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BPC-157: Safety, Legal Status, and Human Evidence

Is BPC-157 safe, legal, or FDA approved? What rat studies and the few small human reports show, plus FDA, Health Canada, WADA and NCAA status.

By Peptidia EditorialReviewed October 27, 2026

Also known as: BPC 157 · BPC157 · Body Protection Compound 157 · Body Protective Compound-157 · Pentadecapeptide BPC 157

Direct answer

Direct answer

BPC-157 is a synthetic 15-amino-acid peptide. It is not approved as a medicine by the FDA or Health Canada, and WADA prohibits it at all times. Almost all evidence comes from rat studies, much of it from one research group in Zagreb. A 2026 systematic review found only three small uncontrolled human studies, 30 people in total, with very low certainty. A placebo-controlled trial in hamstring strain is registered and recruiting but has no results yet.

Status at a glance

As of October 27, 2026

United States (FDA)
Not approved for any use. No approved drug application is listed in Drugs@FDA. U.S. Food and Drug Administration
FDA compounding
On FDA's list of bulk drug substances that may present significant safety risks, in the group nominated but withdrawn (previously category 2). U.S. Food and Drug Administration
Canada (Health Canada)
No authorized drug product in Health Canada's Drug Product Database. Health Canada
Sport (WADA)
Prohibited at all times. Named under S0, non-approved substances. World Anti-Doping Agency
College sport (NCAA)
Named on the NCAA banned substances list under peptide hormones, growth factors, related substances and mimetics. NCAA

WADA updates its Prohibited List every January; the 2027 List takes effect January 1, 2027. Athletes should check the list in force and their own federation's rules.

Public Evidence Passport preview

Preclinical + very low-certainty uncontrolled human reports

Almost all evidence comes from rat studies, much of it from one research group. Human data are limited to three small studies without control groups. No peer-reviewed randomized controlled trial in people has been published.

Strongest source tier
Tier 3 — systematic review of three small uncontrolled human studies
Editorial review
October 27, 2026
Source coverage
9 inspectable records in this public preview

What matters

  • BPC-157 is not an approved medicine in the United States or Canada.
  • Nearly all supporting studies are in rats, and many come from the group that first described the peptide.
  • The only human reports are three small uncontrolled studies, rated very low certainty by a 2026 systematic review.
  • A randomized, placebo-controlled hamstring trial is recruiting; no peer-reviewed human RCT has been published.
  • WADA and the NCAA both list BPC-157 as banned.

What it is

BPC-157 is a 15-amino-acid peptide. Its originating research group at the University of Zagreb describes it as a stable gastric pentadecapeptide. It is popular among athletes for musculoskeletal injury recovery, even though it has no regulatory approval for human use.

BPC-157 is investigational. No regulator in the United States or Canada has approved it for any use, so no approved product exists whose quality and safety have been reviewed for people.

Proposed mechanism (preclinical)

In rats, BPC-157 sped the healing of experimental colon and skin defects and closed colocutaneous fistulas, whether it was given in drinking water or by injection. The authors examined how this effect relates to the nitric-oxide system. In another rat study, treatment after experimental spinal cord injury was followed by better tail motor function and less loss of nerve tissue. The same group reports anti-inflammatory effects in animals and effects on several molecular pathways.

These are animal findings. How BPC-157 acts in people has not been established. Both cited rat studies come from the Zagreb group (Sikiric, Seiwerth and colleagues), and independent replication by unaffiliated laboratories is limited.

What the human evidence shows

A 2026 systematic review in Acta Orthopaedica Belgica searched four databases up to June 2026 for human studies of BPC-157 for any use. It found three small studies without control groups, 30 participants in total: a retrospective study in knee pain, a retrospective pilot in interstitial cystitis, and a prospective safety pilot in two people. All three reported symptom improvement in most participants and no treatment-related adverse events. The reviewers judged each study to be of poor quality and rated the overall certainty of evidence as very low.

Without comparison groups, these reports cannot show that BPC-157 caused the improvements. The reviewers concluded that BPC-157 should not be used clinically in humans outside ethically approved, regulated, high-quality clinical trials.

One randomized, double-blind, placebo-controlled phase 2 trial in MRI-confirmed hamstring strain is registered on ClinicalTrials.gov. It is sponsored by a company, began recruiting in 2026, and has no results yet. An older inflammatory bowel disease program (PL-14736) is often cited as human proof, but its results were never published in a peer-reviewed journal.

Safety and side effects

Human safety is not established. The three small human studies reported no treatment-related adverse events, but samples this small cannot establish safety. Long-term effects in people are unknown.

FDA says compounded drugs containing BPC-157 may carry a risk of immune reactions to the peptide (immunogenicity) for some routes, and may raise problems with peptide-related impurities and characterization of the active ingredient. FDA also says it has no, or only limited, safety information for the proposed routes.

How BPC-157 is absorbed and cleared in people has not been measured in the cited studies, and human oral bioavailability is uncharacterized.

Regulatory and sport context

BPC-157 is not approved by the FDA or Health Canada and remains investigational. WADA names it in section S0 of the Prohibited List, which covers substances with no current approval by any government health authority for human therapeutic use. Substances in S0 are prohibited at all times, in and out of competition. The NCAA also names BPC-157 on its banned substances list.

Common questions

Is BPC-157 safe?

Not established. The only human data are three small uncontrolled studies with 30 participants. They reported no treatment-related adverse events, but a 2026 systematic review rated the certainty as very low, and samples this small cannot establish safety. FDA flags immune-reaction and impurity risks for compounded products and says it has little safety information. The reviewers concluded it should not be used clinically outside regulated trials.

Sources:Human evidence for BPC-157 in orthopaedic and regenerative medicine: a systematic review of efficacy and safetyCertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks

What are the side effects of BPC-157?

They are not well characterized. No controlled human trial has published adverse event data. The three small uncontrolled studies reported no treatment-related adverse events, which cannot rule out rare or delayed harms. FDA's stated concerns for compounded products are immune reactions against the peptide and peptide-related impurities. Long-term effects in people are unknown.

Sources:Human evidence for BPC-157 in orthopaedic and regenerative medicine: a systematic review of efficacy and safetyCertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks

Is BPC-157 legal or FDA approved?

It is not FDA approved for any use, and Health Canada's Drug Product Database lists no authorized product. FDA places it on its list of bulk drug substances that may present significant safety risks, in the group whose nominations were withdrawn. Rules on selling or owning unapproved substances differ by country, so this page confirms only that it is not an approved medicine.

Sources:Drugs@FDA: FDA-Approved DrugsCertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksDrug Product Database online query

Is BPC-157 banned by WADA?

Yes. The WADA Prohibited List names BPC-157 under S0, non-approved substances. S0 covers pharmacological substances with no current approval by any government health authority for human therapeutic use, and these are prohibited at all times, in and out of competition.

Sources:The Prohibited List

Is BPC-157 banned by the NCAA?

Yes. The NCAA banned substances page names BPC-157 in the class of peptide hormones, growth factors, related substances and mimetics. The NCAA says its list is not exhaustive and that student-athletes should check with their athletics staff before using any substance, including supplements.

Sources:NCAA Banned Substances

Does BPC-157 work orally?

Not established in people. In a rat study, BPC-157 given in drinking water sped the healing of experimental colon and skin defects. The cited studies did not measure how it is absorbed in people, and human oral bioavailability is uncharacterized, so these rat results cannot show that oral use has meaningful effects in people.

Sources:Pentadecapeptide BPC 157, in clinical trials as a therapy for inflammatory bowel disease (PL14736), is effective in the healing of colocutaneous fistulas in rats: role of the nitric oxide-systemHuman evidence for BPC-157 in orthopaedic and regenerative medicine: a systematic review of efficacy and safety

Is BPC-157 a GLP-1?

No. BPC-157 is a 15-amino-acid peptide that its originating group calls a stable gastric pentadecapeptide. None of the cited studies describe it as acting on the GLP-1 receptor or test it for weight loss. Unlike approved GLP-1 medicines, it has no approved use and no published randomized human trial.

Sources:Human evidence for BPC-157 in orthopaedic and regenerative medicine: a systematic review of efficacy and safetyStable gastric pentadecapeptide BPC 157 can improve the healing course of spinal cord injury and lead to functional recovery in rats

What is the difference between BPC-157 and TB-500?

They are different molecules. BPC-157 is a 15-amino-acid peptide; TB-500 is a short fragment of thymosin beta-4, which FDA identifies by the sequence LKKTETQ. Both are unapproved, both appear on FDA's list of bulk substances that may present significant safety risks, and WADA prohibits both. Neither has a published controlled human trial for muscle or tendon repair, and using them together has not been tested in controlled trials.

Sources:Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksThe Prohibited ListHuman evidence for BPC-157 in orthopaedic and regenerative medicine: a systematic review of efficacy and safety

Inspect the record

Sources

  1. 01
    Human evidence for BPC-157 in orthopaedic and regenerative medicine: a systematic review of efficacy and safety

    2026 PROSPERO-registered systematic review. Found three uncontrolled human studies (30 participants); certainty rated very low.

    PubMed
  2. 02
    BPC 157 for Acute Hamstring Muscle Strain Repair

    Registered randomized, double-blind, placebo-controlled phase 2 trial. Recruiting; no results yet.

    ClinicalTrials.gov
  3. 03PubMed
  4. 04PubMed
  5. 05
    Drugs@FDA: FDA-Approved Drugs

    FDA database of approved drug products; no BPC-157 product is listed.

    U.S. Food and Drug Administration
  6. 06
    Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks

    FDA compounding safety list; BPC-157 appears under nominated but withdrawn.

    U.S. Food and Drug Administration
  7. 07
    Drug Product Database online query

    Canadian database of authorized drug products; searched by name.

    Health Canada
  8. 08
    The Prohibited List

    Sport anti-doping list; BPC-157 is named under S0.

    World Anti-Doping Agency
  9. 09
    NCAA Banned Substances

    College sport banned drug classes with examples.

    NCAA

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