As of October 2026, the FDA and the EMA have not approved BPC-157. An FDA review in May 2026 found five small human studies. One was randomized against a placebo, in 53 people with ulcerative colitis, but its results exist only as a meeting abstract, and the FDA called the data inadequate. None tested it the way it is proposed for compounding. Since 28 October 2026, HHS says it does not intend to take enforcement action against licensed pharmacies that compound BPC-157 acetate under ten conditions. WADA bans it in sport at all times. Whatever the compound turns out to do, nobody can tell you from the outside what is in a given vial.
Reading up on BPC-157? Get the week's peptide and GLP-1 news every Wednesday, with the document behind each line.
What is BPC-157?
BPC-157 is a lab-made chain of 15 amino acids, modeled on part of a protein found in human stomach fluid. A team led by Predrag Sikiric at the University of Zagreb first described it in the early 1990s. Since then it has mostly been studied in rats and mice, and it is widely discussed online for injury recovery.
Does BPC-157 work?
Nobody knows. A randomized trial assigns people by chance to the compound or to a comparison. For BPC-157, the only randomized trial with results, in ulcerative colitis, reported them only as a meeting abstract, and the FDA called the data inadequate.
What we found. 0 completed randomized trials by our count. 5 small human studies, counted by the FDA in its May 2026 review. 1 of them was randomized against a placebo, and its results exist only as a meeting abstract, so it does not count. 1 trial enrolling. 1 trial registered in 2015 with no results posted.
| Study | Tested in | Status | What it shows |
|---|---|---|---|
| Five human studies found by the FDA in its May 2026 review | People | Completed. Small | None used a route proposed for compounding. One was randomized: the next row |
| Randomized, placebo-controlled trial in 53 people with ulcerative colitis, one of the five | People | Completed. Results only in a meeting abstract | The FDA called the data inadequate to support efficacy or safety. An abstract is not a posted or published result, so it does not count toward the number |
| Phase 1 safety trial, NCT02637284 on ClinicalTrials.gov (opens in new tab) | People | Registered in 2015. No results posted | No results posted in more than ten years |
| Phase 2 trial for hamstring strain, NCT07437547 on ClinicalTrials.gov (opens in new tab) | People | Enrolling, 120 participants | No results yet |
| Animal safety studies reviewed by the FDA | Animals | Completed. Not by the routes proposed for compounding | No gene damage in tests and no birth defects in pregnant rats. Changes in blood clotting time and in liver signals |
| Cancer-risk studies | Animals | Not conducted | The FDA's review names this as a gap |
Animal studies exist. They cannot tell you what happens in people.
How we count a trialIs BPC-157 safe?
Nobody knows that either. No completed human trial has established its safety. The FDA's May 2026 review found no study of cancer risk and open questions about impurities. In animals, the safety studies flagged changes in blood clotting time and in liver signals. All of that is about the compound. The vial is the next section.
Is BPC-157 legal?
- United States
- Not approved by the FDA.
- Compounding
- On 28 October 2026 HHS said it does not intend to take enforcement action against a US pharmacy or physician who compounds BPC-157 acetate for a patient with a prescription. Ten conditions apply. The policy lasts until the FDA decides BPC-157 in a final rule. BPC-157 is still not on the FDA's compounding list, and compounded drugs are not FDA approved.
- European Union
- No marketing authorisation, and no clinical trial registered in the EU.
- Sport
- Banned at all times under class S0 of WADA's 2026 Prohibited List.
- Controlled substances
- Not on the DEA's list, August 2026 edition.
Full answer: Is BPC-157 legal in the US and the EU?
Not medical advice. Approval and sport status as of . Medical disclaimer
What is in a vial sold as BPC-157?
None of the studies above tested a vial sold online. A "research use only" label guarantees nothing about purity. A certificate of analysis counts only if it names your lot number, a lab with no stake in the result, and the method used. Purity and identity are separate tests.
Three questions to ask the seller:
- Which lot number is this certificate for?
- Who ran the test, and are they independent of you?
- Does the report confirm identity by mass spectrometry, or purity alone?
What don't we know?
- Whether it does anything in people. The only randomized trial with results exists as a meeting abstract, and the FDA called the data inadequate.
- Whether it raises cancer risk. The FDA's review found no cancer-risk study.
- What the 2015 Phase 1 trial found. Its results were never posted.
- What is in any given vial.
The other side
A personal result is real to the person who had it. It cannot separate the compound from the vial, or from healing that would have happened anyway.
What would change this record?
- A final FDA rule on the 503A bulks list that adds BPC-157 or leaves it off. It would end the HHS interim policy for BPC-157 and show on the FDA's bulk-substances page.
- HHS narrowing or withdrawing its interim policy of 28 October 2026.
- Posted results from the 2015 Phase 1 trial or from the Phase 2 hamstring trial. They would show on the trial registry.
- A published cancer-risk study.
Change log
- HHS published an interim enforcement policy that covers BPC-157 acetate. The Compounding line, the status line and the change triggers were updated. HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (opens in new tab)
- Corrected. One of the five human studies the FDA found was randomized against a placebo: 53 people with ulcerative colitis. Its results exist only as a meeting abstract, which the FDA called inadequate, so it fails our fourth test and the count stays 0. The record had said none of the five had a comparison group. FDA briefing document, Pharmacy Compounding Advisory Committee, BPC-157 (opens in new tab)
- Record checked. No change logged yet.
Three questions to ask next
Ask better questions.
More questions about BPC-157
Does BPC-157 cause cancer?
- Nobody knows. The FDA's May 2026 review found no study of cancer risk.
Are any human trials of BPC-157 running now?
- Yes, one on this record. A Phase 2 trial for hamstring strain is enrolling 120 participants, and it has no results yet.
Why did the 2015 trial never post results?
- This record holds no reason. The registry shows a Phase 1 trial registered in 2015 and no posted results.
Has BPC-157 been tested in people at all?
- Yes, in five small studies. One was randomized against a placebo, in 53 people with ulcerative colitis, and its results exist only as a meeting abstract. The FDA called that data inadequate. None used a route proposed for compounding.
Is BPC-157 the same as pentadeca arginate?
- No. Pentadeca arginate is a name sellers use for a modified version of BPC-157, and it has no peer-reviewed study under that name.
THE PEPTIDE TABLE
RECORD · BPC-157
- Checked
- 29 OCT 2026
- Sources read
- 8
- Approved?
- NO
- Sport (WADA)
- BANNED
- COMPLETED RANDOMIZED TRIALS
- 0
- GRADE
- D
Ask better questions.
thepeptidetable.com/table/bpc-157
The record on one slip. Save it as a picture and send it to whoever asked you about BPC-157.
Record checked on . Each source shows the date it was checked.
In the same group
Often confused with Pentadeca arginate (PDA). Sellers use that name for a modified BPC-157, and it has no peer-reviewed study of its own.