Peptide LibraryAdverse events, serious adverse events and discontinuations
Insufficient information to assessSafety outcome · 3 studies · 14 participants
Not enough evidence to tell
Very few people have been studied receiving BPC-157: 2 in one small pilot study and 12 in another, plus a phase 1 trial whose results were never made available. These reports mention no side effects, but the studies had no comparison groups, were very short and were only published as abstracts. The certainty of the evidence is very low, so we do not know whether BPC-157 is safe for people. The absence of reported side effects in so few people is not evidence of safety.
What the research measured: In a two-person uncontrolled intravenous pilot, infusions were reported as tolerated with no side effects and no measurable effects on heart, liver, kidney, thyroid or glucose biomarkers through day 3. In a 12-patient uncontrolled pilot of injection into the bladder wall for interstitial cystitis, no dropouts and no adverse events were reported. A phase 1 study in healthy male volunteers assessed safety and tolerability, but no results are available.
What remains unknown: Unanswered questions include the frequency of common and rare adverse events, serious harms and discontinuations compared with placebo. Safety with repeated or long-term use is unknown, as are differences by route (injection under the skin, by mouth, intravenous). Safety is also untested in women, younger people, people with chronic conditions, and in pregnancy. The quality and contamination of compounded or unregulated products and possible long-term risks such as effects on tumor growth are also unknown. The full results of the phase 1 trial have not been published.
Reviewers’ note: At least one included study has no risk-of-bias assessment, so no certainty rating is given.
How the certainty was judged
| Domain | Judgment | Why |
|---|---|---|
| Starting level | — | |
| Risk of bias | — | Both studies with safety data are uncontrolled, open-label pilot studies available only as abstracts. One selected two participants who had already tolerated intravenous BPC-157 before. Neither describes systematic adverse-event monitoring in detail, and funding and conflicts are not reported for private clinics offering the treatment. |
| Inconsistency | — | The two studies reporting safety data both describe no adverse events, so the results do not conflict. The phase 1 study contributes no data to compare. |
| Indirectness | — | No study had a placebo or comparison group, so adverse events cannot be compared against a control as the question specifies. Follow-up was a few days or not stated, which limits relevance to harms from real-world use. |
| Imprecision | — | Only 14 participants with reported data (2 and 12), no events and no effect estimates. This sample is far too small to detect uncommon or even moderately common adverse events. The phase 1 study gives no sample size or results. |
| Publication bias | — | The phase 1 industry-developed trial of PL 14736 exists only as conference abstracts and was never fully published with results. The remaining evidence is small, abstract-only private-clinic reports, a pattern prone to selective reporting. |
Included studies
- Phase 1 safety, tolerability and pharmacokinetics of PL 14736 (BPC-157) in healthy male volunteers (Other design)
- Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study. (Uncontrolled pilot study, 2 participants)
- Effect of BPC-157 on Symptoms in Patients with Interstitial Cystitis: A Pilot Study. (Uncontrolled pilot study, 12 participants)
Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · GRADE (handbook, 2013) · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.