BPC-157

Investigated uses

• Ulcerative colitis and proposed tissue-repair uses; human evidence is sparse.

Mechanism and hypotheses

• No clinically established receptor target or mechanism has been demonstrated for BPC-157.
• Hypothesized: Angiogenesis, nitric-oxide signaling, cytoprotection and tissue-repair pathways have been proposed largely from animal and laboratory studies.

Human evidence

• FDA identified only very limited human exposure, including a small ulcerative-colitis study and small/short reports; efficacy and safety were insufficiently established. Limitations: Sparse reporting, uncertain formulation, tiny samples and no robust replicated randomized evidence.
• A recruiting Phase 2 trial, NCT07437547, is evaluating BPC-157 against placebo for acute grade II hamstring strain; no results are posted.

Safety highlights

• Human adverse-event incidence is unknown because exposure data are sparse and formulations are not standardized.
• FDA highlights immunogenicity, peptide impurities and insufficient safety information; theoretical angiogenic or growth-signaling concerns are unresolved.

Regulatory context

BPC-157 is not an FDA-approved drug. In July 2026, PCAC recommended BPC-157-related bulk drug substances for possible inclusion on the 503A Bulks List for ulcerative colitis. The recommendation is nonbinding and was not a final FDA listing as of August 9, 2026.