BPC-157

Not FDA-approved Evidence grade C — small or uncontrolled human studies / case series Updated 2026-10-20

This page describes published research and public regulatory records. It is not medical advice. SoluneFit does not sell, supply, or recommend any compound. The SoluneFit app includes a private, on-device tracker for people who want a record of what they and their clinician have already decided — the app neither suggests compounds nor doses.

Also known as: BPC 157, Bepecin, PL-14736, PL 14736, body protection compound 157, pentadecapeptide BPC 157, BPC-157 acetate.

Regulatory status

Not approved and not a component of any FDA-approved drug. FDA's briefing for the 23-24 July 2026 PCAC proposed NOT adding BPC-157 (free base or acetate) to the 503A bulks list, citing poor characterisation, unknown immunogenicity and insufficient evidence in ulcerative colitis [1][2]; PCAC outcome UNVERIFIED: FDA has posted no minutes or vote summary as of 2026-10-20 (non-FDA reports describe a non-binding vote for inclusion, rulemaking pending). FDA's compounding-risk page lists it as nominated then withdrawn, with little safety information for the proposed routes [3]. FDA has treated BPC-157 sold for human use as an unapproved new drug (warning letter, 2023) [4].

What it is

Synthetic 15-amino-acid peptide (pentadecapeptide) based on a fragment of a protein described in gastric juice.

A synthetic 15-amino-acid peptide studied mostly in rodents for gut, tendon and wound healing. It is not approved anywhere; human data are limited to a few small early trials, abstracts and case series.

What the published research shows

Human data: a 32-person phase 1 enema study, a 53-patient ulcerative colitis trial reported only as an abstract (no significant difference from placebo), and case series of 2-17 people; the rest is rodent work.

Published human studies and reports (these describe trial populations, not SoluneFit claims):

Healthy volunteers, phase 1 (Veljaca 2002/2003 abstracts, as summarised by FDA): 32 randomised (24 active): rectal enema 0.25, 0.5, 1 or 2 mg/kg once, then daily for 7 days; no significant adverse events versus placebo; BPC-157 mostly not detectable in plasma.
Mild-to-moderate ulcerative colitis (Ruenzi 2005 abstract, as summarised by FDA): 53 randomised: 80 mg enema or placebo daily for 2 weeks; disease-activity change -3.2 vs -1.6, difference not significant; FDA judged the data inadequate for efficacy or safety.
Case series (Lee & Padgett 2021; Lee et al. 2024, as summarised by FDA): Knee pain, 17 charts reviewed: intra-articular 2-4 mg, 1-2 doses; interstitial cystitis, 12 women: intravesical 10 mg total. No adverse events reported; uncontrolled.
Animal pharmacokinetics (He et al. 2022): Rats and beagle dogs, single IV and IM doses: elimination half-life under 30 min; IM bioavailability about 14-19 % (rats) and 45-51 % (dogs); cleared mainly in urine and bile.

Mechanism, as reported

Not established. Rodent work points to effects on blood-vessel growth, nitric oxide and tissue repair, but the molecular target is unknown and dose-response data are missing.

Practical record

Elimination half-life: 0.5 h (confidence: low). No human pharmacokinetics exist. The only published PK (He 2022, rats and dogs, summarised by FDA): IV half-life 5.3 min in dogs and 15.2 min in rats; after an intramuscular dose the elimination half-life was under 30 min and the peptide was undetectable by 4 h. No subcutaneous study. The app's decay curve uses 30 min as a placeholder consistent with the IM data; the 4 h figure it used before 2026-10-20 was contradicted by that data. Treat the curve as a guess.
Studied routes: oral, subcutaneous, intranasal, transdermal.
Typical supply: No approved product. Nominated compounded forms were 250 µg-1 mg capsules, 2 mg/mL injection, 50 µg/spray nasal spray, 1 mg suppository and transdermal cream; also sold in the US as oral 'dietary supplements'.
Reconstitution: Water-soluble at 5 mg/mL; reconstituted solution reported stable 2-3 weeks at 4 °C (supplier data cited by FDA).
Storage: Lyophilised powder: stable about 3 weeks at room temperature; desiccated below -18 °C for long-term storage (supplier data cited by FDA).

Safety signals on record

Reported adverse events: Small human studies reported headache and flatulence at placebo rates. FDA's adverse-event database holds three injection reports: injection-site redness and swelling, shortness of breath needing an ER visit, and diffuse skin and gum darkening that recurred on re-exposure (with TB-500).
Contraindications: None established (no label).
Interactions: None documented.
Notes: FDA flags a possible immunogenicity risk for injected and nasal forms and missing impurity/endotoxin data for products on the market. In 28-day dog and rat studies FDA noted clotting-time changes and raised ALT, glucose and triglycerides. No carcinogenicity data. Prohibited in sport (WADA S0, per FDA).

Sources

General wellness education, not medical advice. Unapproved compounds have no established dosing, purity standard, or safety profile.

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