Peptide profile

BPC-157: FDA Status, Research and Uses

By Living+. Updated October 28, 2026.

Key takeaway

BPC-157 is a lab-made peptide of 15 amino acids, first described in 1993 as a piece of a protein found in gastric juice. It is not FDA approved, and no product with it is approved in any country. It has been studied mostly in rats for gut, tendon and other tissue injury, with only tiny human pilot studies ^{[1, 8, 17]}.

At a glance

Where it stands

Checked October 28, 2026

FDA approvedNoNo approved product
Pharmacy compounding (503A)HHS interim policyOn HHS's interim enforcement policy (Appendix A), released Oct 28, 2026. HHS does not intend to take action against a state-licensed pharmacy, federal facility or licensed physician compounding BPC-157 acetate for subcutaneous, intramuscular, oral and topical forms, with a patient-specific prescription and the policy's other conditions (FDA-registered source with a certificate of analysis, single ingredient, adverse event reporting). It is not FDA approval and not a place on the 503A bulks list; HHS may revisit it if a safety or quality problem arises. The July 2026 advisory committee voted in favor of listing it, and FDA's final rule is still pending.
Outsourcing facilities (503B)Not nominatedNot listed in any 503B category on FDA's 503B list updated March 21, 2025.
WADA (sport)ProhibitedS0 Non-approved substances

Same data as the Status Tracker. Checked against 11 sources

Key facts

Class: Synthetic peptide fragment of a gastric juice protein called BPC ^{[1, 8]}
Length: 15 amino acids ^{[1, 8]}
Half-life: Not established in humans. 5.3 minutes in dogs to 15.2 minutes in rats after IV dosing ^[1]
Route in studies: Mostly intraperitoneal injection in rats. Small human studies used enema, knee joint, bladder wall and IV routes ^{[1, 13]}
First studied: 1993 ^{[1, 8]}

How it works

Researchers at the University of Zagreb in Croatia first described BPC-157 in 1993. They called it a 15 amino acid piece of a larger protein, named BPC, that they found in gastric juice. They proposed that it could protect organs from stress damage ^[8]. FDA notes that the name BPC-157 does not follow standard drug naming rules, so products sold under that name may not all be the same substance ^[1].

In rat studies, BPC-157 was linked to faster repair of cut tendons and of injured stomach, gut and liver tissue ^{[13, 1]}. Review authors have proposed that it acts on blood vessel growth signals and nitric oxide pathways ^[18]. FDA's 2026 review says this is not settled. It says the molecular targets of BPC-157 have not been found and its mechanism is poorly understood ^[1].

How BPC-157 behaves in people is not known. FDA found no data on how the human body absorbs or clears it. It does not appear to reach the blood when given as an enema ^[1]. In rats and dogs, it was broken down quickly into small fragments and single amino acids, then cleared in urine and bile ^[14].

What the research shows

4 human trials2 animal studies

2025Human trial
IV safety pilot (Lee and Burgess)
Tested for short-term safety
2 healthy adults Open pilot, IV infusions on 2 days
No changes in tested heart, liver, kidney, thyroid or glucose markers and no side effects reported ^[11].
Read the study
2024Human trial
Interstitial cystitis pilot (Lee et al.)
Studied for bladder pain
12 women with interstitial cystitis Single-arm pilot, one bladder wall injection procedure, no control group
Authors reported symptom relief in all 12 and no adverse events ^[10].
Read the study
2021Human trial
Knee pain chart review (Lee and Padgett)
Studied for knee pain after knee joint injection
16 adults with knee pain Retrospective chart review with phone survey, no control group
12 got BPC-157 alone and 4 also got thymosin beta-4. 14 of 16 reported relief, but pain was self-rated and there was no comparison group ^[9].
Read the study
2015Human trial
PCO-02 oral tablet phase 1 (NCT02637284)
42 healthy volunteers (planned) Phase 1, randomized, placebo-controlled, masked
Registered to study safety and blood levels of oral tablets. No results are posted, and FDA found no published paper ^{[12, 1]}.
Read the study
2022Animal study
Rat and dog pharmacokinetics (He et al.)
Rats and beagle dogs Pharmacokinetic study, single IV and single and repeated intramuscular doses
Half-life was under 30 minutes. It was broken into small fragments and cleared in urine and bile ^[14].
Read the study
2003Animal study
Rat Achilles tendon study (Staresinic et al.)
Studied for tendon repair
Rats Cut tendon model, daily intraperitoneal dosing for up to 14 days, saline control
Treated rats had stronger tendons and better walking scores than controls ^[13].
Read the study

Doses used in studies

No human dose of BPC-157 has been established. FDA says the available data do not support its use for ulcerative colitis, the use it reviewed in 2026 ^[1]. Most research used rats. In a rat tendon study, doses were 10 micrograms, 10 nanograms or 10 picograms per kg of body weight, given once a day into the abdomen ^[13]. The 1993 paper said most animal doses were in the microgram and nanogram per kg range ^[8].

Small human studies used one 10 mg bladder wall treatment in 12 women ^[10] and IV infusions of 10 mg and then 20 mg in 2 adults ^[11]. FDA's review also lists 2 to 4 mg knee joint doses, enema doses up to 2 mg/kg daily for 8 days in 24 healthy people, and 80 mg enemas daily for 2 weeks in people with ulcerative colitis ^[1].

Dosing is set by a licensed provider.

Side effects and safety

FDA says it lacks enough safety information to know whether BPC-157 would cause harm in people ^[2]. FDA found no human studies of BPC-157 taken by mouth, under the skin, in the nose or on the skin. The few human studies were short and small, and gave limited safety data ^[1]. A 2026 systematic review found only 3 human studies with 30 people in total and rated the evidence as very low certainty ^[17].

FDA's adverse event database has reports of injection site reactions, shortness of breath, and darkening of the skin and gums after BPC-157 use. FDA could not tell whether BPC-157 caused them ^[1]. In two enema studies in healthy people, the most common side effects were headache and gas ^[1].

FDA is also concerned that BPC-157 may trigger immune reactions, especially when injected or sprayed in the nose, and that products may contain impurities or clumped peptide ^{[1, 2]}. There is no FDA label and no boxed warning because no BPC-157 product is approved ^[1].

Legal and regulatory history

October 28, 2026
HHS issued an interim enforcement policy for certain peptides used in 503A compounding. Until a final rule decides whether BPC-157 goes on the 503A bulks list, HHS does not intend to take action against state-licensed pharmacies, federal facilities or licensed physicians who compound it under the policy's conditions ^[19]. For BPC-157 acetate, the policy covers subcutaneous, intramuscular, oral and topical dosage forms ^[19]. For oral forms, the compounder must document adequate oral bioavailability in humans ^[19]. Conditions include a single active ingredient, bulk substance from an FDA-registered facility with a certificate of analysis, reporting of serious adverse events to FDA and a patient-specific prescription ^[19]. The policy is not FDA approval and does not place BPC-157 on the 503A bulks list ^[19]. HHS may revisit it if a safety signal or product quality issue arises ^[19]. A Federal Register notice of availability, which calls the policy a draft, publishes October 30, 2026 ^[20]. Source
July 23, 2026
FDA's Pharmacy Compounding Advisory Committee discussed BPC-157 for the 503A bulks list, with ulcerative colitis as the use reviewed. FDA staff proposed that BPC-157 and BPC-157 acetate NOT be added. FDA says it will not make a final decision until the committee process and its reviews are complete ^{[4, 5]}. HHS's October 28, 2026 policy states the committee voted in favor of inclusion ^[19]. Source
May 14, 2026
FDA's 503A categories list, updated May 14, 2026, does not place BPC-157 in category 1, 2 or 3. FDA lists it with substances that were previously in category 2 but whose nominations were withdrawn ^{[3, 2]}. Source
April 16, 2026
A Federal Register notice (91 FR 20465) announced the July 23 to 24, 2026 advisory committee meeting on BPC-157 and other peptides ^[15]. Source
January 1, 2026
The WADA 2026 Prohibited List took effect. It names BPC-157 under S0 Non-approved substances, banned at all times in sport ^[6]. Source
September 30, 2021
WADA published its 2022 List, the first to name BPC-157 as an example in section S0. That list took effect on January 1, 2022 ^[7]. Source

Common questions

Is BPC-157 FDA approved?

No. FDA says there is no approved product containing BPC-157 in any country, and it is not part of any FDA-approved drug ^[1].

Can a US pharmacy legally compound BPC-157?

BPC-157 is still not on FDA's 503A bulks list and is not FDA approved, and FDA's final rule is pending ^{[1, 5, 19]}. Since October 28, 2026, an HHS interim policy says HHS does not intend to take action against state-licensed pharmacies, federal facilities or licensed physicians who compound BPC-157 acetate under set conditions ^[19]. It covers subcutaneous, intramuscular, oral and topical forms ^[19]. The policy is not FDA approval, and HHS may revisit it ^[19].

Is BPC-157 still in FDA Category 2?

No. FDA's May 14, 2026 list does not place it in any category. FDA lists it as previously in category 2, with the nominations withdrawn ^{[3, 2]}. That alone does not make it eligible for compounding ^[5]. HHS's October 28, 2026 interim policy is a separate step ^[19].

What happened at the July 2026 FDA advisory meeting on BPC-157?

The committee discussed BPC-157 on July 23, 2026. FDA staff proposed not adding it to the 503A bulks list ^{[4, 5]}. HHS's October 28, 2026 policy states the committee voted in favor of inclusion ^[19]. The committee only advises, and FDA's final rule is still pending ^{[5, 19]}.

Has BPC-157 been tested in humans?

Only in very small studies. A 2026 review found 3 human studies with 30 people in total, all of poor quality ^[17]. They were a knee pain chart review, a bladder pain pilot and a 2 person IV safety pilot ^{[9, 10, 11]}.

Is BPC-157 banned in sports?

Yes. The WADA 2026 Prohibited List names BPC-157 under S0 Non-approved substances, banned in and out of competition ^[6].

What is the half-life of BPC-157?

It has not been measured in humans. In animal studies it was 5.3 minutes in dogs to 15.2 minutes in rats ^[1].

Has oral BPC-157 been studied in people?

FDA found no published human studies of BPC-157 by mouth. An oral tablet trial was registered in 2015 but has no posted results ^{[1, 12]}.

What side effects have been reported with BPC-157?

FDA reports include injection site reactions, shortness of breath and skin or gum darkening, but cause is unclear. Enema studies reported headache and gas ^[1].

Key takeaway

At a glance

Key facts

How it works

What the research shows

IV safety pilot (Lee and Burgess)

Interstitial cystitis pilot (Lee et al.)

Knee pain chart review (Lee and Padgett)

PCO-02 oral tablet phase 1 (NCT02637284)

Rat and dog pharmacokinetics (He et al.)

Rat Achilles tendon study (Staresinic et al.)

Doses used in studies

Side effects and safety

Legal and regulatory history

Common questions

Sources