Evidence topic

The regulatory record

By Peptide America · Publisher

These reviews answer questions whose evidence is a regulatory record rather than a literature: what an agency action did, what it did not do, and what the interval between the two permits. The distinction matters commercially, because every one of these events has been reported somewhere as a clearance.

Each piece states the action, its date, and the position it leaves a molecule in; where this index has verified no further action, the review says so and gives the date the check was made.

15 reviews · page 1 of 2

  1. What are the side effects of BPC-157, and what is actually known about its safety?

    BPC-157 Side Effects: The Safety Record

    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.

    The human trial record · The regulatory record · BPC-157 · 16 sources

  2. What is known about CJC-1295 taken with ipamorelin?

    CJC-1295 With Ipamorelin: The Evidence

    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.

    The human trial record · The regulatory record · CJC-1295 · Ipamorelin · Sermorelin · 12 sources

  3. Which incretin drugs are approved, which are still in trials, and which of them are peptides?

    Incretin Pipeline: Retatrutide and CagriSema

    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 regulatory record · The human trial record · Semaglutide · Tirzepatide · Retatrutide · Liraglutide · Dulaglutide · 25 sources

  4. What is the difference between Melanotan I and Melanotan II?

    Melanotan I vs II: One Approved, One Not

    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.

    The regulatory record · Marketing claims tested · Afamelanotide · Melanotan II · 20 sources

  5. Which peptides sold for weight loss are actually FDA-approved for it?

    Peptides for Weight Loss, by US Legal Status

    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.

    The regulatory record · Marketing claims tested · Semaglutide · Tirzepatide · Liraglutide · Setmelanotide · Tesamorelin · Retatrutide · AOD-9604 · MOTS-c · 24 sources

  6. How do Semax and Selank differ, and what is the evidence and legal status of each?

    Semax vs Selank: Two Russian Peptides Compared

    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.

    The human trial record · The regulatory record · Semax · Selank · 14 sources

  7. How do sermorelin and tesamorelin differ?

    Sermorelin vs Tesamorelin: How They Differ

    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.

    The regulatory record · The human trial record · Sermorelin · Tesamorelin · Ipamorelin · 16 sources

  8. What side effects does the tesamorelin label record?

    Tesamorelin Side Effects: What the Label Says

    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.

    The human trial record · The regulatory record · Tesamorelin · 8 sources

  9. Does a lawful compounding status mean a peptide is supported by evidence?

    A Lawful Peptide Is Not a Proven One

    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.

    The regulatory record · The human trial record · Vasoactive intestinal peptide · 6 sources

  10. What does Category 3 of the FDA 503A bulks list actually mean?

    Category 3: Nominated, Not Reviewed

    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 regulatory record · GHRP-2 · GHRP-6 · Mechano growth factor · ARA-290 · Secretin · Thymulin · L-carnosine · 8 sources

  11. Does the cosmetic-science evidence for copper tripeptide support injecting it?

    GHK-Cu: Topical Evidence, Injectable Sales

    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.

    Marketing claims tested · The regulatory record · GHK-Cu · 9 sources

  12. What is the record on Melanotan II, which was removed from Category 2 and never reviewed?

    Melanotan II: The Record on a Tanning Peptide

    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.

    The human trial record · The regulatory record · Melanotan II · 14 sources

The record behind the reviews

A review argues from the ledger; the ledger itself is published as reference tables, and every molecule’s dated posture is in the molecule index. Terms of art are defined in the glossary.