At a glance
- BPC-157 is not an FDA-approved drug: Drugs@FDA has no record of it.
- It was on FDA's Category 2 safety-risk list until the nomination was withdrawn. A withdrawal is not an approval.
- PubMed lists 232 publications mentioning it, including 0 randomized controlled trials and 108 animal-only studies.
- ClinicalTrials.gov lists 4 registered studies testing it (2 active).
- FDA's adverse event system (FAERS) holds 20 reports mentioning it; 16 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
FDA's stated risk · Original FDA text (English) Compounded drugs containing BPC-157 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization. FDA has identified no, or only limited, safety-related information for the proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans. Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Possibilities for Cytoprotective Liver Therapy, Stable Gastric Pentadecapeptide BPC 157, and Standard Agents-A Narrative Review.
- Investigational Peptides in Orthopaedic Practice: Evidence, Safety, and Patient Counseling for BPC-157, Thymosin Beta-4, and TB-500.
- Human evidence for BPC-157 in orthopaedic and regenerative medicine: a systematic review of efficacy and safety.
- Case Report: Regenerative peptides for Inferior alveolar nerve injury: a narrative review with hypothesis-generating three clinical cases.
- BPC 157 in Rodent Ischemia-Reperfusion Injury: A Critical Review of Preclinical Evidence.
- Dangers of Injectable Peptides and Other Unregulated "Biohacking" Drugs.
- Synthetic Peptides in Pharmacy Compounding: Analysis of PCAC Recommendations and Industry Safety Standards.
- Efficient Expression of Small Molecule Bioactive Peptides in Bacillus licheniformis.
- Peptides in Regenerative Medicine: A Comprehensive Review of Clinical Applications in Tissue Repair and Chronic Pain Management.
- Peptide Supplements and Their Therapeutic Applications in Sports Medicine.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 4
- Active
- 2
- With posted results
- 0
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| Impact of BPC-157 on Recovery Following Rotator Cuff Repair Surgery | Not yet recruiting | Phase 1 | January 1, 2027 |
| BPC 157 for Acute Hamstring Muscle Strain Repair | Recruiting | Phase 2 | February 2, 2026 |
| A Clinical Trial to Evaluate the Effects of Peptide Gummies on Markers of Inflammation, Physical Performance, and Recovery | Completed | N/A | September 1, 2025 |
| PCO-02 - Safety and Pharmacokinetics Trial | Unknown status | Phase 1 | Oct 2015 |
All 4 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 20
- Serious
- 16
- With death outcome
- 0
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.