BPC-157 Not available

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BPC-157

An unapproved peptide studied mainly in rodents

Not FDA-approved · not available for sale or prescription

FDA advisory vote, July 2026 · FDA staff opposed · no FDA action

Stylised model of the real sequence

Overview.

BPC-157 is not approved as a drug anywhere and has almost no controlled human data; most of the evidence comes from rodent studies. It is a synthetic 15-amino-acid peptide modeled on a fragment of a human gastric juice protein ("body protection compound"). Its large rodent literature suggests protective and healing effects on gut, tendon, ligament and muscle tissue. It is not on any government essential-medicines list.

Also known as Body Protection Compound-157 · PL-10 · PL 14736 · Bepecin

The molecule, decoded.

Sequence

GEPPPGKPADDAGLV

Length
15 residues
Molecular weight
1,419.5 g/mol
Formula
C62H98N16O22
CAS number
137525-51-0
Half-life
Not established in humans (IV in animals: about 5.3 minutes in dogs, 15.2 minutes in rats)
Routes studied
oral (tablet, Phase 1 human trial; no results posted), rectal enema (human: UC RCT and healthy volunteers), intra-articular injection (human), intravesical injection (human pilot, interstitial cystitis), intravenous (human pilot, 2 subjects), intraperitoneal (animal), subcutaneous (animal)
Modifications
none (linear free peptide; no terminal acetylation or amidation reported)

How it works.

Proposed mechanisms include upregulation of growth-factor and nitric-oxide signaling pathways, promotion of angiogenesis (VEGFR2-dependent endothelial cell migration), modulation of the gut-brain axis, and effects on fibroblast activity and collagen deposition. Antioxidant and anti-inflammatory (cytokine-modulating) effects are also reported. Mechanistic work is almost entirely in vitro or in rodents; the molecular target(s) in humans are not established.

Evidence · Early or small human studies

What the research shows

RCT, meeting abstract2005

The only randomized, double-blind, placebo-controlled trial FDA identified, a 2005 meeting abstract, gave 53 patients with mild-to-moderate ulcerative colitis a BPC-157 (PL 14736) enema or placebo for two weeks; the Disease Activity Index fell 3.2 vs 1.6 points, a difference that was not statistically significant, and FDA judged the data inadequate to support efficacy or safety.

53 adults with mild-to-moderate ulcerative colitis

review of pilot studies2026

A 2026 review of regenerative peptides for pain concluded that human evidence for BPC-157 is limited to small pilot studies (musculoskeletal pain, interstitial cystitis and intravenous use) and that comprehensive controlled trials are still needed before clinical use.

review of human pilot studies

retrospective chart review2021

A retrospective chart review at one clinic reported that 14 of 16 patients given knee injections of BPC-157 (alone or with thymosin beta-4) described symptom relief, including 11 of 12 given BPC-157 alone; with no control group, the design cannot show that BPC-157 caused the relief.

16 adult primary-care patients with knee pain (Institute for Hormonal Balance, Orlando, FL)

literature review2025

A 2025 literature and patent review noted that BPC-157 has not been approved by FDA or other regulators because comprehensive human clinical studies are lacking; the effects it describes come from preclinical models of tissue injury, inflammatory bowel disease and central nervous system disorders.

literature/patent review (no single population)

review of rodent studies2019

A 2019 review of musculoskeletal soft-tissue healing noted that efficacy in humans is unconfirmed and that only a handful of research groups have published in-depth studies; in rodent injury models, BPC-157 consistently sped tendon, ligament and skeletal-muscle healing.

rodent tendon/ligament/muscle injury models (narrative review)

What to know first.

Based on: mostly lab and animal studies; human data are limited to one small trial with no significant benefit and a few uncontrolled reports.

Reported side effects

  • Small human studies (enema, intra-articular, intravesical, IV; 2 weeks or less) had limited safety monitoring; headache and flatulence were the most frequent effects after enemas in healthy volunteers
  • FDA's adverse-event database (FAERS, to Dec 2025) holds three reports after injected BPC-157: injection-site redness and swelling (with concomitant thymosin), shortness of breath leading to an ER visit, and diffuse hyperpigmentation with gingival darkening that recurred on rechallenge with a 'research purposes only' BPC-157 + TB-500 product; causality is uncertain
  • Theoretical concern that pro-angiogenic activity could promote tumor growth (unconfirmed in humans)

Cautions

  • No controlled human safety data; not approved by any drug regulator
  • Product quality/purity of research-vendor material is inconsistent and unregulated
  • Cannot legally be compounded today: the July 2026 advisory vote is not binding and FDA has not acted on it

Checked 2026-09

Where it stands.

Not FDA-approved · not available for sale or prescription. BPC-157 is not FDA-approved and is not available for sale or prescription. In July 2026, FDA staff recommended against adding it to the list of substances pharmacies may compound; FDA’s advisory committee voted 8–6, with 1 abstention, to recommend it anyway. The vote is advisory, and FDA has not acted on it.
FDA
Not approved (no NDA/BLA). Reviewed at FDA's Pharmacy Compounding Advisory Committee (PCAC) on 23 Jul 2026 for ulcerative colitis only: FDA staff proposed NOT adding BPC-157 (free base) or BPC-157 acetate to the 503A Bulks List; the committee voted 8 yes, 6 no, 1 abstain on each form to recommend inclusion (non-binding). No proposed or final FDA rule as of 26 Sep 2026.
Compounding
Nominated for the 503A Bulks List by LDT Health Solutions for the International Peptide Society (received 16 Nov 2018, FDA-2018-N-2973-0002) and by Wells Pharmacy Network (received 16 Nov 2020, FDA-2015-N-3534-0279). BPC-157 was held in 503A Category 2 (safety risks); both nominators withdrew on 14 Apr 2026 (FDA-2015-N-3534-0484/-0485), and FDA's Category 2 page (updated 22 Apr 2026) now lists it under 'nominated but withdrawn'. FDA nonetheless evaluated both forms on its own initiative and proposed NOT adding them; on 23 Jul 2026 the PCAC voted 8-6-1 on each form to recommend inclusion (non-binding). As of 26 Sep 2026 FDA has published no proposed or final rule: the substance is not on the 503A bulks list (21 CFR 216.23, unchanged since 2019) and is not in 503A Category 1.
Sport (WADA)
Prohibited at all times (in- and out-of-competition) under S0 Non-Approved Substances; named explicitly as an example substance in the WADA 2026 Prohibited List ("...including but not limited to BPC-157...").
Enforcement
  • FDA warning letter to Tailor Made Compounding LLC (Kentucky), dated 2020-04-01, names BPC-157 among bulk substances compounded without qualifying for a Section 503A exemption.
  • Tailor Made Compounding LLC pleaded guilty in October 2020 to distributing unapproved new drugs, including BPC 157; on 24 Feb 2021 it was sentenced to three years' probation and forfeited $1,788,906.82, and its owner received probation, home incarceration and a $20,000 fine (U.S. Attorney's Office, E.D. Kentucky).
References (9)
  1. U.S. FDA · download
  2. PubMed · PMID 41898733
  3. PubMed · PMID 34324435
  4. PubMed Central · PMC11859134
  5. PubMed · PMID 30915550
  6. U.S. FDA · download
  7. World Anti-Doping Agency
  8. usada.org · bpc 157 peptide prohibited
  9. U.S. FDA · tailor made compounding llc 594743 04012020

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