Synthetic cytoprotective pentadecapeptide (tissue-repair / healing research compound) Limited Human Data

BPC-157

Also Known As: PL-14736, PL-10, PLD-116, Bepecin, PCO-02, Body Protection Compound 157, Stable Gastric Pentadecapeptide BPC 157, Pentadecapeptide BPC 157

BPC-157 ("Body Protection Compound 157", development codes PL-14736 / PL-10 / PLD-116 / Bepecin / PCO-02) is a synthetic pentadecapeptide whose sequence corresponds to a partial segment of a 60-amino-acid fragment of a protein originally identified in human gastric juice; the intact 15-mer has not been demonstrated to circulate naturally in humans. Most of the published characterisation comes from the Predrag Sikiric group at the University of Zagreb, with cytoprotective, angiogenic and tissue-regenerative effects reported in rodent models; no specific cell-surface receptor has been cloned or pharmacologically characterised. Human clinical evidence is limited: a Phase I PK programme (NCT02637284) was never published, a Phase II ulcerative-colitis enema trial (Pliva, PL-14736) was completed but its full results were never peer-reviewed, and a Phase 2 hamstring-strain trial (NCT07437547, Hudson Biotech) has been recruiting since February 2026. The U.S. FDA placed BPC-157 on its 503A compounding Category 2 list ("substances that may present significant safety risks") on 29 September 2023; a Pharmacy Compounding Advisory Committee meeting on 23 July 2026 will re-examine BPC-157 acetate and BPC-157 free base. WADA lists BPC-157 in Class S0 (non-approved substances), prohibited in- and out-of-competition, and the U.S. Department of Defense includes it on the Prohibited Dietary Supplement Ingredients List under DoDI 6130.06.

Identity & Chemistry

Two-dimensional skeletal chemical structure of BPC-157, a 15-amino-acid synthetic pentadecapeptide (Gly-Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val) showing the peptide backbone and side chains.
Image credit: Innerstream, via Wikimedia Commons · Public Domain (PD-chem)
Amino Acid Sequence
H-Gly-Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val-OH (GEPPPGKPADDAGLV)
Molecular Formula
C₆₂H₉₈N₁₆O₂₂
Molecular Weight
1419.55 g·mol⁻¹ (free base; trifluoroacetate salt is the typical research-supply form)
CAS Number
137525-51-0
PubChem CID
9941957
DrugBank ID
DB11882
IUPAC Name
(4S)-4-[(2-aminoacetyl)amino]-5-[(2S)-2-[(2S)-2-[(2S)-2-[[2-[[(2S)-6-amino-1-[(2S)-2-[[(2S)-1-[[(2S)-3-carboxy-1-[[(2S)-3-carboxy-1-[[(2S)-1-[[2-[[(2S)-1-[[(1S)-1-carboxy-2-methylpropyl]amino]-4-methyl-1-oxopentan-2-yl]amino]-2-oxoethyl]amino]-1-oxopropan-2-yl]amino]-1-oxopropan-2-yl]amino]-1-oxopropan-2-yl]amino]-1-oxopropan-2-yl]carbamoyl]pyrrolidin-1-yl]-1-oxohexan-2-yl]amino]-2-oxoethyl]carbamoyl]pyrrolidine-1-carbonyl]pyrrolidine-1-carbonyl]pyrrolidin-1-yl]-5-oxopentanoic acid
Solubility
Soluble in water and dilute aqueous buffers. In research labs the lyophilised peptide is typically reconstituted with sterile water for injection or bacteriostatic water; one in-vitro property frequently cited by the Sikiric group is unusual stability in human gastric juice (>24 h). Most research-grade material ships as the trifluoroacetate (TFA) salt, whose mass per vial exceeds the free-base mass quoted here.
Storage
Lyophilised peptide stored at −20 °C protected from light. Reconstituted solutions kept at 2–8 °C with limited working stability — the manufacturer-specific certificate of analysis governs. For research use only.

Mechanism of Action

BPC-157 is a synthetic pentadecapeptide whose proposed activity centres on cytoprotection and angiogenesis, putatively via modulation of the nitric-oxide / VEGF / endothelial-NO-synthase axis and several growth-factor and neurotransmitter systems; no specific receptor has been identified, and the molecular mechanism is NOT established.

The Sikiric group at the University of Zagreb has characterised BPC-157 as a "cytoprotective mediator" — a peptide that is unusually stable in human gastric juice (>24 h in vitro) and that, in rodent models, prophylactically and therapeutically protects gastric, intestinal, hepatic, pancreatic, cardiovascular and central-nervous tissues against a wide range of injurious stimuli (Sikiric 2020; 2024). The most reproducible mechanistic finding is angiogenic / vasculogenic activity: multiple groups, including the independent replication by Chang et al. 2011 in J Appl Physiol, report increased fibroblast outgrowth and migration, accelerated re-endothelialisation, and bypass-vessel recruitment around occluded vasculature in rats. However, NO specific cell-surface receptor for BPC-157 has been formally identified, cloned, or pharmacologically characterised — the proposed molecular targets above are inferred from downstream signalling read-outs (eNOS phosphorylation, VEGFR2 activation, FAK – Paxillin) rather than direct binding studies. The 2025 narrative review by McGuire et al. (Curr Rev Musculoskelet Med) summarises the field as showing "robust preclinical regenerative and cytoprotective effects" while explicitly concluding that "until well-designed clinical trials are conducted, BPC-157 should be considered investigational." Mechanism statements here are therefore intentionally hedged — studies report, proposed pathways, inferred from preclinical data — and never framed as established human pharmacology.

Molecular Targets

  • Nitric-oxide system / eNOS — modulation of NO release; experimental effects partly persist under pharmacological NO-synthase inhibition, suggesting parallel pathways
  • VEGFR2 – Akt – eNOS axis and Src – Caveolin-1 – eNOS axis — proposed angiogenic and vasotonic signalling routes inferred from downstream read-outs in rodent models
  • Growth-hormone receptor / FAK – Paxillin / growth factors (FGF, TGF-β, EGR-1) — up-regulation reported in tenocyte and wound-healing models; inferred, not direct binding

Signaling Pathways

  • Putative VEGFR2 / Akt / eNOS signalling axis with downstream NO production and increased angiogenesis / re-endothelialisation
  • FAK – Paxillin–mediated tenocyte migration and outgrowth in vitro (Chang 2011, J Appl Physiol)
  • Modulation of the dopaminergic and serotonergic systems — counteracts both excessive (amphetamine) and deficient (MPTP, reserpine, neuroleptic) dopaminergic states in rodents

Research Applications

The published evidence base is dominated by in-vitro and rodent studies (tendon, muscle, gastrointestinal, CNS and cardiovascular models), supplemented by a very small number of uncontrolled human case series and IV pilot reports. A Phase I PK trial (NCT02637284) was registered but never published; a Phase II ulcerative-colitis enema trial of PL-14736 (Pliva) was completed but its full results were never peer-reviewed; a Phase 2 hamstring-strain RCT (NCT07437547) is currently recruiting.

Achilles tendon healing — rat, in vivo (i.m. / oral)

in vivo

Studies report, both in the Sikiric group and in independent replication (Chang 2011, J Appl Physiol), accelerated healing after Achilles tendon transection or tendon-to-bone detachment in rats — measured by histology, biomechanics (load-to-failure) and the Achilles Functional Index over 14–30 days. Co-administration mitigated corticosteroid-induced impairment of tendon healing in the Krivic study.

— Chang et al., J Appl Physiol 2011;110(3):774–780; Krivic et al., J Orthop Res 2006;24(5):982–989

Tenocyte migration — in vitro

in vitro

Studies report dose-dependent fibroblast outgrowth from tendon explants, improved cell survival under H₂O₂ oxidative stress, and accelerated migration via the FAK – Paxillin axis — a cellularly consistent independent replication by the Pang group.

— Chang et al., J Appl Physiol 2011

Ulcerative colitis enema — human Phase II (PL-14736, Pliva)

Phase II

The Pliva multicentre randomised double-blind placebo-controlled PL-14736 trial was completed but its full results have never been published in a peer-reviewed journal. This editorial caveat is a well-recognised limitation of the BPC-157 evidence base.

— McGuire et al. 2025, Curr Rev Musculoskelet Med (review)

Acute hamstring strain — human Phase 2, NCT07437547 (recruiting)

Phase II

Studies report the launch of a randomised, double-blind, placebo-controlled Phase 2 trial in adults with MRI-confirmed Grade II hamstring strain; subcutaneous BPC-157 once daily for 14 days alongside standardised rehabilitation, n=120, Peking University Shenzhen Hospital. Start: 2 February 2026; primary completion estimated February 2027.

— ClinicalTrials.gov NCT07437547 (Hudson Biotech)

Pharmacokinetics — rats and dogs

preclinical

Studies report a short IV elimination half-life of intact BPC-157 (rats ≈ 15.2 min; dogs ≈ 5.27 min) with rapid metabolism to small peptide fragments and ultimately constituent amino acids; intramuscular bioavailability ≈ 14–19% in rats and ≈ 45–51% in dogs. No published human PK data exist.

— He et al., Front Pharmacol 2022;13:1026182

Clinical Status

Regulatory Status
BPC-157 is not approved by any regulator — neither the FDA, EMA, MHRA, TGA nor any other agency — for any clinical indication. The U.S. FDA placed BPC-157 on its 503A compounding Category 2 list ("substances that may present significant safety risks") on 29 September 2023, effectively prohibiting Section 503A traditional compounding pharmacies from preparing it for human use. The original nominations were subsequently withdrawn, and FDA has scheduled a Pharmacy Compounding Advisory Committee meeting on 23 July 2026 to re-examine BPC-157 acetate and BPC-157 (free base) as separate substances for the 503A bulks list. As of May 2026, no 503A or 503B compounding pharmacy can legally prepare BPC-157 for patient use until and unless PCAC reviews the substance and FDA acts. The World Anti-Doping Agency lists BPC-157 in Class S0 (non-approved substances), prohibited in- and out-of-competition; the U.S. Department of Defense includes it on the Prohibited Dietary Supplement Ingredients List under DoDI 6130.06.
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Highest Trial Phase
Highest registered phase: Phase II (PL-14736 ulcerative-colitis enema, Pliva — completed but full results never peer-reviewed); a new Phase 2 hamstring-strain trial (NCT07437547) is currently recruiting.
Sponsor
Pliva (Croatia) sponsored the earlier PL-14736 development programme; the only registered human PK study (NCT02637284, status "Active, not recruiting") was sponsored by PharmaCotherapia d.o.o.; the ongoing Phase 2 hamstring-strain trial (NCT07437547) is sponsored by Hudson Biotech. There is no marketing-authorisation holder; the substance is investigational.
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Key Clinical Trials

  • Phase I pilot study of PCO-02 (BPC-157) safety and pharmacokinetics in healthy volunteers
    Phase I
    NCT02637284
  • Randomized, double-blind, placebo-controlled Phase 2 trial of pentadecapeptide BPC 157 for accelerated repair of acute Grade II hamstring strain
    Phase II
    NCT07437547

Safety Profile

Observed in research settings

In rodent toxicology BPC-157 has been described as well tolerated, with no lethal dose reached in the studied dose range (Sikiric 2024). Controlled human safety data are essentially absent: the only registered Phase I PK trial was never published, the Phase II UC enema trial was never peer-reviewed, and the only recent human reports are uncontrolled case series (Lee & Padgett 2021 intra-articular knee n=16; Lee 2024 interstitial cystitis n=12) and a 2-subject IV pilot (Lee & Burgess 2025). Long-term human safety, immunogenicity and oncogenicity data do not exist — observed in research settings.

Adverse Events Reported in Studies

  • No clustered treatment-related adverse events reported in published rodent toxicology (Sikiric group; "no behavioural change from BPC 157 alone")
  • No measurable changes in cardiac, hepatic, renal, thyroid biomarkers or blood glucose in a 2-subject IV pilot in healthy adults (Lee & Burgess 2025; n=2, NOT a clinical safety trial)
  • Local injection-site reactions with subcutaneous / intramuscular administration are occasionally reported in open-label case series but have not been systematically captured

Serious Adverse Events

  • FDA safety position: the U.S. FDA classified BPC-157 on 29 September 2023 as a 503A Category 2 substance presenting "significant safety risks", citing insufficient human data and impurity / immunogenicity concerns
  • Theoretical oncologic concern: because BPC-157 is pro-angiogenic in preclinical models, narrative reviews and the Wikipedia drug-box flag a theoretical concern that promoting blood-vessel formation could in principle support tumour vascularisation. No human or long-term oncogenicity data exist to confirm or refute this concern (McGuire 2025)
  • WADA Class S0 listing: athletes are prohibited from using BPC-157 in- and out-of-competition; therapeutic-use exemptions are not available because the substance is not an approved therapeutic agent in any jurisdiction

References

  1. Sikiric P, Boban Blagaic A, Strbe S, Krezic I, Smoday IM, Kalogjera L, Drmic D, Stupnisek M, Kokot A, Vlainic J, Sever M, Pevec D, Tepes M, Skoric A, Kralj T, Brcic L, Strinic D, Pevec P, Boban M, Seiwerth S The stable gastric pentadecapeptide BPC 157 pleiotropic beneficial activity and its possible relations with neurotransmitter activity Pharmaceuticals (Basel) 2024;17(4):461. 2024 .

    DOI: 10.3390/ph17040461 PMID: 38675421 View Source

  2. Sikiric P, Hahm K-B, Blagaic AB, et al. Stable gastric pentadecapeptide BPC 157, Robert's stomach cytoprotection / adaptive cytoprotection / organoprotection, and Selye's stress coping response: progress, achievements and the future Gut and Liver 2020;14(2):153–167. 2020 .

    DOI: 10.5009/gnl18490 View Source

  3. Chang C-H, Tsai W-C, Lin M-S, Hsu Y-H, Pang JHS The promoting effect of pentadecapeptide BPC 157 on tendon healing involves tendon outgrowth, cell survival and cell migration J Appl Physiol 2011;110(3):774–780. 2011 .

    DOI: 10.1152/japplphysiol.00945.2010 PMID: 21030672 View Source

  4. Krivic A, Anic T, Seiwerth S, Huljev D, Sikiric P Achilles detachment in rat and stable gastric pentadecapeptide BPC 157: promoted tendon-to-bone healing and opposed corticosteroid aggravation J Orthop Res 2006;24(5):982–989. 2006 .

    DOI: 10.1002/jor.20096 PMID: 16583442 View Source

  5. Klicek R, Sever M, Radic B, et al. Pentadecapeptide BPC 157, in clinical trials as a therapy for inflammatory bowel disease (PL14736), is effective in the healing of colocutaneous fistulas in rats: role of the nitric oxide-system J Pharmacol Sci 2008;108(1):7–17. 2008 .

    DOI: 10.1254/jphs.fp0072161 PMID: 18818478 View Source

  6. He L, Feng D, Guo H, Zhou Y, Li Z, Zhang K, Zhang W, Wang S, Wang Z, Hao Q, Zhang C, Gao Y, Gu J, Zhang Y, Li W, Li M 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. 2022 .

    DOI: 10.3389/fphar.2022.1026182 View Source

  7. 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. 2025 .

    DOI: 10.1007/s12178-025-09990-7 PMID: 40789979 View Source

  8. U.S. Food and Drug Administration Pharmacy Compounding Advisory Committee — notice of meeting; establishment of a public docket; request for nominations (BPC-157 acetate and BPC-157 free base under 503A bulk drug substances review) Federal Register 2026-07361, 16 April 2026. 2026 .

    View Source

Frequently Asked Questions

Is BPC-157 approved by the FDA?
No. BPC-157 has never been approved by the FDA, EMA, or any other regulator for any clinical indication. In September 2023 the FDA placed BPC-157 on its Category 2 ("significant safety risks") list of bulk drug substances under the 503A compounding framework, effectively prohibiting U.S. compounding pharmacies from preparing it for human use; FDA has scheduled a PCAC meeting on 23 July 2026 to re-examine BPC-157 acetate and BPC-157 free base.
Are BPC-157 and PL-14736 the same molecule?
Yes. PL-14736 (along with PL-10 and PLD-116) was an earlier development designation used by the Croatian pharmaceutical company Pliva for BPC-157 during its clinical development programme for inflammatory bowel disease; the molecule is identical. Bepecin and PCO-02 are additional development codes for the same compound. BPC-156 and BPC-158, by contrast, are different peptide fragments and must not be conflated with BPC-157.
What is the half-life of BPC-157?
In published rodent and dog pharmacokinetic data, the IV elimination half-life of intact BPC-157 is approximately 15.2 minutes in rats and 5.27 minutes in dogs, with rapid metabolism to small peptide fragments and ultimately to constituent amino acids. No published human half-life data exist: the only registered human PK trial (NCT02637284) was never published.
Is BPC-157 banned by WADA?
Yes. BPC-157 is on the World Anti-Doping Agency Prohibited List under Class S0 — Non-Approved Substances, prohibited at all times (in- and out-of-competition). Therapeutic Use Exemptions are not available because BPC-157 is not an approved therapeutic agent in any jurisdiction.
Has BPC-157 been tested in humans?
Only minimally. One Phase II ulcerative-colitis enema trial of PL-14736 (Pliva) was completed but full results were never published; one Phase I PK trial (NCT02637284) was registered but never published; one Phase 2 hamstring-strain trial (NCT07437547) is currently recruiting. The remaining "human data" consist of small open-label case series and a 2-subject IV pilot — none of which constitute controlled clinical evidence.
Does BPC-157 cause cancer?
This is not known. Because BPC-157 is pro-angiogenic in preclinical models, narrative reviews note a theoretical concern that promoting blood-vessel formation could in principle support tumour vascularisation. No human or long-term oncogenicity data exist to confirm or refute this concern.

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