Digestive & weight Synthetic pentadecapeptide (gastric-derived)
BPC-157
Regulatory status
Status at a glance
503A compounding status
Advisory committee voted to include
FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted in favor of adding this substance to the 503A bulks list. PCAC votes are non-binding recommendations; FDA and HHS make the final decision, and the substance is not on the bulks list unless FDA adds it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- On the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
BPC-157 is a synthetic 15-amino-acid peptide studied for tissue and gut repair, and 35 of the 36 studies in a 2025 systematic review were animal or lab work. The one human report, a retrospective series of 12 patients with chronic knee pain, found that seven (58%) described relief lasting more than 6 months. It had no control group, effect size, or safety data. BPC-157 is not FDA-approved, is prohibited in sport, and remains unsettled in FDA compounding review.
At a glance
- What it is
- Synthetic peptide made of 15 amino acids, based on a protein found in gastric juice
- FDA status
- Not approved by the FDA for any use
- Research
- Almost all done in animals rather than in humans
- Sport
- Prohibited at all times in competitive sport under the World Anti-Doping Agency
- Evidence strength
- Low research
Summary
BPC-157 is a synthetic peptide studied for tissue and gut repair. Learn what the research shows, why the evidence is mostly preclinical, and its FDA status.
What is BPC-157?
BPC-157, short for “Body Protection Compound-157,” is a synthetic pentadecapeptide, a chain of 15 amino acids (sequence GEPPPGKPADDAGLV). It is a lab-made fragment modeled on a larger protective protein that occurs naturally in human gastric juice, the acidic fluid the stomach uses to break down food.
Unlike a hormone such as insulin, BPC-157 does not appear to act on a single, well-defined receptor. Researchers instead describe it as a “cytoprotective” agent, meaning a molecule associated with protecting and maintaining the integrity of cells and tissue in laboratory and animal models.
BPC-157 has never been approved as a medicine through the FDA.
The history of BPC-157
The idea behind BPC-157 dates to 1975, when a Croatian medical student named Predrag Sikiric attended a lecture on the body’s stress response at the University of Zagreb. He reasoned that if stress can damage the stomach, the stomach might also produce its own protective substance.
By 1983, Sikiric had assembled a team that collected human and animal gastric juice from hospitals, emergency rooms, and slaughterhouses to search for the active ingredient. In 1989, the group isolated a 15 amino acid peptide called BPC-157. The name and number carried personal and patriotic meaning for Sikiric during a turbulent period in Croatia’s history, as described in a 2026 STAT News profile of the researcher.
From 1993, the Zagreb pharmaceutical company PLIVA, later working with Parke-Davis, developed the peptide and ran early animal studies along with two small human trials for ulcerative colitis in the early 2000s. The second of those trials reported a positive effect that did not reach statistical significance. After GlaxoSmithKline acquired PLIVA’s research institute in 2006, the program was shelved, and the rights returned to Sikiric in 2009.
Without a pharmaceutical company continuing its development, BPC-157 followed an unusual path. Around 2010, it spread through online forums and Sikiric’s published papers, and suppliers began selling it directly. It has circulated as a research chemical ever since. Most of the underlying studies still come from Sikiric’s own laboratory. A 2025 systematic review identified 544 BPC-157 articles published between 1993 and 2024, most of them from a small number of research groups.
The only registered interventional human trial of BPC-157 was a small Phase I safety study of oral tablets (NCT02637284) run in Tijuana, Mexico around 2015 and 2016. It was never completed to publication and remains listed with an “unknown” status and no posted results, so even its basic safety findings in humans were never independently reported.
How does BPC-157 work?
The proposed mechanisms come almost entirely from animal and cell studies. The most consistent finding is that BPC-157 promotes angiogenesis, the growth of new blood vessels, mainly through the VEGFR2-Akt-eNOS pathway and by influencing the nitric oxide system, which helps regulate blood flow and vascular health.
In laboratory models, researchers have also reported that BPC-157 increases collagen production, activates fibroblasts, reduces inflammatory signaling, and affects pain pathways. In tendon cells, it has been shown to increase expression of the growth hormone receptor. Across rodent studies, it has been associated with faster healing of muscle, tendon, ligament, bone, and gastrointestinal tissue.
In animal data, BPC-157 is metabolized in the liver, cleared by the kidneys, and has a short half-life of under 30 minutes. None of these findings have been confirmed in controlled human studies.
Is BPC-157 FDA-approved?
Safety note
Status: Not approved by the FDA for any use
Category: Wellness and performance · Primary body area: Digestive & weight
No, BPC-157 has never been approved by the FDA, or any comparable regulator, for any condition, and it has not completed the controlled human trials that approval requires.
Its regulatory status has also changed several times:
- 2023: The FDA placed BPC-157 in Category 2 of its interim 503A bulk drug substances list, the category for substances that may present significant safety risks, which restricted compounding pharmacies from making it.
- April 2026: The FDA removed BPC-157 from that category because the nominators withdrew their nominations. BPC-157 is still not on the 503A bulks list or in Category 1.
- July 23, 2026: Its Pharmacy Compounding Advisory Committee voted in favor of allowing the peptide to be compounded, meaning prepared for individual patients by licensed compounding pharmacies rather than mass-produced and sold as a standardized, FDA-approved drug.
That vote is a recommendation only. The FDA still has to write and finalize a rule, so BPC-157 is not currently cleared for compounding and remains unapproved. Being permitted for compounding would also not be the same as FDA approval.
BPC-157 is also prohibited at all times in sport under the World Anti-Doping Agency’s S0 category for non-approved substances.
What does the research show?
Editor’s note
Evidence strength: Low research
Its human evidence is limited to a single small retrospective report (12 patients with chronic knee pain), while the rest of the literature, including all 35 studies in the 2025 systematic review, is preclinical animal or lab work.
The research on BPC-157 is overwhelmingly preclinical. The 2025 systematic review in orthopedic sports medicine screened the literature and included 36 studies, of which 35 were preclinical (animal or laboratory) and only one involved humans. There are no completed randomized controlled human trials, and there is no long-term human data.
A 2019 review reached a similar conclusion, describing consistent healing effects in rodents while noting that efficacy is “yet to be confirmed in humans.” The animal research is broad and fairly consistent, but the human research needed to draw firm conclusions has not been done.
The most replicated animal findings involve tendons. In rats with a cut Achilles tendon, BPC-157 improved tendon strength, elasticity, and function and shrank the defect by day 14.
The one human report is a retrospective, uncontrolled series of 12 patients with chronic knee pain. After a single knee injection, seven of them (58%) reported relief lasting more than 6 months. The report published no effect size or safety data.
What is the difference between BPC-157 and TB-500?
BPC-157 is often mentioned alongside TB-500, a synthetic fragment of the protein thymosin beta-4. The two share several features. Both are peptides, unapproved by the FDA, prohibited in sports, and have been studied mainly in animals rather than in humans.
The differences are largely mechanistic:
| Feature | BPC-157 | TB-500 |
|---|---|---|
| Origin | Derived from a gastric protein | Synthetic fragment of thymosin beta-4 |
| Proposed action | Broad cytoprotective agent | Acts mainly by regulating actin, a structural protein involved in cell movement |
| Animal research emphasis | Gastrointestinal tissue | Wound and cardiac tissue |
Neither has controlled human evidence.
Sources: peer-reviewed studies cited above are indexed on PubMed and cited by DOI where used; key references include the 2025 systematic review in the HSS Journal (DOI: 10.1177/15563316251355551), a 2026 review in the International Journal of Molecular Sciences (DOI: 10.3390/ijms27062876), Sikiric et al. in Pharmaceuticals (DOI: 10.3390/ph18060928), and a 2019 review in Cell and Tissue Research (DOI: 10.1007/s00441-019-03016-8); regulatory, trial-registry, and historical details are from the FDA, ClinicalTrials.gov, USADA, and a 2026 STAT News profile. This document is educational research and does not constitute medical advice, a health claim, or an offer to sell; BPC-157 is not approved by the FDA, and its regulatory status should be re-verified before publication, as the FDA compounding review is ongoing.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
- [4]
- [5]
- ClinicalTrials.gov NCT02637284
- [6]
- [7]
- [8]
- [9]
- [10]
- [11]
- [12]
- [13]
- [14]
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