does not establish benefits for research material sold under the PT-141 name.
The PT-141 monograph (https://peptideamerica.org/molecules/pt-141) and approved-product review (https://peptideamerica.org/evidence/pt-141-status) explain the formulation and indication boundaries. RECONNECT answers a narrower question about measured outcomes; it is not evidence for broader performance claims or a self-treatment protocol.

#### Sources
1. Kingsberg SA, Clayton AH, Portman D, et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019;134:899–908. https://pubmed.ncbi.nlm.nih.gov/31599840/
2. Simon JA, Kingsberg SA, Portman D, et al. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol. 2019;134:909–917. https://pubmed.ncbi.nlm.nih.gov/31599847/

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### Semaglutide Withdrawal: Weight Regain Evidence
https://peptideamerica.org/evidence/semaglutide-withdrawal-weight-regain · published October 2026 · updated October 2026

Question: How much weight returns after stopping semaglutide?
Short answer: Regain was common after withdrawal in two STEP studies, but their averages describe selected groups and different follow-up periods; they do not predict an individual outcome or establish a tapering method.

#### Two different withdrawal questions
STEP 1 asked what happened after a course of treatment ended. Its extension followed 327 participants from selected sites for a year after week 68. Both study medication and the structured lifestyle intervention stopped. This was an exploratory follow-up of a subset, not a new randomization between stopping and continuing treatment [1].
In that extension group, mean loss during treatment was 17.3 percent with semaglutide and 2.0 percent with placebo. Over the following year, participants regained 11.6 and 1.9 percentage points respectively. The semaglutide group remained an average 5.6 percent below its original weight at week 120 [1].

#### What two-thirds regained means
The widely repeated two-thirds figure describes the share of the earlier average loss that returned. It does not mean two-thirds of participants regained everything, or that every person regained precisely that fraction. A group average also leaves room for people with greater or smaller changes [1].
The extension group had lost more weight during treatment than the full original trial population. Its 17.3 percent figure therefore should not be substituted for the main STEP 1 estimate in a comparison with another drug. The participants and analysis set have changed [1].

#### A randomized continuation comparison
STEP 4 gives a different comparison. All 902 entrants initially received semaglutide. After 20 weeks, 803 who reached the maintenance dose were randomized to continue treatment or switch to placebo. Both groups continued lifestyle intervention during the following 48 weeks [2].
By randomization, mean weight loss was 10.6 percent. From that point, those continuing semaglutide lost a further 7.9 percent, while those switching to placebo gained 6.9 percent. The between-group difference was 14.8 percentage points. These changes start at week 20, not the original pretreatment weight [2].

#### Why the designs matter
STEP 4 helps distinguish medication withdrawal from the simultaneous end of structured lifestyle support in STEP 1. Regain occurred in its placebo-switch group despite continued lifestyle intervention. It does not show that lifestyle care is useless; it shows what happened under the particular support provided in this trial [1, 2].
The run-in also selects the population. STEP 4 randomized people who reached the trial maintenance dose, rather than everyone who ever tried semaglutide. Both studies enrolled adults without diabetes. Their findings should not be treated as a precise forecast for a different product, population or interrupted prescription [1, 2].

#### Benefits, tolerability and unanswered questions
Most cardiometabolic improvements in the STEP 1 extension moved back toward baseline after withdrawal. That extension did not systematically collect adverse events. STEP 4 reported gastrointestinal events in 49.1 percent continuing semaglutide versus 26.1 percent switched to placebo during the randomized phase; those rates do not include every difficulty experienced during initial treatment [1, 2].
Neither design tested a taper against abrupt withdrawal, a reduced-dose maintenance strategy or a personalized restart plan. The evidence supports discussing long-term treatment goals and continuity with the prescriber, not deriving a stopping schedule from these averages. The semaglutide monograph (https://peptideamerica.org/molecules/semaglutide) covers the product and regulatory record; trial comparisons (https://peptideamerica.org/evidence/dulaglutide-versus-semaglutide-trials) address a different question about relative treatment effects.

#### Sources
1. Wilding JPH, Batterham RL, Davies M, et al. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022;24:1553–1564. https://pubmed.ncbi.nlm.nih.gov/35441470/
2. Rubino D, Abrahamsson N, Davies M, et al. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021;325:1414–1425. https://pubmed.ncbi.nlm.nih.gov/33755728/

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### Tirzepatide: Sleep Apnea Trial Evidence
https://peptideamerica.org/evidence/tirzepatide-sleep-apnea-trials · published October 2026 · updated October 2026

Question: Does tirzepatide treat sleep apnea or only reduce weight?
Short answer: Two controlled trials found fewer breathing events in adults with obesity and moderate-to-severe sleep apnea. They do not establish a weight-independent effect, a cure for everyone or a reason to stop PAP without reassessment.

#### Two populations, one clinical question
SURMOUNT-OSA comprised two 52-week randomized, double-blind trials with 469 participants in total. Trial 1 enrolled 234 adults unable or unwilling to use positive airway pressure, or PAP. Trial 2 enrolled 235 already using PAP who planned to continue it. Both populations had obesity and moderate-to-severe obstructive sleep apnea [1].
The main outcome was the apnea-hypopnea index, or AHI: the number of breathing interruptions or reductions per hour of sleep. Baseline means were 51.5 events per hour in trial 1 and 49.5 in trial 2. This is a diagnosed sleep-disordered breathing population, not a study of ordinary snoring or general sleep quality [1].

#### The breathing-event results
At week 52, mean AHI fell by 25.3 events per hour with tirzepatide versus 5.3 with placebo in trial 1. In trial 2, the reductions were 29.3 and 5.5. The estimated treatment differences were therefore 20.0 and 23.8 fewer events per hour, respectively [1].
Weight, sleep apnea-specific hypoxic burden and patient-reported sleep outcomes also improved. The trial was not designed to demonstrate fewer heart attacks or deaths over the long term. A change in a risk marker should not be presented as proof of those clinical outcomes [1].

#### PAP use changes how the result is read
Participants in trial 2 temporarily suspended PAP before specified study assessments under the research protocol, allowing investigators to measure breathing outcomes without its immediate effect. This was a measurement procedure, not a finding that every treated patient could permanently discontinue PAP [1].
The trial did not test a strategy of replacing PAP with medication, and PAP adherence was not a prespecified endpoint. Someone already using PAP needs clinical reassessment of their own sleep apnea rather than assuming an average trial improvement settles their treatment needs [1].

#### Remission and mild disease are not the same
A combined secondary endpoint counted either AHI below 5, or AHI from 5 to 14 together with an Epworth Sleepiness Scale score of 10 or less. It was reached by 42.2 percent versus 15.9 percent in trial 1, and 50.2 percent versus 14.3 percent in trial 2 [1].
That endpoint combines two states: very low breathing-event frequency and residual mild sleep apnea without excessive measured sleepiness. Calling the entire group cured would erase that distinction. It would also overlook participants who improved without reaching either threshold [1].

#### Weight association is not a separate trial
A later post hoc analysis examined the time course and relationship to weight reduction in the same SURMOUNT-OSA program. Greater weight reduction was associated with larger improvements in AHI and hypoxic burden. It is additional analysis of these participants, not independent replication [2].
Within-group improvement appeared earlier than a statistically significant comparison with placebo on the portable-monitor measures. Those are different tests. The authors concluded that further research was needed to separate weight reduction from other potential effects of tirzepatide; the analysis does not establish a direct effect independent of weight [2].

#### Tolerability and scope
The most frequent adverse events were gastrointestinal and generally mild or moderate. The study excluded people without obesity, and its duration limits conclusions about long-term outcomes. The published results should therefore stay attached to the studied population and treatment, rather than every injectable product advertised for sleep [1].
The tirzepatide monograph (https://peptideamerica.org/molecules/tirzepatide) provides the separate product and safety record. The incretin pipeline review (https://peptideamerica.org/evidence/incretin-pipeline) distinguishes approved drugs from investigational compounds. A mechanism shared by related molecules does not make their sleep-apnea evidence interchangeable.

#### Sources
1. Malhotra A, Grunstein RR, Fietze I, et al. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. N Engl J Med. 2024;391:1193–1205. https://pubmed.ncbi.nlm.nih.gov/38912654/
2. Malhotra A, Grunstein RR, Azarbarzin A, et al. Tirzepatide for sleep-disordered breathing in SURMOUNT-OSA: Time course and association with body weight. Sleep Med. 2025;136:106853. https://pubmed.ncbi.nlm.nih.gov/41135142/

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### Carnosine: Glucose and Vascular Evidence
https://peptideamerica.org/evidence/carnosine-glucose-vascular-evidence · published October 2026 · updated October 2026

Question: Why do carnosine studies report positive and negative metabolic results?
Short answer: Different reports from one small trial assessed different outcomes: a glucose-test signal did not extend to demonstrated vascular, muscle or body-composition benefits.

#### One study can produce several papers
The carnosine literature includes a report with a positive glucose-control title and another with a negative vascular-and-metabolic title. Reading only those titles can make the evidence look like independent trials disagreeing. The reports belong to the same fourteen-week research program in adults with prediabetes or well-controlled type 2 diabetes [1, 2].
The vascular report identifies trial registration NCT02917928. A later musculoskeletal paper identifies the same registration and explicitly describes its findings as a secondary analysis. It reports 49 randomized participants and 43 completers [2, 3].
Publications are not interchangeable with independent experiments. Multiple papers can describe different measurements from the same participants. Counting each paper as a new successful trial would overstate replication, even when every paper is accurately cited.

#### What improved on the glucose test
The glucose report describes 43 adults followed for fourteen weeks. It assessed glucose handling with an oral glucose tolerance test rather than using a cardiovascular event as its outcome. Blood glucose was lower at the 90-minute and 120-minute measurements, and the total glucose area under the curve also improved compared with placebo [1].
The reported difference at 120 minutes was 1.60 mmol/L. Insulin levels did not change significantly, and the report found no additional changes in its secondary outcomes. The authors framed the findings as preliminary support for larger trials in prediabetes and early type 2 diabetes [1].
A glucose-tolerance result answers a meaningful question, but it does not establish that participants avoided a heart attack, developed fewer diabetes complications or could stop prescribed treatment. Those claims require different measurements and follow-up.

#### What did not improve
The vascular report assessed blood pressure, endothelial function, arterial stiffness, lipids and liver and kidney measures. It found no improvement compared with placebo in the outcomes it evaluated. Participants generally had good glycemic control, which limits extrapolation to people with more severe disease [2].
The musculoskeletal analysis found no advantage for hand-grip strength, appendicular lean mass, body fat, visceral fat or the assessed bone measures [3]. These results do not establish a muscle-building or body-composition benefit from the intervention.
A positive result for one endpoint and a negative result for another can coexist without either report being wrong. The mistake is treating a broad phrase such as metabolic health as though it were a single outcome.

#### Why the limits matter
Forty-nine randomized participants and a fourteen-week intervention leave substantial uncertainty about smaller effects, long-term outcomes and uncommon harms [2, 3]. Failure to detect a difference does not prove that no effect is possible in any population. Equally, a possible effect is not the same as an established benefit.
The participants and measurements should accompany the claim. Findings in well-controlled prediabetes or type 2 diabetes cannot automatically be extended to athletic performance, advanced complications or healthy-aging goals. A persuasive mechanism is a reason to test those questions, not a substitute for testing them.

#### Oral findings are not injection evidence
These studies evaluated oral supplementation [1, 2, 3]. They do not establish the effectiveness or safety of injected carnosine. A change in route is not a minor detail that can be removed when translating a trial into a product claim.
The L-carnosine monograph (https://peptideamerica.org/molecules/l-carnosine) distinguishes its supplement and compounding records. For the clinical evidence, the useful conclusion is specific: glucose handling showed a preliminary signal, while vascular and musculoskeletal benefits were not demonstrated in this trial. Independent replication and longer outcome studies remain the relevant next steps.

#### Sources
1. Hariharan R, Cameron J, Menon K, et al. Carnosine supplementation improves glucose control in adults with pre-diabetes and type 2 diabetes: A randomised controlled trial. Nutr Metab Cardiovasc Dis. 2024. https://pubmed.ncbi.nlm.nih.gov/38172006/
2. Saadati S, Cameron J, Menon K, et al. Carnosine Did Not Affect Vascular and Metabolic Outcomes in Patients with Prediabetes and Type 2 Diabetes: A 14-Week Randomized Controlled Trial. Nutrients. 2023. https://pubmed.ncbi.nlm.nih.gov/38004228/
3. Saadati S, Jansons P, Scott D, et al. The Effect of Carnosine Supplementation on Musculoskeletal Health in Adults with Prediabetes and Type 2 Diabetes: A Secondary Analysis of a Randomized Controlled Trial. Nutrients. 2024. https://pubmed.ncbi.nlm.nih.gov/39770949/

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### Dulaglutide vs Semaglutide: Trial Results
https://peptideamerica.org/evidence/dulaglutide-versus-semaglutide-trials · published October 2026 · updated October 2026

Question: What does the dulaglutide-versus-semaglutide evidence actually compare?
Short answer: Semaglutide produced larger glucose and weight changes in SUSTAIN 7, but that trial did not compare cardiovascular protection or every current formulation and strength.

#### The direct comparison
SUSTAIN 7 randomized 1,201 adults with type 2 diabetes inadequately controlled on metformin. It was an open-label trial: participants and investigators knew the assigned treatment. Its primary endpoint was change in HbA1c, and body-weight change was a confirmatory secondary endpoint, both measured at 40 weeks [1].
Semaglutide produced greater reductions in HbA1c and weight than dulaglutide in both tested comparisons. The between-group weight differences were approximately 2.26 kg and 3.55 kg. This supports a specific conclusion about the treatments, population and time point studied [1].
It does not establish that one molecule is better for every patient or every outcome. The trial did not use heart attacks, strokes or cardiovascular death as its primary comparison, and it was not a study of people without diabetes seeking obesity treatment.

#### What REWIND adds
REWIND asked a different question. It randomized 9,901 adults with type 2 diabetes and either previous cardiovascular disease or cardiovascular risk factors to dulaglutide or placebo. Its primary outcome combined nonfatal heart attack, nonfatal stroke and cardiovascular death, with median follow-up of 5.4 years [2].
The primary outcome occurred in 12.0 percent of the dulaglutide group and 13.4 percent of the placebo group. The hazard ratio was 0.88, with a 95 percent confidence interval of 0.79 to 0.99. All-cause mortality did not differ significantly [2].
That is evidence for a cardiovascular outcome against placebo in the studied population. It is not a head-to-head cardiovascular comparison with semaglutide. Using the weight ranking from SUSTAIN 7 to rank cardiovascular protection would combine questions the trials kept separate.

#### The later dulaglutide study
AWARD-11 randomized 1,842 adults with type 2 diabetes inadequately controlled on metformin and compared three dulaglutide treatment groups. It assessed HbA1c and weight changes, with the main efficacy comparisons at 36 weeks [3].
The highest-strength group achieved greater HbA1c and weight reductions than the lower-strength comparator. For weight, the treatment-regimen analysis reported reductions of 4.6 kg versus 3.0 kg. The study contained no semaglutide group [3].
These findings show why an older head-to-head comparison should not be treated as a test of every later option. They do not justify placing results from separate studies into a new ranking: populations, follow-up and analytic methods may differ.

#### Reading the outcomes side by side
The most useful comparison starts with the question being asked. Glucose control, weight change and cardiovascular events are related clinical concerns, but they are not interchangeable endpoints. A study can establish an effect on one without settling the others.
For a direct relative claim, look for both treatments in the same randomized study. For a claim about long-term events, look for those events as actual outcomes rather than an assumed consequence of a laboratory or weight change.

Three trials, three different comparisons
Study | Comparison | What it answers
SUSTAIN 7 [1] | Semaglutide versus dulaglutide | HbA1c and weight at 40 weeks
REWIND [2] | Dulaglutide versus placebo | Cardiovascular events over years
AWARD-11 [3] | Different dulaglutide strengths | Glucose and weight within one medicine

#### Tolerability and individual decisions
Gastrointestinal problems were common in SUSTAIN 7 and were the leading reason for discontinuation. REWIND also recorded more gastrointestinal adverse events with dulaglutide than placebo, and AWARD-11 reported nausea and vomiting across its groups [1, 2, 3]. Neither greater average weight loss nor a favorable cardiovascular result removes the need to consider tolerability.
The dulaglutide (https://peptideamerica.org/molecules/dulaglutide) and semaglutide (https://peptideamerica.org/molecules/semaglutide) monographs contain their separately dated regulatory and safety records. These trial results support a discussion of treatment goals and evidence, not a dose conversion or an instruction to switch medicines.

#### Sources
1. Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018. https://pubmed.ncbi.nlm.nih.gov/29397376/
2. Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019. https://pubmed.ncbi.nlm.nih.gov/31189511/
3. Frias JP, Bonora E, Nevarez Ruiz L, et al. Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11). Diabetes Care. 2021. https://pubmed.ncbi.nlm.nih.gov/33397768/

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### LL-37 Wound Healing: What Trials Found
https://peptideamerica.org/evidence/ll-37-wound-healing-trials · published October 2026 · updated October 2026

Question: Do LL-37 wound studies establish that the peptide works?
Short answer: A small topical pilot showed healing signals, but the larger trial found no overall advantage; an exploratory subgroup result does not establish a benefit for injected LL-37.

#### The first topical trial
The 2014 placebo-controlled study enrolled 34 people with hard-to-heal venous leg ulcers. It tested topical LL-37 during a four-week blinded treatment phase, after a run-in period, with additional follow-up. This was a small early study of wound treatment rather than a general trial of immune enhancement [1].
Two active-treatment groups showed favorable healing signals, but the results were not uniform. For the healing-rate comparison with placebo, one group reached conventional statistical significance and another did not. The highest-concentration group showed no healing difference from placebo [1].
The study supported further investigation. It did not establish that increasing exposure would improve healing, and the favorable title should be read alongside the individual comparisons and the small sample.

#### The larger comparison
The 2021 HEAL LL-37 study evaluated topical LL-37 alongside compression therapy in 148 treated patients with difficult venous leg ulcers. It was a double-blind, placebo-controlled phase IIb trial. Analysis of the full study population found no significant healing improvement compared with placebo [2].
A post hoc analysis found favorable results in patients with larger wounds. The investigators described that finding as a reason for a further study designed and powered to assess that subgroup, rather than as confirmation that the overall trial succeeded [2].
An exploratory result is not worthless. It changes the next research question: whether patients with a defined wound characteristic benefit. It does not change the answer to the original full-population comparison.

#### A biomarker study is different
A separate study followed 19 patients with venous leg ulcers and examined their own circulating LL-37. Higher concentrations correlated with healing rates. The investigators did not administer LL-37 as the intervention being tested [3].
That distinction matters when several papers are presented together as evidence that a purchased peptide works. A correlation can support a biological hypothesis or suggest a marker worth studying. It cannot establish that adding the substance causes the favorable outcome.
Naturally occurring LL-37 may reflect processes already involved in healing. Only an appropriate intervention comparison can separate the effect of administered treatment from the characteristics of patients whose wounds heal more readily.

#### Route and background care
The controlled studies discussed here placed the peptide on a specific kind of wound; the larger study also used compression therapy [1, 2]. Neither tested a systemic injection for immunity, infection prevention or general recovery. Moving from local wound exposure to injection changes the clinical question.
The trial product, route, wound type and accompanying care are part of the evidence. Removing those details leaves a claim much broader than the studies. A seller cannot establish an injectable benefit merely by pointing to a topical trial, whether that trial is positive or negative.

#### Safety and the practical conclusion
The topical trial reports did not identify major safety concerns under their study conditions [1, 2]. That is not a demonstration of long-term safety by another route. Short follow-up and modest sample sizes also limit the ability to detect uncommon harms.
The strongest defensible summary is that LL-37 remains an investigational wound-healing approach with mixed findings. The LL-37 monograph (https://peptideamerica.org/molecules/ll-37) provides the separately dated regulatory record. These wound studies should not be used as instructions for self-treatment or as proof of a clinical supply route.

#### Sources
1. Grönberg A, Mahlapuu M, Ståhle M, et al. Treatment with LL-37 is safe and effective in enhancing healing of hard-to-heal venous leg ulcers: a randomized, placebo-controlled clinical trial. Wound Repair Regen. 2014. https://pubmed.ncbi.nlm.nih.gov/25041740/
2. Mahlapuu M, Sidorowicz A, Mikosinski J, et al. Evaluation of LL-37 in healing of hard-to-heal venous leg ulcers: A multicentric prospective randomized placebo-controlled clinical trial. Wound Repair Regen. 2021. https://pubmed.ncbi.nlm.nih.gov/34687253/
3. Krejner A, Litwiniuk M, Grzela T. LL-37 but Not 25-Hydroxy-Vitamin D Serum Level Correlates with Healing of Venous Leg Ulcers. Arch Immunol Ther Exp (Warsz). 2017. https://pubmed.ncbi.nlm.nih.gov/27663530/

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### Retatrutide and Lean Mass: Trial Evidence
https://peptideamerica.org/evidence/retatrutide-lean-mass-evidence · published October 2026 · updated October 2026

Question: Does retatrutide preserve muscle while reducing body fat?
Short answer: The DXA substudy found substantial fat loss and a lean-mass loss proportion similar to other obesity treatments; it did not demonstrate zero lean-mass loss or preserved muscle strength.

#### The study behind the claim
The 2025 body-composition report is a substudy of a phase 2 trial in adults with type 2 diabetes. Its prespecified primary endpoint was the percentage change in total fat mass at 36 weeks, measured with dual-energy X-ray absorptiometry, or DXA. It was not primarily designed to test strength or physical performance [1].
The parent trial randomized 281 participants and compared retatrutide with placebo and dulaglutide. Its primary endpoint was HbA1c change at 24 weeks; weight change was among the secondary outcomes [2]. The body-composition paper therefore answers an additional question within an existing trial, rather than providing a second independent randomized population.

#### The denominator narrows
Of the 281 participants in the main study, 189 entered the body-composition substudy. There were 155 baseline DXA scans, and 103 participants completed treatment with both baseline and week-36 scans. The efficacy analysis used available on-treatment scans before treatment discontinuation [1].
Those numbers matter when interpreting a strong fat-loss headline. The paired-scan completers are a subset of the original randomized population. Their results should not be described as a measurement of body composition in every participant or every person who begins treatment.
Missing follow-up measurements do not automatically invalidate a study, but they make the analysis population part of the finding. A reliable summary states both the result and whose measurements produced it.

#### Fat loss is not zero lean-mass loss
The investigators found greater reductions in total fat mass with several retatrutide groups than with placebo or dulaglutide. Their interpretation was that the proportion of lost weight coming from lean mass was similar to that seen with other obesity treatments [1].
That statement does not mean lean mass remained unchanged. Nor does it establish that retatrutide preserves muscle better than semaglutide or tirzepatide: neither of those drugs was a randomized comparison group in this substudy [1, 2].
DXA-derived lean mass and muscle function are also different outcomes. The primary endpoint here was fat mass. A claim of preserved strength would need an appropriate strength measurement and comparison; it cannot be inferred from the scale or from the proportion of weight loss attributed to fat.

#### Newer weight trials answer other questions
The published phase 3 TRIUMPH-1 trial randomized 2,339 adults with obesity without diabetes and followed treatment for 80 weeks. Its reported treatment-regimen analysis showed a mean weight reduction of 25.0 percent in the highest-strength group versus 3.9 percent with placebo [3].
That larger trial strengthens the evidence about weight change in its studied population. It does not enlarge the paired-DXA sample in the earlier diabetes substudy or convert a weight result into a muscle-function result. The populations, follow-up and endpoints should remain visible when the studies are discussed together.
Headline percentages can also differ according to how a study handles treatment discontinuation and other events. A sponsor headline from one analysis should not be silently substituted for a publication’s treatment-regimen estimate.

#### The practical reading
The body-composition findings are compatible with meaningful fat reduction while some lean mass is also lost. They do not support a promise that a person can lose substantial weight without any lean-tissue change, or that an investigational product is safe for unsupervised use.
The studies concerned defined trial populations and controlled study products [1, 2, 3]. A seller’s research-use-only vial is not validated by these results. The retatrutide monograph (https://peptideamerica.org/molecules/retatrutide) keeps the regulatory and clinical evidence separate; this review provides neither a self-treatment protocol nor a comparison of home dosing strategies.

#### Sources
1. Coskun T, Wu Q, Schloot NC, et al. Effects of retatrutide on body composition in people with type 2 diabetes: a substudy of a phase 2, double-blind, parallel-group, placebo-controlled, randomised trial. Lancet Diabetes Endocrinol. 2025. https://pubmed.ncbi.nlm.nih.gov/40609566/
2. Rosenstock J, Frias J, Jastreboff AM, et al. Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA. Lancet. 2023. https://pubmed.ncbi.nlm.nih.gov/37385280/
3. Jastreboff AM, Kaplan LM, Davies MJ, et al. Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity. N Engl J Med. 2026. https://pubmed.ncbi.nlm.nih.gov/42814954/

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### Thymosin Alpha-1: Sepsis Trial Results
https://peptideamerica.org/evidence/thymosin-alpha-1-sepsis-trials · published October 2026 · updated October 2026

Question: Does thymosin alpha-1 improve survival in sepsis?
Short answer: The larger blinded trial did not establish a survival benefit; its corrected estimate remains compatible with benefit or harm, and immune-marker changes do not settle the question.

#### The earlier signal
The 2013 ETASS study randomized 361 patients with severe sepsis across six hospitals in China. It compared thymosin alpha-1 plus conventional treatment with a control group and used a single-blind design. Death from any cause within 28 days was the primary outcome [1].
Mortality was 26.0 percent in the thymosin group and 35.0 percent in the control group. That numerical difference deserves attention, but the statistical result depended on the analysis: the nonstratified comparison had a p value of 0.062, while the survival comparison had a p value of 0.049. The relative-risk confidence interval extended from 0.54 to 1.02, crossing the no-difference value [1].
This is a suggestive result rather than an unambiguous demonstration. Choosing only the more favorable p value hides the uncertainty that the report itself makes visible.

#### The larger blinded test
TESTS, published in 2025, randomized 1,106 adults across 22 centers in China. It was double-blind and placebo-controlled. The principal question was again whether treatment reduced all-cause mortality within 28 days; the modified intention-to-treat analysis included 1,089 participants who received study treatment [2].
The trial did not establish a mortality advantage. It also reported no statistically significant difference in its secondary or safety outcomes. These findings are more informative about the tested sepsis population than a general description of thymosin alpha-1 as an immune modulator [2].
Neither study was a trial of routine immune support in healthy people. Patients receiving intensive care for sepsis cannot stand in for people seeking fewer colds, improved energy or longevity.

#### The correction matters
A May 2025 correction explained that updated survival information for nine participants had not been included in the original survival analyses. The corrected hazard ratio for 28-day mortality is 0.97, with a 95 percent confidence interval of 0.76 to 1.24. The original estimate was 0.99 [3].
The correction changes the number a careful review should cite, but it does not turn the result into a demonstrated survival benefit. The interval spans the no-difference value of one and includes effects in either direction. The correction also addresses lymphocyte data and the data-sharing statement; it is a correction, not a retraction [3].

#### Immune measurements and survival
ETASS reported greater improvement in monocyte HLA-DR, an immune-related measurement, in the treatment group [1]. A biological response can help explain how a treatment might work, but it cannot replace the outcome the trial was designed to test. An improved laboratory marker does not by itself mean that fewer patients die.
TESTS reported possible differences between patient subgroups [2]. Such signals can guide another trial, but they should not be presented as a proven selection rule. A subgroup claim needs confirmation in patients selected for that characteristic, with the intended comparison specified before outcomes are examined.

#### What the evidence supports
Thymosin alpha-1 has been studied in people; describing it as having no human evidence would be wrong. Describing sepsis survival benefit as established would also go beyond these trials. The useful conclusion is narrower: an earlier signal did not become a clear overall benefit in the larger blinded comparison.
The thymosin alpha-1 monograph (https://peptideamerica.org/molecules/thymosin-alpha-1) keeps its separately dated US regulatory record. A trial result and a US supply authorization answer different questions, and neither an immune-marker change nor a foreign clinical study settles both.

#### Sources
1. Wu J, Zhou L, Liu J, et al. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013. https://pubmed.ncbi.nlm.nih.gov/23327199/
2. Wu J, Pei F, Zhou L, et al. The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial. BMJ. 2025. https://pubmed.ncbi.nlm.nih.gov/39814420/
3. The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial. BMJ. 2025. https://pubmed.ncbi.nlm.nih.gov/40447307/

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### Afamelanotide: Light Tolerance Evidence
https://peptideamerica.org/evidence/afamelanotide-light-tolerance · published October 2026 · updated October 2026

Question: What did afamelanotide trials actually measure?
Short answer: Two controlled EPP trials found longer pain-free sunlight exposure; a separate vitiligo study tested combination treatment, so neither provides a general safety endorsement for cosmetic tanning.

#### Pain-free exposure
Erythropoietic protoporphyria, or EPP, can make sunlight exposure acutely painful. The afamelanotide studies therefore asked a concrete clinical question: whether treatment increased the time people with EPP could spend in direct sunlight without pain. The main outcome was not the darkness of a tan or satisfaction with appearance [1].
Two randomized, double-blind trials enrolled 74 participants in Europe and 94 in the United States. Both compared afamelanotide implants with placebo. The US study reported median pain-free exposure of 69.4 hours with treatment versus 40.8 hours with placebo over six months. The European study reported 6.0 versus 0.8 hours over nine months [1].

#### Reading the hours correctly
Those figures describe accumulated exposure over the study periods, not the amount of sunlight safe on any single day. They are also medians rather than a prediction for every participant. Turning them into a daily sun-exposure allowance would create advice that the reported results do not provide [1].
The different totals in the two studies should remain separate. They came from distinct study populations and observation periods, rather than from a single pooled comparison. Both studies reported improved quality of life; the European study also reported fewer phototoxic reactions, 77 with treatment versus 146 with placebo [1].

#### The vitiligo comparison
A separate randomized study investigated generalized vitiligo in 55 adults. Twenty-eight received afamelanotide together with narrowband UV-B phototherapy, while 27 received phototherapy alone. The combination produced faster and greater repigmentation, with reported repigmentation of 48.64 percent versus 33.26 percent at day 168 [2].
That trial does not establish afamelanotide alone as equivalent to the combination. It enrolled particular skin phototypes and a defined degree of vitiligo involvement. Results were more apparent in phototypes IV to VI, while the reported comparison did not reach significance for phototype III. Those eligibility and subgroup details limit generalization [2].

#### The boundary of the evidence
The EPP trials reported mostly mild adverse events, with serious events not considered treatment-related. The vitiligo study noted redness in both groups and minor infections and nausea in the combination group. Neither abstract establishes that unregulated tanning products share the studied implants, manufacturing controls or safety profile [1, 2].
The afamelanotide monograph (https://peptideamerica.org/molecules/afamelanotide) distinguishes the approved product from research material. The comparison of Melanotan I and II (https://peptideamerica.org/evidence/melanotan-i-versus-ii) addresses the naming confusion. A pigmentation effect is not evidence that different peptides, products or intended uses can be substituted.

#### Sources
1. Langendonk JG, Balwani M, Anderson KE, et al. Afamelanotide for Erythropoietic Protoporphyria. N Engl J Med. 2015;373(1):48–59. https://pubmed.ncbi.nlm.nih.gov/26132941/
2. Lim HW, Grimes PE, Agbai O, et al. Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. JAMA Dermatol. 2015;151(1):42–50. https://pubmed.ncbi.nlm.nih.gov/25230094/

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### ARA-290 for Neuropathy: Trial Findings
https://peptideamerica.org/evidence/ara-290-neuropathy-trials · published October 2026 · updated October 2026

Question: Does ARA-290 have convincing evidence for neuropathic pain?
Short answer: Small sarcoidosis studies reported symptom and nerve-fiber signals, but pain results were less consistent; the evidence does not establish a broadly effective neuropathy treatment.

#### The first controlled signal
ARA-290, also called cibinetide, has been studied in small-fiber neuropathy associated with sarcoidosis. A randomized pilot enrolled 22 patients, assigning twelve to the peptide and ten to placebo. The investigators assessed neuropathic symptoms, pain, fatigue, quality of life and other outcomes over four weeks [1].
The small-fiber neuropathy screening score improved more with ARA-290 than with placebo. However, the Brief Pain Inventory and fatigue scores improved similarly in both groups. Reporting only the favorable symptom score would make the pain evidence appear more consistent than the study found [1].

#### Nerve fibers as an endpoint
A subsequent 28-day randomized study enrolled 64 participants with sarcoidosis-associated small nerve-fiber loss and neuropathic pain. Its main endpoint was change in corneal nerve-fiber area, measured through corneal microscopy. That is a measure of nerve structure, rather than a direct measure of how much pain a patient experiences [2].
One of the three active-treatment groups showed a statistically significant improvement in corneal nerve-fiber area compared with placebo. Changes in that measure correlated with other nerve and functional measurements. These observations support further investigation of a possible effect on nerve biology, but a correlation does not establish that every structural improvement produces a meaningful clinical benefit [2].

#### The pain result
Pain improved in all groups in the larger study. Among participants with moderate-to-severe pain, the investigators described a clinically meaningful placebo-corrected reduction in one treatment group, but its p value was 0.157. The difference therefore did not meet the conventional threshold for statistical significance [2].
The distinction is especially important for a treatment marketed through pain-relief claims. A statistically significant nerve-fiber endpoint and a nonsignificant pain comparison can coexist. The former cannot be substituted for the latter, and a favorable mechanistic interpretation should not erase that uncertainty [2].

#### Scope and safety
The pilot reported no safety concerns on its clinical and laboratory assessments. Twenty-two participants followed for four weeks cannot establish long-term safety or reliably reveal rare harms. The later study also remained short, and both studies concerned a specific sarcoidosis-related population [1, 2].
These findings do not establish equal benefit for diabetic neuropathy, unexplained burning pain or every condition described as nerve damage. The ARA-290 monograph (https://peptideamerica.org/molecules/ara-290) includes other studies and the separate US status. The strongest conclusion from these two reports is an early disease-specific signal that still needs clearer confirmation on patient-centered outcomes.

#### Sources
1. Heij L, Niesters M, Swartjes M, Hoitsma E, Drent M, Dunne A, et al. Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study. Mol Med. 2012 Nov 15;18(1):1430-6. https://pubmed.ncbi.nlm.nih.gov/23168581/
2. Culver DA, Dahan A, Bajorunas D, Jeziorska M, van Velzen M, Aarts LPHJ, et al. Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO52-BIO60. https://pubmed.ncbi.nlm.nih.gov/28475703/

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### Aviptadil for COVID-19: Trial Results
https://peptideamerica.org/evidence/aviptadil-covid-trials · published October 2026 · updated October 2026

Question: Did aviptadil improve outcomes in severe COVID-19?
Short answer: Neither of the two cited randomized trials met its primary endpoint; the larger TESICO comparison found no significant improvement in recovery or mortality.

#### The early trial
Aviptadil is synthetic vasoactive intestinal peptide, a molecule studied for several biological effects in the lungs. An early randomized trial enrolled 196 people with COVID-19 respiratory failure across ten US hospitals. It compared intravenous aviptadil with placebo and assessed whether patients were alive and free of respiratory failure at day sixty [1].
That primary endpoint did not reach statistical significance. The investigators nevertheless reported a favorable secondary survival result and several subgroup signals, including findings among patients receiving particular forms of respiratory support. These were observations within a trial whose principal comparison had failed, and should be described with that limitation [1].

#### The larger test
TESICO studied hospitalized adults with COVID-19-associated acute hypoxemic respiratory failure. For the aviptadil comparison, 471 participants were randomized and 461 who received at least part of an infusion entered the modified intention-to-treat analysis. Most were in intensive care when enrolled [2].
The primary outcome ranked patients at day ninety according to survival, hospitalization, oxygen needs and time recovered at home. Aviptadil did not significantly improve that outcome: the odds ratio was 1.11, with a 95% confidence interval of 0.80 to 1.55 and p = 0.54. An independent monitoring board recommended stopping the aviptadil trial for futility [2].

#### Mortality and adverse outcomes
By day ninety, 86 participants assigned aviptadil and 83 assigned placebo had died. The reported cumulative mortality percentages were 38 percent and 36 percent, respectively; the mortality comparison was not statistically significant. These findings did not confirm a survival benefit suggested by the earlier trial [2].
The main early safety composite occurred in 63 percent of the aviptadil group and 56 percent of the placebo group. That comparison also did not reach statistical significance. It should not be described as proof of increased harm, but neither does it justify a sweeping assurance of safety in every setting [2].

#### What remains uncertain
TESICO also included a remdesivir comparison with a much smaller sample, which the authors considered insufficient for definitive conclusions. That limitation belongs to the remdesivir comparison and should not be used to dismiss the separate aviptadil findings. The trial design allowed participants to enter one or both comparisons [2].
The evidence reviewed here concerns severe acute COVID-19 in hospitalized patients. It does not establish benefit for long COVID, chronic environmental-illness claims or routine respiratory wellness. The VIP monograph (https://peptideamerica.org/molecules/vasoactive-intestinal-peptide) separates these trial results from the molecule’s regulatory position; permission to compound and proof of clinical benefit remain different questions.

#### Sources
1. Youssef JG, Lavin P, Schoenfeld DA, Lee RA, Lenhardt R, Park DJ, et al. The Use of IV Vasoactive Intestinal Peptide (Aviptadil) in Patients With Critical COVID-19 Respiratory Failure: Results of a 60-Day Randomized Controlled Trial. Crit Care Med. 2022 Nov 1;50(11):1545-1554. https://pubmed.ncbi.nlm.nih.gov/36044317/
2. Brown SM, Barkauskas CE, Grund B, Sharma S, Phillips AN, Leither L, et al. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial. Lancet Respir Med. 2023 Sep;11(9):791-803. https://pubmed.ncbi.nlm.nih.gov/37348524/

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### Cerebrolysin After Stroke: Mixed Evidence
https://peptideamerica.org/evidence/cerebrolysin-stroke-trials · published October 2026 · updated October 2026

Question: Why do Cerebrolysin stroke trials appear to disagree?
Short answer: The large CASTA trial missed its overall endpoint, while the smaller exploratory CARS study reported better arm recovery during rehabilitation; neither result can substitute for the other.

#### Two different questions
Cerebrolysin has been tested both shortly after ischemic stroke and alongside early rehabilitation. Those settings are related, but their outcomes are not identical. A treatment can fail a combined measure of disability and neurological recovery while producing a signal on a narrower motor task; the endpoint and trial design determine what each result means [1, 2].
CASTA enrolled 1,070 patients and assigned 529 to Cerebrolysin and 541 to placebo. Treatment began within 12 hours of symptom onset, both groups also received aspirin, and follow-up lasted 90 days. Its confirmatory endpoint combined three established scales covering disability, daily functioning and stroke severity. The overall comparison was neutral [1].

#### The subgroup signal
After dividing participants by initial severity, investigators reported a favorable trend in the more severely affected subgroup. They also observed a mortality difference in that subgroup. The abstract explicitly describes the analysis as post hoc and calls for confirmation in another trial. A result selected after the primary comparison cannot be presented as though the entire trial demonstrated a survival benefit [1].
Subgroup findings can be useful for planning another study, particularly when a biological explanation is plausible. Their evidentiary role remains narrower than a successful prespecified confirmatory endpoint. Reporting the subgroup without the neutral overall result would conceal the central finding of CASTA [1].

#### The rehabilitation result
CARS compared Cerebrolysin with placebo while both groups participated in a standardized rehabilitation program. Treatment began 24 to 72 hours after stroke, and the principal outcome was arm function at day 90, measured with the Action Research Arm Test. The published abstract reports a favorable effect, with a Mann-Whitney estimator of 0.71 and a 95% confidence interval of 0.63 to 0.79 [2].
That estimator is not a claim of 71 percent improvement in arm function. It is a statistical measure comparing the distributions of outcomes in the two groups. The authors describe the trial as exploratory and relatively small, and specifically request a larger randomized trial to confirm the result. The trial tested treatment alongside rehabilitation, not treatment replacing rehabilitation [2].

#### A defensible conclusion
The evidence is mixed for identifiable reasons: patient selection, timing, accompanying rehabilitation and the outcome being measured differ. The positive motor-recovery study should remain visible beside the negative larger confirmatory comparison. Choosing only one produces a simpler story than the trials support [1, 2].
These stroke trials do not establish a benefit for healthy-person memory, general cognitive enhancement or brain injury of every kind. The Cerebrolysin monograph (https://peptideamerica.org/molecules/cerebrolysin) includes the broader literature and the separate US regulatory record. A clinical result in one setting does not itself establish marketing permission in another country.

#### Sources
1. Heiss WD, Brainin M, Bornstein NM, Tuomilehto J, Hong Z; Cerebrolysin Acute Stroke Treatment in Asia (CASTA) Investigators. Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial. Stroke. 2012;43(3):630–636. https://pubmed.ncbi.nlm.nih.gov/22282884/
2. Muresanu DF, Heiss WD, Hoemberg V, et al. Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial. Stroke. 2016;47(1):151–159. The abstract lists three of the eleven authors in the Department of Clinical Research of the manufacturer. https://pubmed.ncbi.nlm.nih.gov/26564102/

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### Elamipretide for Fatigue: Trial Results
https://peptideamerica.org/evidence/elamipretide-fatigue-trials · published October 2026 · updated October 2026

Question: Does elamipretide improve fatigue and exercise capacity?
Short answer: A 218-person trial in primary mitochondrial myopathy found no improvement in walking distance or fatigue; encouraging Barth syndrome extension results came from a different disease and an uncontrolled phase.

#### The largest comparison
Elamipretide is often discussed as a mitochondrial treatment, but that description does not identify the patients for whom an outcome was demonstrated. MMPOWER-3 tested genetically confirmed primary mitochondrial myopathy, a group of disorders affecting mitochondrial energy production. Its 218 participants were assigned equally to elamipretide or placebo, and the investigators assessed walking distance and fatigue after 24 weeks [1].
Neither primary outcome improved significantly. The difference in six-minute walking distance was -3.2 meters, with a confidence interval from -18.7 to 12.3 meters and p = 0.69. The fatigue comparison also missed statistical significance, p = 0.37. Those results do not establish a meaningful benefit concealed behind a positive trial headline; the trial itself concluded that the two principal outcomes did not improve [1].

#### The Barth syndrome distinction
TAZPOWER studied Barth syndrome, a rare genetic condition involving cardiolipin, rather than the broader mitochondrial myopathy population. Twelve participants entered its randomized crossover phase, which compared treatment and placebo within the same participants. Neither the walking-distance endpoint nor the Barth syndrome symptom endpoint was met during that blinded comparison [2].
Ten participants continued into an open-label extension, and eight reached 36 weeks. At that point, walking distance had increased by 95.9 meters and the symptom score had improved by 2.1 points. These observations deserve reporting, but they occurred after the placebo comparison had ended. Participants and investigators knew the treatment, and the later result describes a smaller continuing group [2].

#### What the comparison supports
The two studies cannot be joined into a general claim that mitochondrial peptides restore energy. They involve different diseases, different follow-up periods and different control conditions. A positive change during an extension does not reverse a negative randomized comparison in another population. Likewise, the negative myopathy trial does not prove that every possible use in Barth syndrome is ineffective [1, 2].
Tolerability is a separate outcome. MMPOWER-3 reported that most adverse events were mild or moderate and described treatment as well tolerated. That finding concerns the product, participants and duration actually studied; it does not establish the quality of material sold under the SS-31 name or demonstrate long-term safety in healthy people [1].

#### The practical reading
For fatigue claims, the closest large controlled study is the negative MMPOWER-3 trial, not the favorable extension alone. A claim about healthy aging or ordinary tiredness requires evidence in those populations; neither of these trials enrolled them. Mechanistic similarity is a reason to investigate, rather than a substitute for that investigation [1, 2].
The elamipretide monograph (https://peptideamerica.org/molecules/elamipretide) separates the product label from the wider research literature. The mitochondrial class (https://peptideamerica.org/classes/mitochondrial) also includes molecules with different evidence and regulatory positions, so a shared class label should never be read as interchangeable clinical support.

#### Sources
1. Karaa A, Bertini E, Carelli V, et al. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. Neurology. 2023;101(3):e238–e252. https://pubmed.ncbi.nlm.nih.gov/37268435/
2. Reid Thompson W, Hornby B, Manuel R, et al. A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism. Genet Med. 2021;23(3):471–478. https://pubmed.ncbi.nlm.nih.gov/33077895/

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### Kisspeptin-10 and Testosterone: Evidence
https://peptideamerica.org/evidence/kisspeptin-testosterone-evidence · published October 2026 · updated October 2026

Question: Does kisspeptin-10 treat low testosterone?
Short answer: Small studies show hormone stimulation in healthy men, but they do not establish symptom improvement or treatment benefit in men with clinical hypogonadism.

#### A hormone response
Kisspeptin-10 acts upstream of the reproductive hormones commonly measured in low-testosterone evaluations. The early human study tested whether it stimulated luteinizing hormone and altered hormone pulses. It enrolled healthy men and measured short-term physiological responses (https://peptideamerica.org/glossary/provocation-test), rather than testing treatment of a diagnosed disorder [1].
In a six-man part of that study, luteinizing hormone rose rapidly after administration. Other four-man infusion experiments measured increases in luteinizing hormone, testosterone and pulse frequency. These findings establish biological activity under the experimental conditions. They do not establish improvements in sexual symptoms, fertility, mood or long-term health [1].

#### What the twelve-day study added
The later study recruited fifteen healthy men across three experimental parts, with twelve men serving as controls. It examined acute responses, continuous administration over five days and intermittent administration over twelve days. The distinction between the latter two conditions matters: the twelve-day result was not obtained with uninterrupted exposure [2].
After five days of continuous administration, testosterone remained elevated but gonadotropin concentrations resembled those with vehicle. The intermittent twelve-day condition sustained gonadotropin increases, and a subsequent challenge still produced a response. The authors interpreted these results as useful for developing chronic administration approaches, not as proof that a clinical disorder had been treated [2].

#### The missing clinical outcome
Testosterone concentration is a laboratory measurement. A treatment claim additionally needs evidence about the patients concerned, the outcomes that matter to them and the balance of benefit and harm. Neither cited experiment tested whether men with clinical hypogonadism experienced sustained symptom relief or improved fertility [1, 2].
The small groups also constrain safety interpretation. A short experiment in healthy volunteers cannot reliably characterize uncommon adverse reactions or the consequences of prolonged use in patients with other conditions. Describing a hormone response as a proven replacement for established treatment would move beyond the studies [1, 2].

#### Fragment identity
The peptide studied here is kisspeptin-10. Results from another kisspeptin fragment, an animal experiment or a different reproductive condition require separate assessment. The name kisspeptin alone does not establish that a study tested the same substance or answered the same clinical question.
The kisspeptin-10 monograph (https://peptideamerica.org/molecules/kisspeptin-10) keeps the physiological studies alongside the regulatory record. The defensible conclusion from these two reports is hormone stimulation in small groups of healthy men. Evidence for a patient benefit remains a separate question from evidence that the endocrine axis responds.

#### Sources
1. George JT, Veldhuis JD, Roseweir AK, et al. Kisspeptin-10 is a potent stimulator of LH and increases pulse frequency in men. J Clin Endocrinol Metab. 2011;96(8):E1228–E1236. https://pubmed.ncbi.nlm.nih.gov/21632807/
2. Yeung AC, Phylactou M, Koysombat K, et al. Chronic subcutaneous kisspeptin-10 stimulates gonadotropin secretion for 12 days in healthy men. Eur J Endocrinol. 2026;195(2):206–216. https://pubmed.ncbi.nlm.nih.gov/42549827/

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### Setmelanotide: Who Lost Weight in Trials?
https://peptideamerica.org/evidence/setmelanotide-weight-loss-trials · published October 2026 · updated October 2026

Question: Can setmelanotide trial results predict general weight loss?
Short answer: No. The cited trials enrolled people with specific rare disorders, and their response rates cannot be applied to ordinary obesity or compared directly with unrelated weight-loss trials.

#### The population behind the percentage
Setmelanotide targets the melanocortin-4 receptor pathway, which contributes to appetite and body-weight regulation. The pivotal 2020 report studied people with severe obesity caused by POMC or LEPR deficiency. These were selected genetic conditions, not a broad sample of people seeking weight loss. Their biology is central to interpreting the results [1].
At approximately one year, eight of ten participants in the POMC trial and five of eleven in the LEPR trial had lost at least 10 percent of their initial weight. Those are responder proportions: 80 percent and 45 percent of two small groups. They do not mean that participants lost 80 percent or 45 percent of their body weight [1].

#### The study design
The trials were primarily single-arm and open-label. Participants who lost enough weight in an initial treatment phase entered a blinded withdrawal sequence, followed by further open-label treatment. That structure gives information about treatment response and withdrawal, but it is different from maintaining parallel drug and placebo groups for an entire year [1].
Hunger improvements were assessed in a subset meeting age and initial-response criteria. The published hunger percentages therefore have a different denominator from the overall weight-response counts. Combining them into one universal expectation would erase the selection rules that shaped the analysis [1].

#### Bardet-Biedl and Alström syndromes
A subsequent study enrolled 38 participants with Bardet-Biedl or Alström syndrome. It began with 14 weeks of randomized double-blind treatment and then continued into an open-label period. Among participants aged at least twelve with Bardet-Biedl syndrome, 32.3 percent reached a weight reduction of at least 10 percent after 52 weeks of setmelanotide [2].
The investigators reported the Alström syndrome findings as inconclusive. A shared pathway hypothesis did not justify treating the two syndromes as interchangeable evidence. The trial also illustrates why the initial randomized phase and the later one-year responder endpoint should be described separately [2].

#### Benefits alongside adverse effects
Injection-site reactions and changes in skin pigmentation were prominent in these reports. All ten participants in the POMC trial reported injection-site reactions and hyperpigmentation. In the later syndrome trial, hyperpigmentation occurred in 23 of 38 participants and injection-site redness in 18. Small samples and limited follow-up cannot resolve every uncommon or long-term risk [1, 2].
The useful question is whether a person has the disorder studied and meets the current product indication, not whether setmelanotide belongs on a generic ranking of weight-loss peptides. The setmelanotide monograph (https://peptideamerica.org/molecules/setmelanotide) keeps the label and other studies together; the weight-loss evidence comparison (https://peptideamerica.org/evidence/weight-loss-peptides-by-status) distinguishes the wider group.

#### Sources
1. Clément K, van den Akker E, Argente J, et al. Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials. Lancet Diabetes Endocrinol. 2020;8(12):960–970. https://pubmed.ncbi.nlm.nih.gov/33137293/
2. Haqq AM, Chung WK, Dollfus H, et al. Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period. Lancet Diabetes Endocrinol. 2022;10(12):859–868. https://pubmed.ncbi.nlm.nih.gov/36356613/

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### BPC-157 Oral and Nasal: What the Record Shows
https://peptideamerica.org/evidence/bpc-157-oral-and-nasal · published September 2026 · updated September 2026

Question: Does BPC-157 work when taken by mouth or as a nasal spray, and how do those forms compare with injection?
Short answer: That is not known, because no published study has measured how much BPC-157 reaches the bloodstream when it is swallowed or sprayed into the nose, in people or in any animal, and none has compared either route with injection. The claim that it survives stomach acid comes from its originators' own reviews; the one oral trial in people, registered in 2015, has posted no results; and PubMed holds no study of nasal BPC-157 at all. The form does not change its legal position: as of September 2026 no pharmacy may lawfully compound it in any form.

#### Why the route is the question
BPC-157 (https://peptideamerica.org/molecules/bpc-157) is sold in three broad forms: injectable vials, capsules or other oral products, and nasal sprays. The injectable is the form the human reports used, and the oral and nasal forms are sold as alternatives to it. Whether they work the same way depends on something that has to be measured rather than assumed: how much of the peptide survives the trip and reaches the blood, which pharmacologists call bioavailability.
Even for injection that figure exists only in animals. In the one formal pharmacokinetic study, in rats and beagle dogs, about 14 to 19 percent of an injection into muscle reached the circulation in rats and 45 to 51 percent in dogs; unchanged BPC-157 had a half-life of under 30 minutes, and it was broken down quickly into small peptide fragments and then single amino acids [1]. That study gave the peptide into a vein or a muscle only. It has no oral arm and no nasal arm [1].
A 2026 pharmaceutics review of the whole literature put the gap plainly: no pharmaceutical-grade formulation of BPC-157 has been developed or validated, the peptide lacks permeability data, the measurements that show whether a drug can cross the gut wall, and its human pharmacokinetic profile remains critically undercharacterized [2].

#### Does BPC-157 survive the stomach?
The case for oral BPC-157 rests on one repeated claim, that the peptide is stable in human gastric juice. It comes from the Zagreb group that first described the compound and named it after a protein found in gastric juice. A 2020 review by that group calls it "native to and stable in human gastric juice (for more than 24 h)" [3], and a 2012 review says it "may be the new drug stable in human gastric juice" [4]. Both state stability as a property of the molecule; neither abstract reports the experiment behind it. The 2026 pharmaceutics review repeats the same description [2].
Surviving the stomach is also only the first step. A peptide that stays intact in gastric juice still has to cross the lining of the gut and escape the enzymes of the intestine and liver before any of it reaches the blood, and none of those steps has been measured for BPC-157 [2]. PubMed indexes 70 records that pair BPC-157 with oral administration, such as the peptide given to rats in drinking water or by stomach tube, and none is indexed as a clinical trial [5]. Of the 8 records that pair it with pharmacokinetics, bioavailability or absorption, the only pharmacokinetic study is the injection study above [5, 1], and a search for the arginate salt, often described as the stable oral form, returns no record at all [5].

#### Has oral BPC-157 been tested in people?
Once, on paper, and no result has been posted. A phase 1 trial of oral BPC-157 tablets in healthy volunteers, randomized, placebo-controlled and masked, was registered by its sponsor in December 2015 to measure safety and, as secondary outcomes, blood levels over time [6]. Its record was last updated the day it was posted, it carries an unknown status, and it has posted no results [6]. Of the 4 records PubMed tags as human among the oral studies, none gave BPC-157 to a person by mouth [5].
The originating group has also written that a bowel-disease formulation of the peptide, coded PL 14736, was tested in phase II trials [4]. PubMed indexes no report of those trials: across every name the peptide goes by, including PL 14736, it holds no record under the clinical-trial publication type [7].
The second oral study on the registry is of a different kind. A gummy containing BPC-157 was registered by the company that sells it, with its intervention entered as a dietary supplement; it enrolled 40 people in a single group with no comparison, ran from September to November 2025, was first posted in August 2026 after it had finished, and has posted no results [6]. An uncontrolled study of a seller's own product, registered after the fact, cannot show that the peptide was absorbed or that it did anything.

Every human study of BPC-157, by route, on PubMed and ClinicalTrials.gov as of September 2026
Route | Human record | Result available
By mouth, tablets | Phase 1, randomized, placebo-controlled; 42 planned; registered 2015 [6] | None; status unknown
By mouth, gummy | Single group, no control; 40 people; sponsored by its seller [6] | None posted
Nasal spray | No study registered or published [6, 5] | Not applicable
Injection into the knee | 16 patients, chart review, no control [8] | Pain relief reported; no comparison
Injection around the bladder | 12 women, single arm [9] | No adverse events reported
Into a vein | 2 adults, no control [10] | No side effects reported

#### What about BPC-157 nasal spray?
There is no study of it. Across all five names, PubMed holds exactly one record that mentions BPC-157 alongside the nose, and it is not a study of nasal delivery: in a 1997 rat experiment the peptide was injected into the abdomen, and an irritant, capsaicin, was the substance placed in the nose [11, 5]. ClinicalTrials.gov returns no registered study of nasal BPC-157 [6].
FDA has addressed the form directly in enforcement. In a June 2023 warning letter to an online seller, the agency recorded that the firm took orders for "BPC-157" as an injectable and as a nasal spray, and stated that the products it listed were unapproved new drugs [12]. The same letter explained the agency's concern with nasal products in general: they "may be rapidly absorbed through the highly vascularized nasal mucosa directly into systemic blood circulation," and if toxic substances are introduced into the nose, harm such as bleeding, ulceration or a hole in the nasal septum may occur [12].

#### Oral versus injection: what can be compared?
Nothing, on the published record. A comparison needs a measurement for each route, and there is an injection figure only in rats and dogs, no oral figure in any species, and no nasal figure at all [1, 2, 5]. Claims that one form works as well as another, or that a larger oral amount makes up the difference, are not drawn from data, because the data do not exist. The animal numbers themselves cannot be carried over to people [2].
The uncertainty about the material is the same in every form. FDA's stated concerns about BPC-157, immune reactions and peptide-related impurities, attach to the substance, and the agency wrote that it lacked sufficient information to know whether the drug would cause harm when given to people [13]. The BPC-157 safety record (https://peptideamerica.org/evidence/bpc-157-safety-record) sets out what is and is not known about harm, and the human trial record (https://peptideamerica.org/evidence/bpc-157-human-trials) reads the three injection reports in full.

#### Is oral or nasal BPC-157 legal?
The route does not change the answer. BPC-157 is not an approved drug in any form, FDA removed it from Category 2 of its compounding list in April 2026 without adding it to Category 1, and the July 2026 advisory committee vote to recommend it for the section 503A list, reported as 8 to 6 with one abstention, is advisory until FDA issues a final rule [14, 15, 16]. As of September 2026 no licensed pharmacy may lawfully compound it as an injection, a capsule or a spray; the pending (https://peptideamerica.org/status/pending) status page carries the dated record.
FDA's enforcement record treats BPC-157 as a drug whatever its form. Its 2023 letter called the listed injectable and nasal products new drugs that could not lawfully be sold without approval [12], and in October 2020 a Kentucky compounding pharmacy pleaded guilty to distributing unapproved new drugs whose list, in the Justice Department's account of the plea agreement, includes BPC-157 [17]. A registry entry that describes a BPC-157 gummy as a dietary supplement is the sponsor's own description, not a finding by FDA [6].
For athletes the form is also irrelevant. The World Anti-Doping Agency's 2026 Prohibited List names BPC-157 in section S0, non-approved substances, prohibited at all times, and the list makes no exception for the route [18].

#### Sources
1. He L, Feng D, Guo H, et al. Pharmacokinetics, distribution, metabolism, and excretion of body-protective compound 157, a potential drug for treating various wounds, in rats and dogs. Front Pharmacol. 2022;13:1026182. Intravenous and intramuscular administration only. https://pubmed.ncbi.nlm.nih.gov/36588717/
2. Mateescu DM, Gavrilescu DM, Constantinescu FE, et al. BPC-157 as an investigational peptide therapeutic: biopharmaceutical challenges, formulation strategies, and translational development barriers. Pharmaceutics. 2026;18(5):625. Abstract re-read September 2026. https://pubmed.ncbi.nlm.nih.gov/42198317/
3. Sikiric P, Drmic D, Sever M, et al. Fistulas healing. Stable gastric pentadecapeptide BPC 157 therapy. Curr Pharm Des. 2020;26(25):2991-3000. https://pubmed.ncbi.nlm.nih.gov/32329684/
4. Sikiric P, Seiwerth S, Rucman R, et al. Focus on ulcerative colitis: stable gastric pentadecapeptide BPC 157. Curr Med Chem. 2012;19(1):126-132. https://pubmed.ncbi.nlm.nih.gov/22300085/
5. PubMed, National Library of Medicine. Searches run September 2026 on five BPC-157 name variants (232 records). With oral-route terms (oral, orally, per-orally, drinking water, intragastric, gavage): 70 records, 4 tagged Humans and each read (an editorial, a review and two rat studies, one also measuring sphincter pressure in pancreatitis patients not given the peptide), 0 under the clinical-trial type. With intranasal or nasal: 1 record, a rat study. With arginate: 0. With pharmacokinetic, bioavailability, absorption or plasma-concentration terms: 8 records, each title read; the one pharmacokinetic study among them gave the peptide intravenously and intramuscularly only. Controls in the same run: aspirin 8,916 under the clinical-trial type; the invalid tag returned 0; the invalid identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22BPC+157%22+OR+%22BPC-157%22+OR+%22pentadecapeptide+BPC%22+OR+%22body+protection+compound%22+OR+%22PL+14736%22%29+AND+%28intranasal+OR+nasal%29
6. ClinicalTrials.gov, National Library of Medicine, v2 API, read September 2026. NCT02637284, a phase 1, randomized, quadruple-masked, placebo-controlled study of oral BPC-157 tablets in healthy volunteers, 42 planned, started October 2015, status unknown, first posted and last updated December 22, 2015, no results. NCT07752381, a single-group, open-label study of a BPC-157 gummy registered by its seller as a dietary supplement, 40 enrolled, September 1 to November 1, 2025, first posted August 7, 2026, no results. "BPC-157 nasal" returned 0 studies. https://clinicaltrials.gov/study/NCT02637284
7. PubMed, National Library of Medicine. Searches run September 2026 across five BPC-157 name variants including PL 14736: 232 records, 57 tagged Humans, 0 under the clinical-trial, randomized-controlled-trial and case-report publication types, with the aspirin control and the 99999999 identifier in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22BPC+157%22+OR+%22BPC-157%22+OR+%22pentadecapeptide+BPC%22+OR+%22body+protection+compound%22+OR+%22PL+14736%22%29+AND+%28%22TB-500%22+OR+%22TB500%22+OR+%22thymosin+beta+4%22+OR+%22thymosin+beta-4%22%29
8. Lee E, Padgett B. Intra-articular injection of BPC 157 for multiple types of knee pain. Altern Ther Health Med. 2021;27(4):8-13. https://pubmed.ncbi.nlm.nih.gov/34324435/
9. Lee E, Walker C, Ayadi B. Effect of BPC-157 on symptoms in patients with interstitial cystitis: a pilot study. Altern Ther Health Med. 2024;30(10):12-17. https://pubmed.ncbi.nlm.nih.gov/39325560/
10. Lee E, Burgess K. Safety of intravenous infusion of BPC157 in humans: a pilot study. Altern Ther Health Med. 2025;31(5):20-24. https://pubmed.ncbi.nlm.nih.gov/40131143/
11. Kalogjera L, Ries M, Baudoin T, et al. Dose-dependent protective effect of BPC 157 on capsaicin-induced rhinitis in rats. Eur Arch Otorhinolaryngol. 1997;254 Suppl 1:S9-S11. The peptide was injected into the abdominal cavity; capsaicin was applied to the nose. https://pubmed.ncbi.nlm.nih.gov/9065615/
12. US Food and Drug Administration. Warning letter, Warrior Labz SARMS, MARCS-CMS 655280, June 12, 2023. Content current as of June 20, 2023; read September 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/warrior-labz-sarms-655280-06122023
13. US Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks (the Category 2 rationale for BPC-157). Content current as of April 22, 2026. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
14. US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
15. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because FDA has published no vote record for the meeting.
16. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent account; it prints BPC-157 at 8–6–1.
17. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution
18. World Anti-Doping Agency. The 2026 Prohibited List, in effect from January 1, 2026. Section S0, Non-Approved Substances, prohibited at all times, naming BPC-157. Read September 2026.

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### BPC-157 Side Effects: The Safety Record
https://peptideamerica.org/evidence/bpc-157-safety-record · published September 2026 · updated September 2026

Question: What are the side effects of BPC-157, and what is actually known about its safety?
Short answer: No controlled human study has measured the side effects of BPC-157, so no reliable list of them exists. Three uncontrolled reports from one clinic, covering 30 people, recorded no adverse events; FDA's stated concerns are immune reactions and impurities; and the cancer question is a theory drawn from animal biology, not an observation in people.

#### What counts as a side effect when there is no trial?
The side-effect list printed on an approved drug's label comes from controlled trials, in which people given the drug are compared with people given a placebo, and a reaction is counted as a side effect when it turns up more often in the treated group. That comparison is what separates an effect of the drug from the aches, infections and headaches that happen to any group of people over a few months.
BPC-157 (https://peptideamerica.org/molecules/bpc-157) has never been through that comparison. PubMed holds 232 papers on it under its five names, and none is indexed as a clinical trial or a randomized controlled trial [4]. A 2025 systematic review of the literature up to June 2024 included 36 studies, 35 of them in animals or cells and one in people, and found no clinical safety data [5]. Anything described online as a side effect of BPC-157 is therefore one of three things: an observation in a small uncontrolled study, a finding in animals, or a risk inferred from how the molecule behaves. The sections below keep the three apart.

#### What has been reported in people?
Three human reports exist, all from the same Florida practice and the same lead author, and together they cover 30 people [1, 2, 3]. None had a comparison group, and none is indexed as a trial.
Their safety findings are thin for different reasons. The knee report was a telephone survey of patients treated up to a year earlier, and its abstract reports pain relief without reporting on adverse events either way [1]. The bladder study recorded no adverse events and no dropouts among 12 women [2]. The intravenous study found no change in blood markers of the heart, liver, kidneys, thyroid or glucose and no reported side effects, but both of its two participants had received intravenous BPC-157 before enrolling, so they were people who had already tolerated it [3].
Thirty people without a control group cannot reveal an uncommon harm, and they cannot show that a symptom was or was not caused by the peptide. PubMed also indexes no case report on BPC-157 at all, of harm or of benefit [4], so the human record holds neither a controlled safety signal nor an individual account of one. The BPC-157 human trial record (https://peptideamerica.org/evidence/bpc-157-human-trials) reads the same three reports for what they say about benefit.

Every published human report on BPC-157, as indexed in PubMed in September 2026
Report | Design | People | How it was given | Adverse events reported
Knee pain, 2021 [1] | Retrospective chart review with telephone follow-up; no comparison group | 16 (12 BPC-157 alone, 4 with thymosin beta-4) | Injected into the knee | Not reported in the abstract
Interstitial cystitis, 2024 [2] | Single-arm pilot; no comparison group | 12 women | Injected around the bladder during cystoscopy, once | None; no dropouts
Intravenous safety, 2025 [3] | Pilot; no comparison group | 2 adults already given it before | Intravenous infusion on two consecutive days | None; blood markers unchanged

#### What did FDA say about its safety?
FDA placed BPC-157 in Category 2 of its interim bulk substances list in September 2023, the category for substances that may present significant safety risks, which barred licensed pharmacies from compounding it [8]. Its stated reasons, still on the agency's safety-risk page as of April 22, 2026, are that compounded drugs containing BPC-157 "may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization" [7].
Each of those phrases names a specific worry. Immunogenicity means the body mounting an immune response against the peptide itself. Peptide-related impurities are the fragments and by-products left over from making a peptide, and API characterization is the work of confirming that the active ingredient is what it claims to be and how pure it is. FDA added that it had identified "no, or only limited, safety-related information for the proposed routes of administration," and that the agency therefore "lacks sufficient information to know whether the drug would cause harm when administered to humans" [7]. The April 2026 removal from Category 2 did not answer any of those questions; the Category 2 removal (https://peptideamerica.org/reference/category-2-removal) page explains what it did change.

#### Does BPC-157 cause cancer?
There is no human evidence either way. The question comes from the mechanism. In animal studies BPC-157 promotes the growth of new blood vessels, working through the VEGFR2 receptor and nitric oxide signaling [6], and tumors depend on new blood vessels to grow. A 2026 review of unregulated injectable peptides, which names BPC-157, lists pathological blood vessel growth and cancer promotion among the potential risks of these products [9]. That is a hypothesis from biology. No study has observed BPC-157 causing or promoting cancer in people, and no study has been large or long enough to rule it out.
The animal toxicology is reassuring in the short term and silent on the long term. A 2020 preclinical safety program in mice, rats, rabbits and dogs found no serious toxicity, no genetic toxicity and no harm to developing fetuses; injection-site irritation was mild, and repeated dosing in dogs lowered creatinine at one dose level, though not at lower ones, a change that reversed within two weeks of stopping [10]. Its abstract reports no lifetime carcinogenicity study, which is the test that would speak to the cancer question.

#### How long does BPC-157 last in the body?
Only in animals has that been measured. In rats and dogs, unchanged BPC-157 had an elimination half-life of under 30 minutes after injection into a vein or a muscle, and it was broken down quickly into small peptide fragments and then single amino acids, which left the body in urine and bile [11]. The 2024 systematic review repeats the same under-30-minute figure, from the same animal work [5].
No human pharmacokinetic study has been published. A phase 1 study of the safety and pharmacokinetics of an oral preparation in healthy volunteers was registered in 2015, and its record was last updated that December, carries an unknown status and has posted no results [12]. A 2026 pharmaceutics review describes BPC-157's human pharmacokinetics as largely uncharacterized [13]. An animal half-life cannot be carried over to people, and it supports no conclusion about use.

#### What is the risk from the product itself?
Some of the risk sits in the material rather than the molecule. BPC-157 sold online is research-use-only chemical supply, made and sold outside drug manufacturing standards, so nothing independent guarantees that a vial holds the stated peptide, in the stated amount, free of contamination and sterile. FDA's own concerns about impurities and API characterization are concerns about exactly that [7].
Reviewers name the same gap. The 2025 systematic review concluded that adverse effects are possible from unregulated manufacturing, contamination or unknown clinical safety [5], and the 2026 review of injectable peptides lists contamination, manufacturing impurities and inaccurate dosing among the risks [9]. Blends multiply the problem, because each added peptide brings its own uncertainty; the review of GLOW and KLOW blends (https://peptideamerica.org/evidence/glow-and-klow-blends) and the review of the BPC-157 and TB-500 stack (https://peptideamerica.org/evidence/bpc-157-and-tb-500-stack) cover the two most common combinations.

#### Which trials are under way?
Four studies naming BPC-157 are registered on ClinicalTrials.gov, and none has posted results [12]. The most substantial is a randomized, double-blind, placebo-controlled phase 2 trial in acute hamstring strain, recruiting since February 2026 and due to finish in 2028. If it reports as designed, it will be the first placebo-controlled human data on BPC-157, including the first comparison of adverse events against placebo.

Registered studies naming BPC-157 on ClinicalTrials.gov, as of September 2026 [12]
Study | Design | Planned size | Status
NCT07437547, acute hamstring strain | Phase 2, randomized, double-blind, placebo-controlled | 120 | Recruiting since February 2026; completion estimated February 2028
NCT07803250, after rotator cuff repair | Phase 1, randomized | 30 | Not yet recruiting; start estimated January 2027
NCT02637284, healthy volunteers, oral preparation | Phase 1, randomized, safety and pharmacokinetics | 42 | Unknown; last updated December 2015; no results
NCT07752381, a gummy sold as a dietary supplement | Single arm, no comparison group | 40 enrolled | Completed November 2025; no results posted

#### What is BPC-157's legal status?
BPC-157 is not an approved drug, and no licensed pharmacy may lawfully compound it as of September 2026. FDA removed it from Category 2 in April 2026 without adding it to Category 1, and in July 2026 the Pharmacy Compounding Advisory Committee voted to recommend it for the section 503A bulks list, by a margin reported as 8 to 6 with one abstention in two independent law-firm accounts [14, 15]. FDA has published no vote record for that meeting [16], and the vote is advisory until the agency issues a final rule. The pending (https://peptideamerica.org/status/pending) status page and the July 2026 vote ledger (https://peptideamerica.org/reference/pcac-july-2026) carry the dated record.

#### Sources
1. Lee E, Padgett B. Intra-articular injection of BPC 157 for multiple types of knee pain. Altern Ther Health Med. 2021;27(4):8-13. A retrospective chart review with telephone follow-up of 16 patients; no comparison group. https://pubmed.ncbi.nlm.nih.gov/34324435/
2. Lee E, Walker C, Ayadi B. Effect of BPC-157 on symptoms in patients with interstitial cystitis: a pilot study. Altern Ther Health Med. 2024;30(10):12-17. Twelve women, single arm, one treatment; no comparison group. https://pubmed.ncbi.nlm.nih.gov/39325560/
3. Lee E, Burgess K. Safety of intravenous infusion of BPC157 in humans: a pilot study. Altern Ther Health Med. 2025;31(5):20-24. Two adults, each of whom had received intravenous BPC-157 before the study. https://pubmed.ncbi.nlm.nih.gov/40131143/
4. PubMed, National Library of Medicine. Searches run September 2026 across five BPC-157 name variants, returning 232 records, 57 carrying the Humans MeSH term, and 0 under each of the clinical-trial, randomized-controlled-trial and case-report publication types. The filters were proved live in the same run against the control term aspirin (8,916 records under the clinical-trial type), and the invalid identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22BPC+157%22+OR+%22BPC-157%22+OR+%22pentadecapeptide+BPC%22+OR+%22body+protection+compound%22+OR+%22PL+14736%22%29+AND+%28%22TB-500%22+OR+%22TB500%22+OR+%22thymosin+beta+4%22+OR+%22thymosin+beta-4%22%29
5. Vasireddi N, Hahamyan H, Salata MJ, et al. Emerging use of BPC-157 in orthopaedic sports medicine: a systematic review. HSS J. 2025;21(4):485-495. https://pubmed.ncbi.nlm.nih.gov/40756949/
6. McGuire FP, Martinez R, Lenz A, Skinner L, Cushman DM. Regeneration or risk? A narrative review of BPC-157 for musculoskeletal healing. Curr Rev Musculoskelet Med. 2025;18(12):611-619. https://pubmed.ncbi.nlm.nih.gov/40789979/
7. US Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks (the Category 2 rationale for BPC-157). Content current as of April 22, 2026. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
8. US Food and Drug Administration. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, guidance for industry, January 2025, docket FDA-2015-D-3517: the policy that defines Categories 1, 2 and 3, under which BPC-157 was placed in Category 2 in September 2023. Read September 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/interim-policy-compounding-using-bulk-drug-substances-under-section-503a-federal-food-drug-and
9. Moiz A, O'Keefe EL, O'Keefe JH. Dangers of injectable peptides and other unregulated "biohacking" drugs. Mo Med. 2026;123(4):337-343. https://pubmed.ncbi.nlm.nih.gov/42757290/
10. Xu C, Sun L, Ren F, et al. Preclinical safety evaluation of body protective compound-157, a potential drug for treating various wounds. Regul Toxicol Pharmacol. 2020;114:104665. https://pubmed.ncbi.nlm.nih.gov/32334036/
11. He L, Feng D, Guo H, et al. Pharmacokinetics, distribution, metabolism, and excretion of body-protective compound 157, a potential drug for treating various wounds, in rats and dogs. Front Pharmacol. 2022;13:1026182. https://pubmed.ncbi.nlm.nih.gov/36588717/
12. ClinicalTrials.gov, National Library of Medicine, v2 API. Searches run September 2026: "BPC-157" and its spelling variants returned the same four registered studies, NCT07437547, NCT07803250, NCT02637284 and NCT07752381, each read individually; none has posted results. Control in the same run: "aspirin" returned 2,968 studies. https://clinicaltrials.gov/api/v2/studies?query.term=BPC-157
13. Mateescu DM, Gavrilescu DM, Constantinescu FE, et al. BPC-157 as an investigational peptide therapeutic: biopharmaceutical challenges, formulation strategies, and translational development barriers. Pharmaceutics. 2026. https://pubmed.ncbi.nlm.nih.gov/42198317/
14. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting.
15. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account; it prints BPC-157 at 8–6–1, and the two accounts agree substance by substance.
16. US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026

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### CJC-1295 With Ipamorelin: The Evidence
https://peptideamerica.org/evidence/cjc-1295-and-ipamorelin · published September 2026 · updated September 2026

Question: What is known about CJC-1295 taken with ipamorelin?
Short answer: No study has tested the two together. CJC-1295's human record is two small hormone studies in healthy adults and a phase 2 trial stopped without results; ipamorelin's is a pharmacokinetic study and a postoperative trial that missed its endpoint; and neither molecule has a lawful compounding route in the United States.

#### Two mechanisms, one target
The pair is sold on the idea that two different signals to the pituitary release more growth hormone than either alone. The two molecules do act through different receptors. CJC-1295 (https://peptideamerica.org/molecules/cjc-1295) is a growth hormone-releasing hormone analog: its developer built it from the first 29 amino acids of the hormone, with four substitutions and a reactive lysine group that attaches to albumin in the blood after injection, which is what gives it a half-life measured in days [3]. Ipamorelin (https://peptideamerica.org/molecules/ipamorelin) is a ghrelin mimetic, a synthetic peptide that acts at the ghrelin receptor instead [7].
Their timing differs as much as their targets. In healthy adults, CJC-1295 had an estimated half-life of 5.8 to 8.1 days and kept growth hormone raised for six days or more after one injection [1]. Ipamorelin had a terminal half-life of 2 hours and produced a single pulse of growth hormone that peaked at about 40 minutes and then faded [8]. Whether combining them adds anything has not been measured in people.

CJC-1295 and ipamorelin compared, as of September 2026
Measure | CJC-1295 | Ipamorelin
Class | GHRH analog, albumin-binding [3] | Ghrelin mimetic [7]
Half-life in people | 5.8 to 8.1 days [1] | About 2 hours [8]
Human studies published | 2 clinical trials, both hormone studies in healthy adults [4] | 2 clinical trials: one pharmacokinetic, one postoperative [9]
Efficacy result | None; a phase 2 trial was terminated without posted results [5] | Missed its endpoint in postoperative ileus [7]
Adverse events cited by FDA | Increased heart rate, systemic vasodilatory reaction [6] | Serious adverse events including death with intravenous use [6]
FDA position | Nomination withdrawn; on no list [6] | 503A nominations withdrawn; 503B Category 2 [6, 10]
Tested together | No [4] | No [4]

#### With DAC and without
The name CJC-1295 covers two different molecules in the marketplace. The compound in the published studies is the version with the albumin-binding group, often labeled "with DAC", and its developer's own paper credits that group with keeping it in the blood for days [3]. Material sold as "CJC-1295 without DAC" lacks that group, so the multi-day figures in the human studies do not describe it.
No clinical trial in PubMed has tested either version alongside ipamorelin [4]. A reader weighing the product sold as the pair is therefore weighing two separate records, one of which may not even concern the molecule in the vial.

#### The human record for each
CJC-1295 was studied in people in the mid-2000s. Two randomized, placebo-controlled, ascending-dose trials in healthy adults aged 21 to 61 found that a single injection raised growth hormone two- to tenfold for six days or more and IGF-1 1.5- to threefold for 9 to 11 days [1]. A second study in healthy men aged 20 to 40 found that the natural pulses of growth hormone survived: their frequency and size were unchanged a week after one injection, while the level between pulses rose 7.5-fold and IGF-1 rose 45 percent [2]. A phase 2 trial in adults with HIV-associated abdominal fat, planned for 120 patients, began in December 2005 and was terminated in 2006; the registry states no reason and holds no results [5]. No efficacy result for CJC-1295 has ever been published.
Ipamorelin's record is similar in size. A dose-escalation study gave it by infusion to healthy men, eight at each of five rates, and measured the drug and growth hormone in the blood [8]. Its one published efficacy trial randomized 114 patients after bowel surgery; the median time to a tolerated meal was 25.3 hours against 32.6 with placebo, a difference that was not statistically significant [7]. A second phase 2 trial in the same setting enrolled 320 patients and was completed in 2014, and its registry record holds no posted results [11]. The ipamorelin trial (https://peptideamerica.org/evidence/ipamorelin-trial) review reads the first trial in full.

#### The combined record
PubMed holds 11 papers that mention CJC-1295 and ipamorelin together, and none is a trial of the pair [4]. Nine are narrative articles and reviews published in 2026 on peptide use in sport, orthopedics, aging and aesthetics; the other two are laboratory methods for detecting these peptides in doping control, one of them in seized material [4]. ClinicalTrials.gov registers no study of the combination [4].
The pairing is therefore a market convention, not a finding. Its rationale, two receptors instead of one, is pharmacology that has not been carried into a controlled comparison, and nothing published shows whether the combination changes the benefit, the harm or neither.

#### Adverse events as reported
The published human studies report few harms, and none was designed to find uncommon ones. The CJC-1295 trials in healthy adults reported no serious adverse reactions and described the compound as relatively well tolerated [1]. In the ipamorelin surgical trial, treatment-emergent adverse events of any kind occurred in 87.5 percent of patients on ipamorelin and 94.8 percent on placebo [7].
The FDA's reading of the record is less reassuring. Its Category 2 page states that the agency has identified serious adverse events associated with CJC-1295, including increased heart rate and a systemic vasodilatory reaction, and that available clinical data are limited [6]. For ipamorelin it cites a published report of serious adverse events, including death, when the drug was given intravenously for gastric motility, and a risk of immune reactions from aggregation or peptide-related impurities [6]. No adverse-event data exist for the two taken together.

#### Legal status of each
Neither molecule has a lawful compounding route. CJC-1295's nomination for the 503A bulks list was withdrawn by its nominators, and the FDA now lists it among the substances whose nominations were withdrawn; it sits on no list [6]. The nominations of ipamorelin acetate and ipamorelin free base were withdrawn on September 19, 2024, and when the FDA presented its evaluation to the advisory committee on October 29, 2024 regardless, the committee voted 0–12, with one abstention, against listing each form [10]. Under the separate 503B policy for outsourcing facilities, ipamorelin acetate has been in Category 2 since September 29, 2023 [6].
Both substances also appear in a federal criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names CJC 1295 and Ipamorelin among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [12]. The plea concerns that one company's distribution, not any seller named in this index.
The CJC-1295 withdrawal (https://peptideamerica.org/evidence/cjc-1295-withdrawal) review explains why a withdrawn nomination is not a clearance, and the nomination tracker (https://peptideamerica.org/reference/nominations) sets the dispositions side by side. In the same GH secretagogues (https://peptideamerica.org/classes/gh-secretagogues) class, sermorelin (https://peptideamerica.org/molecules/sermorelin) is the GHRH analog that 503A pharmacies may compound with a prescription, and sermorelin vs tesamorelin (https://peptideamerica.org/evidence/sermorelin-versus-tesamorelin) compares it with the class's approved drug. Material sold without a prescription as CJC-1295, ipamorelin or the two blended is research-use-only supply, outside pharmacy quality standards.

#### Sources
1. Teichman SL, Neale A, Lawrence B, et al. Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults. J Clin Endocrinol Metab. 2006;91(3):799–805. https://pubmed.ncbi.nlm.nih.gov/16352683/
2. Ionescu M, Frohman LA. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. J Clin Endocrinol Metab. 2006;91(12):4792–4797. https://pubmed.ncbi.nlm.nih.gov/17018654/
3. Jetté L, Léger R, Thibaudeau K, et al. Human growth hormone-releasing factor (hGRF)1-29-albumin bioconjugates activate the GRF receptor on the anterior pituitary in rats: identification of CJC-1295 as a long-lasting GRF analog. Endocrinology. 2005;146(7):3052–3058. https://pubmed.ncbi.nlm.nih.gov/15817669/
4. PubMed, National Library of Medicine, and ClinicalTrials.gov. Census run September 2026: CJC-1295 under three spellings returns 33 records and 2 under "clinical trial"[Publication Type]; the same names or "modified GRF" combined with ipamorelin return 11 records and 0 trials, all 11 read by title and type. Positive controls in the same run: aspirin 8,916 trials, aspirin with clopidogrel 1,412; the invalid tag returned 0 and an invalid identifier errored. ClinicalTrials.gov lists one CJC-1295 study and none of the combination. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22CJC-1295%22+OR+%22CJC+1295%22+OR+%22CJC1295%22+OR+%22modified+GRF%22%29+AND+ipamorelin
5. ClinicalTrials.gov. NCT00267527: phase 2 study of CJC 1295 for 12 weeks in HIV infected patients with HIV associated visceral obesity. Sponsor ConjuChem; planned enrollment 120; start December 2005; Terminated, September 2006; no reason or results posted. Read September 2026. https://clinicaltrials.gov/study/NCT00267527
6. US Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks. Entries for CJC-1295 (nominated but withdrawn) and ipamorelin acetate (503B Category 2, added September 29, 2023). Content current as of April 22, 2026. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
7. Beck DE, Sweeney WB, McCarter MD. Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients. Int J Colorectal Dis. 2014 Dec;29(12):1527-34. https://pubmed.ncbi.nlm.nih.gov/25331030/
8. Gobburu JV, Agersø H, Jusko WJ, Ynddal L. Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers. Pharm Res. 1999;16(9):1412–1416. https://pubmed.ncbi.nlm.nih.gov/10496658/
9. PubMed, National Library of Medicine. Census run August 2026 on "ipamorelin": 54 indexed records, 2 under "clinical trial"[Publication Type], both read, with the filter proved live against a control term in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%22ipamorelin%22+AND+%22clinical+trial%22%5BPublication+Type%5D
10. US Food and Drug Administration. Pharmacy Compounding Advisory Committee, October 29, 2024, meeting transcript: ipamorelin nominations withdrawn September 19, 2024; votes of zero yes, 12 no and 1 abstention on each form. Read September 2026. https://www.fda.gov/media/185414/download
11. ClinicalTrials.gov. NCT01280344: phase II dose-finding study of ipamorelin compared to placebo for recovery of gastrointestinal function after small or large bowel resection. Sponsor Helsinn Therapeutics; enrollment 320; Completed, May 2014; no results posted. Read September 2026. https://clinicaltrials.gov/study/NCT01280344
12. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. The plea agreement, as the release describes it, names CJC 1295 and Ipamorelin among the unapproved new drugs distributed; the company agreed to forfeit $1,788,906.82. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution

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### GLOW and KLOW Peptide Blends: What Is in Them
https://peptideamerica.org/evidence/glow-and-klow-blends · published September 2026 · updated September 2026

Question: What are the GLOW and KLOW peptide blends, and has either been tested in people?
Short answer: Neither blend is an approved drug, and no human trial has tested either combination. Injectable GHK-Cu has no lawful compounding route, BPC-157, TB-500 and KPV await FDA action after an advisory vote, and none of the four has a published controlled trial as an injection.

#### What is in GLOW and in KLOW?
GLOW and KLOW are product names, not drug names. Sellers describe GLOW as an injectable blend of three peptides, GHK-Cu (https://peptideamerica.org/molecules/ghk-cu), BPC-157 (https://peptideamerica.org/molecules/bpc-157) and TB-500 (https://peptideamerica.org/molecules/tb-500), marketed mainly for skin and recovery, and describe KLOW as the same three with KPV (https://peptideamerica.org/molecules/kpv) added. That is a marketing description read on seller product pages in September 2026. No pharmacopeia, regulator or published study defines either name, so the ratio, the amount of each peptide and the other ingredients can differ from one product to the next.
The names have no scientific literature of their own. As of September 2026, none of the phrases GLOW peptide, KLOW peptide, GLOW blend or KLOW blend appears in any PubMed record [9]. ClinicalTrials.gov returns no study of either blend and no registered study that combines any two of the four peptides [10].

#### What is the US status of each component?
No component is an approved drug, and the four do not share one legal position. Three of them, BPC-157, TB-500 and KPV, were removed from Category 2 of FDA's interim 503A bulks list in April 2026 without being added to Category 1, and in July 2026 the Pharmacy Compounding Advisory Committee voted to recommend each for the 503A list [6, 7, 8]. That vote is advisory; FDA has issued no final rule, so none of the three may yet be lawfully compounded. GHK-Cu followed a different path: FDA's list document places GHK-Cu in Category 1 except for injectable routes, and the injectable route sits on no list [1]. A blend sold for injection therefore contains at least one ingredient, injectable GHK-Cu, with no lawful compounding route at all.

Each component of the two blends, as the index records it in September 2026. The three pending peptides left Category 2 in April 2026 and went before the advisory committee in July 2026.
Component | US status | Human trial record | FDA's stated concern
GHK-Cu (https://peptideamerica.org/molecules/ghk-cu) | Category 1 except injectable routes; the injectable route sits on no list [1] | Two small topical trials, one no better than placebo; no trial of the injected form [11] | Injectable form may pose a risk of immunogenicity from aggregation and impurities; limited human data [2]
BPC-157 (https://peptideamerica.org/molecules/bpc-157) | Off Category 2; advisory committee voted to list it; no final rule [6, 7] | No published controlled trial; three uncontrolled reports covering 30 people [12, 13, 14] | Possible immunogenicity, peptide impurities and API characterization problems; little or no safety data [3]
TB-500 (https://peptideamerica.org/molecules/tb-500) | Off Category 2; advisory committee voted to list it; no final rule [7, 8] | No published trial; one phase 1/2 trial registered in 2026, no results posted [15, 16] | Possible immunogenicity from aggregation and impurities; no human exposure data identified [4]
KPV (https://peptideamerica.org/molecules/kpv) | Off Category 2; advisory committee voted to list it; no final rule [7, 8] | No clinical trial of any kind in PubMed; none registered [9, 10] | No human exposure data identified by any route; FDA cannot say whether it would cause harm [5]

#### What has been tested in people?
Nothing that matches the product. For the combination, the six PubMed records that name GHK-Cu, BPC-157 and TB-500 together are all 2026 review articles on peptide therapies, and BPC-157 and KPV never appear together in an indexed record [9]. PubMed indexes no trial of any combination of the four [9].
Component by component, the record is thin. BPC-157 has no record under either trial publication type across four of its names [11] and three uncontrolled human reports from one practice, with 16, 12 and 2 participants [12, 13, 14]. TB-500's single trial-type record is a tuberculosis study matched on the letters TB [15]; a first randomized trial of the fragment was registered in 2026 and is still recruiting [16]. KPV returns no trial of any kind [9, 17]. GHK-Cu has two human trials, both applying it to skin [18]; the topical versus injectable review (https://peptideamerica.org/evidence/ghk-cu-topical-versus-injectable) reads them in full.
The trial registry shows studies under way for single components, including a phase 2 trial of BPC-157 in hamstring strain and a phase 2 trial of a topical GHK-Cu gel, and none has posted results [10]. The BPC-157 human trial record (https://peptideamerica.org/evidence/bpc-157-human-trials) and the TB-500 versus thymosin beta-4 review (https://peptideamerica.org/evidence/tb-500-versus-thymosin-beta-4) set out what each molecule's human record does and does not contain.

#### Why is a blend not the sum of its evidence?
Even if each peptide had a strong record alone, a combination would need its own. Four peptides in one vial are a new formulation, and a formulation is judged on its own stability, purity and behavior in the body. A 2026 pharmaceutics review of BPC-157 alone describes a molecule whose human pharmacokinetics remain largely uncharacterized and which has no approved formulation or validated dosing regimen [19]. Mixing it with three other peptides adds questions no single-peptide study answers: whether each peptide remains stable in the same solution, and whether one alters how another behaves.
A blend also defeats attribution. When a person reports an effect, good or bad, after injecting four peptides at once, no one can say which peptide caused it, or whether the combination did. The one dataset that could separate them, a controlled trial that tests each component and the mixture, does not exist [9, 10].
Content is a further unknown. A laboratory analysis of products sold online as TB-500 found that their contents did not consistently match their labels [20], and a 2026 review of unregulated injectable peptides lists contamination, manufacturing impurities and inaccurate dosing among their risks [21]. A research-use-only blend carries that uncertainty for every ingredient it contains.

#### What did FDA say about these substances?
The concerns are about the molecules, not about any seller. FDA placed BPC-157 in Category 2 in September 2023, citing immunogenicity risk and impurity questions [22], and its safety-risk page, current as of April 22, 2026, states that compounded BPC-157 may pose a risk of immunogenicity for certain routes and may have complexities with peptide-related impurities and API characterization, meaning confirming what the active ingredient is and how pure it is [3]. For TB-500 it cites the potential for aggregation and impurities and states that it has identified no human exposure data [4]; for KPV it states that it has identified no human exposure data by any route [5]; for injectable GHK-Cu it cites immunogenicity from aggregation and impurities and limited human data [2].
The April 2026 removal of BPC-157, TB-500 and KPV from Category 2 ended an explicit prohibition and conferred no authorization; what Category 2 removal does not mean (https://peptideamerica.org/reference/category-2-removal) explains the difference. The July 2026 votes were reported as 8–6 with one abstention for each of the three, by two law-firm accounts that agree, and FDA itself has published no vote record for that meeting [6, 7, 8]; the July 2026 vote ledger (https://peptideamerica.org/reference/pcac-july-2026) prints the figures with their provenance. GHK-Cu was not on that agenda.

#### How does topical GHK-Cu differ from an injected blend?
They are different products under different law. A GHK-Cu cream or serum sold to improve appearance is a cosmetic, which does not need FDA premarket approval; a product intended to affect the structure or function of the body is a drug [23]. GHK-Cu for non-injectable routes sits in Category 1, while the injectable route sits on no list [1]. Its two human trials both applied it to skin [18], so the topical record cannot vouch for an injection, and it says nothing about BPC-157, TB-500 or KPV. The topical versus injectable review (https://peptideamerica.org/evidence/ghk-cu-topical-versus-injectable) covers that split in detail.

#### What are the side effects of GLOW and KLOW?
They are not known. No study has measured the side effects of either blend, and none of the four components has a controlled human safety record for the way the blends are used. The uncontrolled BPC-157 pilots, covering 14 people across two reports, recorded no adverse events, but reports that small cannot detect an uncommon harm [13, 14].
What is known is the list of open questions. FDA's concerns about immune reactions and impurities apply to each injected component [2, 3, 4]. Reviewers add theoretical risks from the biology, such as unwanted blood vessel growth, and from product quality, such as contamination and inaccurate dosing [21]. A 2026 review of unapproved peptides in sports medicine, covering GHK-Cu, BPC-157 and TB-500, concludes that rigorous human safety data are scarce and that there is potential for serious harm [24]. Each component's monograph, linked in the table above, carries the full record.

#### Sources
1. US Food and Drug Administration. Bulk drug substances nominated for use in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act. Updated May 14, 2026. Read August 2026. The document's update note states that "GHK-Cu (except for injectable routes of administration) was removed from category 1 on April 22, 2026, because the nominations for GHK-Cu were withdrawn by the nominators," that a nominator clarified on May 5, 2026 that it intended to withdraw only the injectable nomination, and that GHK-Cu (except for injectable routes of administration) "will be added back to category 1"; the substance is listed in Category 1 on that page. https://www.fda.gov/media/94155/download
2. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for GHK-Cu (for injectable routes of administration). Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
3. US Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks (the Category 2 rationale for BPC-157). Content current as of April 22, 2026. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
4. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for thymosin beta-4, fragment (LKKTETQ), also known as TB-500. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
5. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for KPV. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
6. US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
7. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting.
8. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. Prints all seven July 23–24, 2026 votes as a table, including BPC-157, KPV and TB-500 at 8–6–1.
9. PubMed, National Library of Medicine. Searches run September 2026: the quoted phrases "GLOW peptide", "KLOW peptide", "GLOW blend" and "KLOW blend" not found in any record; GHK-Cu, BPC-157 and TB-500 names together return 6 records, all 2026 review or overview articles; BPC-157 and KPV names together return 0; under "clinical trial"[Publication Type] BPC-157 returns 0, KPV 0 of 113 and GHK-Cu 3, against a control term returning 8,916. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22GHK-Cu%22+OR+%22copper+tripeptide%22%29+AND+%28%22BPC-157%22+OR+%22BPC+157%22%29+AND+%28%22TB-500%22+OR+%22TB500%22+OR+%22thymosin+beta+4%22%29
10. ClinicalTrials.gov, National Library of Medicine, v2 API. Searches run September 2026: GHK-Cu 3 registered studies, BPC-157 4, TB-500 1, KPV 0; no study of either blend name; every pairing of the four peptides returns 0; control term returns 2,968. https://clinicaltrials.gov/api/v2/studies?query.term=BPC-157%20AND%20TB-500
11. PubMed, National Library of Medicine. Census run August 2026 across four BPC-157 name variants, union 230 records; 0 under "clinical trial"[Publication Type] and 0 under "randomized controlled trial"[Publication Type], against a control term returning 8,904 records. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22BPC+157%22+OR+%22pentadecapeptide+BPC%22+OR+%22body+protection+compound%22+OR+%22PL+14736%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
12. Lee E, Padgett B. Intra-articular injection of BPC 157 for multiple types of knee pain. Altern Ther Health Med. 2021;27(4):8-13. https://pubmed.ncbi.nlm.nih.gov/34324435/
13. Lee E, Walker C, Ayadi B. Effect of BPC-157 on symptoms in patients with interstitial cystitis: a pilot study. Altern Ther Health Med. 2024;30(10):12-17. https://pubmed.ncbi.nlm.nih.gov/39325560/
14. Lee E, Burgess K. Safety of intravenous infusion of BPC157 in humans: a pilot study. Altern Ther Health Med. 2025;31(5):20-24. https://pubmed.ncbi.nlm.nih.gov/40131143/
15. PubMed, National Library of Medicine. Census run August 2026: "TB-500" OR "TB500" returns 31 records, 1 under "clinical trial"[Publication Type], which is a study of tuberculosis incidence matched on the letters TB, and 0 randomized trials. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22TB-500%22+OR+%22TB500%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
16. ClinicalTrials.gov, National Library of Medicine. NCT07487363: a phase 1/2, randomized, double-blind, placebo-controlled study of TB-500 (thymosin beta 4 17-23 fragment) in adults with stable atherosclerotic cardiovascular disease. Read September 2026: recruiting; no results posted. https://clinicaltrials.gov/api/v2/studies/NCT07487363
17. PubMed, National Library of Medicine. Census run August 2026 across four KPV name variants, 97 records, 0 under "clinical trial"[Publication Type] and 0 under "randomized controlled trial"[Publication Type]. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22KPV+peptide%22+OR+%22lysine-proline-valine%22+OR+%22Lys-Pro-Val%22+OR+%22KPV+tripeptide%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
18. PubMed, National Library of Medicine. Census run September 2026 across three GHK-Cu name variants: 3 trial-type records, two topical human trials and one rabbit wound study; the injection-scoped search returns 0 under either trial type. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22GHK-Cu%22+OR+%22copper+tripeptide%22+OR+%22glycyl-histidyl-lysine%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
19. Mateescu DM, Gavrilescu DM, Constantinescu FE, et al. BPC-157 as an investigational peptide therapeutic: biopharmaceutical challenges, formulation strategies, and translational development barriers. Pharmaceutics. 2026. https://pubmed.ncbi.nlm.nih.gov/42198317/
20. Delcourt V, Garcia P, Chabot B, et al. TB500/TB1000 and SGF1000: a scientific approach for a better understanding of misbranded and adulterated drugs. Drug Test Anal. 2023;15(4):458–464. https://pubmed.ncbi.nlm.nih.gov/36482504/
21. Moiz A, O'Keefe EL, O'Keefe JH. Dangers of injectable peptides and other unregulated "biohacking" drugs. Mo Med. 2026;123(4):337-343. https://pubmed.ncbi.nlm.nih.gov/42757290/
22. US Food and Drug Administration. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, guidance for industry, January 2025, docket FDA-2015-D-3517: the policy that defines Categories 1, 2 and 3, under which BPC-157 was placed in Category 2 in September 2023. Read September 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/interim-policy-compounding-using-bulk-drug-substances-under-section-503a-federal-food-drug-and
23. US Food and Drug Administration. FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated. Content current as of November 18, 2025. Read September 2026. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated
24. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026 Aug;56(8):1921-1935. https://pubmed.ncbi.nlm.nih.gov/41966639/

---

### Incretin Pipeline: Retatrutide and CagriSema
https://peptideamerica.org/evidence/incretin-pipeline · published September 2026 · updated October 2026

Question: Which incretin drugs are approved, which are still in trials, and which of them are peptides?
Short answer: As of September 2026, five of the incretin drugs tracked here are FDA-approved: semaglutide, tirzepatide, liraglutide, dulaglutide and, since April 1, 2026, the orforglipron tablet sold as Foundayo. Retatrutide, CagriSema, zenagamtide (amycretin), survodutide and mazdutide remain investigational in the United States. All are peptides except orforglipron, a small molecule, and dulaglutide, a much larger fusion protein.

#### The tracker
Incretin drugs act on the receptors for gut hormones released after a meal, chiefly GLP-1 and GIP, and the newest candidates add the glucagon or amylin receptor. The table gives each molecule's United States position as of September 2026 and the latest milestone its sponsor or the FDA has dated. Approval is decided by the FDA record; a strong trial result, however large, does not change the status column.

Each row is one incretin molecule or combination; status is the US position as of September 2026.
Molecule | Sponsor | Receptor targets | Peptide? | US status | Latest dated milestone
Semaglutide (https://peptideamerica.org/molecules/semaglutide) | Novo Nordisk | GLP-1 | Yes; peptide backbone of 4,113.58 g/mol [1] | Approved [1] | Wegovy label revised June 2026 [1]
Tirzepatide (https://peptideamerica.org/molecules/tirzepatide) | Eli Lilly | GIP, GLP-1 | Yes; built on the GIP sequence, 4,813.53 Da [2] | Approved [2] | Zepbound label revised August 2026 [2]
Liraglutide (https://peptideamerica.org/molecules/liraglutide) | Novo Nordisk | GLP-1 | Yes; a modified GLP-1 peptide [3] | Approved [3] | Saxenda label supplement approved June 2, 2026 [3]
Dulaglutide (https://peptideamerica.org/molecules/dulaglutide) | Eli Lilly | GLP-1 | No; Fc fusion protein of about 63 kDa [5] | Approved (Trulicity), diabetes indications only [5] | Licensed September 18, 2014 [4]
Orforglipron | Eli Lilly | GLP-1 | No; small molecule, 902.0 g/mol as the calcium salt [7] | Approved (Foundayo), weight reduction [7] | Approved April 1, 2026 [6]
Retatrutide (https://peptideamerica.org/molecules/retatrutide) | Eli Lilly | GIP, GLP-1, glucagon | Yes [8] | Investigational; phase 3 complete in obesity | BLA submission planned for the first quarter of 2027 [10]
CagriSema (cagrilintide with semaglutide) | Novo Nordisk | Amylin, GLP-1 | Yes; an amylin analogue plus semaglutide [16] | Investigational; application under FDA review | Submitted December 18, 2025; US decision listed for the fourth quarter of 2026 [16][18]
Zenagamtide (amycretin) | Novo Nordisk | GLP-1, amylin | Yes; a single peptide [19] | Investigational; phase 3 | AMAZE phase 3 program initiated, reported August 2026 [18]
Survodutide | Boehringer Ingelheim | Glucagon, GLP-1 | Yes; an acylated peptide [20] | Investigational; phase 3 | SYNCHRONIZE-1 met its endpoints, April 28, 2026 [21]
Mazdutide | Innovent Biologics, licensed from Lilly | Glucagon, GLP-1 | Yes; an oxyntomodulin analogue [22] | Not approved in the US [23] | Approved in China, June 27, 2025 [22]

#### Which are peptides, and why orforglipron is not
A peptide is a short chain of amino acids, and every injectable incretin drug in the table is one or is built from one. Tirzepatide is a peptide: its label describes a molecule based on the GIP sequence with a molecular weight of 4,813.53 Da [2]. Retatrutide is a peptide as well; its discovery paper calls it a triple agonist peptide at the glucagon, GIP and GLP-1 receptors [8]. Semaglutide and liraglutide are modified GLP-1 peptides [1][3], zenagamtide is described by its sponsor as a single peptide acting at two receptors [19], and survodutide is an acylated peptide [20].
Two approved drugs fall outside the peptide label from opposite directions. Dulaglutide joins a GLP-1 analogue to an antibody fragment, and its label describes a fusion protein of about 63 kilodaltons [5]; the index files it as a protein. Orforglipron is the non-peptide control row: the Foundayo label gives it a chemical formula and a molecular weight of 902.0 g/mol for its calcium salt, a small synthetic molecule taken as a daily tablet [7]. It activates the same GLP-1 receptor without being a peptide at all.
Being a peptide says nothing about legal status. The approved peptide drugs (https://peptideamerica.org/reference/approved-peptides) table lists the peptides with a US approval, and the GLP-1 receptor agonists (https://peptideamerica.org/classes/glp-1-receptor-agonists) page compares the class members this index covers.

#### Retatrutide
Retatrutide is investigational, and its phase 3 obesity program has now read out. TRIUMPH-1 randomized 2,339 adults with obesity, or overweight with a weight-related condition, and without diabetes; the earlier sponsor release reported average weight loss of 28.3 percent at 80 weeks at the highest dose tested against 2.2 percent on placebo [9]. The subsequently published treatment-regimen analysis reported 25.0 percent versus 3.9 percent; the body-composition review (https://peptideamerica.org/evidence/retatrutide-lean-mass-evidence) explains why analyses and endpoints must be kept distinct [25]. The registry lists that trial as completed, with primary completion in April 2026 [11]. TRIUMPH-2 and TRIUMPH-3 met their primary endpoints in July 2026, and Lilly plans to submit a biologics license application in the first quarter of 2027 [10]. No approval can come before that submission is reviewed.
Until then there is no lawful route to the drug outside a trial. Lilly's own release states that retatrutide is legally available only to participants in its clinical trials [9]. The FDA has stated that retatrutide cannot be used in compounding under federal law [12], and in March 2026 it issued warning letters to two firms selling retatrutide online as research-use-only material, finding the products to be unapproved new drugs intended for human use [13][14]. The retatrutide monograph (https://peptideamerica.org/molecules/retatrutide) carries the full record, and the registry files it as research-only.

#### Retatrutide versus tirzepatide
No head-to-head result exists yet, but a head-to-head trial does. TRIUMPH-5 is a phase 3, double-blind trial comparing retatrutide directly with tirzepatide in adults with obesity; its primary endpoint is percent change in body weight at week 80, and its estimated primary completion is November 2026 [15]. Until it reports, any claim that one drug beats the other is an inference across separate trials.
What can be compared now is mechanism and each drug's result against its own placebo. Tirzepatide acts at two receptors and retatrutide at three, adding glucagon [2][8]. In SURMOUNT-1, weight fell 20.9 percent at tirzepatide's highest dose against 3.1 percent on placebo over 72 weeks [24]; in TRIUMPH-1, 28.3 percent against 2.2 percent over 80 weeks [9]. Those trials differed in length, population and analysis, so the gap between the two numbers is not a measured difference between the drugs.
Tolerability cannot be ranked from the record either. In TRIUMPH-1, nausea affected up to 42.4 percent of retatrutide participants against 14.8 percent on placebo, and discontinuation for adverse events reached 11.3 percent at the highest dose against 4.9 percent [9]. Tirzepatide's approved label lists its own adverse reactions [2]. The legal difference is simpler: tirzepatide is approved and retatrutide is not.

#### CagriSema
CagriSema is Novo Nordisk's weekly injection combining cagrilintide, a long-acting amylin analogue, with semaglutide (https://peptideamerica.org/molecules/semaglutide). The company submitted it to the FDA on December 18, 2025 for weight reduction in adults with obesity, or overweight with a weight-related condition [16]. The filing rests on REDEFINE 1, a 68-week trial in 3,417 adults, in which weight fell 20.4 percent with CagriSema against 3.0 percent on placebo when counted regardless of whether participants stayed on treatment [16]. The company lists a US decision among its milestones for the fourth quarter of 2026 [18].
The head-to-head trial went the other way. In REDEFINE 4, an open-label trial of 809 people, CagriSema produced 23.0 percent weight loss at 84 weeks against 25.5 percent with tirzepatide (https://peptideamerica.org/molecules/tirzepatide) and did not meet its primary endpoint of non-inferiority [17]. Cagrilintide on its own is not approved, and the FDA has stated that it cannot be used in compounding under federal law [12].

#### The other candidates
Zenagamtide, also known as amycretin, is a single Novo Nordisk peptide acting at both the GLP-1 and amylin receptors [19]. Its AMAZE phase 3 program in obesity is under way, and a phase 3 program in type 2 diabetes is planned [18][19].
Survodutide, from Boehringer Ingelheim, pairs the glucagon and GLP-1 receptors. In SYNCHRONIZE-1 it produced up to 16.6 percent average weight loss at 76 weeks against 3.2 percent on placebo [21]. Mazdutide, an oxyntomodulin analogue developed by Innovent Biologics under a license from Lilly, was approved in China in June 2025 for chronic weight management [22]. A Chinese approval carries no weight in the United States.
None of the five investigational drugs has an application listed in Drugs@FDA [23]. Each remains a trial drug in the United States, whatever a seller's listing says.

#### Sources
1. Novo Nordisk. WEGOVY (semaglutide) injection and tablet, US prescribing information. Revised June 2026. DailyMed set ID ee06186f-2aa3-4990-a760-757579d8f77b. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b
2. Eli Lilly and Company. ZEPBOUND (tirzepatide) injection, US prescribing information. Revised August 2026. DailyMed set ID 487cd7e7-434c-4925-99fa-aa80b1cc776b. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b
3. US Food and Drug Administration. SAXENDA (liraglutide) injection, for subcutaneous use — prescribing information, NDA 206321 supplement 024, approved June 2, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206321Orig1s024lbl.pdf
4. Drugs@FDA, US Food and Drug Administration. Application BLA 125469, TRULICITY (dulaglutide), sponsor Eli Lilly and Company; original approval dated September 18, 2014. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125469
5. TRULICITY (dulaglutide) injection, prescribing information, structured product label version 62, effective June 16, 2026. Sections 1 Indications and Usage and 11 Description. https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=TRULICITY
6. US Food and Drug Administration. NDA 220934 approval letter, FOUNDAYO (orforglipron) tablets, Eli Lilly and Company; signed April 1, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220934Orig1s000ltr.pdf
7. Eli Lilly and Company. FOUNDAYO (orforglipron) tablets, US prescribing information; Indications and Usage and section 11 Description. DailyMed set ID 8ac446c5-feba-474f-a103-23facb9b5c62. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ac446c5-feba-474f-a103-23facb9b5c62
8. Coskun T, Urva S, Roell WC, et al. LY3437943, a novel triple glucagon, GIP, and GLP-1 receptor agonist for glycemic control and weight loss: From discovery to clinical proof of concept. Cell Metab. 2022;34(9):1234–1247.e9. https://pubmed.ncbi.nlm.nih.gov/35985340/
9. Eli Lilly and Company. Lilly's triple agonist, retatrutide, delivered powerful weight loss in pivotal Phase 3 obesity trial (TRIUMPH-1 topline results). Press release, May 21, 2026.
10. Eli Lilly and Company. Lilly's triple agonist, retatrutide, successful in two additional Phase 3 obesity trials (TRIUMPH-2 and TRIUMPH-3 topline results). Press release, July 23, 2026.
11. ClinicalTrials.gov, NCT05929066 (TRIUMPH-1). Phase 3; sponsor Eli Lilly and Company; status Completed; actual primary completion April 6, 2026. https://clinicaltrials.gov/study/NCT05929066
12. US Food and Drug Administration. FDA's concerns with unapproved GLP-1 drugs used for weight loss, content current as of June 15, 2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
13. US Food and Drug Administration. Warning letter, MARCS-CMS 721806, March 31, 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026
14. US Food and Drug Administration. Warning letter, MARCS-CMS 721600, March 31, 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mile-high-compounds-llc-721600-03312026
15. ClinicalTrials.gov, NCT06662383 (TRIUMPH-5). Retatrutide compared to tirzepatide in adults who have obesity; phase 3; status Active, not recruiting; estimated primary completion November 2026. https://clinicaltrials.gov/study/NCT06662383
16. Novo Nordisk. Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management. Company announcement, December 18, 2025.
17. Novo Nordisk. Headline results from REDEFINE 4. Company announcement, February 23, 2026.
18. Novo Nordisk A/S. Financial report for the period 1 January 2026 to 30 June 2026, furnished on Form 6-K, August 4, 2026; R&D pipeline update and anticipated key R&D milestones in 2026. https://www.sec.gov/Archives/edgar/data/0000353278/000035327826000023/caq22026.htm
19. Novo Nordisk. Novo Nordisk's investigational zenagamtide shows significant A1C reductions with up to 14.6% weight loss in adults with type 2 diabetes, presented at ADA 2026. Press release, June 5, 2026.
20. Zimmermann T, Thomas L, Baader-Pagler T, et al. BI 456906: Discovery and preclinical pharmacology of a novel GCGR/GLP-1R dual agonist with robust anti-obesity efficacy. Mol Metab. 2022;66:101633. https://pubmed.ncbi.nlm.nih.gov/36356832/
21. Zealand Pharma. Survodutide SYNCHRONIZE-1 topline results. Company announcement, April 28, 2026.
22. Innovent Biologics. Innovent announces mazdutide, first dual GCG/GLP-1 receptor agonist, received approval from China's NMPA for chronic weight management. Press release, June 27, 2025.
23. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe by active-ingredient name, with orforglipron as the positive control and an invented name as the negative control. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22SURVODUTIDE%22
24. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205–216. https://pubmed.ncbi.nlm.nih.gov/35658024/
25. Jastreboff AM, Kaplan LM, Davies MJ, et al. Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity. N Engl J Med. 2026. https://pubmed.ncbi.nlm.nih.gov/42814954/

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### Melanotan I vs II: One Approved, One Not
https://peptideamerica.org/evidence/melanotan-i-versus-ii · published September 2026 · updated September 2026

Question: What is the difference between Melanotan I and Melanotan II?
Short answer: Melanotan I is the research name of afamelanotide, which FDA approved in 2019 as Scenesse, an implant for adults with the rare light-sensitivity disease erythropoietic protoporphyria; Melanotan II is a different, non-selective compound with no approval, whose only tanning-related trial is a three-volunteer pilot from 1996 and whose later human record is mostly case reports of harm. No approved product is indicated for tanning, and material sold under either name is not Scenesse.

#### Two compounds, one letter apart
Both are synthetic analogues of alpha-melanocyte-stimulating hormone, the hormone that tells skin cells to make the brown pigment melanin, and both were first reported in people in the mid-1990s by overlapping authors studying skin pigmentation [5, 9]. They then went in opposite directions. The first, published as melanotan-I, was developed into an approved drug under the name afamelanotide (https://peptideamerica.org/molecules/afamelanotide) [2, 5]. The second, Melanotan II (https://peptideamerica.org/molecules/melanotan-ii), was studied briefly in the 1990s, drifted toward sexual function, and was never itself developed into an approved product [9, 13].
The chemistry explains part of the split. Afamelanotide is a 13-amino-acid peptide that acts at the melanocortin 1 receptor, the one that governs pigmentation [1]. Melanotan II is a cyclic analogue that acts at several melanocortin receptors at once, which is why the pilot study that showed it could darken skin also recorded spontaneous erections in the men who took it [9]. The table sets out the rest.

Melanotan I and Melanotan II compared, as of September 2026
Measure | Melanotan I (afamelanotide) | Melanotan II
Receptor | Melanocortin 1, the pigmentation receptor [1] | Several melanocortin receptors, not selective [9]
FDA approval | Scenesse implant, approved October 8, 2019 [6] | None; no application in Drugs@FDA [13]
Approved use | Pain-free light exposure in adults with erythropoietic protoporphyria [1] | None
Controlled trials | 13 trial-type records; two pivotal placebo-controlled trials in the approved disease [2, 3] | 4 trial-type records, 1996 to 2000, on pigmentation and erections [10]
Tested for cosmetic tanning | Early pigmentation studies only; not an approved use [5, 1] | No tanning trial; the one related trial record is a 1996 pilot in three volunteers [11]
Known harms | Label: implant site reactions and nausea most common; warnings for serious allergic reactions and pigment changes [8] | Case reports: melanoma, kidney infarction, priapism, systemic toxicity [15, 16, 20, 17]
503A bulks list, May 2026 | In no category [7] | In no category; nomination withdrawn [14, 12]
Index status | Approved (https://peptideamerica.org/status/approved), as the Scenesse product | Research-only (https://peptideamerica.org/status/research-only)

#### What Scenesse is approved to do
The approval is narrow. FDA approved the Scenesse implant under application 210797 on October 8, 2019 [6], and its label, in the version effective May 11, 2026, names one use: to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria, an inherited disease in which light exposure causes painful phototoxic reactions [1]. The product is a subcutaneous implant, dispensed on prescription [6].
Its evidence is measured in hours of daylight. In the two pivotal placebo-controlled trials, 74 patients in Europe and 94 in the United States, the primary endpoint was time spent in direct sunlight without pain; after six months the United States trial reported a median of 69.4 hours against 40.8 hours on placebo [3]. Most of the compound's other trial records are other skin conditions, such as vitiligo, and none of them supports a wider label [2, 4].
Skin darkening appears on the label as a warning, not a benefit. The label states that afamelanotide may darken the skin generally and darken existing moles and freckles, and it recommends a full body skin examination twice a year [8]. Its most common side effects in the trials were implant site reactions, in 21 percent against 10 percent on the vehicle implant, and nausea, in 19 percent against 14 percent [8].

#### What the Melanotan II record contains
Four records carry a clinical-trial publication type, all published between 1996 and 2000 [10]. The first, a pilot phase I study, found that the peptide produced measurable darkening of the skin and, incidentally, erections [9]. The next three followed the incidental finding into erectile dysfunction rather than tanning. Across the five names the compound goes by, the one trial-type record that touches tanning is that 1996 pilot in three volunteers [11].
What accumulated after the trials stopped is a case-report literature. PubMed indexes 23 case reports on the compound, and 9 of the records that mention melanoma are case reports [11]. Published cases describe melanoma in association with use, a kidney infarction, priapism and systemic toxicity with muscle breakdown after injection [15, 16, 20, 17]. Case reports show association, not cause; no controlled study of cosmetic tanning stands beside them [11].
FDA's statement on the compound, still published among substances whose nominations were withdrawn, is that compounded drugs containing it may pose a risk of immune reactions, and that published case reports discuss serious adverse events including melanoma, a brain swelling syndrome called posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism [12]. The Melanotan II evidence review (https://peptideamerica.org/evidence/melanotan-ii) reads each record.

#### What is the legal position of each?
No approved product is indicated for tanning as of September 2026. Scenesse is a prescription implant labeled for the one disease named above [1, 6], and the approval belongs to that product and its label rather than to the compound under any other name. Melanotan II has no approved product, appears in no category of the section 503A bulks list published on May 14, 2026, and left Category 2 only because its nominators withdrew the nomination, with FDA's safety finding left standing [14, 12].
Both names also turn up in enforcement. In April 2020 FDA warned a Kentucky compounding pharmacy that products it made with Melanotan II and twenty-one other substances were not eligible for the compounding exemptions [18]; in October 2020 that pharmacy, Tailor Made Compounding, pleaded guilty to distributing unapproved new drugs, and the Justice Department's account of the plea agreement names Melanotan II among them [19].
Material sold online as "melanotan 1" or "melanotan 2" is sold as research-use-only chemical supply. It is not the Scenesse implant, it is not made under its application, and nothing in the 2019 approval extends to it. The melanocortins (https://peptideamerica.org/classes/melanocortins) class page files both compounds beside PT-141 (https://peptideamerica.org/molecules/pt-141) and setmelanotide (https://peptideamerica.org/molecules/setmelanotide), the two other approved drugs that act on the same receptor family.

#### Sources
1. SCENESSE (afamelanotide) implant, prescribing information, structured product label version 11, effective May 11, 2026. Sections 1 Indications and Usage and 11 Description. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=SCENESSE
2. PubMed, National Library of Medicine. Census run September 2026 across five name variants of afamelanotide, including melanotan-I: 269 records, 142 tagged Humans, 13 under the clinical-trial publication type and 5 under the randomized type, all 13 read; two concern erythropoietic protoporphyria, the rest vitiligo, solar urticaria, acne, Hailey-Hailey disease, immunogenicity, an acute-stroke feasibility study and the 1997 and 2000 pigmentation reports under the name melanotan-I. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22afamelanotide%22+OR+%22Scenesse%22+OR+%22melanotan-I%22+OR+%22CUV1647%22+OR+%22Nle4-D-Phe7-alpha-MSH%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
3. Langendonk JG, Balwani M, Anderson KE, et al. Afamelanotide for erythropoietic protoporphyria. N Engl J Med. 2015;373(1):48-59. https://pubmed.ncbi.nlm.nih.gov/26132941/
4. Lim HW, Grimes PE, Agbai O, et al. Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. JAMA Dermatol. 2015;151(1):42-50. https://pubmed.ncbi.nlm.nih.gov/25230094/
5. Ugwu SO, Blanchard J, Dorr RT, et al. Skin pigmentation and pharmacokinetics of melanotan-I in humans. Biopharm Drug Dispos. 1997;18(3):259-269. https://pubmed.ncbi.nlm.nih.gov/9113347/
6. Drugs@FDA, US Food and Drug Administration. Application NDA 210797, SCENESSE (afamelanotide), 16 mg subcutaneous implant, prescription, original approval October 8, 2019, Type 1 new molecular entity. Read September 2026. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210797
7. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read September 2026: neither afamelanotide nor the name melanotan appears in any of the three categories. https://www.fda.gov/media/94155/download
8. SCENESSE (afamelanotide) implant, US prescribing information, version 11, effective May 2026. Sections 4 to 6 and 8. DailyMed set ID 94f53286-11dd-7fbb-e053-2a95a90a7c48. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94f53286-11dd-7fbb-e053-2a95a90a7c48
9. Dorr RT, Lines R, Levine N, et al. Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study. Life Sci. 1996;58(20):1777-1784. https://pubmed.ncbi.nlm.nih.gov/8637402/
10. PubMed, National Library of Medicine. Census run August 2026 across five Melanotan II name variants: 360 records, 119 tagged Humans, 4 under the clinical-trial publication type and 1 under the randomized type, all four published 1996 to 2000 and each read. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22melanotan+II%22+OR+%22melanotan-II%22+OR+%22melanotan+2%22+OR+%22melanotan-2%22+OR+%22MT-II+peptide%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
11. PubMed, National Library of Medicine. Census extended September 2026 on the same five names: 23 records under the case-reports publication type; 17 records with the term melanoma, 9 of them case reports; 23 records with the terms tanning, tan or sunless, of which exactly 1 carries a trial publication type, the 1996 pilot phase I study in three volunteers. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22melanotan+II%22+OR+%22melanotan-II%22+OR+%22melanotan+2%22+OR+%22melanotan-2%22+OR+%22MT-II+peptide%22%29+AND+%22case+reports%22%5BPublication+Type%5D
12. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entry for Melanotan II. Read August 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
13. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 for "melanotan": no matching application; control bremelanotide returned NDA 210557 in the same run. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22melanotan%22
14. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A, updated May 14, 2026. Read in full August 2026: Melanotan II appears in none of Category 1, 2 or 3. https://www.fda.gov/media/94155/download
15. Paurobally D, Jason F, Dezfoulian B, et al. Melanotan-associated melanoma. Br J Dermatol. 2011;164(6):1403-1405. https://pubmed.ncbi.nlm.nih.gov/21564053/
16. Peters B, Hadimeri H, Wahlberg R, et al. Melanotan II: a possible cause of renal infarction: review of the literature and case report. CEN Case Rep. 2020;9(2):159-161. https://pubmed.ncbi.nlm.nih.gov/31953620/
17. Nelson ME, Bryant SM, Aks SE. Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clin Toxicol (Phila). 2012;50(10):1169-1173. https://pubmed.ncbi.nlm.nih.gov/23121206/
18. US Food and Drug Administration. Warning letter, Tailor Made Compounding LLC, case 594743, April 1, 2020. Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
19. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. The plea agreement, as the release describes it, names Melanotan II among the unapproved new drugs distributed; the company agreed to forfeit $1,788,906.82. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution
20. Dreyer BA, Amer T, Fraser M. Melanotan-induced priapism: a hard-earned tan. BMJ Case Rep. 2019;12(2). https://pubmed.ncbi.nlm.nih.gov/30796078/

---

### Peptides for Weight Loss, by US Legal Status
https://peptideamerica.org/evidence/weight-loss-peptides-by-status · published September 2026 · updated September 2026

Question: Which peptides sold for weight loss are actually FDA-approved for it?
Short answer: Four, each for a specific label: semaglutide (Wegovy), tirzepatide (Zepbound) and liraglutide (Saxenda) for chronic weight management, and setmelanotide (Imcivree) only for rare genetic and hypothalamic obesity; tesamorelin is approved for a narrower use, AOD-9604 failed its human weight trial, and MOTS-c and retatrutide have no approved use at all.

#### Weight-loss peptides at a glance
Most peptides sold for weight loss are not FDA-approved for it. Four peptide drugs carry an FDA-approved weight indication in September 2026, and three of them are GLP-1-class drugs for general obesity; the fourth is approved only for a handful of rare conditions. Everything else marketed under the phrase "weight loss peptides" is either approved for a different purpose, failed when it was tested for weight, or has never been tested for weight in people.
The table orders each molecule by its US legal status in this index, then alphabetically. The status column restates the index's registry label; it is a legal position, not a verdict on how well a molecule works.

Molecules marketed for weight loss, by US legal status, as of September 2026
Molecule | US status | Approved indication | Best human evidence
Liraglutide (https://peptideamerica.org/molecules/liraglutide) | FDA-approved | Chronic weight management (Saxenda; generic versions also labeled for it) [5][7] | 56-week randomized trial: −8.4 kg against −2.8 kg on placebo [6]
Semaglutide (https://peptideamerica.org/molecules/semaglutide) | FDA-approved | Chronic weight management and cardiovascular risk reduction (Wegovy) [1] | STEP 1, 68 weeks: −14.9 percent against −2.4 percent on placebo [2]
Setmelanotide (https://peptideamerica.org/molecules/setmelanotide) | FDA-approved | Only obesity from acquired hypothalamic damage, Bardet-Biedl syndrome, or confirmed POMC, PCSK1 or LEPR deficiency (Imcivree) [8] | Phase 3: 32.3 percent of Bardet-Biedl patients 12 and older lost at least 10 percent at 52 weeks [10]
Tesamorelin (https://peptideamerica.org/molecules/tesamorelin) | FDA-approved | Excess abdominal fat in adults with HIV and lipodystrophy only (EGRIFTA WR) [12] | Phase 3 in HIV: visceral fat −10.9 percent against −0.6 percent at six months [11]
Tirzepatide (https://peptideamerica.org/molecules/tirzepatide) | FDA-approved | Chronic weight management and obstructive sleep apnea with obesity (Zepbound) [3] | SURMOUNT-1, 72 weeks: up to −20.9 percent against −3.1 percent on placebo [4]
MOTS-c (https://peptideamerica.org/molecules/mots-c) | PCAC-recommended · pending | None | Mouse studies only; no human trial has administered it [18][19]
AOD-9604 (https://peptideamerica.org/molecules/aod-9604) | Nomination withdrawn | None | Phase 2b in 502 randomized adults: no significant weight difference from placebo at 12 weeks [15]
Retatrutide (https://peptideamerica.org/molecules/retatrutide) | No lawful route | None; investigational | Phase 2, 48 weeks: up to −24.2 percent against −2.1 percent on placebo [13]

#### Approved for weight management
Three peptides are FDA-approved for chronic weight management in the general population of adults with obesity or with overweight and a weight-related condition. Semaglutide (https://peptideamerica.org/molecules/semaglutide) holds the indication as Wegovy, for adults and children 12 and older with obesity and for adults with overweight and a weight-related condition; the same label also covers cardiovascular risk reduction in adults with cardiovascular disease and either obesity or overweight, and a liver disease, MASH with moderate to advanced fibrosis [1]. Tirzepatide (https://peptideamerica.org/molecules/tirzepatide) holds it as Zepbound, whose sleep-apnea trials (https://peptideamerica.org/evidence/tirzepatide-sleep-apnea-trials) support its approval for moderate to severe obstructive sleep apnea in adults with obesity [3]. Liraglutide (https://peptideamerica.org/molecules/liraglutide) holds it as Saxenda, for adults and for children 12 and older who weigh more than 60 kg and have obesity [5]; generic liraglutide labeled for the same use is now listed on DailyMed [7].
Each of the three labels frames the drug as an addition to a reduced-calorie diet and increased physical activity, not a replacement for them [1][3][5]. The trial results in the table were measured on that basis, against placebo groups given the same lifestyle program.
Setmelanotide (https://peptideamerica.org/molecules/setmelanotide) is the fourth approved peptide with a weight indication, and it is the narrowest. Imcivree is approved to reduce excess body weight only in people with acquired hypothalamic obesity, Bardet-Biedl syndrome, or genetically confirmed POMC, PCSK1 or LEPR deficiency, and its label states that it is not indicated for general (polygenic) obesity because it would not be expected to work there [8]. Its approval rests on small trials, which is what rare diseases allow: in the single-arm phase 3 trials, 8 of 10 patients with POMC deficiency and 5 of 11 with LEPR deficiency lost at least 10 percent of body weight at about one year [9].
The approved peptide drugs (https://peptideamerica.org/reference/approved-peptides) table and the approved (https://peptideamerica.org/status/approved) status page list every approved molecule in this index, including those approved for uses unrelated to weight.

#### Approved for something else, marketed for weight
Tesamorelin (https://peptideamerica.org/molecules/tesamorelin) is an FDA-approved peptide, but not for weight loss. Its approval covers the reduction of excess abdominal fat in adults with HIV who have lipodystrophy, and nothing wider [12]. The phase 3 trial behind it enrolled HIV-infected patients and measured visceral fat, the deep abdominal compartment around the organs, rather than body weight [11].
The distinction matters because tesamorelin is widely sold as a general fat-loss peptide. The one randomized body-composition trial outside HIV reduced visceral fat and left the fat under the skin statistically unchanged; the review of tesamorelin's off-label use (https://peptideamerica.org/evidence/tesamorelin-off-label) sets out that result in full.

#### Tested for weight loss and failed
AOD-9604 (https://peptideamerica.org/molecules/aod-9604), a fragment of human growth hormone, is the one molecule in this group whose human weight program ran and failed. FDA's briefing document for its December 2024 advisory committee meeting describes the sponsor's phase 2b trial in 502 randomized adults with obesity: weight loss at twelve weeks, the primary endpoint, did not differ significantly from placebo, and the sponsor terminated development for obesity in February 2007 [15]. FDA concluded that the available data do not support effectiveness for obesity by any route [15].
The committee then voted 12 to 0 against placing AOD-9604 on the section 503A bulks list [16]. The nomination was later withdrawn, and FDA lists the substance among those that may present significant safety risks in compounding, citing immunogenicity concerns and limited safety information [17].

#### Investigational or never tested for weight in humans
Retatrutide (https://peptideamerica.org/molecules/retatrutide) is a real drug candidate with real trial results and no approval. Its phase 2 obesity trial reported weight reductions of up to 24.2 percent at 48 weeks against 2.1 percent on placebo [13], and it remains investigational. FDA has stated that retatrutide cannot be used in compounding under federal law, is not a component of any FDA-approved drug, and has not been found safe and effective for any condition [14]. The review of the incretin pipeline (https://peptideamerica.org/evidence/incretin-pipeline) follows its late-stage program.
MOTS-c (https://peptideamerica.org/molecules/mots-c) has never been tested for weight in people. The evidence for a metabolic effect comes from mice, where it reduced diet-induced obesity and insulin resistance [18]. Every human trial-type record indexed for it measures the body's own circulating MOTS-c rather than administering the peptide [19], and FDA has stated that it identified no human exposure data on drug products containing it by any route [24].

#### Commonly called peptides, but not peptides
Several compounds sold beside weight-loss peptides are not peptides at all. A peptide is a short chain of amino acids. 5-amino-1MQ and SLU-PP-332 are small synthetic organic molecules with no amino-acid chain, and orforglipron is a small-molecule GLP-1 receptor agonist designed to be taken by mouth. Each sits outside this index, and none inherits the legal position of any peptide in the table above.

#### Is a compounded version lawful?
It depends on the molecule, and for most of them the answer is no or only narrowly. For semaglutide (https://peptideamerica.org/molecules/semaglutide) and tirzepatide (https://peptideamerica.org/molecules/tirzepatide), mass compounding ended when FDA declared their shortages resolved; a 503A pharmacy may still compound either for an individual patient whose prescriber documents a clinical need an approved product cannot meet, and a lower price does not qualify [22]. Liraglutide (https://peptideamerica.org/molecules/liraglutide) is a component of approved drugs and appears in no category of the 503A bulks list [23]. Setmelanotide (https://peptideamerica.org/molecules/setmelanotide) and tesamorelin (https://peptideamerica.org/molecules/tesamorelin) are approved products, and for both the approved product is the lawful route.
Retatrutide (https://peptideamerica.org/molecules/retatrutide) cannot be compounded under federal law, in FDA's own words [14]; the research-only (https://peptideamerica.org/status/research-only) page explains what "research use only" labeling does and does not permit. AOD-9604 (https://peptideamerica.org/molecules/aod-9604) was voted down by FDA's advisory committee and its nomination withdrawn [16][17]. MOTS-c (https://peptideamerica.org/molecules/mots-c) is pending: the committee voted in July 2026 to recommend it for the 503A list, by a margin reported by two law firms because FDA has published no minutes of that meeting [20][21], and no final rule has followed. A recommendation is not a listing; the pending (https://peptideamerica.org/status/pending) page tracks what would change that.

#### Sources
1. Novo Nordisk. WEGOVY (semaglutide) injection and tablet, US prescribing information. Revised June 2026. DailyMed set ID ee06186f-2aa3-4990-a760-757579d8f77b. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b
2. Wilding JPH, Batterham RL, Calanna S, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384(11):989–1002. https://pubmed.ncbi.nlm.nih.gov/33567185/
3. Eli Lilly and Company. ZEPBOUND (tirzepatide) injection, US prescribing information. Revised August 2026. DailyMed set ID 487cd7e7-434c-4925-99fa-aa80b1cc776b. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b
4. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205–216. https://pubmed.ncbi.nlm.nih.gov/35658024/
5. Novo Nordisk. SAXENDA (liraglutide) injection, US prescribing information. Revised June 2026. DailyMed set ID 3946d389-0926-4f77-a708-0acb8153b143. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3946d389-0926-4f77-a708-0acb8153b143
6. Pi-Sunyer X, Astrup A, Fujioka K, et al. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015;373(1):11–22. https://pubmed.ncbi.nlm.nih.gov/26132939/
7. Liraglutide injection, US prescribing information for a generic product approved under ANDA 214568 and indicated to reduce excess body weight and maintain weight reduction long term. Revised February 2026. DailyMed set ID 625ac780-70a9-41e4-a892-bcba0f803f1c. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=625ac780-70a9-41e4-a892-bcba0f803f1c
8. Rhythm Pharmaceuticals. IMCIVREE (setmelanotide) injection, US prescribing information. Revised April 2026. DailyMed set ID 70c3ccf7-4df0-4c75-ba07-fede9970c8d9. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=70c3ccf7-4df0-4c75-ba07-fede9970c8d9
9. Clément K, van den Akker E, Argente J, et al. Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials. Lancet Diabetes Endocrinol. 2020;8(12):960–970. https://pubmed.ncbi.nlm.nih.gov/33137293/
10. Haqq AM, Chung WK, Dollfus H, et al. Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period. Lancet Diabetes Endocrinol. 2022;10(12):859–868. https://pubmed.ncbi.nlm.nih.gov/36356613/
11. Falutz J, Potvin D, Mamputu JC, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010;53(3):311–322. https://pubmed.ncbi.nlm.nih.gov/20101189/
12. Theratechnologies. FDA approval of EGRIFTA WR (tesamorelin F8) for excess visceral abdominal fat in adults with HIV and lipodystrophy. March 2025.
13. Jastreboff AM, Kaplan LM, Frías JP, et al. Triple-Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial. N Engl J Med. 2023;389(6):514–526. https://pubmed.ncbi.nlm.nih.gov/37366315/
14. US Food and Drug Administration. FDA's concerns with unapproved GLP-1 drugs used for weight loss, content current as of June 15, 2026. Read August 2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
15. US Food and Drug Administration. FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, December 4, 2024, section on AOD-9604-related bulk drug substances: clinical evidence of effectiveness, including the sponsor's phase 2b OPTIONS study (536 enrolled, 502 randomized; no significant difference from placebo in weight loss at the 12-week primary endpoint) and the sponsor's February 21, 2007 announcement terminating development for obesity. Read September 2026. https://www.fda.gov/media/183584/download
16. US Food and Drug Administration. Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, December 4, 2024, questions 2, 2a and the accompanying table of uses evaluated. Read August 2026. https://www.fda.gov/media/185642/download
17. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for AOD-9604 in the table of substances nominated but withdrawn. Read August 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
18. Lee C, Zeng J, Drew BG, et al. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metab. 2015;21(3):443–454. https://pubmed.ncbi.nlm.nih.gov/25738459/
19. PubMed, National Library of Medicine. Search across three name variants for MOTS-c, run September 2026: 254 indexed records, 5 under the clinical-trial publication type; all five were read, and none administers the peptide. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22MOTS-c%22+OR+%22MOTS-C+peptide%22+OR+%22mitochondrial+open+reading+frame+of+the+twelve+S+rRNA+type-c%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
20. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting.
21. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, reporting MOTS-c at 7–5–2.
22. Orrick. FDA moves to shut the door on large-scale compounding of GLP-1 drugs. May 2026.
23. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: liraglutide appears in none of Category 1, Category 2, or Category 3. https://www.fda.gov/media/94155/download
24. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for MOTs-C (the page's spelling) in the table of substances nominated but withdrawn. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

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### Semax vs Selank: Two Russian Peptides Compared
https://peptideamerica.org/evidence/semax-versus-selank · published September 2026 · updated September 2026

Question: How do Semax and Selank differ, and what is the evidence and legal status of each?
Short answer: They share an origin and a gap. Both are short synthetic peptides developed in Russia, and every trial-type record for either one was published in Russian; Semax was studied in stroke and nerve disease, Selank in anxiety. Neither is approved or lawfully compoundable in the United States as of September 2026, though a federal advisory panel voted in July 2026 to recommend Semax for the compounding list and did not vote on Selank.

#### What are Semax and Selank?
Semax (https://peptideamerica.org/molecules/semax) and Selank (https://peptideamerica.org/molecules/selank) are both seven-amino-acid peptides made in Russia, and both carry the same stabilizing tail of proline, glycine and proline. What sits in front of that tail is different. Semax begins with a fragment of adrenocorticotropic hormone, the pituitary hormone that drives the adrenal glands; Selank begins with tuftsin, a small fragment of an antibody protein with effects on the immune system.
The marketing follows the parent molecules. Semax is sold as a nootropic for focus and memory, on the strength of animal work showing that it raises brain-derived neurotrophic factor, a protein that supports nerve cells, and its receptor in the rat hippocampus [1]. Selank was developed as an anti-anxiety drug meant to work without the sedation of benzodiazepines, and anxiety is what its Russian trials tested [5, 6]. The table sets the two records side by side.

Semax and Selank compared, as of September 2026
Measure | Semax | Selank
Built from | A fragment of adrenocorticotropic hormone, with a proline-glycine-proline tail | Tuftsin, an immune peptide fragment, with the same tail
Studied in people for | Stroke, optic nerve disease and motor neuron disease [2, 3, 4] | Anxiety disorders and neurasthenia [5, 6]
PubMed records | 216, of which 49 tagged Humans [2] | 89, of which 22 tagged Humans [5]
Trial-type records | 4, all in Russian [2] | 3, all in Russian, in one journal [5]
US approval | None; no application in Drugs@FDA [14] | None
503A bulks list, May 2026 | In no category [8] | In no category [8]
FDA safety finding | Immunogenicity risk; too little safety information to know whether it would cause harm [9] | Immunogenicity risk; important information on human safety lacking [9]
Advisory committee vote | Recommended for the 503A list, reported 8–5 with one abstention [10, 11] | Not on the agenda [11]
Index status | Pending (https://peptideamerica.org/status/pending) | Nomination withdrawn; research-only (https://peptideamerica.org/status/research-only) supply

#### What has each been tested for in people?
Semax has four trial-type records in PubMed, and all four are Russian-language: a 1997 study of 30 patients in the acute period of ischemic stroke compared with 80 on conventional therapy [3], a 2000 study in optic nerve disease [4], a 2007 study of 27 patients with motor neuron disease [2], and a 2018 study that followed 110 patients through stroke rehabilitation [2]. None enrolled healthy adults, and none measured memory or attention in people without a neurological diagnosis [2]. The nootropic claim is an inference from rat biology and from patients with brain injury.
Selank has three, all in Russian and all in one journal [5]. A 2008 study compared it with the benzodiazepine medazepam in 62 patients with generalized anxiety disorder or neurasthenia and reported similar anti-anxiety effects in the two groups [6]. A 2014 study compared it with phenazepam, another benzodiazepine, in 60 patients with anxiety and somatoform disorders and reported a pronounced anti-anxiety effect [7]. The third, from 2015, concerns optimizing the treatment of anxiety disorders with it [5].
The two records share one limit. No trial of either peptide appears in the English-language literature [2, 5], and FDA has approved neither. The Semax evidence review (https://peptideamerica.org/evidence/semax-evidence) reads the four Semax trials in detail, and the human trial record (https://peptideamerica.org/reference/trial-record) prints both counts beside every other molecule in the index.

#### What are the side effects of Semax and Selank?
No controlled study published in English reports them, and no FDA label exists for either, so there is no reliable side-effect list for either peptide. The 2014 Selank study names tolerability in its title, yet its abstract reports no adverse-event figures [7]; the 2008 study's abstract reports none either [6]. Any list of Semax or Selank side effects met online is therefore not drawn from a counted comparison with placebo.
What FDA has published is a statement of what it does not know. For Selank, the agency found that compounded drugs containing it may pose a risk of immunogenicity, an immune reaction against the peptide, because of aggregation and peptide-related impurities, and that it lacks important information about the safety of Selank in humans [9]. For Semax it recorded the same immunogenicity concern and wrote that it has no, or only limited, safety information for the proposed routes and therefore lacks enough information to know whether the drug would cause harm if given to people [9]. Both statements remain published among the substances whose nominations were withdrawn.

#### Is either one legal in the United States?
Neither is an approved drug, and no licensed pharmacy may lawfully compound either one as of September 2026. Drugs@FDA holds no application under the name Semax [14], and neither peptide appears in any category of the section 503A bulks list FDA published on May 14, 2026 [8]. Both were once in Category 2 of FDA's interim list, the category for substances that may present significant safety risks, and both now sit in the agency's table of nominations withdrawn [9].
The difference is the July 2026 advisory meeting. The Pharmacy Compounding Advisory Committee voted to recommend adding Semax to the 503A list, by a margin reported as 8 to 5 with one abstention in two independent law-firm accounts; FDA has published no vote record, and the vote is advisory until the agency issues a final rule [10, 11]. Selank was not among the seven substances voted on at that meeting [11]. The vote ledger (https://peptideamerica.org/reference/pcac-july-2026) carries the tallies, and the pending (https://peptideamerica.org/status/pending) page explains what an advisory vote does and does not change.
Both peptides also appear in federal enforcement records. In April 2020 FDA warned a Kentucky compounding pharmacy that products it made with Selank and twenty-one other substances were not eligible for the compounding exemptions [12]. In October 2020 that pharmacy, Tailor Made Compounding, pleaded guilty to distributing unapproved new drugs from October 2018 to April 2020; the Justice Department's account of the plea agreement names both Semax and Selank among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [13].

#### Semax or Selank: what the comparison shows
The two peptides invite comparison, one pitched for focus and one for calm, and the record pairs them too: similar size, the same origin, the same language barrier around their trials, and the same FDA finding that human safety information is lacking. What separates them in the United States is procedural rather than scientific. Semax has a recommendation from an advisory committee and awaits rulemaking; Selank has no pending nomination at all.
Product sold under either name to US buyers is research-use-only chemical supply or an import, made outside pharmacy licensure and with nothing independent confirming what a vial or spray contains. The neuropeptides (https://peptideamerica.org/classes/neuropeptides) class page files both beside the other brain-targeted peptides in the index, including DSIP (https://peptideamerica.org/molecules/dsip), the one substance that committee voted against at the same meeting.

#### Sources
1. Dolotov OV, Karpenko EA, Inozemtseva LS, et al. Semax, an analog of ACTH(4-10) with cognitive effects, regulates BDNF and trkB expression in the rat hippocampus. Brain Res. 2006;1117(1):54-60. https://pubmed.ncbi.nlm.nih.gov/16996037/
2. PubMed, National Library of Medicine. Semax census run September 2026 across three name variants: 216 records, 49 tagged Humans, 4 under the clinical-trial publication type and 1 under the randomized type; 93 records Russian-language and 125 English-language; the trial filters return 0 in English and all 4 in Russian. The four trial-type records are a 1997 acute-stroke study, a 2000 optic-nerve study, a 2007 motor-neuron-disease study of 27 patients and a 2018 post-stroke rehabilitation study of 110 patients, each read. Filters proved live against the control term aspirin in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22Semax%22+OR+%22ACTH%284-10%29+Pro-Gly-Pro%22+OR+%22Met-Glu-His-Phe-Pro-Gly-Pro%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
3. Gusev EI, Skvortsova VI, Miasoedov NF, et al. [Effectiveness of semax in acute period of hemispheric ischemic stroke (a clinical and electrophysiological study)]. Zh Nevrol Psikhiatr Im S S Korsakova. 1997;97(6):26-34. Russian. https://pubmed.ncbi.nlm.nih.gov/11517472/
4. Polunin GS, Nurieva SM, Baiandin DL, Sheremet NL, Andreeva LA. [Evaluation of therapeutic effect of new Russian drug semax in optic nerve disease]. Vestn Oftalmol. 2000;116(1):15-18. Russian. https://pubmed.ncbi.nlm.nih.gov/10741256/
5. PubMed, National Library of Medicine. Selank census run August 2026 across three name variants: 89 records, 22 tagged Humans, 3 under the clinical-trial publication type and 2 under the randomized type; all three trial-type records are anxiety-disorder studies published in Russian in one journal between 2008 and 2015, each read. Filters proved live against a control term in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22Selank%22+OR+%22TP-7+peptide%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
6. Zozulia AA, Neznamov GG, Siuniakov TS, et al. [Efficacy and possible mechanisms of action of a new peptide anxiolytic selank in the therapy of generalized anxiety disorders and neurasthenia]. Zh Nevrol Psikhiatr Im S S Korsakova. 2008;108(4):38-48. Russian. Abstract re-read September 2026: 62 patients, 30 given selank and 32 medazepam. https://pubmed.ncbi.nlm.nih.gov/18454096/
7. Medvedev VE, Tereshchenko ON, Israelian AIu, et al. [A comparison of the anxiolytic effect and tolerability of selank and phenazepam in the treatment of anxiety disorders]. Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(7):17-22. Russian. Abstract re-read September 2026: 60 patients; no adverse-event figures reported in the abstract. https://pubmed.ncbi.nlm.nih.gov/25176261/
8. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full: neither Selank (read August 2026) nor Semax (read September 2026) appears in Category 1, 2 or 3. https://www.fda.gov/media/94155/download
9. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entries for Selank acetate (TP-7) and Semax (heptapeptide). Read August and September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
10. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting.
11. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent account; it prints all seven votes of the July 23–24, 2026 meeting (BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon and emideltide), Semax at 8–5–1. Selank is not among them.
12. US Food and Drug Administration. Warning letter, Tailor Made Compounding LLC, case 594743, April 1, 2020. Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
13. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. The plea agreement, as the release describes it, names Semax and Selank among the unapproved new drugs distributed; the company agreed to forfeit $1,788,906.82. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution
14. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic, substance and brand names for "semax": no matching application. Control in the same run: bremelanotide returned NDA 210557. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22semax%22

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### Sermorelin vs Tesamorelin: How They Differ
https://peptideamerica.org/evidence/sermorelin-versus-tesamorelin · published September 2026 · updated September 2026

Question: How do sermorelin and tesamorelin differ?
Short answer: They share a mechanism and little else. Both are GHRH analogs that make the pituitary release its own growth hormone, but tesamorelin is the full 44-amino-acid hormone with an added hexenoyl group, licensed as a biologic for abdominal fat in HIV and barred from compounding, while sermorelin is the hormone's first 29 amino acids, a withdrawn approval with an old trial record that 503A pharmacies compound today.

#### Structure and mechanism side by side
Sermorelin and tesamorelin are both analogs of growth hormone-releasing hormone, the hypothalamic peptide that tells the pituitary gland to release growth hormone. Neither supplies growth hormone. Each stimulates the gland to release its own, so the body's feedback control stays in place.
The structures differ. Sermorelin (https://peptideamerica.org/molecules/sermorelin) is the first 29 amino acids of the hormone, the fragment the Geref trials called GHRH(1–29) [1, 2]. Tesamorelin (https://peptideamerica.org/molecules/tesamorelin) keeps all 44 amino acids of human GHRH and adds a hexenoyl group, a six-carbon chain with a double bond at position 3, to the tyrosine at its amino end [10]. Its label states that it binds the human GHRH receptor with a potency similar to the natural hormone, and that it raises growth hormone, IGF-1 and IGFBP-3 [10].
The length difference also has a legal consequence. FDA treats an amino acid chain of more than 40 amino acids as a protein, and therefore as a biological product [15]. At 44 amino acids tesamorelin crosses that line; at 29 sermorelin does not. The table sets out the rest.

Sermorelin and tesamorelin compared, as of September 2026
Measure | Sermorelin | Tesamorelin
Structure | First 29 amino acids of GHRH [1, 2] | Full 44-amino-acid GHRH plus a hexenoyl group [10]
Approved product | Geref, approved 1990 and 1997; approval withdrawn in 2009 [4, 5, 6] | EGRIFTA (2010), EGRIFTA SV, EGRIFTA WR (2025) [10, 11, 12]
Approved indication | None today; the approval-era efficacy trial enrolled children with growth hormone deficiency [1] | Excess abdominal fat in adults with HIV and lipodystrophy [10]
FDA category | Peptide drug, under the 40-amino-acid protein line [15] | Protein; application deemed a biologics license on March 23, 2020 [13, 15]
US legal route | 503A compounding with a prescription (compoundable (https://peptideamerica.org/status/compoundable)) | The licensed product with a prescription (approved (https://peptideamerica.org/status/approved))
Compounding status | Compounded under 503A; FDA found Geref was not withdrawn for safety or effectiveness [4] | Not eligible for the 503A or 503B exemptions [14]
Human trial base | 71 clinical trials, the most recent published in 2005 [3] | 26 randomized trials, 20 naming HIV or lipodystrophy [9]
Labeled side effects | No current label; Drugs@FDA holds no Geref label [5, 6] | Arthralgia, injection site reactions, extremity pain, peripheral edema, myalgia [10]

#### Approval history
Sermorelin reached the market first. Drugs@FDA records two Geref applications: NDA 019863, approved December 28, 1990 as a new molecular entity, and NDA 020443, approved September 26, 1997 as a new dosage form with orphan status [5, 6]. The sponsor told the FDA on December 2, 2008 that the product was being discontinued; the agency published the withdrawal of approval on May 19, 2009, and on March 4, 2013 it determined that Geref had not been withdrawn from sale for reasons of safety or effectiveness [4].
Tesamorelin was approved as EGRIFTA on November 10, 2010 [12]. The EGRIFTA SV formulation followed, and on March 25, 2025 the FDA approved EGRIFTA WR under supplement S-020 to the same application [12]. Both the EGRIFTA SV and EGRIFTA WR labels were listed on DailyMed in September 2026, and the EGRIFTA WR label states that the two are not substitutable [10, 11]. On March 23, 2020, between those approvals, the application was deemed a biologics license, BLA 022505, along with the other products on the FDA's transition list [12, 13].

#### Trial record
Sermorelin's trial record is sizable and old. Across the names it is indexed under, PubMed holds 71 clinical trials: 9 published before 1990, 57 in the 1990s, 5 between 2000 and 2009, and none since, the most recent from 2005 [3]. The approval-era evidence is pediatric: a one-year open-label study in 110 children with growth hormone deficiency found that height velocity rose from 4.1 to 7.2 centimeters a year after twelve months [1]. The adult trials are small. In one, nightly injections in 11 men aged 64 to 76 raised nocturnal growth hormone without changing IGF-1 or the scan measures of muscle and fat [2]. Sermorelin versus growth hormone (https://peptideamerica.org/evidence/sermorelin-versus-growth-hormone) reads the adult trials in full.
Tesamorelin's record is modern and concentrated in one population. In a phase 3 trial of 404 adults with HIV and excess abdominal fat, visceral fat fell 10.9 percent with tesamorelin against 0.6 percent with placebo over six months [7]. Of 26 papers carrying the randomized-trial publication type, 20 name HIV or lipodystrophy [9]. Outside HIV, a twelve-month trial in 60 abdominally obese adults with reduced growth hormone secretion found visceral fat fell 35 square centimeters against placebo, with no significant change in fat under the skin [8].
Neither record supports general fat loss. The tesamorelin label states that it is not indicated for weight loss management because its effect on weight is neutral [10], and tesamorelin off-label (https://peptideamerica.org/evidence/tesamorelin-off-label) covers the trials outside HIV. Sermorelin has no modern trial of body composition at all [3].

#### Labeled safety then and now
Sermorelin has no current label to consult. Drugs@FDA marks both Geref applications as discontinued and holds no label for either [5, 6], so its safety record is the trials. In the pediatric study, treatment was well tolerated, with no adverse changes in blood chemistry or hormone measures, no change in fasting glucose and no excessive rise in IGF-1 [1]. The trials were small and none was sized to detect uncommon harms.
Tesamorelin carries a current label, and its warnings follow from raising growth hormone. The most common adverse reactions, each above 5 percent, are arthralgia, injection site erythema and pruritus, pain in an extremity, peripheral edema and myalgia [10]. The warnings cover fluid retention, glucose intolerance, with 5 percent of treated patients against 1 percent on placebo reaching an HbA1c of 6.5 percent or higher, raised IGF-1 whose long-term effects are unknown, hypersensitivity reactions in 4 percent, and an increased risk of neoplasms [10]. It is contraindicated in pregnancy, active malignancy and disruption of the hypothalamic-pituitary axis [10].
Because the two share a mechanism, questions about IGF-1 and glucose apply in principle to both. The difference is that tesamorelin's label measured them in a controlled population, and sermorelin's small, older trials did not measure them at that scale.

#### Who can lawfully supply each today?
Sermorelin is compoundable. Licensed 503A pharmacies prepare it against a valid prescription, and its history as the active ingredient of an approved drug, withdrawn on a commercial decision the FDA confirmed in writing, underpins that position [4]. The sermorelin monograph (https://peptideamerica.org/molecules/sermorelin) records the status with its verification date.
Tesamorelin is approved, and only the licensed product is lawful. Its application became a biologics license on March 23, 2020 [12, 13], and the FDA's notice to compounders states that biological products that transitioned that day are not eligible for the compounding exemptions in sections 503A and 503B [14]. A compounded tesamorelin therefore has no lawful route under either section. The tesamorelin monograph (https://peptideamerica.org/molecules/tesamorelin) records the approval and the label.
For both molecules, material sold without a prescription as research-use-only product sits outside pharmacy quality standards, whatever the molecule's own status.

#### Where does ipamorelin fit?
Ipamorelin (https://peptideamerica.org/molecules/ipamorelin) is often grouped with these two, but it is not a GHRH analog. It is a ghrelin mimetic, an agonist at the ghrelin receptor rather than the GHRH receptor [16]. Its one randomized efficacy trial, in postoperative ileus, did not reach statistical significance [16].
Its legal position differs from both. Ipamorelin's 503A nominations were withdrawn in 2024, FDA keeps it in Category 2 under the separate 503B policy, and it has no lawful compounding route. The GH secretagogues (https://peptideamerica.org/classes/gh-secretagogues) class page sets the three side by side with the rest of the class.

#### Sources
1. Thorner M, Rochiccioli P, Colle M, et al. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. J Clin Endocrinol Metab. 1996;81(3):1189–1196. https://pubmed.ncbi.nlm.nih.gov/8772599/
2. Vittone J, Blackman MR, Busby-Whitehead J, et al. Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men. Metabolism. 1997;46(1):89–96. https://pubmed.ncbi.nlm.nih.gov/9005976/
3. PubMed, National Library of Medicine. Census run August 2026 across five name variants — "sermorelin" OR "GHRH(1-29)" OR "GRF(1-29)" OR "sermorelin acetate" OR "Geref" — returning 562 indexed records, 334 carrying the Humans MeSH term, 71 under "clinical trial"[Publication Type] and 39 under the stricter "randomized controlled trial"[Publication Type]. By publication year the 71 divide 9 before 1990, 57 in 1990 through 1999, 5 in 2000 through 2009, and 0 in 2010 through 2026; the most recent was published in 2005. The publication-type filter was proved live in the same run against a control term, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22sermorelin%22+OR+%22GHRH%281-29%29%22+OR+%22GRF%281-29%29%22+OR+%22sermorelin+acetate%22+OR+%22Geref%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
4. US Food and Drug Administration. Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. 78 Federal Register 14095, March 4, 2013; docket FDA-2012-P-1071. Read August 2026 from the Government Publishing Office. https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm
5. US Food and Drug Administration. Drugs@FDA: NDA 019863, GEREF (sermorelin acetate), EMD Serono. Original approval December 28, 1990, Type 1 new molecular entity; marketing status Discontinued; no label available on the site. Read September 2026. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019863
6. US Food and Drug Administration. Drugs@FDA: NDA 020443, GEREF (sermorelin acetate), EMD Serono Inc. Original approval September 26, 1997, Type 3 new dosage form, orphan; marketing status Discontinued; no label available on the site. Read September 2026. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443
7. Falutz J, Potvin D, Mamputu JC, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010;53(3):311–322. https://pubmed.ncbi.nlm.nih.gov/20101189/
8. Makimura H, Feldpausch MN, Rope AM, et al. Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial. J Clin Endocrinol Metab. 2012;97(12):4769–4779. https://pubmed.ncbi.nlm.nih.gov/23015655/
9. PubMed, National Library of Medicine. Census run August 2026 across three name variants — "tesamorelin" OR "TH9507" OR "EGRIFTA" — returning 127 indexed records, 28 under "clinical trial"[Publication Type] and 26 under the stricter "randomized controlled trial"[Publication Type]; of the 26, 20 name HIV or lipodystrophy and 6 do not. The publication-type filter was proved live in the same run against a control term, and a deliberately invalid identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22tesamorelin%22+OR+%22TH9507%22+OR+%22EGRIFTA%22%29+AND+%22randomized+controlled+trial%22%5BPublication+Type%5D
10. Theratechnologies. EGRIFTA WR (tesamorelin) for injection, US prescribing information. Revised March 2025. DailyMed set ID 839334d3-8c1d-4c26-9036-2ab524a6ea75. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75
11. Theratechnologies. EGRIFTA SV (tesamorelin) for injection, US prescribing information. Revised March 2024. DailyMed set ID 3d783378-b02d-4f19-99dd-0fc91a042224. Read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224
12. US Food and Drug Administration. Drugs@FDA: BLA 022505, EGRIFTA (tesamorelin acetate), Theratechnologies. Former NDA deemed to be a BLA on March 23, 2020; original approval November 10, 2010; supplement S-020 (EGRIFTA WR) approved March 25, 2025. Read September 2026. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505
13. US Food and Drug Administration. List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020. Lists tesamorelin acetate (Egrifta and Egrifta SV), former NDA 022505. Read September 2026. https://www.fda.gov/media/119229/download
14. US Food and Drug Administration. Notice to Compounders: Changes that affect compounding as of March 23, 2020. Content current as of March 5, 2020. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020
15. US Food and Drug Administration. Definition of the Term "Biological Product". Final rule, 85 Federal Register 10057, February 21, 2020, effective March 23, 2020; 21 CFR 600.3(h)(6). Read September 2026. https://www.federalregister.gov/documents/2020/02/21/2020-03505/definition-of-the-term-biological-product
16. Beck DE, Sweeney WB, McCarter MD. Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients. Int J Colorectal Dis. 2014 Dec;29(12):1527-34. https://pubmed.ncbi.nlm.nih.gov/25331030/

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### Tesamorelin Side Effects: What the Label Says
https://peptideamerica.org/evidence/tesamorelin-label-safety · published September 2026 · updated September 2026

Question: What side effects does the tesamorelin label record?
Short answer: Joint pain, injection site reactions, pain in the arms or legs, swelling and muscle pain are the most common, measured in 543 adults with HIV who took tesamorelin in placebo-controlled trials; the label adds warnings on glucose intolerance, raised IGF-1, fluid retention, allergic reactions and existing cancer, and none of its figures describe use outside that population.

#### Whose side effects the label describes
Tesamorelin (https://peptideamerica.org/molecules/tesamorelin) is approved for one use: reducing excess abdominal fat in adults with HIV who have lipodystrophy. Its side-effect data come from that population. The EGRIFTA WR label counts 740 adults with HIV, lipodystrophy and excess abdominal fat treated in the clinical trials, 543 of whom received tesamorelin during the 26-week placebo-controlled phase, against 263 on placebo [1].
The trials were selective. They enrolled adults aged 18 to 65 with a large waist and waist-to-hip ratio, and excluded people with type 1 or type 2 diabetes, anyone on insulin or diabetes tablets, anyone with a history of cancer, and anyone with hypopituitarism [1]. Those exclusions matter when reading the tables below, because the people most likely to be harmed by a rise in glucose or growth factors were kept out.
The current formulation was not tested separately. The label states that the safety of EGRIFTA WR rests on the trials of the original EGRIFTA formulation, and that its adverse reactions are expected to be similar [1]. The label was revised in March 2025 and was listed on DailyMed in September 2026.

#### Adverse reactions in the trials
The label lists every adverse reaction reported in at least 1 percent of treated patients during the first 26 weeks, and more often than with placebo [1]. Injection site reactions lead the list, followed by joint pain. Joint pain, extremity pain, peripheral swelling and carpal tunnel syndrome are what the label calls edema-related reactions, the fluid-retention effects that follow from raising growth hormone [1].
Injection site reactions appear twice in the label with different figures. The table's grouped entry gives 17 percent against 6 percent with placebo; the warnings section, describing injection site reactions over the same 26 weeks, gives 25 percent against 14 percent [1]. Both are reproduced here as printed.

Adverse reactions in at least 1 percent of patients and more frequent with tesamorelin than placebo, first 26 weeks, combined phase 3 studies, as printed in the label's Table 1
Reaction | Tesamorelin (n = 543) | Placebo (n = 263)
Injection site reaction (grouped) | 17% | 6%
Arthralgia (joint pain) | 13% | 11%
Pain in extremity | 6% | 5%
Myalgia (muscle pain) | 6% | 2%
Peripheral edema (swelling) | 6% | 2%
Paresthesia (tingling) | 5% | 2%
Hypoesthesia (numbness) | 4% | 2%
Rash | 4% | 2%
Dyspepsia | 2% | 1%
Musculoskeletal pain | 2% | 1%
Pain | 2% | 1%
Pruritus (itching) | 2% | 1%
Vomiting | 3% | 0%
Musculoskeletal stiffness | 2% | 0%
Blood creatine phosphokinase increased | 1% | 0%
Carpal tunnel syndrome | 1% | 0%
Joint swelling | 1% | 0%
Muscle strain | 1% | 0%
Night sweats | 1% | 0%
Palpitations | 1% | 0%

#### Warnings and precautions
The warnings follow from what the drug does. Tesamorelin makes the pituitary release more growth hormone, which raises IGF-1, a growth factor, and growth hormone also retains fluid and opposes insulin. Each of those effects has its own warning, and the label gives measured figures for most of them [1].
Antibodies are common. Anti-tesamorelin antibodies were detected in 50 percent of patients after 26 weeks and in 85 percent of those who had a hypersensitivity reaction; about 60 percent of antibody-positive patients showed cross-reactivity with the body's own growth hormone-releasing hormone. Patients with and without antibodies had similar reductions in abdominal fat [1].

Warnings in the EGRIFTA WR label and the figures it gives for each
Warning | What the label reports
Glucose intolerance or diabetes | HbA1c reached 6.5% or higher in 5% of treated patients against 1% on placebo, from a mean baseline of 5.3%; hazard ratio 3.3 (1.4 to 9.6). Glucose checked before and during treatment [1]
Raised IGF-1 | After 26 weeks, 47% had IGF-1 above 2 standard deviation scores and 36% above 3; the effects of prolonged elevation are unknown, and levels are monitored [1]
Fluid retention | Edema, joint pain and carpal tunnel syndrome, either transient or resolving when treatment stops [1]
Hypersensitivity | Reactions in 4% of treated patients, including itching, redness, flushing, hives and rash [1]
Injection site reactions | Redness, itching, pain, irritation and bruising in 25% against 14% on placebo [1]
Neoplasms | Growth hormone is a growth factor: an existing cancer must be inactive and treated before starting, and treatment stops if it recurs [1]
Acute critical illness | Discontinuation considered, because raised growth hormone has been linked to higher mortality in critically ill patients [1]
Diabetic retinopathy | Patients with diabetes monitored for new or worsening retinopathy [1]

#### Who should not take it
The label lists four contraindications: disruption of the hypothalamic-pituitary axis from hypophysectomy, hypopituitarism, a pituitary tumor or surgery, head irradiation or head trauma; active malignancy; known hypersensitivity to tesamorelin or its excipients; and pregnancy [1]. The pregnancy contraindication rests on animal data: tesamorelin given to pregnant rats produced hydrocephaly in their offspring [1].
The label also records what it does not know. Safety and effectiveness in children have not been established, and in children whose growth plates are open it may cause excessive growth. There is no information on patients older than 65, and long-term cardiovascular safety has not been established [1].

#### What the trials measured before and after
The trials measured visceral fat, the fat around the organs, by CT scan at the level of the lower spine. After 26 weeks it fell by an average of 27 square centimeters in the first study and 21 in the second, while it rose by 4 or did not change with placebo; in percentage terms, falls of 18 and 14 percent against a rise of 2 and a fall of 2 [1]. The pooled analysis of 806 patients found a treatment effect of 15.4 percent, with no significant change in the fat under the skin [3].
Body weight did not move. The label's own table shows weight changes of less than one kilogram in either direction, and it states that tesamorelin is not indicated for weight loss because its effect on weight is neutral [1]. Waist circumference fell by 2 to 3 centimeters against about 1 with placebo [1].
The effect lasts only while treatment continues. Patients who stayed on tesamorelin for a year kept a reduction of about 18 percent [2, 4]; those switched to placebo at 26 weeks regained visceral fat, by 25 and 24 square centimeters in the two extension phases, and the reduction was lost [1, 4].

Changes from baseline to week 26 in the two phase 3 studies, as printed in the label's Tables 2 and 3
Measure | Study 1 tesamorelin | Study 1 placebo | Study 2 tesamorelin | Study 2 placebo
Visceral fat, cm² | −27 | +4 | −21 | 0
Visceral fat, % change | −18% | +2% | −14% | −2%
Body weight, kg | −0.4 | 0.0 | +0.5 | +0.3
Waist circumference, cm | −3 | −1 | −2 | −1
IGF-1, ng/mL | +107 | −15 | +108 | +3

#### Why there is no compounded version
Every figure above describes the licensed product. Tesamorelin has 44 amino acids, and the FDA defines any chain of more than 40 as a protein [8], so on March 23, 2020 its application was deemed a biologics license [5, 6]. Biological products that made that transition are not eligible for the compounding exemptions in sections 503A and 503B [7]. There is no lawful compounded tesamorelin, and no compounded product carries this label or was tested in these trials.
Use outside HIV lipodystrophy falls outside the label altogether. The small trials in other populations are reviewed in tesamorelin off-label (https://peptideamerica.org/evidence/tesamorelin-off-label), and the comparison with the compounded GHRH analog sermorelin is set out in sermorelin vs tesamorelin (https://peptideamerica.org/evidence/sermorelin-versus-tesamorelin). The drug's place in its class is on the GH secretagogues (https://peptideamerica.org/classes/gh-secretagogues) page, and its legal position on the approved (https://peptideamerica.org/status/approved) status page.

#### Sources
1. Theratechnologies. EGRIFTA WR (tesamorelin) for injection, US prescribing information. Revised March 2025. DailyMed set ID 839334d3-8c1d-4c26-9036-2ab524a6ea75. Sections 1, 4, 5, 6, 8 and 14 and Tables 1 to 4 read September 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75
2. Falutz J, Potvin D, Mamputu JC, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010;53(3):311–322. https://pubmed.ncbi.nlm.nih.gov/20101189/
3. Falutz J, Mamputu JC, Potvin D, et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010;95(9):4291–4304. https://pubmed.ncbi.nlm.nih.gov/20554713/
4. Falutz J, Allas S, Mamputu JC, et al. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. AIDS. 2008;22(14):1719–1728. https://pubmed.ncbi.nlm.nih.gov/18690162/
5. US Food and Drug Administration. Drugs@FDA: BLA 022505, EGRIFTA (tesamorelin acetate), Theratechnologies. Former NDA deemed to be a BLA on March 23, 2020. Read September 2026. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505
6. US Food and Drug Administration. List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020. Lists tesamorelin acetate (Egrifta and Egrifta SV), former NDA 022505. Read September 2026. https://www.fda.gov/media/119229/download
7. US Food and Drug Administration. Notice to Compounders: Changes that affect compounding as of March 23, 2020. Content current as of March 5, 2020. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020
8. US Food and Drug Administration. Definition of the Term "Biological Product". Final rule, 85 Federal Register 10057, February 21, 2020, effective March 23, 2020; 21 CFR 600.3(h)(6). Read September 2026. https://www.federalregister.gov/documents/2020/02/21/2020-03505/definition-of-the-term-biological-product

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### The Wolverine Stack: BPC-157 With TB-500
https://peptideamerica.org/evidence/bpc-157-and-tb-500-stack · published September 2026 · updated September 2026

Question: What is the Wolverine stack, and has BPC-157 with TB-500 been tested in people?
Short answer: No trial has tested the pair. The Wolverine stack is a marketplace name for BPC-157 used together with TB-500; the only human data on the combination are four patients in one uncontrolled chart review, a rat study found no added benefit from combining them, neither peptide may be lawfully compounded while FDA acts on a July 2026 advisory vote, and both are prohibited in sport.

#### Where does the name come from?
The Wolverine stack is a nickname, used in online marketing and forums, for taking BPC-157 (https://peptideamerica.org/molecules/bpc-157) and TB-500 (https://peptideamerica.org/molecules/tb-500) together; it borrows the name of a comic-book character known for healing quickly. It is not a drug, a formulation or a regimen defined by any regulator or journal. The phrase appears in no PubMed record [1], and no registered study combines the two peptides [4].
The pairing rests on the idea that the two work through different repair pathways and so add to each other. That idea comes from studying each peptide separately, mostly in animals and cells [19]. The same two peptides also appear, with GHK-Cu and sometimes KPV, in the injectable blends sold as GLOW and KLOW, covered in the review of GLOW and KLOW blends (https://peptideamerica.org/evidence/glow-and-klow-blends).

#### How do BPC-157 and TB-500 compare?
They are unrelated molecules with similar records. BPC-157 is a 15-amino-acid fragment of a protein first described in human gastric juice [19]. TB-500 is a synthetic fragment of thymosin beta-4, and analysis of products sold under the name identified it as a seven-residue piece of that 43-residue protein [7]. Neither has a published controlled trial, and both hold the same US and sporting position.

BPC-157 and TB-500 side by side, as of September 2026
Measure | BPC-157 | TB-500
What it is | 15-amino-acid fragment of a gastric juice protein [19] | Seven-residue fragment of thymosin beta-4, Ac-LKKTETQ [7]
Published controlled trials | None; three uncontrolled reports covering 30 people [2, 10, 11] | None of the fragment; its one trial-type record is a tuberculosis study matched on the letters TB [6]
Human evidence often cited | Animal studies and the three small reports | Trials of full-length thymosin beta-4, a different molecule [8, 9]
Registered trials | Four, none with results [4] | One phase 1/2 trial, recruiting, no results [5]
FDA's stated concern | Immunogenicity, impurities and ingredient characterization; little or no safety data [12] | Immunogenicity from aggregation and impurities; no human exposure data identified [13]
US status | Off Category 2 since April 2026; advisory vote to list it, reported 8–6–1; no final rule [15, 16] | The same: off Category 2, the same reported 8–6–1 advisory vote, no final rule [15, 16]
WADA 2026 List | S0, non-approved substances, named [14] | S2.3, growth factors, named [14]

#### What has been tested together?
Almost nothing. Thirteen PubMed records name both peptides. Ten are review or overview articles, one is a laboratory method for detecting doping agents in blood, one is a rat study and one is a human chart review; none is indexed as a clinical trial [1]. ClinicalTrials.gov lists no study of the two together [4].
The human data on the combination come to four people. In a 2021 retrospective review of knee injections at one Florida practice, 4 of 16 patients received BPC-157 together with thymosin beta-4, which the paper calls TB4 without saying whether it was the full protein or the TB-500 fragment; 3 of the 4 reported significant relief in a telephone survey [2]. There was no comparison group, and the survey reached patients up to a year after treatment.
The one controlled test of the pair was in rats, and it did not find that the pair beat either peptide alone. In a 2026 study of 32 rats with a repaired Achilles tendon, split into four groups of eight, TB-500 alone produced the clearest gains in tendon strength and structure, BPC-157 alone improved tissue scores without reaching significance, and the combination "did not confer additional benefits compared to either agent alone" [3]. The authors called the study exploratory, and eight rats a group is a small test, but it is the only direct evidence on whether stacking adds anything.

#### What are the side effects of the stack?
They are not known for the pair, and barely known for either half. The BPC-157 reports that recorded safety, 14 people across two small pilots, found no adverse events [10, 11]; for TB-500, FDA states it has identified no human exposure data at all [13]. The BPC-157 safety record (https://peptideamerica.org/evidence/bpc-157-safety-record) sets out what is and is not known about that half in full.
Taking two unstudied peptides at once adds a problem of its own: if something goes wrong, there is no way to tell which peptide caused it, or whether the combination did. Contents are a further unknown, since a laboratory analysis of products sold as TB-500 found that they did not consistently match their labels [18].

#### What did FDA say about each peptide?
FDA placed BPC-157 in Category 2 of its interim bulks list in September 2023 [17]. Its safety-risk page, current as of April 22, 2026, states that compounded BPC-157 "may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization," and that the agency lacks sufficient information to know whether it would cause harm in people [12].
For TB-500 the same page states that compounded drugs containing the fragment "may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation as well as peptide-related impurities," and that FDA "has not identified any human exposure data" on products containing it [13]. Both peptides left Category 2 in April 2026 without being added to Category 1, which ended the explicit bar without granting permission; the Category 2 removal (https://peptideamerica.org/reference/category-2-removal) page explains the difference.

#### Are BPC-157 and TB-500 allowed in sport?
No. Both are named on the World Anti-Doping Agency's 2026 Prohibited List, in force from January 1, 2026, and both are prohibited at all times, in and out of competition [14]. BPC-157 is named in section S0, non-approved substances, which covers any pharmacological substance not addressed elsewhere on the List that has no current approval by any government health authority for human therapeutic use: "This class covers many different substances including but not limited to BPC-157" [14]. TB-500 is named in section S2.3, growth factors and growth factor modulators: "Thymosin-β4 and its derivatives e.g. TB-500" [14].
An FDA compounding listing would change neither entry. TB-500's place in S2.3 does not depend on approval at all, and a compounding listing is not an approval of a drug for human therapeutic use, which is the test S0 applies [14]. The WADA status table (https://peptideamerica.org/reference/wada-status) sets out every molecule in the index against the List.

#### What would change if FDA acts on the advisory vote?
In July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding both peptides to the section 503A bulks list, each by a margin reported as 8 to 6 with one abstention in two independent law-firm accounts; FDA scientists had recommended against inclusion in each case [15, 16]. The vote is advisory, and FDA has issued no final rule for either.
If FDA does list them, licensed 503A pharmacies could compound each peptide for an individual patient's prescription, under the same framework that governs other bulk substances [17]. Listing would not make either an approved drug, would not create trial evidence for either, and would not test the combination. Each molecule is decided on its own, so the two could also end up in different places. The pending (https://peptideamerica.org/status/pending) status page and the July 2026 vote ledger (https://peptideamerica.org/reference/pcac-july-2026) will carry the outcome when it issues.

#### Sources
1. PubMed, National Library of Medicine. Searches run September 2026: the BPC-157 names combined with the TB-500 and thymosin beta-4 names returned 13 records, each read (ten review or overview articles, one analytical method, one rat study, one retrospective human chart review), 0 under the clinical-trial publication type; the quoted phrase "wolverine stack" was reported as not found in any record. Control term aspirin returned 8,916 records under the clinical-trial type in the same run, and the invalid identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22BPC+157%22+OR+%22BPC-157%22+OR+%22pentadecapeptide+BPC%22+OR+%22body+protection+compound%22+OR+%22PL+14736%22%29+AND+%28%22TB-500%22+OR+%22TB500%22+OR+%22thymosin+beta+4%22+OR+%22thymosin+beta-4%22%29
2. Lee E, Padgett B. Intra-articular injection of BPC 157 for multiple types of knee pain. Altern Ther Health Med. 2021;27(4):8-13. A retrospective chart review with telephone follow-up of 16 patients; no comparison group. https://pubmed.ncbi.nlm.nih.gov/34324435/
3. Biçer O, Adanir O, Güleryüz Y, et al. Effects of BPC-157 and TB-500 on Achilles tendon healing in rats: a histopathological and biomechanical study. Jt Dis Relat Surg. 2026;37(3):822-837. https://pubmed.ncbi.nlm.nih.gov/42542926/
4. ClinicalTrials.gov, National Library of Medicine, v2 API. Searches run September 2026: "BPC-157" returned four registered studies, none with results; "BPC-157 AND TB-500" and "BPC-157 AND thymosin" each returned 0. Control in the same run: "aspirin" returned 2,968 studies. https://clinicaltrials.gov/api/v2/studies?query.term=BPC-157
5. ClinicalTrials.gov, National Library of Medicine. NCT07487363: a phase 1/2, randomized, double-blind, placebo-controlled, sequential dose-escalation study of TB-500 (thymosin beta 4 17-23 fragment) in adults with stable atherosclerotic cardiovascular disease. Status recruiting; no results posted. https://clinicaltrials.gov/api/v2/studies/NCT07487363
6. PubMed, National Library of Medicine. Census run August 2026: "TB-500" OR "TB500" returns 31 indexed records, 1 under "clinical trial"[Publication Type] and 0 under "randomized controlled trial"[Publication Type]; the single clinical-trial record is a study of tuberculosis incidence, matched on the letters TB and unrelated to the peptide. The filter was proved live in the same run against a control term. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22TB-500%22+OR+%22TB500%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
7. Esposito S, Deventer K, Goeman J, Van der Eycken J, Van Eenoo P. Synthesis and characterization of the N-terminal acetylated 17-23 fragment of thymosin beta 4 identified in TB-500, a product suspected to possess doping potential. Drug Test Anal. 2012;4(9):733–738. https://pubmed.ncbi.nlm.nih.gov/22962027/
8. Wang X, Liu L, Qi L, Lei C, Li P, Wang Y, et al. A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy Chinese volunteers. J Cell Mol Med. 2021 Sep;25(17):8222-8228. https://pubmed.ncbi.nlm.nih.gov/34346165/
9. Sosne G, Dunn SP, Kim C. Thymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial. Cornea. 2015 May;34(5):491-6. https://pubmed.ncbi.nlm.nih.gov/25826322/
10. Lee E, Walker C, Ayadi B. Effect of BPC-157 on symptoms in patients with interstitial cystitis: a pilot study. Altern Ther Health Med. 2024;30(10):12-17. Twelve women, single arm, one treatment; no comparison group. https://pubmed.ncbi.nlm.nih.gov/39325560/
11. Lee E, Burgess K. Safety of intravenous infusion of BPC157 in humans: a pilot study. Altern Ther Health Med. 2025;31(5):20-24. Two adults, each of whom had received intravenous BPC-157 before the study. https://pubmed.ncbi.nlm.nih.gov/40131143/
12. US Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks (the Category 2 rationale for BPC-157). Content current as of April 22, 2026. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
13. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for thymosin beta-4, fragment (LKKTETQ), also known as TB-500. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
14. World Anti-Doping Agency. The 2026 Prohibited List, International Standard, in effect from January 1, 2026. Section S0, Non-Approved Substances, and section S2.3, Growth Factors and Growth Factor Modulators, both prohibited at all times. Read September 2026.
15. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; it states that FDA scientists recommended against inclusion in each instance.
16. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account; it prints BPC-157 and TB-500 each at 8–6–1, and the two accounts agree substance by substance.
17. US Food and Drug Administration. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, guidance for industry, January 2025, docket FDA-2015-D-3517: the policy that defines Categories 1, 2 and 3, under which BPC-157 was placed in Category 2 in September 2023. Read September 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/interim-policy-compounding-using-bulk-drug-substances-under-section-503a-federal-food-drug-and
18. Delcourt V, Garcia P, Chabot B, et al. TB500/TB1000 and SGF1000: a scientific approach for a better understanding of misbranded and adulterated drugs. Drug Test Anal. 2023;15(4):458–464. https://pubmed.ncbi.nlm.nih.gov/36482504/
19. Mateescu DM, Gavrilescu DM, Constantinescu FE, et al. BPC-157 as an investigational peptide therapeutic: biopharmaceutical challenges, formulation strategies, and translational development barriers. Pharmaceutics. 2026. https://pubmed.ncbi.nlm.nih.gov/42198317/

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### A Lawful Peptide Is Not a Proven One
https://peptideamerica.org/evidence/lawful-is-not-proven · published September 2026 · updated September 2026

Question: Does a lawful compounding status mean a peptide is supported by evidence?
Short answer: No, and vasoactive intestinal peptide is the proof: it sits in Category 1 of the 503A bulks list, so a pharmacy may compound it today, while its largest randomized trial was stopped for futility and missed every primary endpoint.

#### Two questions that are routinely collapsed
Most of this index argues in one direction: a peptide with no lawful route usually also has a thin human record, and readers are shown the second fact to explain the first. That correlation is real and it is not a mechanism. Lawfulness under section 503A turns on a nomination and a category; evidence turns on trials. Nothing connects them.
The clearest way to show that is a molecule where the two answers diverge, and this index acquired one in 2026. Vasoactive intestinal peptide appears in Category 1 of the section 503A bulks list published May 14, 2026 — the category for substances under evaluation, where a licensed pharmacy may compound for an individual patient with a valid prescription while review continues [1].
It is also a substance with no approved product at all. Drugs@FDA holds no record of vasoactive intestinal peptide or of aviptadil as the active ingredient of any drug product; in the same run and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none [2]. A pharmacy may lawfully prepare a substance that has never been approved for anything.

#### What the randomized record shows
The largest test of the synthetic peptide was run by the National Institutes of Health. TESICO randomized 471 participants with COVID-19-associated hypoxemic respiratory failure to intravenous aviptadil or matched placebo across 28 sites in the United States, with 461 in the modified intention-to-treat population. On the primary day-90 ordinal outcome the odds ratio was 1.11, with a 95 percent confidence interval of 0.80 to 1.55 and p = 0.54. Mortality to day 90 was 38 percent on aviptadil and 36 percent on placebo, a hazard ratio of 1.04. The independent data and safety monitoring board recommended stopping the aviptadil trial for futility on May 25, 2022, and the authors concluded that aviptadil did not significantly improve clinical outcomes [4].
The earlier and smaller trial pointed the same way on its own terms. It randomized 196 patients two to one and its primary endpoint — alive and free from respiratory failure at day 60 — returned an odds ratio of 1.6 with a 95 percent confidence interval of 0.86 to 3.11, which did not reach statistical significance; the authors state plainly that on the primary endpoint there was no difference between aviptadil and placebo, while reporting a secondary survival result at day 60 with an odds ratio of 2.0 and p = 0.035 [3].
The one thing controlled infusion of this peptide does reliably in people is not therapeutic. In a randomized, double-blind, placebo-controlled crossover study, a two-hour infusion provoked migraine attacks in 15 of 21 patients against 1 of 21 on placebo, p < .001 [5]. An early controlled study did find bronchodilation and protection against histamine-induced bronchoconstriction in asthmatic subjects [6], which remains the clearest positive controlled finding in the file and is forty-three years old.

#### Reading the two facts together
Neither fact corrects the other. The compounding status is accurate: a pharmacy may lawfully prepare this substance today, and a reader told otherwise has been misinformed. The evidence position is also accurate: the largest randomized trial of the synthetic peptide was stopped for futility, and no randomized evidence supports the indications the compounded preparation is marketed for.
What follows is a narrower claim than either side of the market usually makes. A lawful status tells a patient that a licensed pharmacy may prepare the substance under a prescription, that a prescriber is accountable for the decision, and that the preparation sits inside pharmacy regulation rather than outside it. Those are real protections and they are the ones the research-only (https://peptideamerica.org/status/research-only) material lacks entirely. None of them is a statement that the compound works.
The inverse error is just as common in the other direction. ARA-290 (https://peptideamerica.org/molecules/ara-290) has five completed trials that administer the peptide to patients and sits in Category 3 with no lawful route at all. Evidence did not buy it a listing, and a listing has not bought this molecule evidence.

#### What a reader should do with this
Check the two records separately, and check the date on each. A category on the FDA list moves: GHK-Cu left Category 1 in April 2026 when its nominators withdrew, and part of it was restored in May, all within one document [1]. A trial record moves too, more slowly and in one direction.
The compoundable (https://peptideamerica.org/status/compoundable) page carries the other substances in this position, and the monograph (https://peptideamerica.org/molecules/vasoactive-intestinal-peptide) carries this one's dated ledger beside its counted literature. This index verifies no seller for this molecule and names none; a lawful status is a necessary condition for a supply route and not a sufficient one.

#### Sources
1. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: Vasoactive Intestinal Peptide appears in Category 1. The same document records the April 22, 2026 removal of GHK-Cu from Category 1 on withdrawal by its nominators, and the addition back of GHK-Cu for non-injectable routes after a nominator clarified on May 5, 2026. https://www.fda.gov/media/94155/download
2. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe run September 2026: a search by active-ingredient name returned no records for vasoactive intestinal peptide or for aviptadil. In the same run and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none — a positive and a negative control beside the zero. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22AVIPTADIL%22
3. Youssef JG, Lavin P, Schoenfeld DA, Lee RA, Lenhardt R, Park DJ, et al. The Use of IV Vasoactive Intestinal Peptide (Aviptadil) in Patients With Critical COVID-19 Respiratory Failure: Results of a 60-Day Randomized Controlled Trial. Crit Care Med. 2022 Nov 1;50(11):1545-1554. https://pubmed.ncbi.nlm.nih.gov/36044317/
4. Brown SM, Barkauskas CE, Grund B, Sharma S, Phillips AN, Leither L, et al. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial. Lancet Respir Med. 2023 Sep;11(9):791-803. https://pubmed.ncbi.nlm.nih.gov/37348524/
5. Pellesi L, Al-Karagholi MA, De Icco R, Coskun H, Elbahi FA, Lopez-Lopez C, et al. Effect of Vasoactive Intestinal Polypeptide on Development of Migraine Headaches: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2118543. https://pubmed.ncbi.nlm.nih.gov/34357396/
6. Morice A, Unwin RJ, Sever PS. Vasoactive intestinal peptide causes bronchodilatation and protects against histamine-induced bronchoconstriction in asthmatic subjects. Lancet. 1983 Nov 26;2(8361):1225-7. https://pubmed.ncbi.nlm.nih.gov/6139572/

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### Category 3: Nominated, Not Reviewed
https://peptideamerica.org/evidence/category-3-nominations · published September 2026 · updated September 2026

Question: What does Category 3 of the FDA 503A bulks list actually mean?
Short answer: It means the nomination was too thin to evaluate: not that the substance is unsafe, which is Category 2, and not that a pharmacy may compound it, which is Category 1. Seven substances in this index sit there and the category has moved none of them.

#### The three categories
The FDA's interim list of bulk drug substances nominated for compounding under section 503A sorts nominations into three files, and the document names them plainly: Category 1 for substances under evaluation, Category 2 for substances that raise significant safety risks, and Category 3 for substances nominated without adequate support [1].
Two of those three are widely understood. Category 1 is a permission during review — a pharmacy may compound with the substance while the agency's work continues. Category 2 is a prohibition with a stated reason, and the agency publishes the reason substance by substance [7]. Category 3 is the one that gets reported as whichever of the other two suits the reporter, and it is neither.
Category 3 records a fact about a document, not about a molecule. A party nominated the substance; the submission that accompanied the nomination did not contain enough for the agency to evaluate; the nomination was filed accordingly. Nothing in that sequence is a finding about safety, and nothing in it is an authorization.

#### What sits there
Seven of the substances this index tracks are in Category 3 on the list FDA published May 14, 2026: GHRP-2 [1], GHRP-6 [2], mechano growth factor [3], ARA-290 [4], secretin [5], thymulin [6], and L-carnosine [8]. The figure is a count of this index's own rows and not a total of the category, which contains a great many substances that are not peptides; no source this index has verified states a peptide subtotal, so none is printed here.
Six of the seven have no lawful United States route of any kind. The seventh is secretin, which is the instructive case: an approved diagnostic product has existed since 2004, and the bulk substance was separately nominated and separately found inadequately supported [5]. An approval and a nomination are different records, filed by different parties, and one does not carry the other.
The evidentiary range inside the category is the second surprise. ARA-290 has five indexed records that administer the peptide to patients in completed trials [4]. Thymulin has none that administer it at all [6]. L-carnosine has the largest randomized literature of any unapproved substance in this index [8]. All three are filed identically, because the category is not measuring any of that.

#### Why the misreading is commercially useful
A substance in Category 3 is on an FDA list. That sentence is true, and it is the whole of what a seller needs. It permits a page to say the compound is "under FDA review" or "nominated to the FDA bulks list" without stating anything false, while a reader takes from it that a decision is pending and favorable.
The correction is short. Being named in Category 3 is the record of a failed submission, not of a pending review. Nothing about the placement suggests the agency is working toward a listing, and for several of these substances the nomination is the only interaction with the agency that has ever occurred.
The two GHRP substances make the point sharpest, because they are simultaneously in Category 2 of the separate section 503B policy governing outsourcing facilities, added September 29, 2023, where FDA does state safety concerns about them [7]. A reader given only the 503A line has been told the half of the record that sounds like progress.

#### What would have to change
A Category 3 substance reaches a lawful compounding route by the same path as anything else: a nomination adequate to evaluate, a review, an advisory committee, and a final rule. None of the seven has begun that path. None was among the seven peptides the advisory committee reviewed in July 2026, so none carries a vote, a recommendation, or a pending rulemaking [1].
Until then the position is the one the nomination tracker (https://peptideamerica.org/reference/nominations) prints and the research-only (https://peptideamerica.org/status/research-only) page explains: material offered for these substances is sold outside pharmacy licensure and outside the quality obligations that attach to a drug. The category on the FDA list changes none of that, which is precisely why it is worth knowing what the category is.

#### Sources
1. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: GHRP-2 appears in Category 3 and in neither Category 1 nor Category 2. https://www.fda.gov/media/94155/download
2. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: GHRP-6 appears in Category 3 and in neither Category 1 nor Category 2. https://www.fda.gov/media/94155/download
3. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: Mechano growth factor (MGF) appears in Category 3; the pegylated form appears in no category. https://www.fda.gov/media/94155/download
4. PubMed, National Library of Medicine. Census run September 2026 across five name variants — "ARA-290" OR "ARA 290" OR "cibinetide" OR "helix B surface peptide" OR "pyroglutamate helix B surface peptide" — returning 99 indexed records, 40 carrying the Humans MeSH term, 5 under "clinical trial"[Publication Type] and 4 under "randomized controlled trial"[Publication Type]. All 5 trial-type records were retrieved through esummary and read individually; every one administers the peptide to human participants. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22ARA-290%22+OR+%22cibinetide%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
5. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: the entry "Secretin, human 99%" appears in Category 3 and in neither Category 1 nor Category 2. https://www.fda.gov/media/94155/download
6. PubMed, National Library of Medicine. Census run September 2026 across two name variants — "thymulin" OR "serum thymic factor" — returning 498 indexed records, 226 carrying the Humans MeSH term, 8 under "clinical trial"[Publication Type] and 5 under "randomized controlled trial"[Publication Type]. All 8 trial-type records were retrieved through esummary and read individually; seven measure endogenous thymulin as a marker of zinc status and one administers a synthetic analogue. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22thymulin%22+OR+%22serum+thymic+factor%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
7. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026. Read September 2026: the Category 2 table lists Growth hormone releasing peptide-2 (GHRP-2) for injectable and nasal routes of administration under the 503B policy, date added September 29, 2023. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
8. PubMed, National Library of Medicine. Census run September 2026 across three name variants — "carnosine" OR "L-carnosine" OR "beta-alanyl-L-histidine" — returning 3,602 indexed records, 1,384 carrying the Humans MeSH term, 196 under "clinical trial"[Publication Type] and 158 under "randomized controlled trial"[Publication Type]. Reported as a magnitude; the 25 most relevant randomized records were retrieved through esummary and read. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22carnosine%22%29+AND+%22randomized+controlled+trial%22%5BPublication+Type%5D

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### Secretin for Autism: A Closed Question
https://peptideamerica.org/evidence/secretin-autism · published September 2026 · updated September 2026

Question: Did the randomized trials of secretin for autism support the treatment?
Short answer: No. A scoped census returns 19 randomized-type records; all 19 were opened, 16 are randomized trials of secretin in autism, and every one of the 16 reports no benefit on its primary measures.

#### The measured set
The number of randomized trials of secretin in autism is usually reported as a handful. It is not. A scoped census run against PubMed in September 2026 — the query pairing secretin with autism, autistic and pervasive developmental — returns 132 indexed records, 22 under the clinical-trial publication type and 19 under the randomized-controlled-trial type [1]. The filter was proved live in the same run: the control term aspirin returned 6,115 records under the identical randomized filter and 8,906 under the clinical-trial filter, the invalid tag clinicaltrial[pt] returned zero for that same control term, and a deliberately invalid record identifier errored [1].
All 19 randomized-type records were retrieved and opened, because a count is not a reading. Sixteen are randomized trials of secretin in autism or pervasive developmental disorder. Of the remaining three, one is a published Comment on another paper, one is a trial in refractory schizophrenia rather than autism, and one is a dietary-intake study that carries the tag without testing the peptide [1]. Sixteen is therefore the figure this review argues from, and it is a measured figure rather than a selected one.

#### What the sixteen found
The sequence opens in the New England Journal of Medicine in 1999. Sixty children were randomized to a single dose of synthetic human secretin or placebo and 56 completed; secretin was not associated with significant improvement in any outcome measure, and the authors concluded that a single dose is not an effective treatment for autism or pervasive developmental disorder [2].
The obvious objections were then tested one at a time. Wrong dose: a randomized placebo-controlled trial of repeated doses of porcine secretin found no group differences on formal measures of language, cognition or autistic symptomatology, and no effect in subgroups defined by cognitive level, diarrhea or a history of regression [3]. A separate controlled study of multiple doses reported that they did not produce any symptomatic improvement [4]. Wrong preparation: a three-arm trial randomized 85 children to biologic porcine secretin, synthetic porcine secretin or placebo and found no amelioration beyond placebo from either preparation, whether or not the children had gastrointestinal problems [5]. Wrong route: a crossover trial of transdermal secretin in 15 children found no significant differences in speech, sociability, sensory or health scores [6].
The larger parallel-group trials agree. A 2000 trial randomized 95 children and found no significant differences in language or autistic behavior at three weeks [7]. A 2001 multisite crossover trial in 56 children reported a change in the primary Autism Diagnostic Observation Schedule social-communication score of -0.8 on placebo against -0.6 on secretin, t54 = 0.346, p < .73, and concluded that there was no evidence for efficacy [8]. A 42-child crossover trial of intravenous synthetic human secretin is titled for its result [9]. A 61-child trial concluded that a single intravenous dose is not effective in changing behavior and communication [10]. A trial of single-dose intravenous secretin in children found no significant differences at six weeks [11].
The most quietly devastating entry tested the mechanism of the belief rather than the drug. Under double-blind conditions, parents of young children with autism were unable to distinguish secretin from placebo: 27 families guessed their child's assignment correctly and 27 guessed incorrectly [12].

#### The two positive signals, stated in full
A negative literature is only trustworthy if it reports its own exceptions, and this one has two. In the single-dose intravenous trial, a marginally statistically significant improvement in autistic behaviors appeared in the treatment group at three weeks after injection, p = .051, which had disappeared by the six-week primary assessment; the authors describe the effect as transient and marginal [11]. In the transdermal crossover trial, improvement in speech reached p = 0.0479 among the subset of children not taking other medications [6].
Both are unadjusted, both are secondary to a primary endpoint that was missed, and one of them sits inside a fifteen-child study. Neither author team claimed more. Reported honestly, they are what a well-powered negative literature looks like when it is not suppressed, and they do not disturb the conclusion the other fifteen trials reached.

#### What secretin is actually for
The approved use is diagnostic and narrow. Given intravenously, secretin provokes a measurable pancreatic response, and controlled work established that synthetic porcine secretin performs accurately in pancreatic function testing in people with chronic pancreatitis [13]. Two products remain marketed on that basis: ChiRhoStim, synthetic human secretin, approved April 9, 2004, and Porcine Secretin, approved April 4, 2002; two earlier products are recorded as discontinued [14].
The distance between that indication and the one the trials tested is the ordinary distance between a diagnostic agent and a therapeutic claim. It is worth naming because the compound's fame ran entirely the other way.

#### Why this belongs in a regulatory index
The record has a live consequence. Secretin is not only an approved product; the bulk substance is separately nominated for pharmacy compounding, and the section 503A list published May 14, 2026 files "Secretin, human 99%" in Category 3, the category for substances nominated without adequate support to evaluate [15].
A reader who meets that line without the trial record behind it may reasonably infer that something is pending and promising. What is actually on file is a nomination the agency could not evaluate, attached to a molecule whose best-known therapeutic claim was tested sixteen times and did not survive once. The monograph (https://peptideamerica.org/molecules/secretin) carries the dated ledger, and Category 3 (https://peptideamerica.org/evidence/category-3-nominations) explains what that filing is and is not.

#### Sources
1. PubMed, National Library of Medicine. Scoped census run September 2026: the query ("secretin") AND ("autism" OR "autistic" OR "pervasive developmental") returns 132 indexed records, 22 under "clinical trial"[Publication Type] and 19 under "randomized controlled trial"[Publication Type]. All 19 randomized-type records were retrieved and read: 16 are randomized trials of secretin in autism or pervasive developmental disorder, one is a published Comment, one is a trial in refractory schizophrenia, and one is a dietary-intake study. In the same run the control term aspirin returned 6,115 records under the identical randomized filter and 8,906 under the clinical-trial filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22secretin%22%29+AND+%28%22autism%22+OR+%22autistic%22%29+AND+%22randomized+controlled+trial%22%5BPublication+Type%5D
2. Sandler AD, Sutton KA, DeWeese J, Girardi MA, Sheppard V, Bodfish JW. Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder. N Engl J Med. 1999 Dec 9;341(24):1801-6. https://pubmed.ncbi.nlm.nih.gov/10588965/
3. Roberts W, Weaver L, Brian J, Bryson S, Emelianova S, Griffiths AM, et al. Repeated doses of porcine secretin in the treatment of autism: a randomized, placebo-controlled trial. Pediatrics. 2001 May;107(5):E71. https://pubmed.ncbi.nlm.nih.gov/11331721/
4. Sponheim E, Oftedal G, Helverschou SB. Multiple doses of secretin in the treatment of autism: a controlled study. Acta Paediatr. 2002;91(5):540-5. https://pubmed.ncbi.nlm.nih.gov/12113323/
5. Unis AS, Munson JA, Rogers SJ, Goldson E, Osterling J, Gabriels R, et al. A randomized, double-blind, placebo-controlled trial of porcine versus synthetic secretin for reducing symptoms of autism. J Am Acad Child Adolesc Psychiatry. 2002 Nov;41(11):1315-21. https://pubmed.ncbi.nlm.nih.gov/12410073/
6. Ratliff-Schaub K, Carey T, Reeves GD, Rogers MA. Randomized controlled trial of transdermal secretin on behavior of children with autism. Autism. 2005 Jul;9(3):256-65. https://pubmed.ncbi.nlm.nih.gov/15937041/
7. Dunn-Geier J, Ho HH, Auersperg E, Doyle D, Eaves L, Matsuba C, et al. Effect of secretin on children with autism: a randomized controlled trial. Dev Med Child Neurol. 2000 Dec;42(12):796-802. https://pubmed.ncbi.nlm.nih.gov/11132252/
8. Owley T, McMahon W, Cook EH, Laulhere T, South M, Mays LZ, et al. Multisite, double-blind, placebo-controlled trial of porcine secretin in autism. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1293-9. https://pubmed.ncbi.nlm.nih.gov/11699803/
9. Molloy CA, Manning-Courtney P, Swayne S, Bean J, Brown JM, Murray DS, et al. Lack of benefit of intravenous synthetic human secretin in the treatment of autism. J Autism Dev Disord. 2002 Dec;32(6):545-51. https://pubmed.ncbi.nlm.nih.gov/12553591/
10. Levy SE, Souders MC, Wray J, Jawad AF, Gallagher PR, Coplan J, et al. Children with autistic spectrum disorders. I: comparison of placebo and single dose of human synthetic secretin. Arch Dis Child. 2003 Aug;88(8):731-6. https://pubmed.ncbi.nlm.nih.gov/12876177/
11. Coniglio SJ, Lewis JD, Lang C, Burns TG, Subhani-Siddique R, Weintraub A, et al. A randomized, double-blind, placebo-controlled trial of single-dose intravenous secretin as treatment for children with autism. J Pediatr. 2001 May;138(5):649-55. https://pubmed.ncbi.nlm.nih.gov/11343038/
12. Coplan J, Souders MC, Mulberg AE, Belchic JK, Wray J, Jawad AF, et al. Children with autistic spectrum disorders. II: parents are unable to distinguish secretin from placebo under double-blind conditions. Arch Dis Child. 2003 Aug;88(8):737-9. https://pubmed.ncbi.nlm.nih.gov/12876178/
13. Somogyi L, Cintron M, Toskes PP. Synthetic porcine secretin is highly accurate in pancreatic function testing in individuals with chronic pancreatitis. Pancreas. 2000 Oct;21(3):262-5. https://pubmed.ncbi.nlm.nih.gov/11039470/
14. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Read September 2026: four applications name secretin as an active ingredient. NDA 021256 (ChiRhoStim, synthetic human secretin, 16 and 40 microgram vials, intravenous) carries an original approval date of April 9, 2004 and prescription marketing status; NDA 021209 (Porcine Secretin) carries an original approval date of April 4, 2002 and prescription status; NDA 021136 (SecreFlo) and NDA 018290 (Secretin-Ferring) are recorded as discontinued. A deliberately invented ingredient name returned no records in the same run. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22SECRETIN%22
15. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: the entry "Secretin, human 99%" appears in Category 3 and in neither Category 1 nor Category 2. https://www.fda.gov/media/94155/download

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### Thymulin's Eight Trials Measure Zinc
https://peptideamerica.org/evidence/thymulin-trial-records · published September 2026 · updated September 2026

Question: Do thymulin's eight trial-type records show that the peptide has been tested in people?
Short answer: No. All eight were opened: seven measure the body's own thymulin as a marker of zinc status inside zinc-supplementation trials, and the eighth administers a different molecule, a synthetic analogue, in a 1989 pilot.

#### The count
PubMed holds 498 indexed records for thymulin under the two names the literature uses, of which 226 carry the Humans subject heading, 8 the clinical-trial publication type, and 5 the randomized-controlled-trial type [1]. The publication-type filters were proved live in the same run: the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter, the invalid tag clinicaltrial[pt] returned zero for that same control term, and a deliberately invalid record identifier errored [1].
Eight is a number a marketer can use and a reader can check, which is why it is worth checking. Eight is also small enough to itemize, so every one of the eight was retrieved and read rather than counted.

#### What the eight records are
Seven of the eight do not administer thymulin. They measure the concentration of the body's own thymulin as a readout of something else, almost always zinc status, because the molecule is biologically active only when bound to zinc and therefore makes a convenient marker for zinc sufficiency.
One is a trial of zinc supplementation in patients with Crohn's disease, which reported that zinc restored plasma concentrations of both zinc and thymulin [2]. Another is a trial of zinc supplementation in young rural Gambian children [3]. The remainder run along the same line: zinc supplementation in children with Down's syndrome, zinc as an adjunct to zidovudine therapy, a zinc-fortified skim milk, thymulin concentrations tracked against melatonin, and thymulin measured against prenatal and childhood exposures in adolescents [1].
The eighth record does administer something, and it is not thymulin. A 1989 double-blind pilot study tested nonathymulin — a synthetic analogue — in multiple sclerosis [4]. That is the whole of the administered human record indexed under these names: one pilot study, of a different molecule, in an unrelated field, thirty-seven years ago.

#### Why the count exists at all
This is not a search artifact to be tuned away. The searches are correct and the records genuinely concern thymulin; what they do not do is test it. The count exists because a molecule that serves as a biomarker accumulates trial-type records from every field that uses the marker, and a publication-type filter cannot distinguish a substance that was given from a substance that was measured.
No filter can make that distinction, which is the general lesson. A trial count is a count of publication types, and the only way to know whether the records administer the compound is to open them. This index therefore records, beside every small count it prints, whether the hits were read and what they were; the human trial record (https://peptideamerica.org/reference/trial-record) carries that column, and this row is the reason the column exists.

#### What is left of the claim
Thymulin is sold as research-use-only material on claims about immune function and thymic aging. The honest statement of its human record is that no indexed trial has administered it to a person, that a synthetic analogue has one 1989 pilot in an unrelated indication, and that everything else counted under the name is a measurement of endogenous concentration.
The regulatory record is correspondingly thin. The section 503A bulks list published May 14, 2026 files Thymulin acetate in Category 3, the category for substances nominated without adequate support to evaluate, and Drugs@FDA holds no approved product with thymulin as an active ingredient [5, 6]. The monograph (https://peptideamerica.org/molecules/thymulin) carries the dated ledger, and Category 3 (https://peptideamerica.org/evidence/category-3-nominations) explains what that filing means.

#### Sources
1. PubMed, National Library of Medicine. Census run September 2026 across two name variants — "thymulin" OR "serum thymic factor" — returning 498 indexed records, 226 carrying the Humans MeSH term, 8 under "clinical trial"[Publication Type] and 5 under "randomized controlled trial"[Publication Type]. All 8 trial-type records were retrieved through esummary and read individually; seven measure endogenous thymulin as a marker of zinc status and one administers a synthetic analogue. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22thymulin%22+OR+%22serum+thymic+factor%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. Brignola C, Belloli C, De Simone G, Evangelisti A, Parente R, Mancini R, et al. Zinc supplementation restores plasma concentrations of zinc and thymulin in patients with Crohn's disease. Aliment Pharmacol Ther. 1993 Jun;7(3):275-80. https://pubmed.ncbi.nlm.nih.gov/8364132/
3. Bates CJ, Evans PH, Dardenne M, Prentice A, Lunn PG, Northrop-Clewes CA, et al. A trial of zinc supplementation in young rural Gambian children. Br J Nutr. 1993 Jan;69(1):243-55. https://pubmed.ncbi.nlm.nih.gov/8457531/
4. Roullet E, Cesaro P, Simon-Lavoine N, Degos JD, Marteau R. Nonathymulin treatment of multiple sclerosis: double-blind pilot study. Acta Neurol Scand. 1989 Dec;80(6):575-8. https://pubmed.ncbi.nlm.nih.gov/2618585/
5. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: Thymulin acetate appears in Category 3 and in neither Category 1 nor Category 2. https://www.fda.gov/media/94155/download
6. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe run September 2026: a search by active-ingredient name returned no records for thymulin. In the same run and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none — a positive and a negative control beside the zero. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22THYMULIN%22

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### What the GHRP Trial Records Measure
https://peptideamerica.org/evidence/ghrp-provocation-studies · published September 2026 · updated September 2026

Question: Do the trial records for GHRP-2 and GHRP-6 support the uses the compounds are sold for?
Short answer: No. All 115 titles were read: they are overwhelmingly pituitary provocation and diagnostic studies, giving the peptide to measure hormone release rather than to treat anything, and the GHRP-6 count also draws in neighboring compounds and animal work.

#### The two counts
PubMed holds, for GHRP-2 across six name variants, 260 indexed records with 160 carrying the Humans subject heading, 59 the clinical-trial publication type and 43 the randomized-controlled-trial type [1]. For GHRP-6 across five name variants it returns 801 indexed records, 316 with the Humans heading, 56 under the clinical-trial type and 25 under the randomized type [2].
Both runs carried their controls. The publication-type filters were proved live against a control term returning 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned zero for that same control term; and a deliberately invalid record identifier errored in the same run [1, 2].
One hundred and fifteen trial-type records between two compounds is a substantial number by the standards of this index, where several molecules return none. It is larger than the count for any other unapproved growth hormone secretagogue here. Every one of the 115 titles was retrieved and read.

#### What the GHRP-2 records contain
The dominant design is a provocation test. The peptide is given once, or over a few hours, and growth hormone, adrenocorticotropic hormone or cortisol release is measured under varying hormonal conditions — across sex-steroid clamps, estradiol repletion, age strata, visceral adiposity, and combinations with growth hormone-releasing hormone. A large share of those records come from a single physiology group working on the regulation of growth hormone pulses [1].
The records that are not provocation studies are few and specific. A phase 1 study established pharmacokinetics and pharmacodynamics in children [3]. An eight-month study of graded doses in growth-hormone-deficient children is the longest administration record indexed [4]. One study measured the effect on food intake in obese adults [5], and one established the compound as a diagnostic test for growth hormone deficiency in adults [6]. One record is a study in pigs [1].
None of that is a trial of the compound for the purposes it is sold for. A provocation study establishes that the peptide releases growth hormone; it does not establish that releasing growth hormone in a person who is not deficient produces any clinical outcome, and no record in the set was designed to answer that. The longest administration record is a dose-ranging study in deficient children, which is a different population from the one buying the material.

#### What the GHRP-6 count actually covers
GHRP-6's 56 records carry an additional problem, and it is one no count can show. The name variants that identify the compound also identify its whole pharmacological neighborhood: the union draws in hexarelin, ghrelin itself, the non-peptide mimetics MK-677 and L-692,429 that were developed from the hexapeptide, and animal work in cattle, dogs and rats [2].
Fifty-six is therefore not fifty-six trials of GHRP-6, and a page that reported it as such would attribute a receptor family's literature to one molecule sold from it. What remains after reading is again a provocation and diagnostic literature: growth hormone and adrenocorticotropic hormone responses, adrenal-insufficiency and growth-hormone-deficiency testing, including a trial proposing the combination with growth hormone-releasing hormone as a diagnostic alternative to the insulin tolerance test [7]. One study measured the effect on sleep architecture alongside the hormonal response [8]. One pharmacokinetic study administered the peptide to nine healthy male volunteers [9].
The single indexed record reporting a therapeutic outcome is not a trial of GHRP-6 alone: a 2026 phase 3 open-label randomized trial in acute ischemic stroke tested epidermal growth factor combined with growth hormone releasing hexapeptide, and it was conducted outside the United States [10]. A combination product studied for a neurological indication abroad is not evidence for what is sold here.

#### The regulatory position the counts do not change
Both compounds sit in Category 3 of the section 503A bulks list published May 14, 2026, the file for substances nominated without adequate support to evaluate [11]. Both are simultaneously in Category 2 under the separate section 503B policy governing outsourcing facilities, added September 29, 2023, where FDA does state safety concerns [12]. Neither was among the seven peptides the advisory committee reviewed in July 2026.
That pairing is the useful summary. These are not obscure molecules with no human exposure; they have been given to people many times, carefully, and measured. What has never been done is a trial of them as a treatment, and the size of the count is what conceals it. The monographs (https://peptideamerica.org/molecules/ghrp-2) carry each dated ledger, GHRP-6 (https://peptideamerica.org/molecules/ghrp-6) carries its own, and Category 3 (https://peptideamerica.org/evidence/category-3-nominations) explains the filing both share.

#### Sources
1. PubMed, National Library of Medicine. Census run September 2026 across six name variants — "GHRP-2" OR "GHRP 2" OR "pralmorelin" OR "growth hormone releasing peptide-2" OR "growth hormone-releasing peptide 2" OR "KP-102" — returning 260 indexed records, 160 carrying the Humans MeSH term, 59 under "clinical trial"[Publication Type] and 43 under "randomized controlled trial"[Publication Type]. All 59 clinical-trial titles were retrieved through esummary and read. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22GHRP-2%22+OR+%22pralmorelin%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. PubMed, National Library of Medicine. Census run September 2026 across five name variants — "GHRP-6" OR "GHRP 6" OR "growth hormone releasing peptide-6" OR "growth hormone-releasing peptide 6" OR "growth hormone releasing hexapeptide" — returning 801 indexed records, 316 carrying the Humans MeSH term, 56 under "clinical trial"[Publication Type] and 25 under "randomized controlled trial"[Publication Type]. All 56 clinical-trial titles were retrieved through esummary and read; the union includes hexarelin, ghrelin, the mimetics MK-677 and L-692,429, and animal studies. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22GHRP-6%22+OR+%22growth+hormone+releasing+hexapeptide%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
3. Pihoker C, Kearns GL, French D, Bowers CY. Pharmacokinetics and pharmacodynamics of growth hormone-releasing peptide-2: a phase I study in children. J Clin Endocrinol Metab. 1998 Apr;83(4):1168-72. https://pubmed.ncbi.nlm.nih.gov/9543135/
4. Mericq V, Cassorla F, Salazar T, Avila A, Iñiguez G, Bowers CY, et al. Effects of eight months treatment with graded doses of a growth hormone (GH)-releasing peptide in GH-deficient children. J Clin Endocrinol Metab. 1998 Jul;83(7):2355-60. https://pubmed.ncbi.nlm.nih.gov/9661608/
5. Laferrère B, Hart AB, Bowers CY. Obese subjects respond to the stimulatory effect of the ghrelin agonist growth hormone-releasing peptide-2 on food intake. Obesity (Silver Spring). 2006 Jun;14(6):1056-63. https://pubmed.ncbi.nlm.nih.gov/16861611/
6. Chihara K, Shimatsu A, Hizuka N, Tanaka T, Seino Y, Katofor Y. A simple diagnostic test using GH-releasing peptide-2 in adult GH deficiency. Eur J Endocrinol. 2007 Jul;157(1):19-27. https://pubmed.ncbi.nlm.nih.gov/17609397/
7. Popovic V, Leal A, Micic D, Koppeschaar HP, Torres E, Paramo C, et al. GH-releasing hormone and GH-releasing peptide-6 for diagnostic testing in GH-deficient adults. Lancet. 2000 Sep 30;356(9236):1137-42. https://pubmed.ncbi.nlm.nih.gov/11030292/
8. Frieboes RM, Murck H, Maier P, Schier T, Holsboer F, Steiger A. Growth hormone-releasing peptide-6 stimulates sleep, growth hormone, ACTH and cortisol release in normal man. Neuroendocrinology. 1995 May;61(5):584-9. https://pubmed.ncbi.nlm.nih.gov/7617137/
9. Cabrales A, Gil J, Fernández E, Valenzuela C, Hernández F, García I, et al. Pharmacokinetic study of Growth Hormone-Releasing Peptide 6 (GHRP-6) in nine male healthy volunteers. Eur J Pharm Sci. 2013 Jan 23;48(1-2):40-6. https://pubmed.ncbi.nlm.nih.gov/23099431/
10. Hernández-Bernal F, Subirós-Martínez N, Gutiérrez-Ronquillo JH, Colina-Ávila E, Guevara-Rodríguez M, Estenoz-García D, et al. Phase III Open-Label, Randomized Clinical Trial of Epidermal Growth Factor and Growth Hormone Releasing Hexapeptide in Acute Ischemic Stroke. J Clin Neurosci. 2026 Oct;152:112195. https://pubmed.ncbi.nlm.nih.gov/42462342/
11. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full September 2026: GHRP-2 appears in Category 3 and in neither Category 1 nor Category 2. https://www.fda.gov/media/94155/download
12. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026. Read September 2026: the Category 2 table lists Growth hormone releasing peptide-6 (GHRP-6) under the 503B policy, date added September 29, 2023. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

---

### Epitalon and the Lifespan Claims
https://peptideamerica.org/evidence/epitalon-longevity · published September 2026 · updated September 2026

Question: Does the evidence support the lifespan and telomerase claims made for Epitalon?
Short answer: No. The telomerase finding is a 2003 cell-culture report; the nine trial-type human records belong almost entirely to epithalamin, a glandular extract, appear in Russian journals or their translated editions, and the most recent was published in 2011.

#### What is the claim, and what is it standing on?
Epitalon is sold on two related promises: that it lengthens telomeres, and that it extends life. The first rests on a single 2003 report in which the tetrapeptide induced telomerase activity and telomere elongation in cultured human fetal fibroblasts [1]. That is a dish, not a person, and the paper came from the St. Petersburg institute that designed the peptide; a 2025 review collects what has and has not been replicated since [2].
The reach of the telomere claim in the literature is measurable. Searched in September 2026, the two tetrapeptide names combined with telomere terms return 10 indexed records, 6 of which carry the Humans subject heading and none of which carries either trial publication type [3]. Six human-tagged records is the whole telomere file, and a human-tagged record is not a person who was dosed and followed; the monograph (https://peptideamerica.org/molecules/epitalon) records the regulatory position; the evidence is counted below.

#### How many human trials of Epitalon exist?
Nine, on the most generous search, and one on the strict one. Across four names — the tetrapeptide as Epitalon or Epithalon, the parent extract epithalamin, and the sequence Ala-Glu-Asp-Gly — PubMed returns 215 indexed records, 79 tagged Humans, 9 under the clinical-trial publication type and 6 under the randomized type [3]. The tetrapeptide names alone return 114 records, 35 tagged Humans, 1 under the clinical-trial type and 0 under the randomized type [3].
A filter that has stopped matching returns zero for every substance in the database, so the same session put a control term with a large trial literature through the identical filters, and the reference records those counts beside the tetrapeptide's one [3].
Each of the nine records was read. Eight study epithalamin or an unnamed pineal-gland peptide preparation, in cervical cancer in 1979 and 1999, craniocerebral trauma in 2004, melatonin rhythm in 2004, arterial pressure in 2008, and the geroprotective series of 2003, 2006 and 2011; six of the nine are Russian-language publications, and every one appears in a Russian journal or its translated edition or carries the designing institute's authors [3]. The trial record (https://peptideamerica.org/reference/trial-record) prints the same nine beside every other count in the index.

#### What do the epithalamin studies report, and why do they not transfer?
The lifespan claim traces to three papers that share an author. A 2011 report followed 39 coronary patients given six courses of epithalamin over three years against 40 patients on basic therapy alone, and reported lower mortality over a 15-year follow-up [5]. A 2006 report from the same authors described a 12-year randomized study in elderly coronary patients in which deaths in the treated group were 28% fewer than in the control group [6]. A 2003 report assessed thymalin and epithalamin in 266 elderly and older persons over six to eight years and reported mortality 1.6- to 1.8-fold lower in the epithalamin group than in the control [7].
Those are the strongest numbers in the file, and none of them concerns the compound in the vial. Epithalamin is a crude extract of pineal gland; Epitalon is a four-amino-acid synthetic designed later as a defined stand-in for it. A mortality figure measured on the extract is a fact about the extract. The abstracts do not describe blinding or placebo, the comparisons are against basic therapy, and the three reports share authors; none of that is disqualifying, and all of it is what a reader would want to know before the word randomized is allowed to carry the claim.

#### What is the one trial that names the tetrapeptide?
It is a 2002 report in retinitis pigmentosa. Its abstract describes work in Campbell rats and in patients with degenerative retinal lesions, states a positive clinical effect in 90% of cases, and gives no denominator, no comparison group and no endpoint definition [4]. PubMed tags it as a controlled clinical trial, which is why it is counted here; nothing about it concerns aging, telomeres or lifespan.
That is the entire controlled human record of the marketed molecule for any endpoint. Under the stricter randomized-controlled-trial type the tetrapeptide returns nothing at all [3]. The honest statement is therefore not that Epitalon has failed a lifespan trial; it is that no such trial has been run, and the extrapolation from a fibroblast culture and a glandular extract to a longevity product is being made by the seller, not by the literature.

#### Where does that leave the regulatory position?
Epitalon left Category 2 of the interim 503A bulks list in April 2026 without Category 1 listing, and in July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding it to the section 503A list. The margin is reported as 7–4 with one abstention by McDermott Will & Schulte and by LumaLex Law, whose separate accounts agree substance by substance [8, 9]; the FDA has published no minutes, transcript or vote summary, so the figure is secondary and this page says so where it prints it. The vote ledger (https://peptideamerica.org/reference/pcac-july-2026) carries the sourcing for the whole meeting.
The FDA's own safety entry for the substance, still published among substances nominated but withdrawn, states that the agency has not identified safety-related information for the proposed route of administration and lacks sufficient information to know whether the drug would cause harm if administered to humans [10]. The substance appears in no category of the bulks list published on May 14, 2026 [11], and Drugs@FDA holds no application under either spelling of the name, while the same query returned an approved application for a control term in the same run [12]. The vote is advisory; the pending (https://peptideamerica.org/status/pending) page explains what it changes, which is nothing yet, and material sold under the name is research-use-only supply outside pharmacy oversight.

#### Sources
1. Khavinson VKh, Bondarev IE, Butyugov AA. Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells. Bull Exp Biol Med. 2003;135(6):590–592. https://pubmed.ncbi.nlm.nih.gov/12937682/
2. Araj SK, Brzezik J, Mądra-Gackowska K, Szeleszczuk Ł. Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties. Int J Mol Sci. 2025 Mar 17;26(6). https://pubmed.ncbi.nlm.nih.gov/40141333/
3. PubMed, National Library of Medicine. Census run September 2026 across four name variants — "Epitalon" OR "Epithalon" OR "epithalamin" OR "Ala-Glu-Asp-Gly" — returning 215 indexed records, 79 carrying the Humans MeSH term, 9 under "clinical trial"[Publication Type] and 6 under "randomized controlled trial"[Publication Type]; 106 of the 215 are Russian-language records and 6 of the 9 trial-type records are Russian-language. The two tetrapeptide names alone — "Epitalon" OR "Epithalon" — return 114 records, 35 tagged Humans, 1 under the clinical-trial type and 0 under the randomized type; the tetrapeptide names combined with telomer* return 10 records, 6 tagged Humans, none of either trial type. All nine trial-type records were opened and read: one names the tetrapeptide (a 2002 retinitis pigmentosa report); the other eight study epithalamin or an unnamed pineal-gland peptide preparation, in cervical cancer (1979, 1999), craniocerebral trauma (2004), melatonin rhythm (2004), arterial pressure (2008) and the geroprotective series of 2003, 2006 and 2011. Every one appears in a Russian journal or its translated edition, or carries the designing institute's authors. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. The counts reproduce the August 2026 run behind the trial-record table exactly. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22Epitalon%22+OR+%22Epithalon%22+OR+%22epithalamin%22+OR+%22Ala-Glu-Asp-Gly%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
4. Khavinson V, Razumovsky M, Trofimova S, Grigorian R, Razumovskaya A. Pineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa. Neuro Endocrinol Lett. 2002;23(4):365–368. https://pubmed.ncbi.nlm.nih.gov/12195242/
5. Korkushko OV, Khavinson VKh, Shatilo VB, Antonyk-Sheglova IA. Peptide geroprotector from the pituitary gland inhibits rapid aging of elderly people: results of 15-year follow-up. Bull Exp Biol Med. 2011;151(3):366–369. https://pubmed.ncbi.nlm.nih.gov/22451889/
6. Korkushko OV, Khavinson VKh, Shatilo VB, Antonyuk-Shcheglova IA. Geroprotective effect of epithalamine (pineal gland peptide preparation) in elderly subjects with accelerated aging. Bull Exp Biol Med. 2006;142(3):356–359. https://pubmed.ncbi.nlm.nih.gov/17426848/
7. Khavinson VKh, Morozov VG. Peptides of pineal gland and thymus prolong human life. Neuro Endocrinol Lett. 2003;24(3-4):233–240. https://pubmed.ncbi.nlm.nih.gov/14523363/
8. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. Its vote table gives Epitalon (free base / acetate), on Friday, July 24, as "7 – 4 (1 abstention)", recommended for inclusion.
9. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.
10. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entry for Epitalon. Read September 2026. The entry states that compounded drugs containing epitalon may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities, that FDA has not identified safety-related information regarding epitalon for the proposed route of administration, and that the agency therefore lacks sufficient information to know whether the drug would cause harm if administered to humans. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
11. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full September 2026: neither "Epitalon" nor "Epithalon" occurs anywhere in the document, so the substance appears in none of Category 1, Category 2, or Category 3. Control in the same read: the same document names GHK-Cu six times. https://www.fda.gov/media/94155/download
12. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name, the substance name and the brand name for "epitalon" and "epithalon": no matching application. Control in the same run: the identical query for "bremelanotide" returned NDA 210557. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22epitalon%22

---

### GHK-Cu: Topical Evidence, Injectable Sales
https://peptideamerica.org/evidence/ghk-cu-topical-versus-injectable · published September 2026 · updated September 2026

Question: Does the cosmetic-science evidence for copper tripeptide support injecting it?
Short answer: No. The two human trials apply the tripeptide to skin and one found it no better than placebo; the injection-scoped literature holds no trial of any type, a topical product sold for appearance is a cosmetic, and the injectable form sits on no list.

#### What is GHK-Cu, and what has been tested in people?
GHK-Cu is the tripeptide glycyl-histidyl-lysine complexed with copper, identified in human plasma and carrying a topical cosmetic literature of its own [1]. Searched in September 2026 across three names, PubMed returns 197 indexed records, 71 tagged Humans, 3 under the clinical-trial publication type and 3 under the randomized type [4]. Split by route in the search itself, the names combined with skin, wound and cosmetic terms return 116 records and the same 3 trial-type records, while combined with injection terms they return 23 records, 3 of them tagged Humans and 0 under either trial type [4].
All three trial-type records were opened. One is a 2006 wound study in rabbits [4]. The other two are the entire human trial record of the molecule, and both applied it to skin: a 1992 venous-ulcer trial and a 2006 trial on laser-resurfaced skin [5, 6]. The filters were proved live against a control term in the same session, and the reference records the counts [4].

#### What did the two human trials find?
The 1992 trial randomized patients with venous stasis ulcers to a 0.4% copper tripeptide cream, to 1% silver sulfadiazine cream, or to an inert vehicle, with blinded evaluators; 86 evaluable patients completed it. Silver sulfadiazine reduced ulcer size more than either of the other two arms, and there was no difference between the copper tripeptide cream and the placebo [5].
The 2006 trial randomized patients undergoing circumoral carbon dioxide laser resurfacing to a post-treatment skin regimen with or without GHK-Cu; 13 patients completed it. Computer analysis and blinded evaluators found no statistically significant difference in the resolution of redness, and no difference between groups in wrinkles or overall skin quality; the one significant result was a questionnaire item on which patients using the product reported higher satisfaction (P = .04) [6].
So the topical record, read rather than summarized, is one negative trial against placebo and one small trial in which the objective measures were flat. The review literature describing the tripeptide's effects on collagen signaling and skin regeneration is built largely from cell culture and small cosmetic studies [1], and a 2026 review of peptide therapies for musculoskeletal and performance uses finds no clinical trial support for the injectable form [2]. None of that is the injected product's evidence, because the injected product has no evidence of its own.

#### What are the three injection-scoped human records?
They were opened, because three human-tagged records under an injection search is exactly the number a seller would round up to a trial. One is a biomaterials paper on polymer microspheres. One is a 2026 review written as a primer on injectable peptides for sports physicians. One is a 2018 pilot of a hair-growth formulation injected intradermally into the scalp [4]. Not one is a trial of injected GHK-Cu, and the injection-scoped search returns nothing at all under either trial publication type [4].
The gap between the two routes is therefore not a matter of degree. The topical literature has trials, thin and mostly negative; the injectable literature has none. A vial sold for regeneration is borrowing its evidence from a cream, and the cream's evidence is what the two paragraphs above describe. The trial record (https://peptideamerica.org/reference/trial-record) prints the counts beside every other molecule in the index.

#### Why is the topical product legal and the injectable not?
They are regulated under different parts of the same statute, and the dividing line is intended use. FDA states that cosmetic products and ingredients do not need premarket approval, with the exception of color additives; that the Federal Food, Drug, and Cosmetic Act defines a cosmetic by its intended use, as an article applied to the body for cleansing, beautifying, promoting attractiveness or altering the appearance; and that a product intended to treat or prevent disease or to affect the structure or function of the body is a drug even if it also affects the appearance [7]. A serum sold to smooth skin is a cosmetic. A vial sold to heal tissue is a drug, and a drug with no approval can lawfully be compounded only through the bulks-list process.
That process is where the injectable route stands today. FDA's list document records that GHK-Cu was removed from Category 1 of the interim 503A bulks list on April 22, 2026 because its nominations were withdrawn, that a nominator clarified on May 5, 2026 that it had meant to withdraw only the injectable route, and that GHK-Cu except for injectable routes will be added back to Category 1, where the document lists it; the injectable route was not put back and sits on no list, and FDA states it intends to consult its advisory committee about the substance before the end of February 2027 [3]. FDA's safety-risk page separately carries an entry for GHK-Cu for injectable routes among substances nominated but withdrawn, stating that compounded injectable drugs containing it may pose risk for immunogenicity and that there are limited data in humans to inform safety-related considerations [8]. Drugs@FDA holds no application under the name, while the identical query returned an approved application for a control term in the same run [9].
Two FDA documents describe the same withdrawal with different category language, and both are cited here as written [3, 8]. What neither document leaves open is the position of the injectable form: no category, no approval, no lawful compounding route, and a written FDA statement that the human data are limited. The research-only (https://peptideamerica.org/status/research-only) page explains why leaving a list is not permission, and the nomination tracker (https://peptideamerica.org/reference/nominations) files the substance by what became of its nomination.

#### Where does that leave a buyer?
With a cosmetic that is legal, lightly evidenced and unremarkable, and an injectable that is none of those. Material sold under the name for injection is research-use-only chemical supply, produced and sold outside pharmacy licensure and quality standards; the research-use-only (https://peptideamerica.org/glossary/research-use-only) entry sets out what that posture does and does not mean. The monograph (https://peptideamerica.org/molecules/ghk-cu) carries the dated regulatory ledger, and the repair peptides (https://peptideamerica.org/classes/repair-peptides) class sets this molecule beside BPC-157 (https://peptideamerica.org/molecules/bpc-157) and TB-500 (https://peptideamerica.org/molecules/tb-500), both of which appear on the July 2026 committee agenda in the vote ledger (https://peptideamerica.org/reference/pcac-july-2026), and both of which share with it a human record that does not contain the use they are sold for.

#### Sources
1. Pickart L, Vasquez-Soltero JM, Margolina A. GHK Peptide as a Natural Modulator of Multiple Cellular Pathways in Skin Regeneration. Biomed Res Int. 2015;2015:648108. https://pubmed.ncbi.nlm.nih.gov/26236730/
2. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026 Aug;56(8):1921-1935. https://pubmed.ncbi.nlm.nih.gov/41966639/
3. US Food and Drug Administration. Bulk drug substances nominated for use in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act. Updated May 14, 2026. Read August 2026. The document's update note states that "GHK-Cu (except for injectable routes of administration) was removed from category 1 on April 22, 2026, because the nominations for GHK-Cu were withdrawn by the nominators," that a nominator clarified on May 5, 2026 that it intended to withdraw only the injectable nomination, and that GHK-Cu (except for injectable routes of administration) "will be added back to category 1"; the substance is listed in Category 1 on that page. The 503A Category 2 list on the same document names six substances — cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10, and quinacrine hydrochloride for intrauterine administration — and GHK-Cu is not among them. https://www.fda.gov/media/94155/download
4. PubMed, National Library of Medicine. Census run September 2026 across three name variants — "GHK-Cu" OR "copper tripeptide" OR "glycyl-histidyl-lysine" — returning 197 indexed records, 71 carrying the Humans MeSH term, 3 under "clinical trial"[Publication Type] and 3 under "randomized controlled trial"[Publication Type]. Split by route in the search itself: combined with the terms topical, cream, serum, skin, wound or cosmetic the names return 116 records and the same 3 trial-type records; combined with the terms injection, injectable, subcutaneous, intravenous or intramuscular they return 23 records, 3 of them tagged Humans and 0 under either trial type. The three injection-scoped human-tagged records were opened: a biomaterials paper on polymer microspheres, a 2026 review primer on injectable peptides for sports physicians, and a 2018 pilot of an intradermal hair-growth formulation; none is a trial of injected GHK-Cu. All three trial-type records were opened and read: a 1992 venous-ulcer trial and a 2006 laser-resurfacing trial, both topical, and a 2006 wound study in rabbits. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. The counts reproduce the August 2026 run behind the trial-record table exactly. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22GHK-Cu%22+OR+%22copper+tripeptide%22+OR+%22glycyl-histidyl-lysine%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
5. Bishop JB, Phillips LG, Mustoe TA, et al. A prospective randomized evaluator-blinded trial of two potential wound healing agents for the treatment of venous stasis ulcers. J Vasc Surg. 1992;16(2):251–257. https://pubmed.ncbi.nlm.nih.gov/1495150/
6. Miller TR, Wagner JD, Baack BR, Eisbach KJ. Effects of topical copper tripeptide complex on CO2 laser-resurfaced skin. Arch Facial Plast Surg. 2006;8(4):252–259. https://pubmed.ncbi.nlm.nih.gov/16847171/
7. US Food and Drug Administration. FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated. Content current as of November 18, 2025. Read September 2026. The page states that under the law cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives; that the FD&C Act defines cosmetics by their intended use, as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance (section 201(i)); and that a product intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, is a drug under section 201(g) even if it affects the appearance. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated
8. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entry for GHK-Cu (for injectable routes of administration). Read September 2026. The entry states that compounded injectable drugs containing GHK-Cu may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities, and that there are limited data in humans to inform safety-related considerations. The table is introduced on that page as a list of substances previously in category 2 of the interim policies that were withdrawn by the nominators; the list document cited as reference 3 records the April 22, 2026 removal as a removal from category 1. This index prints both documents as written and does not reconcile them. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
9. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name, the substance name and the brand name for "GHK-Cu": no matching application. Control in the same run: the identical query for "bremelanotide" returned NDA 210557. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22GHK-Cu%22

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### Melanotan II: The Record on a Tanning Peptide
https://peptideamerica.org/evidence/melanotan-ii · published September 2026 · updated September 2026

Question: What is the record on Melanotan II, which was removed from Category 2 and never reviewed?
Short answer: A tanning peptide with no tanning trial. Four trial-type records, all from 1996 to 2000, studied erections; the 23 case reports since include melanoma, priapism, renal infarction and rhabdomyolysis; FDA's safety finding stands, and the substance sits on no list.

#### What was actually tested in people?
Melanotan II is a cyclic analog of alpha-melanocyte-stimulating hormone and a non-selective melanocortin agonist. Across five name variants PubMed returns 360 indexed records, 119 tagged Humans, 4 under the clinical-trial publication type and 1 under the randomized type [5]. All four were opened, and every one was published between 1996 and 2000; re-measured in September 2026 the counts are identical, and the names combined with tanning terms return 23 records of which exactly 1 carries a trial publication type [13].
That one is the 1996 pilot phase I study: three normal male volunteers, subcutaneous doses escalated from 0.01 mg/kg to 0.03 mg/kg in two subjects and to 0.025 mg/kg in the third, two subjects with measurably increased pigmentation a week after dosing ended, and spontaneous erections lasting one to five hours after each dose, which the authors noted in passing [1]. The tanning record of the compound is that paragraph. The three trials that followed pursued the incidental finding instead: a double-blind placebo-controlled crossover in 10 men with psychogenic erectile dysfunction, in which 8 of 10 developed erections and the mean duration of tip rigidity above 80% was 38.0 minutes against 3.0 on placebo (p = 0.0045) [2]; a summary of the human melanocortin program [3]; and a crossover in 10 men with organic erectile dysfunction, in which 12 of 19 injections produced erections against 1 of 21 placebo doses, mean rigidity duration 45.3 against 1.9 minutes (P = 0.047), with severe nausea after 4 of 19 injections [4].
Then the trials stopped. The compound's development lineage continued under a different name, and the monograph (https://peptideamerica.org/molecules/melanotan-ii) records what the marketed product has been sold for since; the trial record (https://peptideamerica.org/reference/trial-record) prints the four records beside every other count in the index.

#### What has been published since the trials stopped?
Case reports. The five names combined with the case-report publication type return 23 records, 21 of them tagged Humans; combined with the term melanoma they return 17 records, 9 of them case reports; the filters were proved live against a control term in the same run, and the reference records the counts [13].
The named cases are specific. Melanoma has been reported in association with use [6]. Renal infarction has been reported, with a review of the literature attached [7]. Priapism has been reported [8]. A 39-year-old man who injected 6 mg bought over the Internet, six times the starting dose he had been told, presented two hours later with a heart rate that peaked at 146, diffuse muscle tremor and a creatine kinase that rose to 17,773 IU/L, spent three days in intensive care for rhabdomyolysis, and the substance he injected was confirmed by mass spectrometry to be Melanotan II [9].
A case report establishes association rather than cause, and nothing here claims more. The shape of the file is the finding: the published benefit for the marketed use is one paragraph about two men in 1996, and the published harm since is a case-report literature that has kept growing since the trials ended [13].

#### What did removal from Category 2 change?
Less than it is reported to have changed. Melanotan II sat in Category 2 of FDA's interim section 503A bulks list, the category for substances that raise significant safety risks, and left it in April 2026 when its nominators withdrew the nomination; it was not added to Category 1 [11], and on the list FDA published on May 14, 2026 it appears in no category at all [10]. It is not among the seven peptides on the July 2026 committee agenda that the vote ledger (https://peptideamerica.org/reference/pcac-july-2026) records, so no panel has weighed its dossier, and the category 2 removal (https://peptideamerica.org/reference/category-2-removal) table sets out why leaving that category confers nothing.
The safety finding did not leave with it. FDA continues to publish the entry among substances nominated but withdrawn: compounded drugs containing Melanotan II may pose a risk for immunogenicity, and published case reports discuss serious adverse events including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism [11]. In April 2020 FDA had already warned a compounding pharmacy that products compounded with Melanotan II and twenty-one other substances were not eligible for the exemptions in section 503A(a) [12]. Drugs@FDA holds no application under the name, while the identical query returned an approved application for a control term in the same run [14]. A substance whose safety statement still stands and whose nomination no longer does is further from lawful compounding than it was, not closer; the research-only (https://peptideamerica.org/status/research-only) page explains why, and the nomination tracker (https://peptideamerica.org/reference/nominations) files it by that outcome.

#### How does it differ from the approved relative?
The erection findings of 1998 and 2000 were not wasted; they were carried forward under a different molecule. PT-141 (https://peptideamerica.org/molecules/pt-141), bremelanotide, is a metabolite of Melanotan II, and its sponsor completed the development program this compound never had: an approved product for one indication in premenopausal women, with a label that states what it does not cover. The PT-141 review (https://peptideamerica.org/evidence/pt-141-status) reads that record and cites the approval letter and the label. The two molecules share a receptor family, a class in this index, and a history, and they share nothing in regulatory status.

#### What is sold under the name?
Research-use-only chemical supply, produced and sold outside pharmacy licensure and prescriber oversight, and bought as the patient in the rhabdomyolysis case bought his, over the Internet, in an amount no label had set [9]. The research-use-only (https://peptideamerica.org/glossary/research-use-only) entry sets out what that posture does and does not mean, and the melanocortins (https://peptideamerica.org/classes/melanocortins) class collects the molecules that share this receptor family. What a buyer receives under this name is a substance with no tanning trial, a standing FDA safety finding, and a case-report file counted above rather than characterized.

#### Sources
1. Dorr RT, Lines R, Levine N, et al. Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study. Life Sci. 1996;58(20):1777–1784. https://pubmed.ncbi.nlm.nih.gov/8637402/
2. Wessells H, Fuciarelli K, Hansen J, et al. Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study. J Urol. 1998;160(2):389–393. https://pubmed.ncbi.nlm.nih.gov/9679884/
3. Wessells H, Levine N, Hadley ME, et al. Melanocortin receptor agonists, penile erection, and sexual motivation: human studies with Melanotan II. Int J Impot Res. 2000;12 Suppl 4:S74–S79. https://pubmed.ncbi.nlm.nih.gov/11035391/
4. Wessells H, Gralnek D, Dorr R, et al. Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction. Urology. 2000;56(4):641–646. https://pubmed.ncbi.nlm.nih.gov/11018622/
5. PubMed, National Library of Medicine. Census run August 2026 across five name variants — "melanotan II" OR "melanotan-II" OR "melanotan 2" OR "melanotan-2" OR "MT-II peptide" — returning 360 indexed records, 119 carrying the Humans MeSH term, 4 under "clinical trial"[Publication Type] and 1 under "randomized controlled trial"[Publication Type]. All four trial-type records were opened and read; every one concerns erectile function or sexual desire and every one was published between 1996 and 2000. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22melanotan+II%22+OR+%22melanotan-II%22+OR+%22melanotan+2%22+OR+%22melanotan-2%22+OR+%22MT-II+peptide%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
6. Paurobally D, Jason F, Dezfoulian B, et al. Melanotan-associated melanoma. Br J Dermatol. 2011;164(6):1403–1405. https://pubmed.ncbi.nlm.nih.gov/21564053/
7. Peters B, Hadimeri H, Wahlberg R, et al. Melanotan II: a possible cause of renal infarction: review of the literature and case report. CEN Case Rep. 2020;9(2):159–161. https://pubmed.ncbi.nlm.nih.gov/31953620/
8. Dreyer BA, Amer T, Fraser M. Melanotan-induced priapism: a hard-earned tan. BMJ Case Rep. 2019;12(2). https://pubmed.ncbi.nlm.nih.gov/30796078/
9. Nelson ME, Bryant SM, Aks SE. Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clin Toxicol (Phila). 2012;50(10):1169–1173. https://pubmed.ncbi.nlm.nih.gov/23121206/
10. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: Melanotan II appears in none of Category 1, Category 2, or Category 3. https://www.fda.gov/media/94155/download
11. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn. Read August 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
12. US Food and Drug Administration. Warning letter, Tailor Made Compounding LLC, case 594743, April 1, 2020. Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
13. PubMed, National Library of Medicine. Census extended September 2026 on the same five name variants as reference 5. The union re-measured at 360 indexed records, 119 tagged Humans, 4 under "clinical trial"[Publication Type] and 1 under "randomized controlled trial"[Publication Type], identical to the August 2026 run. Combined with "case reports"[Publication Type] the names return 23 records, 21 of them tagged Humans; combined with the term melanoma they return 17 records, 9 of them case reports; combined with the terms tanning, tan or sunless they return 23 records, of which exactly 1 carries a trial publication type, and that record is the 1996 pilot phase I study in three volunteers. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22melanotan+II%22+OR+%22melanotan-II%22+OR+%22melanotan+2%22+OR+%22melanotan-2%22+OR+%22MT-II+peptide%22%29+AND+%22case+reports%22%5BPublication+Type%5D
14. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name, the substance name and the brand name for "melanotan": no matching application. Control in the same run: the identical query for "bremelanotide" returned NDA 210557. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22melanotan%22

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### MOTS-c: Mitochondria, No Human Outcomes
https://peptideamerica.org/evidence/mots-c-evidence · published September 2026 · updated September 2026

Question: Does MOTS-c do in people what the exercise-mimetic marketing claims?
Short answer: Not on any published evidence. The mechanism is real in mice; the five human trial-type records measure the body's own circulating MOTS-c after exercise, heat or metformin, or in a disease cohort, and not one administers the peptide to anyone.

#### What is MOTS-c, and what did the discovery paper show?
MOTS-c is a 16-amino-acid peptide encoded by a short open reading frame inside the mitochondrial 12S ribosomal RNA gene, one of a small family of mitochondrial-derived peptides. The 2015 discovery paper reported that in mice it targets skeletal muscle, inhibits the folate cycle and de novo purine synthesis, activates AMPK, and prevented age-dependent and diet-induced insulin resistance as well as diet-induced obesity [1]. That is the origin of the exercise-mimetic label, and it is a mouse finding.
The animal literature has grown around it: 92 of the 254 indexed records carry the mice or rats subject headings [4]. The monograph (https://peptideamerica.org/molecules/mots-c) records the regulatory position with the date it was verified; what has been done in people, and what has been done to them, is counted below.

#### How many human trials administer MOTS-c?
None. Searched in September 2026 across three names, PubMed returns 254 indexed records, 143 tagged Humans, 5 under the clinical-trial publication type and 4 under the randomized type [4]. All five were opened and read, and not one gives the peptide to a person; every one measures the participant's own circulating MOTS-c rather than administering the peptide [4].
The filters were proved live against a control term in the same session, and the reference records the counts beside the five [4]. The trial record (https://peptideamerica.org/reference/trial-record) prints the same five beside every other count in the index.

#### What do the five records actually measure?
A 2021 study randomized 30 subjects to a single bout of endurance exercise, resistance exercise or rest, ten to each, and measured circulating mitochondrial-derived peptides before and after; MOTS-c showed a trend upward after endurance exercise, and plasma levels were not correlated with fitness [5]. A second 2021 study ran a 16-week aerobic and resistance program in 49 breast cancer survivors, 25 Hispanic and 24 non-Hispanic White, and found that circulating MOTS-c rose after exercise in the non-Hispanic White group and not in the Hispanic group [6].
A 2025 study immobilized one ankle of 19 physically active men for two weeks and randomized them to repeated heat treatment or sham, nine and ten respectively; heat raised circulating MOTS-c (P = 0.033) while immobilization alone did not change it [7]. The remaining two are a 2022 study that measured circulating MOTS-c in breast cancer patients randomized to metformin and found no significant change, and a 2020 multicenter study that used the peptide as a predictor of outcome in diabetic patients with coronary disease [4].
Exercise, heat, metformin, prognosis. Each is a study of MOTS-c as a marker, a molecule the body makes more or less of in response to a stimulus; none is a study of MOTS-c as a treatment, a molecule injected to produce an effect. The distinction is the entire question a buyer arrives with, and the literature has not yet asked it.

#### Why does a marker not become a treatment?
Because a rise in an endogenous signal after exercise says nothing about what an injected dose of the same signal does, at what concentration, for how long, or with what off-target effect; those are the questions a first-in-human program exists to answer, and the record contains none. FDA's own entry for the substance says the same thing in regulatory language: the agency has not identified any human exposure data on drug products containing it administered via any route of administration, and lacks important information regarding any safety issues it raises, including whether it would cause harm if administered to humans [8].
That is the regulator stating the same absence the census above measures, and the two agree. A compound sold as an exercise mimetic on the strength of a mouse study and a human marker literature is a compound whose human exposure data, in FDA's words, do not exist.

#### What is the United States position, and what does a seller change?
MOTS-c left Category 2 of the interim 503A bulks list in April 2026 without Category 1 listing, and in July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding it to the section 503A list on a margin reported as 7–5 with two abstentions by McDermott Will & Schulte and by LumaLex Law, whose separate accounts agree substance by substance [2, 3]; the FDA has published no minutes, transcript or vote summary, so the figure is secondary wherever it is printed. The substance appears in no category of the list published on May 14, 2026 [9], and Drugs@FDA holds no application under the name, while the identical query returned an approved application for a control term in the same run [10].
The vote is advisory; the vote ledger (https://peptideamerica.org/reference/pcac-july-2026) carries the sourcing and the pending (https://peptideamerica.org/status/pending) page explains what a recommendation changes, which is nothing until a final rule issues. Material offered under the name is research-use-only chemical supply outside pharmacy licensure, whatever the listing says, and a seller's existence does not alter a substance's status; the mitochondrial (https://peptideamerica.org/classes/mitochondrial) class sets this molecule beside NAD+ (https://peptideamerica.org/molecules/nad), filed in this index as compoundable, for the clearest contrast the index offers.

#### Sources
1. Lee C, Zeng J, Drew BG, et al. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metab. 2015;21(3):443–454. https://pubmed.ncbi.nlm.nih.gov/25738459/
2. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance.
3. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.
4. PubMed, National Library of Medicine. Census run September 2026 across three name variants — "MOTS-c" OR "MOTS-C peptide" OR "mitochondrial open reading frame of the twelve S rRNA type-c" — returning 254 indexed records, 143 carrying the Humans MeSH term, 5 under "clinical trial"[Publication Type] and 4 under "randomized controlled trial"[Publication Type]; 92 records carry the mice or rats MeSH terms, and 25 carry both the term exercise and the Humans term. All five trial-type records were opened and read, and not one administers the peptide: a 2020 multicenter study using circulating MOTS-c as a predictor of outcome in diabetic patients with coronary disease, a 2021 study of circulating MOTS-c after a single bout of endurance or resistance exercise, a 2021 study of circulating MOTS-c after a 16-week exercise program in breast cancer survivors, a 2022 study of circulating MOTS-c in breast cancer patients randomized to metformin that found no significant change, and a 2025 study of circulating MOTS-c after repeated heat exposure during limb immobilization. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. The counts reproduce the August 2026 run behind the trial-record table exactly. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22MOTS-c%22+OR+%22MOTS-C+peptide%22+OR+%22mitochondrial+open+reading+frame+of+the+twelve+S+rRNA+type-c%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
5. von Walden F, Fernandez-Gonzalo R, Norrbom J, et al. Acute endurance exercise stimulates circulating levels of mitochondrial-derived peptides in humans. J Appl Physiol (1985). 2021;131(3):1035–1042. https://pubmed.ncbi.nlm.nih.gov/34351816/
6. Dieli-Conwright CM, Sami N, Norris MK, et al. Effect of aerobic and resistance exercise on the mitochondrial peptide MOTS-c in Hispanic and Non-Hispanic White breast cancer survivors. Sci Rep. 2021;11(1):16916. https://pubmed.ncbi.nlm.nih.gov/34413391/
7. Elhusseiny R, Ihsan M, Labidi M, et al. Repeated Heat Stress Modulates the Levels of the Mitokines MOTS-C and FGF21 in Active Men during Calf Muscle Immobilization. Med Sci Sports Exerc. 2025;57(12):2764–2774. https://pubmed.ncbi.nlm.nih.gov/40674654/
8. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entry for MOTs-C (the page's spelling). Read September 2026. The entry states that compounded drugs containing the substance may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization, that FDA has not identified any human exposure data on drug products containing it administered via any route of administration, and that FDA lacks important information regarding any safety issues it raises, including whether it would cause harm if administered to humans. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
9. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full September 2026: "MOTS" occurs nowhere in the document, so the substance appears in none of Category 1, Category 2, or Category 3. Control in the same read: the same document names GHK-Cu six times. https://www.fda.gov/media/94155/download
10. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name, the substance name and the brand name for "MOTS-c": no matching application. Control in the same run: the identical query for "bremelanotide" returned NDA 210557. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22MOTS-c%22

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### PT-141: The Approval Buyers Do Not Know About
https://peptideamerica.org/evidence/pt-141-status · published September 2026 · updated September 2026

Question: What is PT-141's actual United States posture, and what does its approval cover?
Short answer: PT-141 is bremelanotide, approved in June 2019 under NDA 210557 for premenopausal women with acquired, generalized hypoactive sexual desire disorder and for nothing else; the label excludes men and postmenopausal women, and no compounded or research-use vial is that product.

#### What was approved, and for whom?
PT-141 is the development code for bremelanotide, a synthetic melanocortin receptor agonist and a metabolite of Melanotan II. FDA approved it under new drug application 210557, effective June 21, 2019, as a single-use subcutaneous autoinjector [5]. The label's indication is the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder, and its limitations of use state that the product is not indicated for that disorder in postmenopausal women or in men, and is not indicated to enhance sexual performance [4].
The product remains on the market. Drugs@FDA lists the one application, NDA 210557, now under the sponsor name Cosette, with the product VYLEESI (AUTOINJECTOR) [11]. That is the whole approved footprint: one indication, one population, one dosage form. The monograph (https://peptideamerica.org/molecules/pt-141) records the dated ledger, and the approved (https://peptideamerica.org/status/approved) page sets out what an approval does and does not cover.

#### What is the trial record behind the approval?
A completed development program, which is what distinguishes this molecule from almost everything else in this index. Across four names PubMed returns 121 indexed records, 91 tagged Humans, 16 under the clinical-trial publication type and 14 under the randomized type; all sixteen were opened, and one 2008 record carries a retraction marker in its own title [1]. Re-measured in September 2026 the counts are identical [10]. The trial record (https://peptideamerica.org/reference/trial-record) prints them beside every other molecule in the index.
The registrational evidence is two identical phase 3 trials, RECONNECT (https://peptideamerica.org/evidence/bremelanotide-desire-distress-trials), in which 1,267 premenopausal women with hypoactive sexual desire disorder were randomized to 24 weeks of bremelanotide 1.75 mg as needed or placebo; 1,247 formed the safety population and 1,202 the efficacy population, most were white, from United States sites, with a mean age of 39. Sexual desire rose by 0.35 on the integrated desire score against placebo and distress fell by 0.33, both P<.001, and nausea, flushing and headache each occurred in 10% or more of treated women [3]. The dose-finding trial before it randomized 327 women across three doses and placebo over 12 weeks; the two higher doses pooled produced 0.7 additional satisfying sexual events a month against 0.2 on placebo (p = 0.0180) [8].
Those are modest effects on validated scales in a defined population, measured in trials whose sponsors are named in the paper, and they were sufficient for approval in that population. They say nothing about any other one.

#### What did the men's trials find, and why is there no men's indication?
The program began in men. A 2004 double-blind, placebo-controlled study evaluated intranasal PT-141 in healthy males and in patients with mild-to-moderate erectile dysfunction [2], and within the clinical-trial type the names combined with the terms erectile, men or male return 6 records, against 9 combined with the term premenopausal and 0 combined with the term postmenopausal [10]. The male work exists, in other words, and it is the older half of the file.
The only approval on the record is the women's indication [11], and the label states in terms that the product is not indicated for men [4]. Why a sponsor took one population forward and not the other is not on the record, and the record is what can be stated: the men's studies were run, that no approval followed them, and that a man buying PT-141 for the use those studies examined is buying for a use the approved product's own label excludes.

#### What does the safety record say?
An integrated review of the development program covers 3,500 subjects across 43 completed studies. In the double-blind phase 3 portion, 1,247 subjects, nausea occurred in 40.0% of treated women against 1.3% on placebo, flushing in 20.3% against 1.3%, headache in 11.3% against 1.9%, and injection-site reactions in 5.4% against 0.5%; nausea was the most common reason for stopping, and 70% of the bremelanotide group proceeded to the open-label phase against 87% of those on placebo [9].
Two findings bear directly on how the compound is sold outside its label. Focal hyperpigmentation was rare when the product was dosed as the label directs but occurred in more than one-third of subjects after up to 16 consecutive daily doses, and small transient rises in blood pressure were recorded on ambulatory monitoring, with the authors advising caution in patients at cardiovascular risk [9]. A buyer dosing a research vial daily for its pigmentation effect is reproducing the exposure that produced the first finding, without the monitoring that produced the second.

#### Is compounded or research-grade PT-141 the approved product?
No. Bremelanotide appears in no category of the section 503A bulks list published on May 14, 2026 [6]. In April 2020 FDA warned a compounding pharmacy that products it compounded using bremelanotide (PT-141) and twenty-one other substances were not eligible for the exemptions in section 503A(a) [7]; that letter came about nine months after the June 2019 approval of the branded product, and its reasoning is not extended here past the date it was written, but it establishes that FDA has addressed compounded PT-141 directly.
A vial sold as PT-141 for research use is not the approved product and carries none of its assurances: not its manufacturing standard, not its dose, not its label, and not the safety record above, which was measured on the approved product at the approved dose. The approved peptide drugs (https://peptideamerica.org/reference/approved-peptides) table places bremelanotide beside the rest of the approved set, and Melanotan II (https://peptideamerica.org/molecules/melanotan-ii), the parent it was derived from, shows in the melanocortins (https://peptideamerica.org/classes/melanocortins) class what the same receptor family looks like with no development program completed at all.

#### Sources
1. PubMed, National Library of Medicine. Census run August 2026 across four name variants — "bremelanotide" OR "PT-141" OR "PT 141" OR "Vyleesi" — returning 121 indexed records, 91 carrying the Humans MeSH term, 16 under "clinical trial"[Publication Type] and 14 under "randomized controlled trial"[Publication Type]. All 16 trial-type records were retrieved and read individually; they constitute the compound's development program from 2003 to 2022, and one 2008 record carries a retraction marker in its own title. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22bremelanotide%22+OR+%22PT-141%22+OR+%22Vyleesi%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
2. Diamond LE, Earle DC, Rosen RC, et al. Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction. Int J Impot Res. 2004;16(1):51–59. https://pubmed.ncbi.nlm.nih.gov/14963471/
3. Kingsberg SA, Clayton AH, Portman D, et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019;134(5):899–908. https://pubmed.ncbi.nlm.nih.gov/31599840/
4. US Food and Drug Administration. VYLEESI (bremelanotide injection), for subcutaneous use — prescribing information, NDA 210557 supplement 002, approved October 23, 2020; Indications and Usage, including Limitations of Use. Read August 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf
5. US Food and Drug Administration. NDA 210557 approval letter, June 21, 2019. Read August 2026. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210557Orig1s000ltr.pdf
6. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: bremelanotide appears in none of Category 1, Category 2, or Category 3. https://www.fda.gov/media/94155/download
7. US Food and Drug Administration. Warning letter, Tailor Made Compounding LLC, case 594743, April 1, 2020. Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
8. Clayton AH, Althof SE, Kingsberg S, et al. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Womens Health (Lond). 2016;12(3):325–337. https://pubmed.ncbi.nlm.nih.gov/27181790/
9. Clayton AH, Kingsberg SA, Portman D, et al. Safety Profile of Bremelanotide Across the Clinical Development Program. J Womens Health (Larchmt). 2022;31(2):171–182. https://pubmed.ncbi.nlm.nih.gov/35147466/
10. PubMed, National Library of Medicine. Census extended September 2026 on the same four name variants as reference 1. The union re-measured at 121 indexed records, 91 tagged Humans, 16 under "clinical trial"[Publication Type] and 14 under "randomized controlled trial"[Publication Type], identical to the August 2026 run. Scoped within the clinical-trial type: combined with the terms erectile, men or male the names return 6 records; combined with the term premenopausal, 9; combined with the term postmenopausal, 0. The scoped counts overlap by construction and are not additive. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22bremelanotide%22+OR+%22PT-141%22+OR+%22PT+141%22+OR+%22Vyleesi%22%29+AND+postmenopausal+AND+%22clinical+trial%22%5BPublication+Type%5D
11. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name "bremelanotide": one application, NDA 210557, sponsor name Cosette, product VYLEESI (AUTOINJECTOR). The same query served as the positive control for the absence checks run on other molecules in this index the same day. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bremelanotide%22

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### Semax: A Russian Drug, Unapproved Here
https://peptideamerica.org/evidence/semax-evidence · published September 2026 · updated September 2026

Question: What supports Semax as a nootropic, and what is its United States posture?
Short answer: A drug's standing in Russia is not an approval here. Four trial-type records exist, all published in Russian between 1997 and 2018, none in the English-language literature, and none tests cognitive enhancement in healthy people; Drugs@FDA holds no application under the name.

#### What is Semax, and where is it a drug?
Semax is a synthetic heptapeptide built from the ACTH(4–7) fragment of adrenocorticotropic hormone with a proline-glycine-proline tail added for stability, developed in Moscow and given there as a nasal spray. Its standing as a medicine is a Russian fact as far as its own literature records it: a 2000 ophthalmology report describes it in its own title as a new Russian drug [9], and the clinical literature that follows lives in that country's journals; no registration record was read for this review, and none is claimed.
The mechanistic case for a nootropic effect is real and is where the marketing starts. In rat hippocampus the peptide raises brain-derived neurotrophic factor and trkB receptor expression [1], and it binds brain tissue with measurable specificity [2]. A receptor finding in a rat is the beginning of a claim, not its proof, and the monograph (https://peptideamerica.org/molecules/semax) records the regulatory position with the date it was verified. What has been done in people, and where, is counted below.

#### How many human trials exist, and in what language?
Four, and all four are Russian-language. Searched in September 2026 across three names, PubMed returns 216 indexed records, 49 tagged Humans, 4 under the clinical-trial publication type and 1 under the randomized type [6]. The language split is the finding: 93 of the records are Russian-language and 125 English-language, yet the trial filters combined with English[Language] return 0 under either type, while combined with Russian[Language] they return all 4 [6]. Only 22 English-language records carry the Humans heading at all [6].
The filters were proved live against a control term in the same session, and the reference records the counts [6]. Adding the terms nootropic or cognit* to the clinical-trial filter returns the same four records, so there is no separate cognition file hiding behind a different vocabulary [6].

#### What do the four trials report?
A 1997 study gave the peptide to 30 patients in the acute period of hemispheric ischemic stroke and compared them with 80 patients on conventional therapy, reporting faster regression of motor deficits at daily doses of 12 mg and 18 mg [7]. A 2000 study in optic-nerve disease divided patients into three groups by route of administration, nasal drops, endonasal electrophoresis and control, and reported improved visual acuity and visual field; its abstract gives no patient count [9].
A 2007 study treated 27 patients with motor neuron disease in an open-label design in sequential groups and found that the peptide did not influence the course of denervation or the clinical scores, while reporting an improvement in a quality-of-life total driven by emotional state and motivation [8]; PubMed tags that record as the one randomized trial in the file, and its own abstract calls it open-label. A 2018 study followed 110 patients after ischemic stroke, divided by rehabilitation timing and by whether they received the peptide, and reported higher plasma BDNF and better Barthel scores in the treated subgroups [3].
That is the whole controlled file: stroke, optic nerve, motor neuron disease. Not one enrolls healthy adults, not one measures memory, attention or any cognitive-enhancement endpoint in a person without a neurological diagnosis, and not one has been published outside that country's journals, let alone reviewed by a regulator outside Russia. The nootropic claim is an inference drawn across that gap, and the trial record (https://peptideamerica.org/reference/trial-record) prints the four records beside every other count in the index.

#### What does the Russian registration mean in the United States?
As a matter of marketing status, nothing. A drug approved by another country's regulator holds no United States approval, and the mechanism that confers one, an application reviewed by FDA, has not been used: Drugs@FDA returns no application under the name, while the identical query returned NDA 210557 for a control term in the same run [12]. The substance appears in no category of the section 503A bulks list published on May 14, 2026 [11].
FDA's own statement on the compound, still published among substances nominated but withdrawn, is that it has no, or limited, safety-related information for the proposed routes of administration and therefore lacks sufficient information to know whether the drug would cause harm if administered to humans [10]. That sentence sits beside a Russian dossier the agency has never examined; the two are not in conflict, because one is a record of what FDA has reviewed and the other is a record of what another country has.
In July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding Semax to the section 503A list, on a margin reported as 8–5 with one abstention by McDermott Will & Schulte and by LumaLex Law, whose separate accounts agree substance by substance [4, 5]; the FDA has published no minutes, transcript or vote summary, so the figure is secondary wherever it is printed. The vote is advisory. The vote ledger (https://peptideamerica.org/reference/pcac-july-2026) carries the arithmetic for all seven substances, and the pending (https://peptideamerica.org/status/pending) page explains what an advisory recommendation changes, which is nothing until a final rule issues.

#### What is sold, and under what posture?
Nasal sprays and vials offered to United States buyers are research-use-only supply or gray-market imports, outside pharmacy licensure and prescriber oversight; the research-use-only (https://peptideamerica.org/glossary/research-use-only) entry sets out what that labeling posture does and does not mean. A reader who buys on the strength of the Russian registration is buying a product that registration does not cover, made by a manufacturer that registration does not govern.
The nearest comparison in this index is the molecule that shared its meeting. DSIP (https://peptideamerica.org/molecules/dsip) is filed in the same neuropeptides (https://peptideamerica.org/classes/neuropeptides) class and is the one peptide the same panel is reported, by the same two accounts, to have voted against, on a record older and thinner than this one [4, 5]; the DSIP review (https://peptideamerica.org/evidence/dsip-rejection) reads that outcome. Semax cleared the panel on a Russian clinical file and a rat mechanism, and neither has been examined by a regulator in the place where the product is being sold.

#### Sources
1. Dolotov OV, Karpenko EA, Inozemtseva LS, et al. Semax, an analog of ACTH(4-10) with cognitive effects, regulates BDNF and trkB expression in the rat hippocampus. Brain Res. 2006;1117(1):54–60. https://pubmed.ncbi.nlm.nih.gov/16996037/
2. Dolotov OV, Karpenko EA, Seredenina TS, et al. Semax, an analogue of adrenocorticotropin (4-10), binds specifically and increases levels of brain-derived neurotrophic factor protein in rat basal forebrain. J Neurochem. 2006;97 Suppl 1:82–86. https://pubmed.ncbi.nlm.nih.gov/16635254/
3. Gusev EI, Martynov MY, Kostenko EV, Petrova LV, Bobyreva SN. [The efficacy of semax in the tretament of patients at different stages of ischemic stroke]. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(3. Vyp. 2):61-68. Russian. The title is reproduced exactly as PubMed indexes it, misspelling included; correcting an indexed title would make the citation unverifiable against the record it points to. https://pubmed.ncbi.nlm.nih.gov/29798983/
4. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance.
5. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.
6. PubMed, National Library of Medicine. Census run September 2026 across three name variants — "Semax" OR "ACTH(4-10) Pro-Gly-Pro" OR "Met-Glu-His-Phe-Pro-Gly-Pro" — returning 216 indexed records, 49 carrying the Humans MeSH term, 4 under "clinical trial"[Publication Type] and 1 under "randomized controlled trial"[Publication Type]. By language: 93 records are Russian-language and 125 English-language; the trial-type filters combined with English[Language] return 0 under either type, and combined with Russian[Language] return all 4; 22 English-language records carry the Humans term. Adding the terms nootropic or cognit* to the clinical-trial filter returns the same 4 records. All four trial-type records were opened and read: a 1997 acute-stroke study of 30 patients against 80 controls, a 2000 optic-nerve-disease study, a 2007 motor-neuron-disease study of 27 patients that its own abstract describes as open-label in sequential groups and that PubMed tags as randomized, and a 2018 post-stroke rehabilitation study of 110 patients; all four are published in Russian in that country's journals. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. The counts reproduce the August 2026 run behind the trial-record table exactly. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22Semax%22+OR+%22ACTH%284-10%29+Pro-Gly-Pro%22+OR+%22Met-Glu-His-Phe-Pro-Gly-Pro%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
7. Gusev EI, Skvortsova VI, Miasoedov NF, et al. [Effectiveness of semax in acute period of hemispheric ischemic stroke (a clinical and electrophysiological study)]. Zh Nevrol Psikhiatr Im S S Korsakova. 1997;97(6):26–34. Russian. https://pubmed.ncbi.nlm.nih.gov/11517472/
8. Serdiuk AV, Levitskiĭ GN, Miasoedov NF, Skvortsova VI. [The study of chronic partial denervation and quality of life in patients with motor neuron disease treated with semax]. Zh Nevrol Psikhiatr Im S S Korsakova. 2007;107(4):29–39. Russian. https://pubmed.ncbi.nlm.nih.gov/18379501/
9. Polunin GS, Nurieva SM, Baiandin DL, Sheremet NL, Andreeva LA. [Evaluation of therapeutic effect of new Russian drug semax in optic nerve disease]. Vestn Oftalmol. 2000;116(1):15–18. Russian. https://pubmed.ncbi.nlm.nih.gov/10741256/
10. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entry for Semax (heptapeptide). Read September 2026. The entry states that compounded drugs containing semax may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities, that FDA has no, or limited, safety-related information for proposed routes of administration, and that the agency therefore lacks sufficient information to know whether the drug would cause harm if administered to humans. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
11. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full September 2026: "Semax" occurs nowhere in the document, so the substance appears in none of Category 1, Category 2, or Category 3. Control in the same read: the same document names GHK-Cu six times. https://www.fda.gov/media/94155/download
12. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name, the substance name and the brand name for "semax": no matching application. Control in the same run: the identical query for "bremelanotide" returned NDA 210557. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22semax%22

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### BPC-157: No Controlled Human Trial on Record
https://peptideamerica.org/evidence/bpc-157-human-trials · published August 2026 · updated September 2026

Question: Has BPC-157 ever been tested in a human clinical trial?
Short answer: Not in a controlled trial. Four name variants searched in August 2026 returned 230 papers and none under the clinical-trial publication type; the only human reports PubMed indexes are three small uncontrolled studies from one clinic, covering 30 people.

#### How was the absence measured?
The claim that a compound has never been tested in people is a measurement, and it is worth exactly as much as the instrument behind it. Four names carry this molecule through the literature, and a search of any one of them alone understates the record: the abbreviated form, the descriptive form used in the pharmacology papers, the full name of the parent protein, and the development code the compound was assigned when a pharmaceutical company still held it.
Searched together in August 2026, those four names return 230 indexed papers, of which 55 carry the Humans subject heading. Filtered to the clinical-trial publication type, the same union returns zero; filtered to the randomized-controlled-trial publication type, it also returns zero [2].
The second number in that sentence is the one that makes the first number mean anything. A publication-type filter that has stopped matching returns zero for every substance in the database, and a dead filter is indistinguishable from a true absence by looking at the output. This census therefore ran a control term with a large and undisputed trial literature through the identical filter in the same session; it returned 8,904 records, and a deliberately invalid record identifier errored in the same run [2]. The instrument was answering. The answer was zero.
A zero under the trial filter is not the same as no human exposure, and the literature shows the difference. Three reports from a single Florida practice describe BPC-157 given to people: a retrospective telephone follow-up of 16 patients who had knee injections [7], a single-arm pilot in 12 women with interstitial cystitis [8], and an intravenous safety pilot in two adults who had received the infusion before [9]. None had a control group or blinding, and none is indexed as a clinical trial.
The reference below carries the query rather than a description of it, so the search can be repeated rather than trusted. That is the standard this index holds itself to, and it is the standard any claim about this compound's evidence should be held to elsewhere.

#### What about the 2025 intravenous pilot study?
The human report most often quoted against the zero is "Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study", by Lee and Burgess, published in Alternative Therapies in Health and Medicine in 2025 [9]. It is a real study and worth describing exactly. It was approved by an institutional review board and run at a private clinic in Florida. Two adults took part, a man of 58 and a woman of 68, and both had received intravenous BPC-157 before the study began.
Each received an infusion on two consecutive days. The authors drew blood and took vital signs before and after, then asked about side effects at every visit. The blood work covered markers of heart, liver, kidney and thyroid function and blood glucose. They report no measurable change in those markers and no side effects, and their conclusion asks for further studies to confirm safety [9].
It is not counted above for two reasons. The first is mechanical: PubMed indexes the paper as a journal article, not under the clinical-trial publication type, so the census filter cannot return it. The second is substantive: two people, no comparison group and no blinding cannot establish safety, and two people who had already taken the infusion cannot show how a first exposure goes. The paper sits in the human column with the other two reports, as uncontrolled experience in 30 people, and not as a trial.

#### What do the 230 papers actually establish?
The literature is not empty; it is preclinical. It describes a synthetic pentadecapeptide corresponding to a fragment of Body Protection Compound, a protein identified in human gastric juice, and it attributes the compound's effects principally to promotion of angiogenesis and to modulation of growth-factor signaling [1]. The models are rodent models of tendon transection, ligament injury, and gastrointestinal damage [1].
Those mechanisms are described in animals and have not been established in humans [1]. That sentence is doing the real work of this page: a mechanism observed in a rat is a hypothesis about a person, and the step that converts one into the other is precisely the step this record does not contain. No product containing BPC-157 has completed the clinical development an approval requires [1].
The distinction matters more here than the volume of publication suggests. Two hundred and thirty papers is a substantial file, and a reader who encounters the number without the publication-type breakdown will reasonably conclude that the compound is well studied. It is well studied in animals. The human column holds three uncontrolled case series and 30 people, and no quantity of the first column fills the second.

#### Why does the regulatory record turn on the same gap?
The absence is not an academic observation; it is the substance of the agency's position. In September 2023 the FDA placed BPC-157 in Category 2 of its interim bulk drug substances list, the category reserved for substances presenting significant safety concerns, citing immunogenicity risk and impurity questions; that placement barred licensed pharmacies from compounding it [3].
In April 2026 the agency removed BPC-157 and eleven other peptides from Category 2 without adding them to Category 1, which ended an explicit prohibition and conferred no authorization. In July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding the compound to the section 503A bulks list [4]. The margin is reported as 8–6 with one abstention by McDermott Will & Schulte and by LumaLex Law, whose separate accounts of the meeting agree substance by substance [5, 6]; the FDA has published no minutes, transcript or vote summary for it, so that figure is secondary and this review says so where it prints one. That vote is advisory, the FDA has issued no final rule, and no licensed United States pharmacy may lawfully compound BPC-157 today. The dated ledger sits on the monograph (https://peptideamerica.org/molecules/bpc-157); the arithmetic of the whole meeting sits in the vote ledger (https://peptideamerica.org/reference/pcac-july-2026).

#### What is a reader weighing without a controlled trial?
BPC-157 draws roughly 183,000 United States searches per month while no controlled human trial of it has been published. That distance between commercial visibility and published evidence is unusually wide even in this market, and it is worth naming plainly rather than hedging: a reader weighing this compound is weighing animal data and three small case series, and the decision that follows is made without a controlled human safety record.
The material offered for sale compounds the problem. Because no lawful compounding route exists, what is sold under the name is research-use-only chemical supply, produced and sold outside pharmacy licensure, prescriber oversight, and pharmaceutical quality standards; its identity, purity, and sterility are whatever the vendor asserts them to be. The research-only (https://peptideamerica.org/status/research-only) page sets out why removal from a prohibition list is not permission, and the glossary (https://peptideamerica.org/glossary/research-use-only) defines what the labeling posture does and does not mean.

#### Sources
1. Mateescu DM, Gavrilescu DM, Constantinescu FE, et al. BPC-157 as an investigational peptide therapeutic: biopharmaceutical challenges, formulation strategies, and translational development barriers. Pharmaceutics. 2026. https://pubmed.ncbi.nlm.nih.gov/42198317/
2. PubMed, National Library of Medicine. Census run August 2026 across four name variants — "BPC 157" (228 records), "pentadecapeptide BPC" (173), "body protection compound" (15), and the development code "PL 14736" (23) — union 230 records, of which 55 carry the Humans MeSH term. Under "clinical trial"[Publication Type] the union returns 0, and under "randomized controlled trial"[Publication Type] it returns 0. The filter was proved live in the same run against a control term returning 8,904 records, and a deliberately invalid identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22BPC+157%22+OR+%22pentadecapeptide+BPC%22+OR+%22body+protection+compound%22+OR+%22PL+14736%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
3. US Food and Drug Administration. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, guidance for industry, January 2025, docket FDA-2015-D-3517: the policy that defines Categories 1, 2 and 3, under which BPC-157 was placed in Category 2 in September 2023. Read September 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/interim-policy-compounding-using-bulk-drug-substances-under-section-503a-federal-food-drug-and
4. US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
5. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance.
6. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.
7. Lee E, Padgett B. Intra-articular injection of BPC 157 for multiple types of knee pain. Altern Ther Health Med. 2021;27(4):8-13. A retrospective chart review with telephone follow-up of 16 patients; no comparison group. https://pubmed.ncbi.nlm.nih.gov/34324435/
8. Lee E, Walker C, Ayadi B. Effect of BPC-157 on symptoms in patients with interstitial cystitis: a pilot study. Altern Ther Health Med. 2024;30(10):12-17. Twelve women, single arm, one treatment; no comparison group. https://pubmed.ncbi.nlm.nih.gov/39325560/
9. Lee E, Burgess K. Safety of intravenous infusion of BPC157 in humans: a pilot study. Altern Ther Health Med. 2025;31(5):20-24. Two adults, each of whom had received intravenous BPC-157 before the study. https://pubmed.ncbi.nlm.nih.gov/40131143/

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### CJC-1295: A Withdrawal, Not a Clearance
https://peptideamerica.org/evidence/cjc-1295-withdrawal · published August 2026 · updated September 2026

Question: Why did CJC-1295 leave Category 2 in September 2024, and what is its status now?
Short answer: Its nominators withdrew the nomination, so the FDA removed it from the prohibition category without adding it to Category 1; the compound sits on no list, and no lawful compounding route exists.

#### What happened
The FDA's interim policy on compounding with bulk drug substances sorts nominated substances into two categories: Category 1 holds substances under review without identified safety concerns, which pharmacies may compound while the review continues, and Category 2 holds substances with significant safety concerns, which they may not [2].
In September 2024 CJC-1295 left Category 2. It left because the parties who had nominated it withdrew the nomination, and it was not added to Category 1. A substance whose nomination is withdrawn does not move from one category to the other; it leaves the process altogether. Ipamorelin's 503A nominations were withdrawn the same month, and this index files both under the same disposition; ipamorelin acetate, unlike CJC-1295, is still named in Category 2 under FDA's separate 503B policy for outsourcing facilities — the nomination tracker (https://peptideamerica.org/reference/nominations) shows the four dispositions side by side.
The compound was not among the peptides the Pharmacy Compounding Advisory Committee reviewed at its July 2026 meeting [3]. Where the six recommended peptides at least hold an advisory vote pointing somewhere, CJC-1295 holds nothing pending at all.

#### Why this reads as good news and is not
Removal from a list titled after safety concerns has an obvious surface reading, and the market has taken it: the departure is regularly reported as a clearance, a de-restriction, or a signal that the agency's objections were dropped. None of those describes what occurred.
The arithmetic is simple and it is worth stating in one line. No listing, no approval, no lawful compounding route. A licensed 503A pharmacy may compound from a bulk substance only where the substance appears on the relevant list or is the subject of an approved product; CJC-1295 satisfies neither condition, and the withdrawal removed the mechanism by which it might have come to satisfy the first.
The research-only (https://peptideamerica.org/status/research-only) page sets out both paths that lead to this position — removal without review, and withdrawal — and why neither is permission.

#### The evidence that makes the position unusual
What distinguishes CJC-1295 from most of the research-peptide market is that it reached formal clinical study. In a randomized, placebo-controlled study in healthy adults, single injections raised growth hormone concentrations two- to ten-fold for six days or more and insulin-like growth factor 1 concentrations 1.5- to three-fold for up to eleven days, with an estimated half-life of 5.8 to 8.1 days [1].
Development did not continue to approval, and no efficacy trial in any indication followed. The pharmacokinetic result is therefore the whole of the human record: a demonstration that the molecule does what it was designed to do to the growth hormone axis, and no demonstration that doing so benefits anyone. A later study found that the natural growth hormone pulses survive the compound's long action; CJC-1295 with ipamorelin (https://peptideamerica.org/evidence/cjc-1295-and-ipamorelin) reads that study and the rest of the human record.
The class context is on the GH secretagogues (https://peptideamerica.org/classes/gh-secretagogues) page, where the same class holds an approved drug, a lawfully compoundable molecule, and this withdrawn pair; the monograph (https://peptideamerica.org/molecules/cjc-1295) carries the dated ledger.

#### What is sold under the name
Because no lawful route exists, material offered as CJC-1295 is research-use-only chemical supply, sold outside pharmacy licensure and outside the quality obligations that attach to a drug. The glossary (https://peptideamerica.org/glossary/research-use-only) sets out what that labeling posture means and, more usefully, what it does not.

#### Sources
1. Teichman SL, Neale A, Lawrence B, et al. Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults. J Clin Endocrinol Metab. 2006;91(3):799–805. https://pubmed.ncbi.nlm.nih.gov/16352683/
2. US Food and Drug Administration. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, guidance for industry, January 2025, docket FDA-2015-D-3517. Read September 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/interim-policy-compounding-using-bulk-drug-substances-under-section-503a-federal-food-drug-and
3. US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026

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### DSIP: The Committee's Only Rejection
https://peptideamerica.org/evidence/dsip-rejection · published August 2026 · updated August 2026

Question: Why was DSIP the only peptide the July 2026 committee refused to recommend?
Short answer: The panel voted against listing on a reported 6–7 with one abstention, and the record it was reading contains no identified gene, precursor protein, or receptor after nearly fifty years, alongside a human literature of a few small studies whose most recent entry dates from 1992.

#### The vote
On July 23 and 24, 2026, the Pharmacy Compounding Advisory Committee reviewed seven of the twelve peptides the FDA had removed from Category 2 of its interim 503A bulks list three months earlier [5]. It recommended six of them for the section 503A list. It refused the seventh.
Delta sleep-inducing peptide was that seventh. Its margin is reported as 6–7 with one abstention by McDermott Will & Schulte and by LumaLex Law, whose separate accounts of the meeting agree substance by substance [6, 7]. That provenance has to be stated, because the FDA has published no minutes, no transcript and no vote summary for this meeting; its meeting page carried none as of August 6, 2026, re-read on August 31, 2026 [5]. On the reported figure the margin is worth reading precisely: this was not a panel that found the dossier obviously deficient and dispatched it, but a panel that split almost evenly and landed one vote short. The full arithmetic of the meeting, molecule by molecule, and the sourcing behind it, is in the vote ledger (https://peptideamerica.org/reference/pcac-july-2026).
The vote is advisory in either direction. A recommendation does not make a substance lawful to compound, and a rejection does not add a prohibition that was not already there; DSIP left Category 2 in April 2026 and sits on no list, which is where it sat before the meeting and where it sits now.

#### The biology the panel was reading
Delta sleep-inducing peptide is a nonapeptide isolated in 1977 from the cerebral venous blood of rabbits in induced sleep [1]. The name records the hypothesis its discoverers formed, not a function anyone has since established: nearly fifty years on, the DSIP gene, precursor protein, and receptor have never been identified.
That is an unusual position for a substance nominated for pharmacy compounding. A review published in 2006 from within the field's own literature describes the sleep-factor hypothesis as "extremely poorly documented and still weak" [2] — a judgment from a friendly source, not a skeptical outsider, and one that has not been overtaken since.

#### The human record
The human literature is small, old, and equivocal. A 1981 report described improved sleep in insomniacs given the synthetic peptide [3]. A 1992 double-blind study of sixteen chronic insomniac patients found higher objective sleep efficiency and shorter sleep latency against placebo across three nights of intravenous dosing — effects that the study's own authors judged weak, possibly an artifact of change in the placebo group, and unlikely to carry major therapeutic benefit [4].
The literature then largely stopped. Sixteen patients across three nights, reported by authors who declined to claim much for the result, is the strongest controlled entry in the file, and it is thirty-four years old. A committee weighing whether pharmacies should be permitted to compound the substance was weighing that.

#### What the outcome means today
DSIP has no lawful United States supply route, none is pending, and the compound is sold for sleep and stress on the strength of a four-decade-old hypothesis its own field has not confirmed. Material offered under the name is research-use-only supply, outside pharmacy oversight; the research-only (https://peptideamerica.org/status/research-only) page explains why removal from a list is not permission.
The contrast within the meeting itself is the clearest way to read the outcome. The same panel recommended Semax on a reported 8–5 on the same days [6, 7], and this index files both molecules as neuropeptides — one recommendation, one rejection, one class, one meeting. The committee read each dossier on its own terms, and the monograph (https://peptideamerica.org/molecules/dsip) carries the dated ledger for this one.

#### Sources
1. Schoenenberger GA, Monnier M. Characterization of a delta-electroencephalogram (-sleep)-inducing peptide. Proc Natl Acad Sci U S A. 1977;74(3):1282–1286. https://pubmed.ncbi.nlm.nih.gov/265572/
2. Kovalzon VM, Strekalova TV. Delta sleep-inducing peptide (DSIP): a still unresolved riddle. J Neurochem. 2006;97(2):303–309. https://pubmed.ncbi.nlm.nih.gov/16539679/
3. Schneider-Helmert D, Graf M, Schoenenberger GA. Synthetic delta-sleep-inducing peptide improves sleep in insomniacs. Lancet. 1981;1(8232):1256–1257. https://pubmed.ncbi.nlm.nih.gov/6112579/
4. Bes F, Hofman W, Schuur J, Van Boxtel C. Effects of delta sleep-inducing peptide on sleep of chronic insomniac patients. A double-blind study. Neuropsychobiology. 1992;26(4):193–197. https://pubmed.ncbi.nlm.nih.gov/1299794/
5. US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
6. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance.
7. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.

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### Glutathione Injections for Skin Lightening
https://peptideamerica.org/evidence/glutathione-skin-lightening · published August 2026 · updated August 2026

Question: Is injectable glutathione established for skin lightening, and what has the FDA said about it?
Short answer: No trial supports it. Seven clinical trials pair glutathione with skin lightening and all seven were read: six test an oral, buccal, or topical preparation, and the seventh tests a four-ingredient injectable for under-eye pigment. The injected route returns no clinical trial at all.

#### What is being claimed, and what would prove it?
Glutathione is a tripeptide of glutamate, cysteine, and glycine, and the body's most abundant intracellular antioxidant. It is synthesized in every cell rather than obtained mainly from outside, which is the first fact that sits awkwardly beside a market built on putting more of it into a vein.
The claim under test is narrow and specific: that injecting glutathione lightens skin. Proving it would take a controlled trial of the injected preparation, in people, with a pigment measure, against a comparator. That is a modest bar and it is the bar this review measures against. The monograph (https://peptideamerica.org/molecules/glutathione) records the regulatory position with the date it was verified.

#### How many controlled trials exist, and what did they test?
Searched in August 2026, the pairing of glutathione with skin lightening, whitening, bleaching, hyperpigmentation, or melanogenesis returns 206 indexed records, of which 98 carry the Humans subject heading, 7 carry the clinical-trial publication type, and 4 the stricter randomized-controlled-trial type [4].
All seven were read rather than counted, because seven is a number small enough to open and because a count of trials is not a finding about what was tested. Six test an oral, buccal, or topical preparation. An eight-week open-label single-arm study gave a glutathione lozenge daily to 30 Filipino women with Fitzpatrick skin types IV or V and reported a fall in melanin index detectable from two weeks, with no serious adverse events [1]. A double-blind randomized study in 46 participants compared combined topical and oral glutathione against each route alone, and found the combination produced a lower melanin index than placebo [2]. The remaining four test creams, a multi-plant powder, an oral cystine preparation, and a topical agent used with focused ultrasound [4].
The seventh is an injectable, and it is not a trial of this question. It randomized 120 patients with periorbital hyperpigmentation to injections of a sodium hyaluronate complex containing vitamin C, tranexamic acid, and glutathione [3]. Four active ingredients delivered under the eye for dark circles is a different product answering a different question from glutathione alone delivered into a vein for overall skin tone, and the trial cannot be read as evidence for the second.

#### What does the injected route return on its own?
Narrowing the same pairing to records that also name an intravenous, intramuscular, injection, or injectable route returns 12 indexed papers. Under the clinical-trial publication type it returns 0. Under the randomized-controlled-trial type it returns 0 [4].
That is the measurement, and it is worth stating what stands behind it. A publication-type filter that has stopped matching returns zero for every substance in the database, so the same session ran a control term with a large and undisputed trial literature through the identical filter: 8,904 records under the clinical-trial type and 6,113 under the randomized type. The invalid tag that once produced a false zero on this site returned 0 for that same control term, and a deliberately invalid record identifier errored in the same run [4].
The zero is therefore a measurement rather than an assertion, and it is bounded by its own search string, which the reference below prints in full so the count can be repeated rather than trusted. What it says is that as of the date it was run, this index found no controlled trial of injected glutathione for skin lightening. It does not say no such study exists anywhere in any form; it says the indexed literature, searched this way, on this date, contains none.
One of the oral trials makes the same point from the inside. Its authors note that the highest plasma concentrations are achieved with intravenous administration but are accompanied by greater levels of risk, and that observation is precisely why they investigated a lozenge instead [1]. The route with the most exposure is the route with the least evidence.

#### What is on the federal record about the injectable trade?
The compounding position and the injectable skin-whitening trade are two different things, and only one of them is inside the pharmacy system. Glutathione is listed in Category 1 of the FDA's interim 503A bulks list, so licensed pharmacies may compound it against a valid prescription while the agency's review continues; the compoundable (https://peptideamerica.org/status/compoundable) page records what that permits.
The trade in imported whitening injectables sits outside that entirely, and the federal record of it is dated. A consent decree of permanent injunction was entered in the United States District Court for the District of New Jersey on September 26, 2017 in United States v. Flawless Beauty LLC, a case the FDA still cites by case number in its own correspondence [5]. Under that decree the company announced on January 18, 2018 a recall of nineteen products, and the announcement the FDA republished states that all of the glutathione products were sold in multi-vial whitening kits, alone or with ampules of vitamin C and sterile water [6].
That action is a dated public record and nothing more; it says nothing about any other business. An enforcement action discloses conduct at one firm on one date. It is not a finding about a molecule, it is not a finding about an industry, and treating it as either would be the same error in the opposite direction from treating six oral trials as evidence for an injection.

#### What is a reader actually deciding here?
Two questions get merged in this market and they have different answers. Does glutathione affect skin pigment? The oral and topical trials say something modest and short-term happens, and the systematic reviews that have looked at the field describe the evidence as limited and mixed. Does injecting it lighten skin? On the record searched here, nobody has run the trial.
The second answer is not a claim that the injection does nothing. It is a claim about what is known, which is the only claim this index makes. A reader weighing an infusion is weighing a route with no controlled evidence, a preparation whose contents are whatever the supplier states, and a documented history of enforcement in the import trade that supplies it.
The nearest comparison in this index is NAD+ (https://peptideamerica.org/molecules/nad), which shares the Category 1 position and has the same distance between its precursor trials and its infusion (https://peptideamerica.org/evidence/nad-infusion-evidence). The approved peptides (https://peptideamerica.org/reference/approved-peptides) table sets out what a compound looks like when the trial actually was run.

#### Sources
1. Handog EB, Datuin MS, Singzon IA. An open-label, single-arm trial of the safety and efficacy of a novel preparation of glutathione as a skin-lightening agent in Filipino women. Int J Dermatol. 2016;55(2):153–157. https://pubmed.ncbi.nlm.nih.gov/26148180/
2. Wahab S, Anwar AI, Zainuddin AN, et al. Combination of topical and oral glutathione as a skin-whitening agent: a double-blind randomized controlled clinical trial. Int J Dermatol. 2021;60(8):1013–1018. https://pubmed.ncbi.nlm.nih.gov/33871071/
3. Guo F, Zhang Z, Su X, et al. Efficacy and safety of injectable sodium hyaluronate with vitamin C, tranexamic acid, and glutathione for pigmented dark circles. J Dermatolog Treat. 2025;36(1):2574306. https://pubmed.ncbi.nlm.nih.gov/41117156/
4. PubMed, National Library of Medicine. Census run August 2026. "glutathione" paired with "skin lightening" OR "skin whitening" OR "skin bleaching" OR "hyperpigmentation" OR "melanogenesis" returns 206 indexed records, 98 carrying the Humans MeSH term, 7 under "clinical trial"[Publication Type] and 4 under "randomized controlled trial"[Publication Type]; all 7 were read individually rather than counted, and 6 test an oral, buccal, or topical preparation while the seventh is an injectable four-ingredient hyaluronate complex for periorbital hyperpigmentation. Narrowing the same pairing to records that also name an intravenous, intramuscular, injection, or injectable route returns 12 records, 0 under the clinical-trial type and 0 under the randomized type. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type, the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22glutathione%22+AND+%28%22skin+lightening%22+OR+%22skin+whitening%22+OR+%22skin+bleaching%22%29+AND+%28%22intravenous%22+OR+%22injection%22+OR+%22injectable%22+OR+%22intramuscular%22%29%29
5. US Food and Drug Administration. Warning letter to Flawless Beauty and Skin, CMS 630567, August 5, 2022, citing the Consent Decree of Permanent Injunction entered by the United States District Court on September 26, 2017 in United States v. Flawless Beauty LLC, et al., No. 17-7091 (D.N.J.). Read August 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flawless-beauty-and-skin-630567-08052022
6. US Food and Drug Administration. Company announcement republished by the FDA: Flawless Beauty, LLC issues voluntary recall of unapproved drugs. Company announcement date January 18, 2018; FDA publish date January 23, 2018. Read August 2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/flawless-beauty-llc-issues-voluntary-recall-unapproved-drugs

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### Ipamorelin's One Trial Missed Its Endpoint
https://peptideamerica.org/evidence/ipamorelin-trial · published August 2026 · updated August 2026

Question: What did the one randomized controlled trial of ipamorelin find?
Short answer: It missed. In 114 patients after bowel resection, median time to a first tolerated meal was 25.3 hours on ipamorelin against 32.6 on placebo, a difference at p equal to 0.15, and the authors report no significant difference in the key or secondary analyses.

#### How much human evidence is there in total?
Two records. Searched in August 2026 the molecule returns 54 indexed papers, 28 carrying the Humans subject heading, and exactly 2 under the clinical-trial publication type — both of which also carry the stricter randomized-controlled-trial type [3].
Both were read rather than counted. One is a dose-escalation pharmacokinetic and pharmacodynamic study in healthy male volunteers, eight subjects at each of five fifteen-minute infusion rates, measuring concentrations of the peptide and of growth hormone and modeling the relation between them [2]. That is a study of what the compound does to a hormone, not of what it does to a person.
The other is the trial this page is about. The publication-type filter was proved live in the same session against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type, the invalid tag that once produced a false zero on this site returned 0 for that same control term, and a deliberately invalid record identifier errored in the same run [3].

#### What did the randomized trial actually test?
It tested postoperative ileus — the temporary shutdown of bowel motility that follows abdominal surgery — in adults undergoing small and large bowel resection by open or laparoscopic technique. The rationale was mechanistic and reasonable: ipamorelin acts at the growth hormone secretagogue receptor, the receptor ghrelin binds, and ghrelin-receptor stimulation has promotility effects in the gut [1].
The design was a multicenter, double-blind, placebo-controlled phase 2 study, registered as NCT00672074. Patients received intravenous infusions of ipamorelin at 0.03 mg per kilogram or placebo twice daily from the first postoperative day until day seven or hospital discharge. One hundred seventeen patients were enrolled and 114 made up the safety and modified intention-to-treat populations. The key efficacy endpoint was the time from the first dose to tolerance of a standardized solid meal [1].
That is a well-formed trial asking a well-formed question, and it deserves to be described as one. The reason it appears in an index of gray-market peptides is that it is the only controlled outcome evidence this compound has, and it is almost never the evidence a reader is shown.

#### What was the result?
Median time to first tolerated meal was 25.3 hours in the ipamorelin group and 32.6 hours in the placebo group, at p equal to 0.15 [1]. The direction favored the drug. The difference did not reach statistical significance.
The authors state the conclusion themselves and state it plainly: there were no significant differences between ipamorelin and placebo in the key or the secondary efficacy analyses [1]. Safety was unremarkable, with treatment-emergent adverse events in 87.5 percent of the ipamorelin group and 94.8 percent of the placebo group, and the authors describe the regimen as well tolerated [1]. They also name their own limitations, calling the study small and noting that it enrolled patients with a broad range of underlying conditions [1].
A seven-hour difference in median time to a meal, in the direction of benefit, at p equal to 0.15, in 114 patients, is exactly the kind of result that gets rewritten by other people into a claim. It is not a positive trial. It is not a demonstration that the compound does nothing either. It is an underpowered proof-of-concept study that did not separate from placebo, which is a specific and useful thing to know and a poor foundation for anything.

#### Why does this trial not support what the compound is sold for?
It was run in a different population, at a different route, for a different indication. The subjects were hospital inpatients recovering from bowel surgery, receiving an intravenous infusion twice daily for up to a week, and the endpoint was gastrointestinal recovery. The compound is marketed to healthy adults, self-injected subcutaneously, for body composition, recovery, and aging.
Nothing in the trial speaks to any of that, and the pharmacokinetic study speaks to it only in the narrow sense that the compound reaches the bloodstream and releases growth hormone in a dose-related way [2]. Read together, the two records say that ipamorelin does the hormonal thing it is designed to do, and that the single time anyone measured whether it changed a clinical outcome, it did not.
The pairing with CJC-1295 (https://peptideamerica.org/molecules/cjc-1295) that dominates the market is worth naming for the same reason: it was invented by sellers rather than by any trial, and neither half of it has an outcome study behind it. CJC-1295's nomination was withdrawn (https://peptideamerica.org/evidence/cjc-1295-withdrawal) in September 2024, and sermorelin (https://peptideamerica.org/molecules/sermorelin) shows what a lawful position in the GH secretagogues (https://peptideamerica.org/classes/gh-secretagogues) class looks like — though its own trial record stopped in 2005 (https://peptideamerica.org/evidence/sermorelin-versus-growth-hormone).

#### Where does that leave ipamorelin in the United States?
Without a lawful compounding route. Its nominations to the section 503A bulks list were withdrawn in September 2024 and it sits in no 503A category; the advisory committee still heard FDA's evaluation in October 2024 and voted 0–12, with one abstention, against listing it. Under the separate 503B policy for outsourcing facilities, FDA has kept ipamorelin acetate in Category 2, its safety-risk file, since September 2023. It was not among the peptides reviewed at the July 2026 advisory committee meeting. The monograph (https://peptideamerica.org/molecules/ipamorelin) records that ledger with the date each entry was verified, and the nomination tracker (https://peptideamerica.org/reference/nominations) shows how often a withdrawal is reported as a clearance.
Material sold under the name is research-use-only chemical supply, produced and sold outside pharmacy licensure and prescriber oversight, and its identity, purity, and sterility are whatever the vendor asserts them to be. That is a separate problem from the evidence, and it compounds it: the one trial that exists administered a manufactured product at a stated dose under a protocol, and the trial's result — which was neutral — does not attach to the contents of an unlabeled vial. The research-only (https://peptideamerica.org/status/research-only) page sets out why removal from a prohibition list is not permission.

#### Sources
1. Beck DE, Sweeney WB, McCarter MD. Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients. Int J Colorectal Dis. 2014 Dec;29(12):1527-34. https://pubmed.ncbi.nlm.nih.gov/25331030/
2. Gobburu JV, Agersø H, Jusko WJ, Ynddal L. Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers. Pharm Res. 1999;16(9):1412–1416. https://pubmed.ncbi.nlm.nih.gov/10496658/
3. PubMed, National Library of Medicine. Census run August 2026 on "ipamorelin", returning 54 indexed records, 28 carrying the Humans MeSH term, 2 under "clinical trial"[Publication Type] and 2 under "randomized controlled trial"[Publication Type]. Both clinical-trial records were read individually rather than counted: the 2014 postoperative ileus study and the 1999 pharmacokinetic-pharmacodynamic study in healthy volunteers. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type, the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%22ipamorelin%22+AND+%22clinical+trial%22%5BPublication+Type%5D

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### KPV: What Has Been Tested in People
https://peptideamerica.org/evidence/kpv-evidence · published August 2026 · updated August 2026

Question: What human evidence exists for KPV?
Short answer: None. Four name variants return 97 indexed papers and no record at all under the clinical-trial or randomized-trial publication types, while the parent hormone searched the same way in the same session returns 86 clinical trials and 48 randomized ones.

#### What is KPV, and what is it a fragment of?
KPV is the tripeptide lysine-proline-valine: three amino acids, and the tail end of alpha-melanocyte-stimulating hormone. The parent hormone has broad anti-inflammatory signaling roles, and the fragment keeps a measurable share of that activity in laboratory models without the pigmentation effects the whole hormone produces [1].
That is a genuinely interesting piece of pharmacology and it is why the compound has a literature at all. It is also the precise point at which a marketing claim usually detaches from the record, because a fragment retaining activity in a cell assay is a finding about a cell assay. The monograph (https://peptideamerica.org/molecules/kpv) records the regulatory position with the date it was verified; this page counts what has been done in people.

#### How many human trials of KPV exist?
Zero. Searched in August 2026 across four name variants, the tripeptide returns 97 indexed records. Under the clinical-trial publication type it returns 0. Under the stricter randomized-controlled-trial publication type it also returns 0 [4].
A publication-type filter that has stopped matching returns zero for every substance in the database, and a dead filter is indistinguishable from a true absence by looking at the output. The same session therefore put a control term with a large and undisputed trial literature through the identical filter: it returned 8,904 records under the clinical-trial type and 6,113 under the randomized type. The invalid tag that once produced a false zero on this site was run against that same control term and returned 0, and a deliberately invalid record identifier errored in the same run [4]. The instrument was answering, and the answer for this compound was nothing.
The reference below carries the query rather than a description of it, so the count can be repeated rather than trusted. That is the standard the method (https://peptideamerica.org/method) page sets out, and it is the standard any claim about this compound's evidence should be held to elsewhere.

#### Why does the Humans subject heading not mean human subjects?
Thirty-two of the 97 records carry the Humans subject heading, and a reader who stops at that number will conclude the opposite of the truth. All 32 were read [4].
They are melanocortin receptor pharmacology — binding affinities, agonist selectivity across receptor subtypes, three-dimensional models of the receptor. They are assays run in human cell lines. They are delivery-vehicle papers: hyaluronic-acid-functionalized nanoparticles carrying the tripeptide to the colon, hydrogel microspheres, carrier-free nanodrugs. One is an iontophoresis study measuring transport across microporated human skin outside the body [4].
The heading marks human tissue, human receptors, and human-derived cells. It does not mark a person who was given the compound and followed, and the difference between those two things is the entire question a reader arrives with. This is the same class of error as counting a search hit without opening it, and the correction is the same: read the records.

#### What does the preclinical record actually show?
It is real work and it is worth describing accurately rather than dismissing. The central paper showed that the intestinal peptide transporter PepT1, which is induced in the colon during inflammatory bowel disease, carries KPV into epithelial and immune cells, where it reduced inflammatory signaling in human cell lines and improved two mouse models of colitis [2]. A separate murine study reached a similar conclusion in the same year [3].
So the compound has a plausible transport mechanism, an identified target, and effects in animals with an induced disease. That is the beginning of a drug development program, and for a great many molecules it is where the story ends, because the step from a mouse to a person is the step most compounds do not survive.
The contrast with the parent hormone makes the gap legible. Searched the same way in the same session, alpha-melanocyte-stimulating hormone returns 6,405 records, 86 clinical trials, and 48 randomized trials [4]. The molecular family has been carried into human research repeatedly. This fragment has not, and its literature cannot borrow the family's.

#### What is KPV's United States position?
KPV was removed from Category 2 of the interim 503A bulks list in April 2026 without being added to Category 1, and in July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding it to the section 503A list. The margin is reported as 8–6 with one abstention — the same margin BPC-157 (https://peptideamerica.org/molecules/bpc-157) and TB-500 (https://peptideamerica.org/molecules/tb-500) received — by McDermott Will & Schulte and by LumaLex Law, whose separate accounts of the meeting agree substance by substance [5, 6]; the FDA has published no minutes, transcript or vote summary for it, so that figure is secondary and this review says so where it prints one. The vote is advisory, no FDA final rule has issued, and no licensed United States pharmacy may lawfully compound it.
That sequence is worth reading beside the count above. A committee recommended a compounding listing for a substance with no published human trial of any kind, which is a fact about what the committee was asked to decide rather than a criticism of how it decided. The vote ledger (https://peptideamerica.org/reference/pcac-july-2026) carries the arithmetic of the whole meeting, and the pending (https://peptideamerica.org/status/pending) page explains what an advisory recommendation changes, which is nothing yet.
Meanwhile the compound is sold as an oral capsule, a topical, and an injectable, and material offered under the name is research-use-only chemical supply produced outside pharmacy licensure. The research-use-only (https://peptideamerica.org/glossary/research-use-only) entry sets out what that labeling posture does and does not mean, and the repair peptides (https://peptideamerica.org/classes/repair-peptides) class collects the molecules that share this position.

#### Sources
1. Luger TA, Brzoska T. alpha-MSH related peptides: a new class of anti-inflammatory and immunomodulating drugs. Ann Rheum Dis. 2007;66 Suppl 3:iii52–iii55. https://pubmed.ncbi.nlm.nih.gov/17934097/
2. Dalmasso G, Charrier-Hisamuddin L, Nguyen HT, Yan Y, Sitaraman S, Merlin D. PepT1-mediated tripeptide KPV uptake reduces intestinal inflammation. Gastroenterology. 2008;134(1):166–178. https://pubmed.ncbi.nlm.nih.gov/18061177/
3. Kannengiesser K, Maaser C, Heidemann J, Luegering A, Ross M, Brzoska T, et al. Melanocortin-derived tripeptide KPV has anti-inflammatory potential in murine models of inflammatory bowel disease. Inflamm Bowel Dis. 2008 Mar;14(3):324-31. https://pubmed.ncbi.nlm.nih.gov/18092346/
4. PubMed, National Library of Medicine. Census run August 2026 across four name variants — "KPV peptide" OR "lysine-proline-valine" OR "Lys-Pro-Val" OR "KPV tripeptide" — returning 97 indexed records, 32 carrying the Humans MeSH term, 0 under "clinical trial"[Publication Type] and 0 under "randomized controlled trial"[Publication Type]. All 32 human-tagged records were read individually rather than counted; they are melanocortin receptor pharmacology, human cell-line assays, delivery-vehicle work, and one iontophoresis study across microporated human skin ex vivo. The parent hormone was searched in the same run — "alpha-MSH" OR "alpha-melanocyte stimulating hormone" OR "alpha melanocyte-stimulating hormone" — returning 6,405 records, 86 clinical trials and 48 randomized trials. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type, the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22KPV+peptide%22+OR+%22lysine-proline-valine%22+OR+%22Lys-Pro-Val%22+OR+%22KPV+tripeptide%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
5. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance.
6. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.

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### NAD+ Infusions and the Precursor Trials
https://peptideamerica.org/evidence/nad-infusion-evidence · published August 2026 · updated August 2026

Question: Do the nicotinamide riboside and nicotinamide mononucleotide trials support intravenous NAD+?
Short answer: No. Those trials tested oral precursors. Counted separately, nicotinamide riboside has 42 clinical trials and nicotinamide mononucleotide 22, while the phrase set naming an infused NAD+ preparation returns 22 papers in total and one relevant randomized trial, in heart failure.

#### Why is a precursor trial not an infusion trial?
Nicotinamide riboside and nicotinamide mononucleotide are precursors. They are swallowed, absorbed through the gut, and converted inside cells into nicotinamide adenine dinucleotide. An NAD+ infusion delivers the finished coenzyme directly into a vein. Different molecule, different route, different pharmacokinetics, and therefore a different question.
The marketplace collapses that distinction routinely, and the collapse is not accidental: the precursor literature is the only substantial human evidence in the neighborhood, so it is the evidence that gets cited. A reader who meets a page listing clinical trials in support of an intravenous drip is usually reading a list of oral supplement trials. The monograph (https://peptideamerica.org/molecules/nad) records the regulatory posture with the date it was verified; this page counts the literatures and keeps them apart.

#### How large is each of the three literatures?
They were searched in August 2026 in one session, and their counts were never added together. Nicotinamide riboside returns 952 indexed records, 418 carrying the Humans subject heading, 42 under the clinical-trial publication type and 32 under the stricter randomized-controlled-trial type [3].
Nicotinamide mononucleotide returns 1,713 records, 593 human-tagged, 22 clinical trials and 16 randomized trials [3]. Between them the two precursors account for a real body of interventional human research, and this index does not dispute it. A systematic review of the oral nicotinamide mononucleotide trials reports consistent safety and modest metabolic effects [4].
The phrase set naming an infused or intravenous NAD+ preparation returns 22 records in total, 11 human-tagged, 4 under the clinical-trial type and 1 under the randomized type [3]. Twenty-two papers is not a literature. It is a shelf.
The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag that once produced a false zero on this site returned 0 for that same control term, and a deliberately invalid record identifier errored in the same session [3].

#### What are the four infusion trials, read individually?
Three of them are about something else. Reading each record rather than counting it returns a chemotherapy sequence in esophageal cancer, a topical preparation investigated for psoriasis, and a 1972 review of nicotinic acid in schizophrenia [3]. None concerns an intravenous NAD+ infusion given for the reasons the infusion is sold for.
The fourth is a genuine randomized placebo-controlled trial, and its subject is neither aging nor wellness nor energy. It enrolled 180 adults with heart failure from ischemic cardiomyopathy, a left ventricular ejection fraction at or below 45 percent, and New York Heart Association class II to III disease. They received intravenous NAD+ at 10 mg daily or a matched placebo for seven days alongside guideline-directed medical therapy, and the primary endpoint was the change in ejection fraction at one month [2].
That is a cardiology trial in a diagnosed population on background therapy, running for a week. It is not a reason to book an infusion, and it is not evidence about a person without heart failure. Its existence is worth reporting precisely because it is the strongest thing in the column, and because a page that cited it as support for wellness infusions would be doing the exact substitution this review is about.

#### What happened when someone measured the infusion itself?
One study asked the most basic question available: during an NAD+ infusion, what happens in the blood. It was a pilot investigation rather than an outcome trial, and it followed plasma and urine through a six-hour intravenous infusion at 3 micromoles per minute [1].
The result is the sentence a reader should take away from this page. Plasma NAD+ and the metabolites measured alongside it, among them nicotinamide, methylnicotinamide, and nicotinamide mononucleotide, did not change until after the second hour. The authors read that as the infused compound being removed from plasma rapidly and completely over the first two hours, and they reported increased urinary excretion of NAD+ and methylnicotinamide at six hours [1].
The authors describe their own study as the first to document the fate of directly infused NAD+ in a human cohort [1]. That is a statement about how little was known, made by the people who set out to find out, and it was published in 2019. It is difficult to reconcile with a market that had by then been selling the infusion for years on the strength of what the molecule does inside a cell.

#### What does Category 1 actually permit?
NAD+ sits in Category 1 of the FDA's interim 503A bulks list, which means licensed pharmacies may compound it against a valid prescription while the agency's review continues. That is a permission to compound during review, and the compoundable (https://peptideamerica.org/status/compoundable) page records it as such. It is not an approval, it is not a finding of efficacy, and it makes no claim about the infusion's effects.
This is the same reading discipline that runs through the index. A regulatory permission answers who may prepare a substance. A trial answers whether it does anything. Glutathione (https://peptideamerica.org/molecules/glutathione) shares the Category 1 posture and has its own gap between route and evidence (https://peptideamerica.org/evidence/glutathione-skin-lightening); MOTS-c (https://peptideamerica.org/molecules/mots-c), the other molecule in the mitochondrial (https://peptideamerica.org/classes/mitochondrial) group, has neither the permission nor the record. The category 1 (https://peptideamerica.org/glossary/category-1) entry defines the listing itself.

#### Sources
1. Grant R, Berg J, Mestayer R, et al. A pilot study investigating changes in the human plasma and urine NAD+ metabolome during a 6 hour intravenous infusion of NAD. Front Aging Neurosci. 2019;11:257. https://pubmed.ncbi.nlm.nih.gov/31572171/
2. Yu X, Xu J, Cao J, et al. Effect of nicotinamide adenine dinucleotide on heart failure caused by ischemic cardiomyopathy: a randomized, placebo-controlled trial. Am J Cardiovasc Drugs. 2026;26(1):97–106. https://pubmed.ncbi.nlm.nih.gov/40954388/
3. PubMed, National Library of Medicine. Census run August 2026, the three literatures counted separately and never summed. "nicotinamide riboside" OR "nicotinamide riboside chloride" returns 952 indexed records, 418 carrying the Humans MeSH term, 42 under "clinical trial"[Publication Type] and 32 under "randomized controlled trial"[Publication Type]. "nicotinamide mononucleotide" returns 1,713 records, 593 human-tagged, 22 clinical trials and 16 randomized. The infusion phrase set — "NAD infusion" OR "NAD+ infusion" OR "intravenous NAD" OR "NAD therapy" — returns 22 records, 11 human-tagged, 4 clinical trials and 1 randomized; all 4 clinical-trial records were read individually, and three concern an esophageal cancer chemotherapy sequence, a topical psoriasis preparation, and a 1972 review of nicotinic acid in schizophrenia. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type, the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22NAD+infusion%22+OR+%22NAD%2B+infusion%22+OR+%22intravenous+NAD%22+OR+%22NAD+therapy%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
4. Yang W, Huang J, Tang Z, Chen C, Sun Y. Safety and Metabolism-Related Outcomes of Oral Nicotinamide Mononucleotide Supplementation in Adults: A Systematic Review and Meta-Analysis. Nutrients. 2026 Jul 10;18(14). https://pubmed.ncbi.nlm.nih.gov/42514320/

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### Sermorelin: The Trial Record Stopped in 2005
https://peptideamerica.org/evidence/sermorelin-versus-growth-hormone · published August 2026 · updated August 2026

Question: Does sermorelin produce the effects attributed to growth hormone therapy?
Short answer: Not on this record. Sermorelin reliably raises growth hormone, but the adult trials that measured what a reader cares about are three studies from the 1990s that disagree with each other, and no clinical trial of the molecule has been published since 2005.

#### What does sermorelin actually do in the body?
Sermorelin is the first 29 amino acids of growth hormone-releasing hormone, the shortest fragment that keeps the full hormone's activity at the pituitary gland. It does not supply growth hormone. It instructs the gland to release its own, which leaves the body's feedback control intact, and that mechanism is genuine, well described, and the reason the molecule is interesting at all.
The mechanism is also the whole of what most sellers are describing when they compare the compound to growth hormone therapy. A stimulus that raises a hormone is not the same claim as a treatment that changes an outcome, and the distance between those two sentences is what this review measures. The monograph (https://peptideamerica.org/molecules/sermorelin) records the regulatory position with the date it was verified; this page concerns the evidence.

#### How large is the human trial record, and when was it written?
Searched across the five names the compound is indexed under in August 2026, the literature runs to 562 records, of which 334 carry the Humans subject heading. Under the clinical-trial publication type the same union returns 71, and under the stricter randomized-controlled-trial type it returns 39; 52 of the 71 carry the adult subject heading and 19 the child heading [4].
The number that reframes all the others is the year. Of those 71 trials, 9 were published before 1990, 57 during the 1990s, 5 between 2000 and 2009, and none at all from 2010 onward. The five records from the 2000s were read individually rather than counted, and the most recent of them was published in 2005 [4].
A publication-type filter that has quietly stopped matching returns zero for every substance in the database, so the same run put a control term with a large and undisputed trial literature through the identical filter: it returned 8,904 records under the clinical-trial type and 6,113 under the randomized type, the invalid tag that this index has been burned by once returned 0 for that same control term, and a deliberately invalid record identifier errored in the same session [4]. The instrument was answering, and the most recent answer it returned was published in 2005.
That gap is the finding a reader should carry away first. Sermorelin is marketed in 2026 as a modern intervention for body composition, sleep, recovery, and aging. Its clinical trial record belongs to the decade of its approval, and nothing has been added to it in the years since the market for it grew.

#### What did the adult trials that measured body composition find?
Three of the 71 are indexed under body composition. All three were read, and they do not agree with one another, which is a more useful fact than any single one of them.
The largest is a 16-week single-blind randomized placebo-controlled study in 19 adults aged 55 to 71, who injected the analogue nightly after four weeks of placebo. Nocturnal growth hormone rose in both sexes, serum IGF-1 rose within two weeks, and skin thickness increased in both. Lean body mass increased in the men only. No other measure of body composition changed in either sex, bone mineral density did not move, body weight did not move, and sleep quality was unaffected [1].
The second is a six-week study in 11 healthy men aged 64 to 76 with low baseline IGF-1, injecting 2 mg nightly at home. Nocturnal growth hormone release rose. IGF-1 did not, nor did IGF binding protein 3 or growth hormone binding protein, and the dual-energy x-ray absorptiometry measures of muscle and fat did not change. Two of six strength measures improved [2]. The authors' own reading was that a single nightly dose is less effective than multiple daily doses at producing the downstream effects.
The third is a 14-day study in 10 men of mean age 68, comparing two doses against their own baseline and against young men. Growth hormone and IGF-1 rose to the levels measured in the young comparison group, but only at the higher dose, and the study measured hormones rather than body composition [3].
Put side by side, the three establish something narrow and defensible: sermorelin raises growth hormone, dose-dependently and reproducibly. Whether that translates into IGF-1 depends on the dose and schedule, since one trial found the rise and another did not. Whether it translates into a body a person would notice is a question that has been asked three times — in 19 subjects, in 11, and in 10 — and answered inconsistently.

#### Why is a hormone response not the same as a clinical outcome?
An outcome is what the patient experiences. A biomarker is a number measured on the way there, and the two part company often enough that regulators treat them as different categories of evidence. Growth hormone and IGF-1 are biomarkers. Lean mass, strength, sleep, and fat are closer to outcomes, and they are the terms in which the compound is sold.
This is not a hypothetical distinction here, because the trials above contain the split in a single study. The six-week trial raised growth hormone and left IGF-1, muscle, and fat exactly where it found them [2]. A page that reported only the hormone result from that trial would be reporting a true number and describing a false effect.
The same discipline applies to the comparison the question asks about. Injected growth hormone and a secretagogue are not two grades of one product; they are different interventions with different evidence and different risk arguments, and the argument that favors the secretagogue is a safety argument about preserved feedback control, not an efficacy argument about equivalent results. Tesamorelin (https://peptideamerica.org/molecules/tesamorelin), the approved drug in the same GH secretagogues (https://peptideamerica.org/classes/gh-secretagogues) class, shows what a completed registrational file for this mechanism looks like, and what it was and was not allowed to claim.

#### What is sermorelin's actual United States position?
It is one of the few molecules in this index with a lawful route. Licensed 503A pharmacies compound sermorelin against a valid prescription, and the compoundable (https://peptideamerica.org/status/compoundable) page records what that permits and what it does not. That position is unusual and it is durable, because the molecule was once the active ingredient of an approved drug rather than a substance that arrived through the research-chemical market.
The withdrawal record is public and dated. Geref was the subject of two applications, approved December 28, 1990 and September 26, 1997. The sponsor wrote to the FDA on December 2, 2008 to say the product was being discontinued and to ask that the application be withdrawn; the agency published the withdrawal of approval on May 19, 2009, effective the following month; and in a determination published March 4, 2013 the agency found that the Geref presentations had not been withdrawn from sale for reasons of safety or effectiveness [5].
That last sentence is the one worth quoting when a reader meets the phrase discontinued drug and hears a safety verdict in it. The agency addressed the question directly, in a document written for the purpose, and answered it the other way. What that record does not do is supply the modern outcome evidence the previous sections looked for and did not find. A drug can leave the market for commercial reasons and still have a thin file, and this one does.
For the neighboring cases, CJC-1295 (https://peptideamerica.org/molecules/cjc-1295) shows the same class with a withdrawn nomination and no lawful route at all, and ipamorelin (https://peptideamerica.org/molecules/ipamorelin) shows what happens when a compound's single controlled trial is run and reported honestly. The approved peptides (https://peptideamerica.org/reference/approved-peptides) table sets out the small set of peptides that cleared the full path.

#### Sources
1. Khorram O, Laughlin GA, Yen SS. Endocrine and metabolic effects of long-term administration of [Nle27]growth hormone-releasing hormone-(1-29)-NH2 in age-advanced men and women. J Clin Endocrinol Metab. 1997;82(5):1472–1479. https://pubmed.ncbi.nlm.nih.gov/9141536/
2. Vittone J, Blackman MR, Busby-Whitehead J, et al. Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men. Metabolism. 1997;46(1):89–96. https://pubmed.ncbi.nlm.nih.gov/9005976/
3. Corpas E, Harman SM, Piñeyro MA, Roberson R, Blackman MR. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men. J Clin Endocrinol Metab. 1992;75(2):530–535. https://pubmed.ncbi.nlm.nih.gov/1379256/
4. PubMed, National Library of Medicine. Census run August 2026 across five name variants — "sermorelin" OR "GHRH(1-29)" OR "GRF(1-29)" OR "sermorelin acetate" OR "Geref" — returning 562 indexed records, 334 carrying the Humans MeSH term, 71 under "clinical trial"[Publication Type] and 39 under the stricter "randomized controlled trial"[Publication Type]. Of the 71, 52 carry the adult MeSH term and 19 the child MeSH term; 3 are indexed under body composition, and all 3 were read individually rather than counted. By publication year the 71 divide 9 before 1990, 57 in 1990 through 1999, 5 in 2000 through 2009, and 0 in 2010 through 2026; the 5 records in the 2000s were read individually and the most recent was published in 2005. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized-controlled-trial type, the invalid tag clinicaltrial[pt] was run against the same control term and returned 0, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22sermorelin%22+OR+%22GHRH%281-29%29%22+OR+%22GRF%281-29%29%22+OR+%22sermorelin+acetate%22+OR+%22Geref%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
5. US Food and Drug Administration. Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. 78 Federal Register 14095, March 4, 2013; docket FDA-2012-P-1071. Read August 2026 from the Government Publishing Office. https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm

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### TB-500 Is Not Thymosin Beta-4
https://peptideamerica.org/evidence/tb-500-versus-thymosin-beta-4 · published August 2026 · updated August 2026

Question: Does the published thymosin beta-4 research apply to the compound sold as TB-500?
Short answer: No. TB-500 is a seven-residue fragment of a 43-residue protein, and the clinical record belongs to the protein. Searched on its own names, TB-500 returns one record under the clinical-trial publication type, and that record is a study of tuberculosis.

#### What is actually in a vial labeled TB-500?
Thymosin beta-4 is a protein of 43 amino acids involved in actin regulation and tissue repair, and it has a real research literature under its own name. TB-500 is a product name attached to material sold on the research-chemical market, and the two are routinely written about as though they were the same substance.
They are not, and the difference has been characterized in print. A 2012 analysis synthesized and identified the substance present in a TB-500 formulation as the N-terminal acetylated 17-23 fragment of thymosin beta-4 — the sequence Ac-LKKTETQ — and proposed a method for detecting it in plasma and urine [1]. Seven residues of forty-three is not a formulation difference. It is a different molecule that shares an origin.
What is in any given vial is a separate question again. A 2023 laboratory analysis of products sold under the TB500 and TB1000 names reported that their contents were not consistently what the product descriptions claimed [2]. That paper is about misbranded and adulterated material sold over the internet, which is the supply channel this compound has, because it has no other. The research-use-only (https://peptideamerica.org/glossary/research-use-only) entry sets out what that labeling posture does and does not mean.

#### How different are the two literatures, counted?
The two names were searched separately in August 2026 and their counts were never added together. Thymosin beta-4, across four spellings, returns 1,107 indexed records, of which 598 carry the Humans subject heading; under the clinical-trial publication type it returns 8, and under the stricter randomized-controlled-trial type it returns 7 [3].
TB-500, across its two spellings, returns 31 indexed records, of which 21 carry the Humans subject heading. Under the clinical-trial publication type it returns 1. Under the randomized-controlled-trial type it returns 0 [3].
The filter was proved live in the same run against a control term that returned 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid publication-type tag this index was once burned by returned 0 for that same control term, and a deliberately invalid record identifier errored in the same session [3]. A dead filter and a true absence print the same number, so the control is the part that makes the 0 worth reading.

#### What is the one TB-500 clinical trial?
It is not one. The single record returned under the clinical-trial publication type is a logistic regression analysis of environmental variables and the incidence of tuberculosis in respiratory patients, which matched the search on the letters TB [3].
It was found by reading the hit rather than counting it, and it is worth naming as a method point rather than a curiosity. A positive control proves that a filter is alive. It says nothing about whether the records the filter returned are about the subject. The honest count for this compound is zero human trials, and reaching it required opening the one result that stood between the search and that answer.
The 21 records carrying the Humans subject heading do not close the gap either, because most of them are analytical chemistry written for sport drug testing rather than for therapy: extraction methods, mass-spectrometry screens, and metabolism studies whose purpose is to detect the substance in an athlete's urine [3]. That is a literature about finding TB-500 in people, not about what it does to them.

#### What has thymosin beta-4 itself been tested for?
The protein's clinical record is small but it is real, and it belongs to specific indications. A first-in-human phase 1 study gave recombinant human thymosin beta-4 to healthy volunteers by intravenous injection in seven single-dose cohorts of 54 subjects in total and three multiple-dose cohorts of 30, reporting mild to moderate adverse events, no dose-limiting toxicities, and dose-proportional exposure [4]. That is a safety and pharmacokinetic result in healthy people, and the authors framed it as groundwork for a trial in acute myocardial infarction.
A phase 2 randomized trial reported improvement in the signs and symptoms of severe dry eye [5]. Those are the indications the protein has been carried into: the eye and the heart, by intravenous or ophthalmic administration, in trials run by sponsors who manufactured a defined product.
None of that is a record about tendon repair, ligament injury, or recovery from training, which are the uses the fragment is sold for. Nor does a trial of a manufactured 43-residue protein establish anything about a seven-residue fragment obtained from an unlicensed supplier. The repair peptides (https://peptideamerica.org/classes/repair-peptides) class holds two neighbors with the same shape of problem: BPC-157 (https://peptideamerica.org/molecules/bpc-157), whose human trial record is empty (https://peptideamerica.org/evidence/bpc-157-human-trials), and GHK-Cu (https://peptideamerica.org/molecules/ghk-cu), whose evidence is topical and whose market is injectable.

#### Where does the regulatory record leave the compound?
TB-500 was removed from Category 2 of the interim 503A bulks list in April 2026 without being added to Category 1, and in July 2026 the Pharmacy Compounding Advisory Committee voted to recommend adding it to the section 503A list. The margin is reported as 8–6 with one abstention by McDermott Will & Schulte and by LumaLex Law, whose separate accounts of the meeting agree substance by substance [6, 7]; the FDA has published no minutes, transcript or vote summary for it, so that figure is secondary and this review says so where it prints one. The vote is advisory, no FDA final rule has issued, and no licensed United States pharmacy may lawfully compound it. The monograph (https://peptideamerica.org/molecules/tb-500) carries that ledger with the date each entry was verified, the vote ledger (https://peptideamerica.org/reference/pcac-july-2026) carries the arithmetic of the whole meeting and the sourcing behind it, and the pending (https://peptideamerica.org/status/pending) page explains what an advisory recommendation changes, which is nothing yet.
That posture and the evidence above answer two different questions, and conflating them is the second common mistake. A committee recommending a substance for a compounding list is not a committee finding that the substance works. The vote concerned whether pharmacies should be permitted to prepare it; the trial record concerns whether anyone has tested it. On the first question there is a recommendation and no rule. On the second, for the fragment as sold, there is nothing at all.

#### Sources
1. Esposito S, Deventer K, Goeman J, Van der Eycken J, Van Eenoo P. Synthesis and characterization of the N-terminal acetylated 17-23 fragment of thymosin beta 4 identified in TB-500, a product suspected to possess doping potential. Drug Test Anal. 2012;4(9):733–738. https://pubmed.ncbi.nlm.nih.gov/22962027/
2. Delcourt V, Garcia P, Chabot B, et al. TB500/TB1000 and SGF1000: a scientific approach for a better understanding of misbranded and adulterated drugs. Drug Test Anal. 2023;15(4):458–464. https://pubmed.ncbi.nlm.nih.gov/36482504/
3. PubMed, National Library of Medicine. Census run August 2026, the two names counted separately. "TB-500" OR "TB500" returns 31 indexed records, 21 carrying the Humans MeSH term, 1 under "clinical trial"[Publication Type] and 0 under "randomized controlled trial"[Publication Type]; the single clinical-trial record was read individually and is a logistic regression study of tuberculosis incidence, matched on the letters TB and unrelated to the peptide. "thymosin beta 4" OR "thymosin beta-4" OR "Tbeta4" OR "thymosin beta(4)" returns 1,107 indexed records, 598 carrying the Humans MeSH term, 8 under the clinical-trial type and 7 under the randomized-controlled-trial type. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized-controlled-trial type, the invalid tag clinicaltrial[pt] returned 0 for that same control term, and a deliberately invalid record identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22TB-500%22+OR+%22TB500%22%29+AND+%22clinical+trial%22%5BPublication+Type%5D
4. Wang X, Liu L, Qi L, Lei C, Li P, Wang Y, et al. A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy Chinese volunteers. J Cell Mol Med. 2021 Sep;25(17):8222-8228. https://pubmed.ncbi.nlm.nih.gov/34346165/
5. Sosne G, Dunn SP, Kim C. Thymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial. Cornea. 2015 May;34(5):491-6. https://pubmed.ncbi.nlm.nih.gov/25826322/
6. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance.
7. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance.

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### Tesamorelin: Approved Drug, Sold Peptide
https://peptideamerica.org/evidence/tesamorelin-off-label · published August 2026 · updated September 2026

Question: Does the evidence behind tesamorelin's approval support general fat loss?
Short answer: No. Every trial the approval rests on enrolled adults with HIV-associated lipodystrophy, and the one randomized trial of body composition outside that population reduced visceral fat while leaving subcutaneous fat statistically unchanged, at p equal to 0.40.

#### What is tesamorelin approved for, and on what evidence?
Tesamorelin is an unusual molecule in this index, because most of the compounds recorded here are asked whether any human evidence exists at all. This one has a registrational file. It has been an approved drug in the United States since November 2010, and in March 2025 the FDA approved EGRIFTA WR, a concentrated formulation reconstituted weekly rather than daily [3].
The approval is narrow, and the narrowness is the whole point. It covers the reduction of excess abdominal fat in adults with HIV who have lipodystrophy, and nothing else. The pivotal trial randomized 404 patients to tesamorelin 2 mg daily or placebo; visceral adipose tissue fell 10.9 percent against 0.6 percent with placebo over six months, reaching approximately 18 percent in patients who continued for a full year [1]. A pooled analysis of the two phase 3 studies reports the same population and the same endpoint [2].
An indication is not a description of a drug's effects; it is a description of the population and endpoint in which those effects were demonstrated. Everything below follows from holding that distinction rather than relaxing it.

#### What does the trial literature outside HIV actually contain?
Searched across the three names the compound is indexed under in August 2026, the literature runs to 127 records, of which 28 carry the clinical-trial publication type and 26 the stricter randomized-controlled-trial type. Of those 28, 21 name HIV or lipodystrophy [7].
The remaining seven were read individually rather than counted, because a count of trials is not a finding about what was tested. One is a trial of a different growth hormone product in which tesamorelin appears incidentally. The rest measure cognition in adults with mild cognitive impairment and in healthy older adults [6], glycemic safety in patients with type 2 diabetes [5], mitochondrial recovery, and a hormone-secretion relationship [7].
One of the seven is a controlled trial of body composition, and it is the one a reader asking about fat loss needs. It is examined in the next section. The point of the census is what surrounds it: a molecule marketed for general fat reduction has, after sixteen years on the market, a single randomized body-composition trial conducted outside the population it was approved for.

#### Why does visceral fat not mean general fat loss?
That trial randomized 60 abdominally obese adults without HIV to tesamorelin 2 mg daily or placebo for twelve months. The subjects were not healthy volunteers; they were selected for reduced growth hormone secretion, which is the same deficit the approved indication describes in a different patient group.
Visceral adipose tissue fell by 35 square centimeters against placebo, with a 95 percent confidence interval of −58 to −12 and p equal to 0.003. Abdominal subcutaneous adipose tissue did not change significantly: a treatment effect of −10 square centimeters, a confidence interval of −32 to +13, and p equal to 0.40 [4].
Those two results are the whole answer, and they point in opposite directions for the reader who arrived here. Visceral fat is the deep abdominal compartment that surrounds the organs; subcutaneous fat is the layer beneath the skin, and it is the compartment a person sees, measures with a tape, and means when the phrase is general fat loss. The trial moved the first and left the second where it found it, in a population already selected for a hormone deficit. A drug that selectively reduces one compartment in deficient patients is not a drug shown to reduce body fat in people generally, and the trial's own authors describe the effect as selective [4].

#### What is sold under the name, and is it the approved product?
The approved product is the lawful supply route, and it is a prescription drug dispensed against a diagnosis. Tesamorelin has no compounding route at all: its application was deemed a biologics license on March 23, 2020 [8], and FDA's notice to compounders states that biological products which transitioned that day are not eligible for the compounding exemptions under section 503A or 503B [9]. The monograph (https://peptideamerica.org/molecules/tesamorelin) records that posture with the date it was verified, and the approved (https://peptideamerica.org/status/approved) hub records the small set of peptides that share it.
Material offered under the molecule's name outside that route is not the approved product and does not inherit its evidence. It is research-use-only chemical supply, sold outside pharmacy licensure and prescriber oversight, and the trial results above attach to a manufactured drug administered at a stated dose under a protocol, not to the contents of an unlabeled vial. The research-use-only (https://peptideamerica.org/glossary/research-use-only) entry sets out what that labeling posture does and does not mean.
The gap that produces the question is a real one: a compound with 70,000 United States searches a month, a real approval, a real evidence base, and an indication that fits almost none of the people searching for it. A contrasting case is BPC-157 (https://peptideamerica.org/molecules/bpc-157), which shares the commercial visibility and has no human trial record at all (https://peptideamerica.org/evidence/bpc-157-human-trials).

#### Sources
1. Falutz J, Potvin D, Mamputu JC, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010;53(3):311–322. https://pubmed.ncbi.nlm.nih.gov/20101189/
2. Falutz J, Mamputu JC, Potvin D, et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010;95(9):4291–4304. https://pubmed.ncbi.nlm.nih.gov/20554713/
3. Theratechnologies. FDA approval of EGRIFTA WR (tesamorelin F8) for excess visceral abdominal fat in adults with HIV and lipodystrophy. March 2025.
4. Makimura H, Feldpausch MN, Rope AM, et al. Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial. J Clin Endocrinol Metab. 2012;97(12):4769–4779. https://pubmed.ncbi.nlm.nih.gov/23015655/
5. Clemmons DR, Miller S, Mamputu JC. Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: a randomized, placebo-controlled trial. PLoS One. 2017;12(6):e0179538. https://pubmed.ncbi.nlm.nih.gov/28617838/
6. Baker LD, Barsness SM, Borson S, et al. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial. Arch Neurol. 2012;69(11):1420–1429. https://pubmed.ncbi.nlm.nih.gov/22869065/
7. PubMed, National Library of Medicine. Census run August 2026 across three name variants — "tesamorelin" OR "TH9507" OR "EGRIFTA" — returning 127 indexed records, 106 carrying the Humans MeSH term, 28 under "clinical trial"[Publication Type] and 26 under the stricter "randomized controlled trial"[Publication Type]. Of the 28, 21 name HIV or lipodystrophy and 7 do not; of the 26, 20 name HIV or lipodystrophy and 6 do not. All 7 residual records were read individually rather than counted: one is a trial of a different growth hormone product in which tesamorelin appears incidentally, and the remainder test cognition, glycemic safety, mitochondrial recovery, adiponectin, and body composition in adults selected for reduced growth hormone secretion. The publication-type filter was proved live in the same run against a control term returning 8,904 records, and a deliberately invalid identifier errored in the same run. https://pubmed.ncbi.nlm.nih.gov/?term=%28%22tesamorelin%22+OR+%22TH9507%22+OR+%22EGRIFTA%22%29+AND+%22randomized+controlled+trial%22%5BPublication+Type%5D
8. US Food and Drug Administration. Drugs@FDA: BLA 022505, EGRIFTA (tesamorelin acetate), Theratechnologies. Records "This Former NDA Was Deemed To Be a BLA on March 23, 2020", the original approval (ORIG-1) on November 10, 2010, and supplement S-020 on March 25, 2025, whose approval letter provides for EGRIFTA WR as a new formulation and multiple-dose presentation. Read September 2026. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505
9. US Food and Drug Administration. Notice to Compounders: Changes that affect compounding as of March 23, 2020. States that transitioning biological products "will not be eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act." Content current as of March 5, 2020. Read September 2026. https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020

## Key pages
- https://peptideamerica.org/molecules — the status index (all 40 molecules, dated)
- https://peptideamerica.org/status/approved — FDA-approved
- https://peptideamerica.org/status/compoundable — Compoundable (503A)
- https://peptideamerica.org/status/pending — PCAC-recommended · pending
- https://peptideamerica.org/status/research-only — No lawful route and Nomination withdrawn
- https://peptideamerica.org/evidence — the evidence reviews (47, each stating its answer first)
- https://peptideamerica.org/reference/pcac-july-2026 — the July 2026 advisory-committee vote ledger
- https://peptideamerica.org/reference/trial-record — the PubMed trial census
- https://peptideamerica.org/method — how statuses are verified
- https://peptideamerica.org/editor — the reference editor

## Complete canonical page inventory
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https://peptideamerica.org/evidence/ll-37-wound-healing-trials
https://peptideamerica.org/evidence/carnosine-glucose-vascular-evidence
https://peptideamerica.org/evidence/dulaglutide-versus-semaglutide-trials
https://peptideamerica.org/evidence/elamipretide-fatigue-trials
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https://peptideamerica.org/evidence/setmelanotide-weight-loss-trials
https://peptideamerica.org/evidence/afamelanotide-light-tolerance
https://peptideamerica.org/evidence/kisspeptin-testosterone-evidence
https://peptideamerica.org/evidence/ara-290-neuropathy-trials
https://peptideamerica.org/evidence/aviptadil-covid-trials
https://peptideamerica.org/evidence/bpc-157-human-trials
https://peptideamerica.org/evidence/tesamorelin-off-label
https://peptideamerica.org/evidence/dsip-rejection
https://peptideamerica.org/evidence/cjc-1295-withdrawal
https://peptideamerica.org/evidence/sermorelin-versus-growth-hormone
https://peptideamerica.org/evidence/tb-500-versus-thymosin-beta-4
https://peptideamerica.org/evidence/nad-infusion-evidence
https://peptideamerica.org/evidence/glutathione-skin-lightening
https://peptideamerica.org/evidence/kpv-evidence
https://peptideamerica.org/evidence/ipamorelin-trial
https://peptideamerica.org/evidence/epitalon-longevity
https://peptideamerica.org/evidence/semax-evidence
https://peptideamerica.org/evidence/mots-c-evidence
https://peptideamerica.org/evidence/ghk-cu-topical-versus-injectable
https://peptideamerica.org/evidence/melanotan-ii
https://peptideamerica.org/evidence/pt-141-status
https://peptideamerica.org/evidence/category-3-nominations
https://peptideamerica.org/evidence/secretin-autism
https://peptideamerica.org/evidence/lawful-is-not-proven
https://peptideamerica.org/evidence/thymulin-trial-records
https://peptideamerica.org/evidence/ghrp-provocation-studies
https://peptideamerica.org/evidence/weight-loss-peptides-by-status
https://peptideamerica.org/evidence/sermorelin-versus-tesamorelin
https://peptideamerica.org/evidence/glow-and-klow-blends
https://peptideamerica.org/evidence/incretin-pipeline
https://peptideamerica.org/evidence/bpc-157-safety-record
https://peptideamerica.org/evidence/bpc-157-and-tb-500-stack
https://peptideamerica.org/evidence/tesamorelin-label-safety
https://peptideamerica.org/evidence/cjc-1295-and-ipamorelin
https://peptideamerica.org/evidence/semax-versus-selank
https://peptideamerica.org/evidence/melanotan-i-versus-ii
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https://peptideamerica.org/evidence/topics/regulatory-record
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https://peptideamerica.org/evidence/topics/marketing-claims/page/2
https://peptideamerica.org/evidence/topics/marketing-claims/page/3
https://peptideamerica.org/reference/pcac-july-2026
https://peptideamerica.org/reference/2026-record
https://peptideamerica.org/reference/nominations
https://peptideamerica.org/reference/category-2-removal
https://peptideamerica.org/reference/approved-peptides
https://peptideamerica.org/reference/trial-record
https://peptideamerica.org/reference/wada-status
https://peptideamerica.org/reference/final-action-watch
https://peptideamerica.org/glossary/503a
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https://peptideamerica.org/glossary/bulks-list
https://peptideamerica.org/glossary/category-1
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https://peptideamerica.org/glossary/pcac
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https://peptideamerica.org/glossary/category-3
https://peptideamerica.org/glossary/prohibited-list
https://peptideamerica.org/glossary/provocation-test
https://peptideamerica.org/glossary/essentially-a-copy
https://peptideamerica.org/glossary/dietary-supplement