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MonographBPC-157

BPC-157: identity, the animal literature and regulatory status

A synthetic 15-residue peptide whose evidence base is almost entirely rodent studies. Identity, the animal literature by model, exactly what human data exist, and dated status.

Last reviewed
2026-09-22
Reviewer
editorial review pending
Revision
1
Sources
39

Summary

The evidence base for BPC-157 is overwhelmingly rodent studies. A 2025 systematic review of the musculoskeletal literature identified 36 includable studies, of which 35 were preclinical and one clinical 1. Nothing on this page should be read as extending those findings to humans: the human record consists of two meeting abstracts, one registered phase 1 study without posted results, three small uncontrolled reports from single clinics, and three further registered studies that have not reported 23456.

BPC-157 is a synthetic 15-residue peptide, GEPPPGKPADDAGLV, reported to be a partial sequence of a body protection compound isolated from human gastric juice and first described by Sikirić and colleagues at the University of Zagreb in 1993 72. No molecular target has been identified, and FDA states that the mechanisms of action remain poorly understood 2. No product containing the free base or the acetate is authorised in any country, and in a briefing document dated 11 May 2026 FDA proposed not adding either substance to the 503A bulk drug substances list 2. BPC-157 has been named by example in section S0 of the WADA Prohibited List since the 2022 List and is prohibited at all times 89.

Identity · BPC-157verified 2026-09-21
Synonyms
Bepecin, BPC 157, PL-10, PL-14736, PLD-116, Body protection compound 157, H-GEPPPGKPADDAGLV-OH
CAS
137525-51-0· FDA / NCATS Global Substance Registration System, PubChem, National Center for Biotechnology Information, U.S. Food and Drug Administration
UNII
8ED8NXK95P· FDA / NCATS Global Substance Registration System, U.S. Food and Drug Administration
PubChem CID
9941957
Formula
C62H98N16O22· PubChem, National Center for Biotechnology Information, FDA / NCATS Global Substance Registration System, U.S. Food and Drug Administration
Mol. weight
1419.5 g/mol· PubChem, National Center for Biotechnology Information, U.S. Food and Drug Administration
Class
Synthetic pentadecapeptide; reported to be a partial sequence of a body protection compound (BPC) isolated from human gastric juice
Targets
None identified in retrieved sources
Modifications
None; linear pentadecapeptide with a free N-terminal amine and a free C-terminal carboxyl, no amidation, acylation, cyclisation, disulfide or non-natural residue recorded
Sequence (one-letter) · 15 residues
  1. G
  2. E
  3. P
  4. P
  5. P
  6. G
  7. K
  8. P
  9. A
  10. D
  11. D
  12. A
  13. G
  14. L
  15. V

Identity and structure

Sequence and residues

The molecule is a linear pentadecapeptide with the one-letter sequence GEPPPGKPADDAGLV, written in three-letter form as H-Gly-Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val-OH 10112. It carries a free N-terminal glycine amine and a free C-terminal valine carboxylate; no amidation, acylation, cyclisation or non-natural residue is recorded in the substance registry protein record or in FDA's structural description 102. A review of the biopharmaceutical literature attributes the peptide's reported resistance to gastric proteolysis to the conformational rigidity of the N-terminal polyproline segment, identifies the Asp10–Asp11 junction as the principal acid-hydrolysis liability, and notes that the sequence contains no methionine, cysteine, tryptophan, asparagine or glutamine and therefore no residue prone to oxidation or deamidation 12.

Acetate, and the absence of an arginate record

The dossier resolves salt identity as follows. The free peptide carries UNII 8ED8NXK95P, CAS 137525-51-0, PubChem CID 9941957 and the formula C62H98N16O22, with a molecular weight of 1419.5 g/mol in PubChem and in FDA's table and 1419.54 on supplier certificates 10132. The acetate is separately registered with UNII PAR2FC72XP and CAS 216441-37-1; the substance registry gives the monoacetate a molecular weight of 1479.59 g/mol, while FDA writes the formula with an unspecified number of acetate equivalents and records the weight as not available for that reason 142. PubChem lists a second registry number, 1628202-19-6, among the acetate synonyms alongside 216441-37-1, and the two are not reconciled by the sources retrieved 15.

No search of PubChem or of the substance registry conducted for the dossier returned any record for a BPC-157 arginate or arginine salt, and FDA's evaluation covers only the free base and the acetate 13102. A material described as an arginate therefore has no identifiers to check a certificate against. FDA treats naming inconsistency across salts and derivatives sold under one common name as a risk in itself, on the grounds that it creates the possibility of dispensing a substance other than the one ordered 2. Other identifiers recorded on the free-peptide record include PL-10, PL-14736 and PLD-116 1013.

Mechanism and pharmacology

No receptor or molecular target has been identified. FDA states that the molecular targets for BPC-157-related substances have not been identified and that the mechanisms of action remain poorly understood, which makes the biological plausibility of the reported effects difficult to assess; a 2026 review reaches the same conclusion, reporting that no high-affinity binding site has been identified 212.

The proposed mechanisms in the primary literature are associations observed in cell and animal models rather than demonstrated binding. They include up-regulation and internalisation of VEGFR2 with activation of the VEGFR2–Akt–eNOS pathway in endothelial cells and in rat hind-limb ischaemia 16, increased growth hormone receptor expression in cultured rat Achilles tendon fibroblasts 17, and increased tendon fibroblast outgrowth, survival under hydrogen peroxide stress and migration with dose-dependent FAK and paxillin phosphorylation 18. A scoping review summarises these as VEGFR2, Akt–eNOS, ERK1/2 and anti-inflammatory signalling 19.

The endogenous origin is reported rather than demonstrated in every source retrieved. FDA uses the qualified wording that BPC-157 is reported to be a pentadecapeptide fragment of a body protection compound found in gastric juice, and notes that the 1993 authors described it as a possible endogenous free radical scavenger and organoprotection mediator 27. A 2026 review states that the parent protein remains uncharacterised 12. Whether an endogenous BPC-157 sequence exists in humans is therefore unresolved on the present record.

Animal disposition has been characterised. After a single intravenous dose the elimination half-life of the parent peptide was 15.2 minutes in Sprague Dawley rats and 5.27 minutes in Beagle dogs, with linear kinetics and intramuscular bioavailability of approximately 14 to 19 per cent in rats and 45 to 51 per cent in dogs; excretion was mainly urinary and biliary, and radiolabelled peptide was rapidly degraded to small fragments and free amino acids 202. Human pharmacokinetics are essentially absent: in the two rectal-enema studies in which plasma was sampled BPC-157 was not detected, and FDA found no human pharmacokinetic data after oral, subcutaneous, nasal or transdermal administration 2.

A disputed literature

The interpretation of this body of work is actively contested in the peer-reviewed literature. An independent review by Jóźwiak and colleagues in 2025 raised the possibility of adverse consequences of sustained angiogenic and nitric-oxide effects 21; the Zagreb group published a comment defending the cytoprotection model and the compound's safety 22; and the review authors published a reply 23. A separate commentary in Inflammopharmacology discusses a large 2024 review by the same group 24. The same independent review states that BPC-157 is not currently listed as prohibited by WADA; the Prohibited List in force names it in section S0, so that statement is contradicted by the primary source 219.

Clinical and preclinical evidence

What human data exist

The human record is set out in full below. Two of the entries are meeting abstracts that FDA read rather than peer-reviewed publications, one is a registered phase 1 study whose registry status has been "unknown" since 2015 and for which FDA located no publication, and three are uncontrolled reports from single clinics 23. Three further registered studies, two randomised and one single-arm, have posted no results 252627. One systematic review found no clinical safety data at all, and a 2026 narrative review of peptides in sports medicine records that rigorous human safety data for the unapproved peptides it surveys, BPC-157 among them, are scarce 11928.

Studies as reported · design and results from the cited publication or registry record
StudyDesignnInterventionComparatorDurationPrimary endpointResult
Veljaca 2002 and 2003, phase 1 tolerability and pharmacokinetics (meeting abstracts)none locatedPlacebo-controlled study in healthy subjects; rectal enema 0.25 to 2 mg/kg, single dose then seven daily doses32 randomised, 24 received BPC-157BPC-157 rectal enemaplacebosingle dose, one-week washout, then 7 daysSafety and tolerability; plasma pharmacokineticsNo significant adverse events attributed to treatment; most plasma concentrations below the assay limit of quantification; headache and flatulence most frequent, without an obvious difference from placebo. Known to the dossier only through FDA's account of a meeting abstract. [fda-pcac-briefing-2026]
Ruenzi 2005, ulcerative colitis (meeting abstract)none locatedMulticentre, randomised, double-blind, placebo-controlled trial53 randomised, 46 completedPL 14736 enema 80 mg once dailyplacebo2 weeksChange in a Disease Activity Index that the abstract does not defineMean index change −3.2 (95% CI −5.58, −0.82) with BPC-157 versus −1.6 (95% CI −3.86, 0.67) with placebo; estimated between-group difference 1.6 (95% CI −4.84, 1.62). FDA judges the data inadequate to support efficacy or safety. [fda-pcac-briefing-2026]
PCO-02, phase 1 in healthy volunteers, MexicoNCT02637284Randomised, quadruple-masked, placebo-controlled; oral tablets containing 1 mg bepecin42 estimatedsingle dose of 1, 3 or 6 tablets, and 3 tablets every 8 hours for two weeksplaceboup to 2 weeks dosing with a 6-month outcome windowAdverse eventsNo results posted. Registry status unknown; last known status active, not recruiting; last update 22 December 2015. FDA located no associated publication. [ctgov-nct02637284]
Lee and Padgett 2021, knee painnoneSingle-clinic retrospective chart review with telephone survey; intra-articular BPC-157, alone or with thymosin beta-417 identified, 16 contacted, 12 received BPC-157 aloneintra-articular BPC-157 2 to 4 mg, 1 or 2 dosesnonerecall 6 to 12 months after injectionNone pre-specified; self-rated pain improvement11 of 12 who received BPC-157 alone reported significant improvement. No validated instrument, no control group and no imaging; the 2025 systematic review instead reports that 7 of 12 had relief lasting more than six months. [lee-2021-altern-ther-health-med]
Lee 2024, interstitial cystitisnoneSingle-arm, open-label, single clinic, in women unresponsive to pentosan polysulfate12intravesical injection of 1 mg at 10 sites in one procedurenonesingle procedureGlobal Response Assessment10 of 12 rated success 100% and 2 of 12 rated 80%; no adverse events reported. Uncontrolled and unblinded, with no comparator and no objective endpoint. [lee-2024-altern-ther-health-med]
Lee and Burgess 2025, intravenous safety pilotnoneSingle-arm, open-label, in two adults who had previously received intravenous BPC-157210 mg intravenous infusion on day 1 and 20 mg on day 2none3 daysSafety: vital signs and laboratory panelNo measurable change in the reported cardiac, hepatic, renal, thyroid or glucose markers and no side effects reported; a sample of two precludes inference. [lee-2025-altern-ther-health-med]
Hamstring strain, phase 2NCT07437547Randomised, quadruple-masked, placebo-controlled, with standardised rehabilitation120 planneddaily subcutaneous injection for 14 daysplacebo14 days of treatment with 8-week follow-upCo-primary: time to return to unrestricted sport; change in MRI injury volume at day 14Recruiting since 2 February 2026; no results. [ctgov-nct07437547]
Rotator cuff repair pilotNCT07803250Randomised, quadruple-masked, sham-controlled, after arthroscopic repair30 in the design module; the summary describes 20daily subcutaneous injection for 90 dayssham90 days, outcomes to 5 monthsIsometric shoulder strength by handheld dynamometryNot yet recruiting; estimated start 1 January 2027. The enrolment figure is internally inconsistent within the registry record. [ctgov-nct07803250]
Peptide gummies, inflammation and recoveryNCT07752381Single-arm, open-label dietary supplement study40two gummies daily containing 500 mcg BPC-157 per servingnone8 weeksChange in hs-CRP and IL-6Completed 1 November 2025; no results posted. [ctgov-nct07752381]
What the human record does not support

No conclusion about effect in humans follows from the table above. Two entries are meeting abstracts, one registered trial has never reported, and the three clinic reports are uncontrolled, unblinded and, in one case, of two people. FDA judges the ulcerative colitis data inadequate to support efficacy or safety 21.

Animal models: musculoskeletal transection

Studies as reported · design and results from the cited publication or registry record
StudyDesignnInterventionComparatorDurationPrimary endpointResult
Stareŝinić et al. 2003, Achilles tendonnoneRat Achilles tendon transected 5 mm proximal to the calcaneal insertion—10 mcg, 10 ng or 10 pg/kg intraperitoneally once dailysalineassessment on days 1 to 14Biomechanical, functional, microscopic and macroscopic measuresIncreased load to failure and Young's modulus, higher Achilles functional index and a smaller defect; effects reported across a 10⁶-fold range of doses, so no dose-response relationship was established. [staresinic-2003-j-orthop-res]
Stareŝinić et al. 2006, quadriceps musclenoneRat quadriceps transected 1.0 cm proximal to the patella—10 mcg, 10 ng or 10 pg/kg intraperitoneally once dailysaline72 daysBiomechanics, motor function, histology, macroscopyIncreased load to failure, recovery of walking and extensor postural thrust, and muscle fibre continuity. [staresinic-2006-j-orthop-res]
Cerovecki et al. 2010, medial collateral ligamentnoneRat medial collateral ligament transection, three routes compared—10 mcg or 10 ng/kg intraperitoneally, topical cream, or 0.16 mcg/mL in drinking wateruntreated control90 daysFunctional, biomechanical, macroscopic and histological measuresImprovement reported for all three routes, with no separation between doses. [cerovecki-2010-j-orthop-res]

Animal and cell models: vascular and tendon signalling

Studies as reported · design and results from the cited publication or registry record
StudyDesignnInterventionComparatorDurationPrimary endpointResult
Hsieh et al. 2017, endothelial cells and hind-limb ischaemianoneCultured endothelial cells and a rat hind-limb ischaemia model—BPC-157untreated cells and control animalsnot statedVEGFR2 expression and downstream signalling; blood flow recoveryUp-regulation and internalisation of VEGFR2 with activation of the VEGFR2–Akt–eNOS pathway. An association in cells and animals, not demonstrated receptor binding. [hsieh-2017-j-mol-med]
Chang et al. 2011, tendon fibroblastsnoneCultured rat Achilles tendon fibroblasts—BPC-157 across a concentration rangeuntreated cellsin vitroOutgrowth, survival under hydrogen peroxide stress, migration, FAK and paxillin phosphorylationIncreased outgrowth, survival and migration with dose-dependent FAK and paxillin phosphorylation. [chang-2011-j-appl-physiol]
Chang et al. 2014, tendon fibroblastsnoneCultured rat Achilles tendon fibroblasts—BPC-157untreated cellsin vitroGrowth hormone receptor expressionIncreased growth hormone receptor expression. [chang-2014-molecules]

Animal models: toxicology and disposition

Studies as reported · design and results from the cited publication or registry record
StudyDesignnInterventionComparatorDurationPrimary endpointResult
Xu et al. 2020, preclinical safetynoneMice, rats, rabbits and dogs; single-dose and 28-day repeat intramuscular dosing, a genotoxicity battery and an embryo-fetal study—rats 0.2 to 4.0 mg/kg; dogs 0.1 to 2.0 mg/kg, intramuscularlyvehicle28 days plus 14-day recoveryToxicity, genotoxicity, teratogenicityNo mutagenicity in Ames, chromosome aberration or micronucleus assays; no embryo-fetal toxicity up to 4.0 mg/kg; intramuscular single-dose NOAELs 20 mg/kg in rats and 10 mg/kg in dogs. FDA reads the 28-day data as showing coagulation (aPTT) and liver-associated signals that have not been reproduced in longer studies. No carcinogenicity study exists. [xu-2020-regul-toxicol-pharmacol]
He et al. 2022, absorption, distribution, metabolism and excretionnoneSprague Dawley rats and Beagle dogs; intravenous and intramuscular dosing of tritiated peptide—tritiated BPC-157, single and repeated dosingnonesingle and repeated dosingHalf-life, bioavailability, distribution, excretionElimination half-life 15.2 minutes in rats and 5.27 minutes in dogs; linear kinetics; intramuscular bioavailability 14 to 19% in rats and 45 to 51% in dogs; urinary and biliary excretion with rapid degradation to fragments and free amino acids. [he-2022-front-pharmacol]
Evidence level

Animal models and cell culture, with one registered phase 1 study that has never reported, two meeting abstracts, three small uncontrolled clinic reports and three registered studies without results. FDA notes that across the rodent studies reviewed the microgram and nanogram per kilogram doses produced effects of comparable magnitude, so no dose-response relationship has been established 12.

Analytical characterisation

There is no United States Pharmacopeia or National Formulary monograph for the free base or the acetate, and none in the European Pharmacopoeia (11th edition, 11.8), the Japanese Pharmacopoeia (18th edition) or the International Pharmacopoeia (12th edition) 2. Certificates of analysis reviewed by FDA typically report purity alone: one nomination certificate for the acetate reported 97.8 per cent against a limit of at least 95 per cent, with individual and total related-substance limits of 3.0 and 5.0 per cent and results of 1.1 and 2.2 per cent, the impurities neither identified nor specified, and a second reported purity alone at 98.34 per cent 2. FDA found no impurity-profile, aggregate, bioburden, bacterial endotoxin or residual-solvent data in the nominations or the public literature and concluded that immunogenicity from impurities and peptide aggregates cannot be ruled out; the expected impurity classes are those of solid-phase peptide synthesis, including truncation and incomplete-coupling sequences, isomeric impurities, free amino acids, residual solvents, coupling reagents and aggregates 2. FDA describes the originally published synthesis as stepwise Fmoc solid-phase condensation on a benzhydrylamine resin, with purification by high-performance liquid chromatography to greater than 95 per cent purity 2.

The most detailed published characterisation comes from anti-doping analysis. A validated weak cation exchange solid-phase extraction method for urine reached a detection limit of 0.1 ng/mL with precision better than 20 per cent, and used a stable metabolite alongside the parent peptide to improve specificity 11. A stable-isotope-labelled, non-targeted ultra-high-performance liquid chromatography and high-resolution mass spectrometry workflow identified nine in vitro metabolites and validated detection of BPC-157 and five main metabolites in human urine at 0.01 to 0.11 ng/mL 29. A 2026 multi-analyte workflow includes BPC-157 among 54 prohibited compounds in dried blood spots, serum and plasma, with detection limits of 0.05 to 1.25 ng/mL 30.

Analytical data

Certificates of analysis, identity data and lot verification for the research material characterised on this page.

View analytical data · BPC-157 / TB-500 blend →

Stability and handling

Laboratory handling data only, as reported in the literature. BPC-157 was reported to resist hydrolysis in human gastric juice in vitro, which FDA cites as the reason its short half-life in vivo is attributed to blood and tissue peptidases; the same property is asserted in the Zagreb group's review literature 231.

  • Lyophilised material is reported stable at room temperature for three weeks, with desiccated storage below −18 °C recommended; solution is reported stable for two to three weeks at 4 °C and three to four months at −20 °C. FDA concludes that the free base is expected to be stable below −18 °C and the acetate below −20 °C, and attributes these particular figures in its own footnotes to commercial supplier pages rather than to peer-reviewed work 2.
  • Solubility is reported as 5 mg/mL in water for both forms, the material described as a white to off-white lyophilised powder with a melting point above 232 °C; those figures are also footnoted to supplier pages, and no formal solubility profiling across physiological pH values has been published 212.
  • In an anti-doping stability study, BPC-157 in serum showed complete degradation after one week at 4 °C and at 22 °C, while all compounds studied were stable for at least two months at −20 °C in the blood matrices examined and remained detectable in dried matrices 30.
  • FDA notes that peptides of this kind are sensitive to pH, temperature, concentration, in-process impurities and excipients, and that aggregation can form during storage or stress and may require size exclusion chromatography or field flow fractionation to detect 2.

Regulatory status

The dated per-jurisdiction rows below are rendered from the database and cover the United Kingdom, the European Union, the United States and the WADA Prohibited List 3233349.

Regulatory status · BPC-157Investigational or unlicensed compound

No medicine containing this compound is authorised in any jurisdiction checked. It has no established safety profile in humans outside registered clinical research. It is supplied for laboratory research only.

The rows below record the absence of authorisation and any compounding, evaluation or anti-doping status found on the date checked.

United Kingdom
No record of BPC-157 or bepecin as an authorised active substance was found in the MHRA products substance index on 2026-09-21.Checked 2026-09-21 · Medicines and Healthcare products Regulatory Agency
European Union
No record found in the European Commission Union Register of medicinal products for human use on 2026-09-21.Checked 2026-09-21 · European Commission, DG SANTE
United States
Not FDA-approved in any product; FDA proposed in May 2026 not to add BPC-157 (free base) or BPC-157 acetate to the 503A bulk drug substances list, and the substance sits on FDA's list of bulk drug substances nominated but withdrawn, previously in category 2.Checked 2026-09-21 · U.S. Food and Drug Administration
WADA Prohibited List
Prohibited at all times as a named example in section S0, Non-Approved Substances, of the Prohibited List in force; all substances in S0 are Specified Substances.Checked 2026-09-21 · World Anti-Doping Agency

The July 2026 advisory committee proposal

Two nominations for the 503A bulk drug substances list, from Wells Pharmacy Network and from LDT Health Solutions with the International Peptide Society, were withdrawn, and FDA elected to evaluate both the free base and the acetate at its own discretion for the treatment of ulcerative colitis 2. In a briefing document dated 11 May 2026 for the Pharmacy Compounding Advisory Committee meeting of 23 and 24 July 2026, FDA proposed not adding either substance to the 503A list, on the grounds that both are not well characterised, that naming inconsistencies across salts and derivatives sold under one common name create a risk of dispensing a different substance from the one ordered, that immunogenicity risk from aggregates and peptide-related impurities cannot be excluded, that the evidence of effectiveness in ulcerative colitis is insufficient, and that approved therapies exist 235. FDA's category 2 page, current as of 22 April 2026, carries BPC-157 in the list of bulk drug substances nominated but withdrawn 34. Three adverse event reports retrieved by FDA through 4 December 2025 describe injection-site redness and swelling, shortness of breath, and reproducible diffuse hyperpigmentation with gingival darkening on rechallenge; each is confounded by concomitant peptides or missing detail 2.

Anti-doping

BPC-157 is named as an example in section S0, Non-Approved Substances, of the Prohibited List in force. Substances in that class are Specified Substances; any pharmacological substance not addressed by a later section and with no current approval by any governmental regulatory health authority for human therapeutic use is prohibited at all times 9. WADA stated on 30 September 2021 that BPC-157 was the first substance ever included by name as an example in section S0, on the 2022 List, which came into force on 1 January 2022 8.

Open questions

  1. The parent body protection compound protein has not been characterised in any source retrieved, and whether an endogenous BPC-157 sequence exists in humans is unresolved 212.
  2. No molecular target has been identified; the VEGFR2, growth hormone receptor and nitric oxide mechanisms are reported as associations in animal and cell models 21617.
  3. No record of an arginate or arginine salt was found in PubChem or the substance registry, and PubChem lists two registry numbers among the acetate synonyms without reconciling them 15142.
  4. No dose-response relationship has been established: across the rodent studies reviewed by FDA, microgram and nanogram per kilogram doses produced effects of comparable magnitude 2.
  5. The Zagreb literature describes BPC-157 as having entered clinical phase II for inflammatory bowel disease, whereas FDA identified only a single meeting-abstract trial and judged the data inadequate, and a 2026 review states that no phase II trial has been completed 31212.
  6. No results have been posted for NCT02637284, whose registry status has been unknown since 2015, for NCT07752381, completed in November 2025, or for any other registered study 327.
  7. The coagulation and liver-associated signals in the 28-day animal studies have not been reproduced in longer studies, and no carcinogenicity study exists 236.
  8. The European finding rests on the Union Register, because the EMA website could not be retrieved when the dossier was compiled 33.

Questions this page answers

What does the evidence base for BPC-157 actually consist of?
Almost entirely animal work. A 2025 systematic review of the musculoskeletal literature identified 36 includable studies, of which 35 were preclinical and one clinical. The human record comprises two meeting abstracts, a registered phase 1 study with no posted results, three small uncontrolled clinic reports and three registered trials that have not reported.
Is BPC-157 an endogenous peptide?
Not as demonstrated by any source retrieved for the dossier. FDA uses the qualified wording that BPC-157 is reported to be a fragment of a body protection compound found in gastric juice, and a 2026 review states that the parent protein remains uncharacterised. Whether an endogenous BPC-157 sequence exists in humans is unresolved.
Does BPC-157 exist as an arginate salt?
No record of a BPC-157 arginate or arginine salt was returned by any PubChem or GSRS search conducted for the dossier, and the FDA evaluation covers only the free base and the acetate. Identifiers for the free base and the acetate are separately registered; a material described as an arginate cannot be verified against a substance record.
What is the current FDA position on BPC-157?
In a briefing document dated 11 May 2026 for the Pharmacy Compounding Advisory Committee meeting of 23 and 24 July 2026, FDA proposed not adding either BPC-157 (free base) or BPC-157 acetate to the 503A bulk drug substances list, citing poor characterisation, naming inconsistencies, immunogenicity risk and insufficient evidence of effectiveness in ulcerative colitis.
Is BPC-157 prohibited in sport?
Yes. It is named as an example in section S0, Non-Approved Substances, of the WADA Prohibited List in force, and substances in that class are prohibited at all times. WADA stated in September 2021 that BPC-157 was the first substance ever included by name as an example in S0, on the 2022 List.

References

  1. 1.Vasireddi N, Hahamyan H, Salata MJ, Karns M, Calcei JG, Voos JE, Apostolakos JM. Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review. HSS Journal (2025). doi:10.1177/15563316251355551 PMID 40756949 · accessed 2026-09-21
  2. 2.Tu M, Adeyemi O, Rupp T, Albuquerque E, Benedict A, Hankla E, Kasim S. FDA Briefing Document, Pharmacy Compounding Advisory Committee: Evaluation of BPC-157-Related Bulk Drug Substances (BPC-157 free base and BPC-157 acetate) for Inclusion on the 503A Bulk Drug Substances List. U.S. Food and Drug Administration (2026). https://www.fda.gov/media/193343/download · accessed 2026-09-21
  3. 3.PCO-02 - Safety and Pharmacokinetics Trial (phase 1, healthy volunteers). ClinicalTrials.gov, sponsor PharmaCotherapia d.o.o. (2015). https://clinicaltrials.gov/study/NCT02637284 · accessed 2026-09-21
  4. 4.Lee E, Padgett B. Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain. Alternative Therapies in Health and Medicine (2021). https://pubmed.ncbi.nlm.nih.gov/34324435/ PMID 34324435 · accessed 2026-09-21
  5. 5.Lee E, Walker C, Ayadi B. Effect of BPC-157 on Symptoms in Patients with Interstitial Cystitis: A Pilot Study. Alternative Therapies in Health and Medicine (2024). https://pubmed.ncbi.nlm.nih.gov/39325560/ PMID 39325560 · accessed 2026-09-21
  6. 6.Lee E, Burgess K. Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study. Alternative Therapies in Health and Medicine (2025). https://pubmed.ncbi.nlm.nih.gov/40131143/ PMID 40131143 · accessed 2026-09-21
  7. 7.Sikiric P, Petek M, Rucman R, Seiwerth S, Grabarevic Z, and colleagues. A new gastric juice peptide, BPC. An overview of the stomach-stress-organoprotection hypothesis and beneficial effects of BPC. Journal of Physiology (Paris) (1993). doi:10.1016/0928-4257(93)90038-u PMID 8298609 · accessed 2026-09-21
  8. 8.WADA publishes 2022 Prohibited List. World Anti-Doping Agency (2021). https://www.wada-ama.org/en/news/wada-publishes-2022-prohibited-list · accessed 2026-09-21
  9. 9.The Prohibited List (List of Prohibited Substances and Methods in force). World Anti-Doping Agency (2026). https://www.wada-ama.org/en/prohibited-list · accessed 2026-09-21
  10. 10.BPC-157 substance record, UNII 8ED8NXK95P (FDA Global Substance Registration System). FDA / NCATS Global Substance Registration System (2026). https://gsrs.ncats.nih.gov/ginas/app/ui/substances/4e592d61-f6dd-428c-96e9-5e56148614e4 · accessed 2026-09-21
  11. 11.Cox HD, Miller GD, Eichner D. Detection and in vitro metabolism of the confiscated peptides BPC 157 and MGF R23H. Drug Testing and Analysis (2017). doi:10.1002/dta.2152 PMID 28035768 · accessed 2026-09-21
  12. 12.Mateescu DM, Gavrilescu DM, Constantinescu FE, Oancea C, Ilie AC, Folescu R, Popa MD, Iurciuc S, Muresan CO, Enache A. BPC-157 as an Investigational Peptide Therapeutic: Biopharmaceutical Challenges, Formulation Strategies, and Translational Development Barriers. Pharmaceutics (2026). doi:10.3390/pharmaceutics18050625 PMID 42198317 · accessed 2026-09-21
  13. 13.BPC-157, CID 9941957: molecular formula, molecular weight, IUPAC name, SMILES and synonyms. PubChem, National Center for Biotechnology Information (2026). https://pubchem.ncbi.nlm.nih.gov/compound/9941957 · accessed 2026-09-21
  14. 14.BPC-157 acetate substance record, UNII PAR2FC72XP (FDA Global Substance Registration System). FDA / NCATS Global Substance Registration System (2026). https://gsrs.ncats.nih.gov/ginas/app/ui/substances/855cd030-58cd-4f4d-80f0-0faa1b427d3c · accessed 2026-09-21
  15. 15.BPC-157 acetate, CID 155977614: molecular formula, molecular weight and synonyms. PubChem, National Center for Biotechnology Information (2026). https://pubchem.ncbi.nlm.nih.gov/compound/155977614 · accessed 2026-09-21
  16. 16.Hsieh MJ, Liu HT, Wang CN, Huang HY, Lin Y, Ko YS, Wang JS, Chang VH, Pang JS. Therapeutic potential of pro-angiogenic BPC157 is associated with VEGFR2 activation and up-regulation. Journal of Molecular Medicine (2017). doi:10.1007/s00109-016-1488-y PMID 27847966 · accessed 2026-09-21
  17. 17.Chang CH, Tsai WC, Hsu YH, Pang JH. Pentadecapeptide BPC 157 enhances the growth hormone receptor expression in tendon fibroblasts. Molecules (2014). doi:10.3390/molecules191119066 PMID 25415472 · accessed 2026-09-21
  18. 18.Chang CH, Tsai WC, Lin MS, Hsu YH, Pang JH. The promoting effect of pentadecapeptide BPC 157 on tendon healing involves tendon outgrowth, cell survival, and cell migration. Journal of Applied Physiology (2011). doi:10.1152/japplphysiol.00945.2010 PMID 21030672 · accessed 2026-09-21
  19. 19.McGuire FP, Martinez R, Lenz A, Skinner L, Cushman DM. Regeneration or Risk? A Narrative Review of BPC-157 for Musculoskeletal Healing. Current Reviews in Musculoskeletal Medicine (2025). doi:10.1007/s12178-025-09990-7 PMID 40789979 · accessed 2026-09-21
  20. 20.He L, Feng D, Guo H, Zhou Y, Li Z, Zhang K, and colleagues. Pharmacokinetics, distribution, metabolism, and excretion of body-protective compound 157 in rats and dogs. Frontiers in Pharmacology (2022). doi:10.3389/fphar.2022.1026182 PMID 36588717 · accessed 2026-09-21
  21. 21.Jozwiak M, Bauer M, Kamysz W, Kleczkowska P. Multifunctionality and Possible Medical Application of the BPC 157 Peptide - Literature and Patent Review. Pharmaceuticals (2025). doi:10.3390/ph18020185 PMID 40005999 · accessed 2026-09-21
  22. 22.Sikiric P, Seiwerth S, Skrtic A, Staresinic M, Strbe S, and colleagues. BPC 157 Therapy: Targeting Angiogenesis and Nitric Oxide's Cytotoxic and Damaging Actions... Comment on Jozwiak et al.. Pharmaceuticals (2025). doi:10.3390/ph18101450 PMID 41155565 · accessed 2026-09-21
  23. 23.Jozwiak M, Bauer M, Kamysz W, Kleczkowska P. Reply to Sikiric et al. Comment on Jozwiak et al. Multifunctionality and Possible Medical Application of the BPC 157 Peptide. Pharmaceuticals (2025). doi:10.3390/ph18101451 PMID 41155566 · accessed 2026-09-21
  24. 24.Whitehouse M. Concerning BPC-157, a natural pentadecapeptide, that acts as a cytoprotectant and is believed to protect the gastro-intestinal tract (GIT). Inflammopharmacology (2025). doi:10.1007/s10787-025-01882-z PMID 40759852 · accessed 2026-09-21
  25. 25.A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Pentadecapeptide BPC 157 for Accelerated Repair of Acute Grade II Hamstring Strain. ClinicalTrials.gov, sponsor Hudson Biotech (2026). https://clinicaltrials.gov/study/NCT07437547 · accessed 2026-09-21
  26. 26.Impact of BPC-157 on Recovery From Rotator Cuff Repair Surgery. ClinicalTrials.gov, sponsor University of Arkansas (2026). https://clinicaltrials.gov/study/NCT07803250 · accessed 2026-09-21
  27. 27.A Clinical Trial to Evaluate the Effects of Peptide Gummies on Markers of Inflammation, Physical Performance, and Recovery. ClinicalTrials.gov, sponsor Parlay Wellness (2026). https://clinicaltrials.gov/study/NCT07752381 · accessed 2026-09-21
  28. 28.Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Medicine (2026). doi:10.1007/s40279-026-02437-0 PMID 41966639 · accessed 2026-09-21
  29. 29.Tian T, Jing J, Li Y, Wang Y, Deng X, Shan Y. Stable Isotope Labeling-Based Nontargeted Strategy for Characterization of the In Vitro Metabolic Profile of a Novel Doping BPC-157 in Doping Control by UHPLC-HRMS. Molecules (2023). doi:10.3390/molecules28217345 PMID 37959764 · accessed 2026-09-21
  30. 30.Mazzarino M, Colpaert T, Deventer K, Van Eenoo P. Rapid and harmonized analytical workflow for the determination of peptidic and non-peptidic doping agents in dried and liquid blood matrices. Analyst (2026). doi:10.1039/d6an00455e PMID 42328738 · accessed 2026-09-21
  31. 31.Sikiric P, Seiwerth S, Rucman R, Turkovic B, Rokotov DS, and colleagues. Focus on ulcerative colitis: stable gastric pentadecapeptide BPC 157. Current Medicinal Chemistry (2012). doi:10.2174/092986712803414015 PMID 22300085 · accessed 2026-09-21
  32. 32.MHRA Products substance index, letter B. Medicines and Healthcare products Regulatory Agency (2026). https://products.mhra.gov.uk/substance-index/?letter=B · accessed 2026-09-21
  33. 33.Union Register of medicinal products for human use - active substance index (page dated 21/09/2026); no entry for retatrutide. European Commission, DG SANTE (2026). https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm · accessed 2026-09-22
  34. 34.Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. Food and Drug Administration (2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks · accessed 2026-09-21
  35. 35.July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. U.S. Food and Drug Administration (2026). https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 · accessed 2026-09-21
  36. 36.Xu C, Sun L, Ren F, Huang P, Tian Z, Cui J, and colleagues. Preclinical safety evaluation of body protective compound-157, a potential drug for treating various wounds. Regulatory Toxicology and Pharmacology (2020). doi:10.1016/j.yrtph.2020.104665 PMID 32334036 · accessed 2026-09-21
  37. 37.Staresinic M, Sebecic B, Patrlj L, Jadrijevic S, Suknaic S, and colleagues. Gastric pentadecapeptide BPC 157 accelerates healing of transected rat Achilles tendon and in vitro stimulates tendocytes growth. Journal of Orthopaedic Research (2003). doi:10.1016/S0736-0266(03)00110-4 PMID 14554208 · accessed 2026-09-21
  38. 38.Staresinic M, Petrovic I, Novinscak T, Jukic I, Pevec D, and colleagues. Effective therapy of transected quadriceps muscle in rat: Gastric pentadecapeptide BPC 157. Journal of Orthopaedic Research (2006). doi:10.1002/jor.20089 PMID 16609979 · accessed 2026-09-21
  39. 39.Cerovecki T, Bojanic I, Brcic L, Radic B, Vukoja I, Seiwerth S, Sikiric P. Pentadecapeptide BPC 157 (PL 14736) improves ligament healing in the rat. Journal of Orthopaedic Research (2010). doi:10.1002/jor.21107 PMID 20225319 · accessed 2026-09-21
For laboratory research use only. This article summarises published literature and regulatory records; it does not describe or recommend any use of a material in or on humans or animals.
Cite this page
Harvard
HelixEVO Labs (2026) BPC-157: identity, the animal literature and regulatory status. Available at: https://helixevo.net/knowledge-base/compounds/bpc-157 (Accessed: 2026-09-25).
APA
HelixEVO Labs. (2026). BPC-157: identity, the animal literature and regulatory status. https://helixevo.net/knowledge-base/compounds/bpc-157
BibTeX
@misc{helixevo-2026-bpc-157-identity-the-animal-literature-a,
  title = {BPC-157: identity, the animal literature and regulatory status},
  author = {{HelixEVO Labs}},
  year = {2026},
  howpublished = {\url{https://helixevo.net/knowledge-base/compounds/bpc-157}},
  note = {Reviewed 2026-09-22; accessed 2026-09-25}
}
Revision history
  1. r1 · 2026-09-25 · Initial import