BPC-157 (PL 14736) — what it does, evidence, and safety

What it is

BPC-157 (Body Protection Compound 157) is a synthetic peptide best known for research into tissue and injury healing — tendon, ligament, gut, and muscle repair. It's based on a fragment of a protein found in stomach fluid. It is not FDA-approved for any use, and US compounding pharmacies currently aren't permitted to compound it; its status is under active FDA review, with a determination pending. There are no brand-name products, and most of the healing evidence so far comes from animal studies rather than large human trials.

What the research found

BPC-157 has been studied mostly for tissue and injury healing — tendon, ligament, gut, and muscle repair. That evidence is almost entirely from animal (rat) studies; human evidence is limited to a handful of small, uncontrolled pilot studies and case reports totalling fewer than about 30 people, with no large human trials — so the healing uses people pursue have not been confirmed in people.

Status and regulatory position

Not FDA approved for any indication. Investigational. US compounding status remains under FDA review and NO final determination has been issued (as of 2026-09-03). BPC-157 was removed from Category 2 of the FDA's 503A bulks list effective ~April 22, 2026; an April 16, 2026 Federal Register notice (document 2026-07361) scheduled a Pharmacy Compounding Advisory Committee (PCAC) meeting for July 23–24, 2026, and that meeting took place as scheduled, with the committee taking separate votes on BPC-157 free base and BPC-157 acetate for the 503A Bulks List. FDA's own pre-meeting briefing document proposed that neither form be included. FDA has published no summary minutes, vote results, or final determination from that meeting, and BPC-157 does not appear on the 503A Bulks List. A PCAC recommendation is advisory and non-binding — FDA states it does not intend to issue a final determination until the advisory-committee input has been considered and all reviews finalized, so a favorable committee vote would not by itself make BPC-157 listed, compoundable, legal, or approved. Removal from Category 2 does not make BPC-157 compoundable — it was never in Category 1, so 503A compounding was never permitted; the practical US access position is unchanged. WADA-banned in regulated sport — BPC-157 is explicitly named in the WADA 2026 Prohibited List under S0 (Non-Approved Substances): "This class covers many different substances including but not limited to BPC-157…", prohibited at all times. (S0 basis = no current governmental regulatory-health-authority approval for human therapeutic use, rather than a named pharmacological class.) ✓ re-verified 2026-07-18 against the 2026 list (effective Jan 1 2026; the 2027 list is not yet published). Not DEA-scheduled ✓ re-verified 2026-07-18.

Safety

BPC-157 is not FDA-approved, and its safety in humans has not been established in clinical trials. It is also banned in regulated sport. VialWise is a research and educational reference, not medical advice — consult a licensed professional.

Disclosures

⚠️ For research and educational purposes only. BPC-157 is not approved by the FDA for any indication and is not permitted for 503A compounding in the US; its regulatory status is under active FDA review with a determination pending (see Regulatory status below). Information in this entry is informational, not medical advice. Always confirm dose calculations with the in-app calculator and consult appropriate professional guidance before any protocol decisions.

⚠️ Precision matters at low doses. BPC-157 is dosed in micrograms (mcg), not milligrams. Small dosing errors that look trivial in absolute terms can be significant in percentage terms when starting doses are small. A one-unit mis-draw at a 5-unit dose is a 20% error; the same one-unit error at a 50-unit dose is only 2%. Always verify draws against the in-app calculator and double-check the unit count on the syringe before injecting — most acutely at the smallest draws in your titration.

⚠️ Note on evidence base. Unlike the FDA-approved GLP-1 peptides covered elsewhere in this library, BPC-157 has no large randomized clinical trials supporting its use. The cited literature consists primarily of preclinical (animal) studies and small case reports. The mechanisms of action, efficacy claims, and dose-response relationships described in this entry should be read with that limitation in mind. This entry exists to consolidate what *is* in the published literature so researchers can make their own assessment — not to imply an evidence base comparable to FDA-approved compounds.

Quick reference

Common vial sizes	(research/compounded). Branded products do not exist — there is no FDA-approved BPC-157 product.
Frequency	Daily; some protocols twice daily for the first 1–2 weeks of an injury-recovery cycle
Half-life	Not established in humans. Two independent reviews report a plasma half-life of under 30 minutes, based on preclinical pharmacokinetic work;[⁶][⁹] a formal two-species preclinical ADME study described in [⁹] reported linear, dose-proportional kinetics and intramuscular bioavailability of 14–51%. Biological effects described in the preclinical literature persist longer than plasma half-life alone would suggest — a disconnect both reviews note but neither resolves.[⁵][⁶][⁹] Human pharmacokinetic data is limited to a preliminary two-subject pilot.[⁹]
Route	Subcutaneous (most common in research community); intramuscular (especially for site-specific tendon/ligament work); oral has been studied for GI indications, though oral bioavailability of a 15-amino-acid peptide is mechanistically questionable[¹]
Onset of action	Subjective effects on tissue recovery typically reported within 5–14 days of starting a cycle in research community reports. Not validated in published human trials.

In depth

BPC-157 (Body Protection Compound 157, sometimes "Body Protective Compound") is a 15-amino-acid synthetic peptide derived from a partial sequence of a protein found in human gastric juice. It was first described in the 1990s by the Sikiric laboratory at the University of Zagreb, which has published the bulk of the preclinical literature on the compound.[¹]

Regulatory status — under review, determination pending. BPC-157 has never received FDA approval for any indication. It progressed through some early-stage clinical work for inflammatory bowel disease (under the development code PL 14736) but has not advanced to large pivotal trials.

In September 2023, the FDA placed BPC-157 in Category 2 of its 503A bulks list evaluation — the category for substances raising significant safety risks. An important nuance that is often lost in secondary coverage: BPC-157 was never in Category 1, so compounding under section 503A was never actually permitted for it in the first place.

Effective on or about April 22, 2026, FDA removed BPC-157 from Category 2. This removal is a procedural step, not a liberalization: it does not make BPC-157 compoundable. The substance moved out of the interim category because FDA opened the formal evaluation of whether it belongs on the 503A Bulks List. An April 16, 2026 Federal Register notice (document 2026-07361) scheduled a Pharmacy Compounding Advisory Committee (PCAC) meeting for July 23–24, 2026, at which BPC-157 (free base and acetate; the indication under review is ulcerative colitis) was on the agenda. That meeting took place on July 23, 2026, and the committee took two separate votes on BPC-157 — one on the free base, one on the acetate ([FDA meeting page](https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026); [FDA voting questions](https://www.fda.gov/media/193711/download)). FDA's own pre-meeting briefing document proposed that BPC-157 not be added to the 503A Bulks List (in FDA's words, *“FDA is proposing that BPC-157 (free base) not be included on the 503A Bulks List”*, and likewise for the acetate), citing that the substance is not well characterized, that human efficacy evidence for injectable routes is minimal, and that safety and immunogenicity data are insufficient.

Net effect for US researchers as of 2026-09-03: unchanged. BPC-157 is not an approved drug and is not lawfully compoundable under 503A. FDA has not published summary minutes, vote results, or a final determination from the July 2026 meeting, and BPC-157 does not appear on the 503A Bulks List ([FDA 503A bulk drug substances page](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act), content current as of 05/14/2026). Whatever the committee recommended, the recommendation is advisory and non-binding. FDA's briefing document states it *“does not intend to issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized”*. The accurate chain is therefore: panel reviewed and voted → FDA determination still pending → 503A compounding not permitted on that basis. A favorable committee vote would not, by itself, make BPC-157 FDA-listed, compoundable, legal, or approved. Researchers in other jurisdictions face different regulatory environments.

Mechanism. Multiple mechanisms have been proposed across the published preclinical literature, including: promotion of nitric oxide production, modulation of growth hormone receptor expression on tendon fibroblasts, promotion of angiogenesis through VEGF pathway upregulation, modulation of dopamine and serotonin systems, and direct cytoprotective effects on gastrointestinal mucosa.[¹][²] The nitric-oxide arm of this picture has recently gained its first *human tissue* support: in an *ex vivo* study of internal mammary artery rings harvested from 12 patients undergoing coronary bypass surgery, investigators reported concentration-dependent vasorelaxation that was endothelium- and NO-dependent.[¹¹] That is human tissue in a laboratory bath, not a clinical outcome in a living patient — it strengthens the mechanistic plausibility of the NO pathway without saying anything about efficacy. No single mechanism has been established as primary, and the multi-mechanism profile is part of why the compound is studied for a broad range of indications.

Evidence quality. Most of the published literature is preclinical — primarily rat models of tendon transection, ligament injury, gastric ulcer, and inflammatory bowel disease.[²][³] Human clinical evidence is limited to case reports and small, uncontrolled pilot studies — a 2021 case series on intra-articular BPC-157 for multiple types of knee pain,[⁸] a 2024 uncontrolled pilot in 12 women with interstitial cystitis,[¹⁰] and an intravenous safety/pharmacokinetic pilot described in the review literature — plus the early PL 14736 inflammatory bowel disease development program. A 2026 independent drug-development review characterises the entire human dataset as "fewer than 30 subjects across three uncontrolled pilot studies," with no approved formulation and no completed Phase II trial.[⁹] None of these studies was randomized or controlled; they are pilot- and case-series-grade evidence and should be read as such. Two 2025 independent third-party reviews — one systematic review from a Hospital for Special Surgery group on orthopedic sports medicine applications,[⁶] and one narrative review explicitly framed around the efficacy-vs-risk balance for musculoskeletal healing[⁷] — provide perspective on the evidence base from outside the originating Sikiric research group. Researchers comparing BPC-157 to FDA-approved compounds should be explicit with themselves that the evidence base is fundamentally different in scale and rigor: there is no semaglutide STEP-1 equivalent for BPC-157.

Common research interests. Despite the limited clinical evidence base, BPC-157 is one of the most discussed peptides in the research community, primarily for: - Tendon and ligament injury recovery (the largest preclinical evidence base) - Gastrointestinal mucosal protection (the original described use) - Joint pain and post-injury rehabilitation - Adjunct use during periods of high physical stress or rapid body composition change

These uses are based on extrapolation from preclinical data plus accumulated researcher experience. They are not FDA-approved indications, and any researcher exploring them is operating in a context where the published evidence does not yet support strong claims.

Reported side effects

Commonly reported

Injection site reactions (local redness, soreness)
Mild nausea or stomach discomfort, especially with oral administration
Lightheadedness or transient blood pressure changes (uncommon)
No consistent pattern of serious adverse events in the published preclinical or case-report literature
Angiogenic activity in the context of malignancy — BPC-157's VEGF-promoting effects raise a theoretical concern about supporting tumor vasculature in researchers with active or undiagnosed malignancy. This concern has not been validated in clinical data but is the most commonly cited theoretical safety issue.
Long-term safety in humans is essentially unknown. No multi-year human safety dataset exists.

Contraindications and warnings

Active malignancy or undiagnosed cancer concern — theoretical contraindication based on angiogenic mechanism (see Side Effects section)

Pregnancy and lactation: no data; default to contraindicated — no published reproductive toxicology in humans

Pediatric use: no data — should not be used in researchers under 18

Active anti-coagulation regimens — no published interaction data; theoretical concern given vascular effects

Concurrent immunosuppressive or chemotherapeutic regimens — no published interaction data

Regulatory note (US): BPC-157 is not FDA-approved and is not lawfully compoundable under section 503A. It was placed in Category 2 of the 503A bulks list evaluation in September 2023 and removed from Category 2 effective ~April 22, 2026 — a procedural move that does not make it compoundable (it was never in Category 1). The PCAC met on July 23–24, 2026 and voted on it for the 503A Bulks List, with FDA's own briefing document proposing that neither the free base nor the acetate be included. FDA has published no minutes, vote results, or determination from that meeting as of 2026-09-03, and BPC-157 is not on the 503A Bulks List. A committee recommendation is advisory and non-binding, so 503A compounding is still not permitted on that basis. Researchers should confirm the current position and be aware of the regulatory environment in their jurisdiction.

Key terms

Peptide: A short chain of amino acids, the building blocks of proteins. Many compounds in this library are peptides.
Preclinical: Research done in cells or animals, before human clinical trials. Promising preclinical results don't always hold up in people.
Subcutaneous: An injection into the fatty layer just under the skin, rather than into a muscle or vein.
WADA Prohibited List: The list of substances banned in regulated sport by the World Anti-Doping Agency.

Sources

Related entries

TB-500 — discussed together in this entry's stacks section
ARA-290 — same mechanism class
BPC-157 / TB-500 Blend — same mechanism class
GHK-Cu — same mechanism class
GLOW — same mechanism class
KLOW — same mechanism class