Repair peptides

BPC-157

Body Protection Compound 157; pentadecapeptide BPC

US status
PCAC-recommended · pending
Class
Repair peptides
Approved product
None
Route
None lawful; sold as research-use-only material

By Peptide America · Publisher · Reviewed August 2026

Regulatory record

4 dated actions on record; no FDA final action yet.
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 as of August 2026.

Every entry above is dated; the record is current as of the review date.

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 sets each route claim against that record.

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 sets out each human report, the animal toxicology and the trials now registered, and the review of the BPC-157 and TB-500 stack covers the combination sold under the Wolverine name.

Educational summary of the cited sources, not medical advice; a prescriber weighs these risks against a person’s own history.

Lawful 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].

Supply

No lawful US supply route exists for this molecule today. Lawfully available alternatives are recorded in the molecule index; the regulatory record on this page tracks the rulemaking that could change this.

Questions

Is BPC-157 legal in the US?

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.

Is BPC-157 FDA-approved?

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].

What are the side effects of BPC-157?

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].

Has BPC-157 been tested in humans?

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.

What did the July 2026 advisory vote change?

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 status page.

Elsewhere in this index

Filed under

Evidence reviews

Reference tables

Same class

  • GHK-CuCompoundable (503A)
  • TB-500PCAC-recommended · pending
  • KPVPCAC-recommended · pending
  • ARA-290No lawful route

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. PMID 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. Source
  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. Source
  4. US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026. Source
  5. American Journal of Managed Care. FDA panel backs 6 peptides for compounding. July 2026. Source
  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. Source
  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. Source
  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. Source
  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. PMID 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. PMID 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. PMID 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. Source
  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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. Source
  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. Source
  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". Source
  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. Source
  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. PMID 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". PMID 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. PMID 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. Source
  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." Source
  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. Source