BPC-157

Synthetic 15-amino-acid peptide (sequence GEPPPGKPADDAGLV; PubChem CID 9941957, CAS 137525-51-0, C62H98N16O22, MW ~1419.5) derived from a partial sequence of a protein found in human gastric juice. In preclinical models it is reported to promote angiogenesis and cytoprotection mainly by upregulating VEGF/VEGFR2 signalling and activating the nitric oxide pathway (eNOS via the Src-Caveolin-1 axis), with additional reported effects on growth-factor and FAK-paxillin signalling that drive endothelial cell migration and tissue repair. Mechanistic data are from animal and in vitro studies, not confirmed in humans.

Human evidence

Extensive animal/preclinical studies; only a few very small human pilot studies, no completed large or randomized clinical trials. A 2025 systematic review (orthopaedic sports medicine) screened 544 articles and found only 1 clinical study met inclusion criteria. Not approved for any indication.

Regulatory status

Not FDA-approved for any use and no USP monograph. Added to the FDA's 503A interim Category 2 ("significant safety risk") list in 2023, then removed from Category 2 in April 2026 (~April 22) as a procedural/transitional step tied to a fresh review cycle — this is NOT approval or authorization to compound. On July 23, 2026 the FDA's Pharmacy Compounding Advisory Committee (PCAC) voted 8-6 with 1 abstention to recommend adding BPC-157 to the Section 503A bulk drug substances list, balloting the free base and acetate forms separately with the same result each time; the indication under consideration was ulcerative colitis (docket FDA-2025-N-6895). The committee voted against the recommendation of the FDA's own review team, which identified only a single small clinical trial (46 participants, rectal/enema administration). The vote is advisory and non-binding — formal notice-and-comment rulemaking is still required before licensed compounding, and even then the substance would be prescription-compounded, not OTC or FDA-approved.

• —Studied in animal models for tendon, ligament and muscle injury healing and connective-tissue repair.
• —Investigated preclinically for gastrointestinal protection and healing (gut/ulcer models; nominated for ulcerative colitis in the 503A context).
• —Examined in laboratory and in vitro studies for angiogenesis, wound healing and cytoprotection across tissues.
• —Researched in preclinical neurological and vascular models for nerve and blood-vessel effects.

• ⚠No completed large-scale human safety trials; published human data are limited to small pilot studies. An IRB-approved pilot IV-infusion study (only 2 participants, up to 20 mg) reported no measurable changes in cardiac, liver, kidney, thyroid or glucose biomarkers and no reported side effects, but the sample is far too small to establish a safety profile.
• ⚠Theoretical, unproven tumour concern: because BPC-157 is reported to promote VEGF/VEGFR2-driven angiogenesis, some reviewers note it could in principle support blood supply to a pre-existing tumour. No human study has tracked cancer incidence; this remains theoretical and not demonstrated, and the literature is divided.
• ⚠The FDA has cautioned that BPC-157 could trigger an immune response depending on route of administration, and has flagged potential peptide-related impurities, difficult API characterization, and incomplete safety information.
• ⚠Gray-market research-use products carry purity and identity uncertainty (anti-doping bodies have warned unregulated vials may not contain what is labelled). BPC-157 is also prohibited in sport under WADA as an S0 non-approved substance (since 2022), with documented athlete sanctions.