Synthetic 15-residue peptide corresponding to a partial sequence of human gastric juice protein BPC

BPC-157 — evidence

What has been published, classified by the kind of document it is. This is not a protocol, not a score, and not a recommendation for use.

Evidence overview

9 records in this file

HUMAN DATA1
ANIMAL1
IN VITRO1
REVIEW3
REGULATORY3

Research areas. Anti-doping; Clinical evidence appraisal; Connective-tissue models; Human case series; Preclinical corpus; United States compounding.

Publication span. 2003–2026.

What we know

A substantial preclinical literature, much of it from one research network, reports effects in rodent models of tendon, gut and other injury.
No FDA-approved drug product exists. The substance is on FDA's withdrawn compounding-nominations table and is named on the WADA Prohibited List (S0).
Independent sports-medicine reviews in 2026 describe the human clinical literature as inadequate for clinical inference.

Editorial reading of the records below, labelled as Therapept analysis. How records are built

What remains uncertain

Whether rodent findings translate to humans under controlled conditions.
How much of the preclinical corpus has been replicated outside the originating network.
Whether commercial research-use material matches the material used in published experiments — a documentation question, not a study result.

Regulatory notes

No FDA-approved product

No approved drug product exists in Drugs@FDA.
Listed on FDA's table of bulk substances nominated for compounding and subsequently withdrawn by the nominator. FDA's published concerns include immunogenicity risk, peptide-related impurities, and complexity of API characterisation.
On 23 July 2026 PCAC discussed BPC-157 (free base) and BPC-157 acetate (use evaluated: ulcerative colitis). FDA briefing materials proposed that they NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed. Committee recommendations are non-binding; FDA has not published a listing decision as of this review.
Not on the 503A Bulks List.

Regulatory status describes how a substance is classified. It is not a safety assessment of any particular material.

Studies and documents

REGULATORY2026FDA advisory-committee briefing
FDA PCAC briefing — BPC-157-related bulk drug substances (23 July 2026)
U.S. Food and Drug AdministrationFDA PCAC briefing
Objective
To record FDA staff's published proposal on 503A Bulks List inclusion for BPC-157.
Endpoint investigated
Proposed compounding-list classification
PCAC discussed BPC-157 (free base) and BPC-157 acetate on 23 July 2026 (use evaluated: ulcerative colitis). The briefing-document introduction states that FDA is proposing that both NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed. A committee recommendation is not a listing decision.
Limitations. Staff proposal and committee advice are non-binding. FDA has not published a listing decision as of this review.
FDA — PCAC briefing for BPC-157-related bulk drug substancesReviewed 12 September 2026
REGULATORY2026Regulatory listing
FDA table of bulk drug substances nominated for compounding and subsequently withdrawn
U.S. Food and Drug AdministrationFDA compounding communications
Objective
To record FDA's published compounding position and stated characterisation concerns.
Endpoint investigated
Compounding classification, not efficacy
BPC-157 appears on FDA's table of bulk substances nominated for compounding and withdrawn by the nominator. Published concerns include immunogenicity risk, peptide-related impurities, and complexity of API characterisation. Placement is a regulatory classification.
Limitations. A withdrawn nomination is not a safety assessment of any particular material, and it is not a clinical evidence review.
FDA — Certain bulk drug substances for use in compounding may present significant safety risksReviewed 12 September 2026
REVIEW2026Narrative review
Injectable peptide therapy: a primer for orthopaedic and sports medicine physicians
Mayfield CK, Bolia IK, Feingold CL, Lin EH, Liu JN, Hatch GFR, Gamradt SC, Weber AEThe American Journal of Sports Medicine
Objective
To summarise published evidence on injectable peptides marketed for orthopaedic and sports indications.
Endpoint investigated
Whether published studies support clinical use in orthopaedics
Sports-medicine review covering BPC-157 among other peptides. It reports that tendon and muscle findings are largely unvalidated in humans, and treats the Lee–Padgett series as limited by design.
Limitations. Narrative review of an uneven literature. Not a systematic evidence grade.
DOI 10.1177/03635465251357593 Mayfield et al., Am J Sports Med (2026)Reviewed 12 September 2026
REVIEW2026Scoping review
Peptide supplements and their therapeutic applications in sports medicine
Tewari K, Liu TP, Im C, Hamad C, Petrigliano F, Cheung EC, Kremen TJThe American Journal of Sports Medicine
Objective
To scope peer-reviewed data on BPC-157, TB-500/Tβ4, CJC-1295, ipamorelin and GHK-Cu in musculoskeletal models.
Endpoint investigated
Published musculoskeletal evidence, animal and human
PRISMA-guided scoping review. Reports that about two-thirds of identified publications used preclinical animal models, and that human clinical studies were limited and mostly lacked robust controls. Concludes that claimed benefits for musculoskeletal recovery remain unsubstantiated by current human trials.
Limitations. Scoping, not a meta-analysis of effect sizes. Groups TB-500 with Tβ4 in the search.
DOI 10.1177/03635465261464420 Tewari et al., Am J Sports Med (2026)Reviewed 12 September 2026
REGULATORY2026Anti-doping listing
WADA Prohibited List — Class S0 Non-Approved Substances
World Anti-Doping AgencyWADA Prohibited List
Objective
To record the substance's position on the 2026 Prohibited List.
Endpoint investigated
Sporting prohibition status
Named in Class S0 (Non-Approved Substances). Prohibited at all times; Specified Substance. This is an anti-doping classification, not a finding about laboratory research use.
Limitations. WADA listing is not a determination of chemical identity or of any research endpoint.
WADA 2026 Prohibited ListReviewed 12 September 2026
HUMAN DATA2021Retrospective case series
Intra-articular injection of BPC 157 for multiple types of knee pain
Lee E, Padgett BAlternative Therapies in Health and Medicine
Population
Adults treated for mixed knee complaints in a clinical practice
Sample
n = 16 (12 BPC-157 alone; 4 combined with TB-500)
Objective
To describe pain scores after intra-articular BPC-157 in a small, uncontrolled series.
Endpoint investigated
Patient-reported knee pain in an uncontrolled series
A retrospective series of sixteen people given intra-articular BPC-157 for mixed knee diagnoses, some also given TB-500. Subsequent sports-medicine reviews cite it as the main human orthopaedic report — and as methodologically inadequate for inference.
Limitations. No control arm, mixed diagnoses, mixed co-interventions, small n, retrospective. Cannot attribute outcomes to the compound. Not a trial.
Lee and Padgett, Altern Ther Health Med (2021)Reviewed 12 September 2026
REVIEW2020Narrative review
Novel cytoprotective mediator, stable gastric pentadecapeptide BPC 157. Vascular recruitment and inflammation resolution
Sikiric P, Hahm KB, Blagaic AB, et al.Current Pharmaceutical Design
Objective
To summarise the originating group's preclinical BPC-157 literature on cytoprotection and vascular effects.
Endpoint investigated
Preclinical cytoprotection and related mechanistic claims
A review from the principal BPC-157 laboratory grouping, collecting animal and mechanistic papers. It is a map of that corpus, not independent confirmation of it.
Limitations. Narrative, not systematic. Dominated by one research network. Does not add new human interventional data.
DOI 10.2174/1381612825666191116102917 Sikiric et al., Curr Pharm Des (2020)Reviewed 12 September 2026
IN VITRO2011In vitro (tendon fibroblasts)
Pentadecapeptide BPC 157 enhances the growth hormone receptor expression in tendon fibroblasts
Chang CH, Tsai WC, Lin MS, Hsu YH, Pang JHMolecules
Population
Cultured tendon fibroblasts
Objective
To examine growth-hormone receptor expression in tendon fibroblasts exposed to BPC-157.
Endpoint investigated
Growth-hormone receptor expression in cultured cells
Cultured tendon fibroblasts exposed to BPC-157 were reported to increase growth-hormone receptor expression. The paper is mechanistic and cellular, not a clinical outcome study.
Limitations. Cell-culture system only. Receptor expression in vitro is not a clinical endpoint and is not a basis for human-use claims.
DOI 10.3390/molecules16119672 Chang et al., Molecules (2011)Reviewed 12 September 2026
ANIMAL2003In vivo (rat) with in-vitro tendocyte assay
Gastric pentadecapeptide BPC 157 accelerates healing of transected rat Achilles tendon and in vitro stimulates tendocytes growth
Staresinic M, Sebecic B, Patrlj L, et al.Journal of Orthopaedic Research
Population
Rat Achilles-tendon transection; cultured tendocytes
Objective
To test whether BPC-157 affected transected Achilles-tendon healing in rats and tendocyte growth in culture.
Endpoint investigated
Tendon healing and tendocyte growth in a rodent model
In a rat Achilles-transection model, BPC-157 was reported to accelerate tendon healing relative to controls, with a parallel in-vitro observation of tendocyte growth. The work is a primary source for the preclinical tendon literature on this compound.
Limitations. Rodent surgical model; findings do not establish human tendon outcomes. Originates in the laboratory group that accounts for much of the BPC-157 literature.
DOI 10.1016/S0736-0266(03)00110-4 Staresinic et al., J Orthop Res (2003)Reviewed 12 September 2026

Last reviewed 12 September 2026 · Compiled by Therapept Editorial · How these records are built