{"format":"citation-manifest/v1","page":"https://bpc157co.com/monograph","claim_count":73,"claims":[{"id":"clm-001","text":"BPC-157 is a synthetic pentadecapeptide, 15 amino acids, sequence GEPPPGKPADDAGLV, molecular weight 1419.5 Da, formula C62H98N16O22, CAS 137525-51-0.","source_url":"https://pubchem.ncbi.nlm.nih.gov/compound/9941957","grade":"chemical-reference","grade_label":"Chemical reference"},{"id":"clm-002","text":"BPC-157 reproduces a fragment of a larger protein (BPC) reported isolated from human gastric juice; the fragment was first fully characterized in 1993.","source_url":"https://pubmed.ncbi.nlm.nih.gov/8298609/","grade":"chemical-reference","grade_label":"Chemical reference"},{"id":"clm-003","text":"BPC-157 entered corporate development (Pliva, Croatia) for inflammatory bowel disease under codes PL-10, PLD-116, PL 14736.","source_url":"https://pubmed.ncbi.nlm.nih.gov/22300085/","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-004","text":"No medicines agency has approved BPC-157 for any use; there is no approved formulation and no validated dosing regimen.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-005","text":"BPC-157 is not FDA approved for any use; FDA's approved-drug database returns no BPC-157 product.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-006","text":"FDA's compounding safety-risks list states compounded BPC-157 may pose immunogenicity risk for certain routes and has peptide-related impurity and API characterization complexities, and that FDA lacks safety information for the proposed routes.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-007","text":"On July 23, 2026, FDA's Pharmacy Compounding Advisory Committee discussed BPC-157 (free base and acetate) for possible inclusion on the 503A Bulks List; the use evaluated was ulcerative colitis.","source_url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-008","text":"FDA's July 2026 PCAC briefing document proposed that BPC-157 (free base) NOT be included and that BPC-157 acetate NOT be included on the 503A Bulks List.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-009","text":"Both BPC-157 nominations (LDT Health Solutions on behalf of International Peptide Society; Wells Pharmacy Network) were withdrawn by the nominators, but FDA elected to proceed with the PCAC presentation; committee advice is non-binding and rulemaking is pending.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-010","text":"The 2026 WADA Prohibited List names BPC-157 under S0 (Non-Approved Substances), prohibited at all times, in and out of competition; all S0 substances are Specified Substances.","source_url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-011","text":"USADA states BPC-157 is prohibited under the S0 Non-Approved Substances category of the WADA Prohibited List.","source_url":"https://www.usada.org/spirit-of-sport/education/bpc-157-peptide-risk/","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-012","text":"Reviews from the originating group state BPC-157 (PL 14736) was tested in a phase II clinical program for inflammatory bowel disease and describe it as safe in trials, with LD1 not achieved in toxicology.","source_url":"https://pubmed.ncbi.nlm.nih.gov/22300085/","grade":"human-uncontrolled","grade_label":"Uncontrolled human series"},{"id":"clm-013","text":"No results from the IBD/ulcerative colitis trials were ever published in peer-reviewed form; a 2026 independent review concluded there is no completed phase II clinical trial of BPC-157.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13210877/","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"clm-014","text":"Group reviews additionally reference ulcerative colitis and multiple sclerosis trials for BPC-157; none has published results.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC8275860/","grade":"human-uncontrolled","grade_label":"Uncontrolled human series"},{"id":"clm-015","text":"Total published human clinical data for BPC-157 come from fewer than 30 subjects across three uncontrolled pilot studies.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13210877/","grade":"human-uncontrolled","grade_label":"Uncontrolled human series"},{"id":"clm-016","text":"No randomized controlled trial of BPC-157 has been published for any indication; the first randomized phase 2 trial (hamstring strain, target n=120) began recruiting in 2026.","source_url":"https://clinicaltrials.gov/study/NCT07437547","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"clm-017","text":"The only published human musculoskeletal study is a retrospective uncontrolled case series of intra-articular knee injections: 16 patients reached by phone survey; 11 of 12 who received BPC-157 alone reported significant pain improvement; 14 of 16 overall reported relief; no standardized instruments, no imaging, no controls.","source_url":"https://pubmed.ncbi.nlm.nih.gov/34324435/","grade":"human-uncontrolled","grade_label":"Uncontrolled human series"},{"id":"clm-018","text":"A 2025 systematic review characterizes the same knee series as 7 of 12 patients reporting relief lasting more than 6 months.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12313605/","grade":"human-uncontrolled","grade_label":"Uncontrolled human series"},{"id":"clm-019","text":"The other two human pilots are an interstitial cystitis pilot and an intravenous safety/pharmacokinetics pilot; the IV pilot is reported with two subjects.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12446177/","grade":"human-uncontrolled","grade_label":"Uncontrolled human series"},{"id":"clm-020","text":"BPC-157 research spans 1993 to the present (33 years).","source_url":"https://pubmed.ncbi.nlm.nih.gov/8298609/","grade":"chemical-reference","grade_label":"Chemical reference"},{"id":"clm-021","text":"This site's graded evidence table contains 23 primary research entries: 15 rat, 2 mouse, 1 rabbit, 1 rat-and-dog PK, 2 in vitro, 1 rat plus human-cell in vitro, and 1 human uncontrolled case series; 0 published human randomized trials.","source_url":"https://bpc157co.com/monograph","grade":"internal-measurement","grade_label":"Internal measurement"},{"id":"clm-022","text":"A 2025 independent systematic review screened 544 BPC-157 articles, included 36, of which 35 were preclinical and exactly 1 was clinical.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12313605/","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-023","text":"Independent reviewers note the majority of BPC-157 studies are small rodent models, that only a handful of research groups have performed in-depth work, that results are consistently positive, and that efficacy is yet to be confirmed in humans.","source_url":"https://pubmed.ncbi.nlm.nih.gov/30915550/","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-030","text":"In vitro and rat work links BPC-157 to VEGFR2 upregulation and internalization, VEGFR2-Akt-eNOS pathway activation, increased vessel density in CAM and tube-formation assays, and faster blood-flow recovery in rat hind-limb ischemia.","source_url":"https://pubmed.ncbi.nlm.nih.gov/27847966/","grade":"animal-and-in-vitro","grade_label":"Animal and in vitro"},{"id":"clm-031","text":"BPC-157 accelerated rat tendon fibroblast explant outgrowth, survival under oxidative stress, and dose-dependent migration and spreading via FAK-paxillin phosphorylation, without directly increasing proliferation.","source_url":"https://pubmed.ncbi.nlm.nih.gov/21030672/","grade":"in-vitro","grade_label":"In vitro"},{"id":"clm-032","text":"BPC-157 dose- and time-dependently increased growth hormone receptor mRNA and protein in rat tendon fibroblasts; adding growth hormone then increased proliferation via JAK2.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC6271067/","grade":"in-vitro","grade_label":"In vitro"},{"id":"clm-033","text":"The originating group reports nitric oxide system interactions and egr-1 gene expression effects across rat models.","source_url":"https://pubmed.ncbi.nlm.nih.gov/22300085/","grade":"animal","grade_label":"Animal"},{"id":"clm-040","text":"In rats with transected Achilles tendon, daily BPC-157 (10 ug, 10 ng, or 10 pg/kg i.p.) was associated with increased load of failure and Young's modulus, higher Achilles functional index, and re-established tendon integrity versus saline over 14 days.","source_url":"https://pubmed.ncbi.nlm.nih.gov/14554208/","grade":"animal","grade_label":"Animal"},{"id":"clm-041","text":"In rat Achilles-to-bone detachment, BPC-157 improved functional, biomechanical and histological measures and reduced 6alpha-methylprednisolone aggravation of repair over 21 days.","source_url":"https://pubmed.ncbi.nlm.nih.gov/16583442/","grade":"animal","grade_label":"Animal"},{"id":"clm-042","text":"In a 72-rat Achilles-to-bone study, BPC-157 (10 ug/kg i.p. daily) increased Achilles functional index at all time points (p<0.05), decreased myeloperoxidase activity, and increased vascular index in days 1-4.","source_url":"https://pubmed.ncbi.nlm.nih.gov/18594781/","grade":"animal","grade_label":"Animal"},{"id":"clm-043","text":"In rat medial collateral ligament transection, improvement was reported over 90 days with intraperitoneal (10 ug or 10 ng/kg), topical cream (1 ug/g), and per-oral (0.16 ug/mL drinking water) BPC-157.","source_url":"https://pubmed.ncbi.nlm.nih.gov/20225319/","grade":"animal","grade_label":"Animal"},{"id":"clm-044","text":"In complete rat quadriceps transection, daily BPC-157 improved load of failure, walking recovery and motor function index, and muscle-fiber continuity across a 72-day observation period.","source_url":"https://pubmed.ncbi.nlm.nih.gov/16609979/","grade":"animal","grade_label":"Animal"},{"id":"clm-045","text":"In rat gastrocnemius crush injury, BPC-157 given intraperitoneally or as topical cream improved macroscopic, microscopic, functional and enzyme (CK, LDH, AST, ALT) outcomes over 14 days.","source_url":"https://pubmed.ncbi.nlm.nih.gov/18668315/","grade":"animal","grade_label":"Animal"},{"id":"clm-046","text":"In rats with muscle crush plus systemic 6alpha-methylprednisolone, BPC-157 restored the corticosteroid-impaired repair when given intraperitoneally or topically.","source_url":"https://pubmed.ncbi.nlm.nih.gov/20190676/","grade":"animal","grade_label":"Animal"},{"id":"clm-047","text":"In a rabbit segmental radius defect model, BPC-157 (local or intramuscular, 10 ug or 10 ng/kg) significantly improved defect repair, with several measures comparable to bone marrow or autologous cortical graft, and more animals reaching complete bony continuity.","source_url":"https://pubmed.ncbi.nlm.nih.gov/10071911/","grade":"animal","grade_label":"Animal"},{"id":"clm-048","text":"In the only head-to-head study (2026, independent group; 32 rats, Achilles transection, 4 weeks), BPC-157 10 ug/kg/day and TB-500 60 ug/kg/day were both associated with improved tendon histology versus control; TB-500 reached statistical significance on maximum load to failure and on Bonar (p=0.016) and Movin scores; BPC-157's totals did not reach significance; the combination added no benefit.","source_url":"https://pubmed.ncbi.nlm.nih.gov/42542926/","grade":"animal","grade_label":"Animal"},{"id":"clm-050","text":"An independent Parke-Davis study (1995) found intraperitoneal BPC-15 dose-dependently and significantly reduced TNBS-induced colonic damage and myeloperoxidase activity in rats; a single intracolonic dose did not.","source_url":"https://pubmed.ncbi.nlm.nih.gov/7815358/","grade":"animal","grade_label":"Animal"},{"id":"clm-051","text":"In rats, BPC-157 (10 ug or 10 ng/kg i.p.) reduced gastric and small-intestinal lesions caused by indomethacin, aspirin, and diclofenac, and attenuated adjuvant arthritis whether dosing began before or after disease induction, in arms out to 1 year.","source_url":"https://pubmed.ncbi.nlm.nih.gov/9403784/","grade":"animal","grade_label":"Animal"},{"id":"clm-052","text":"The originating group frames BPC-157 as counteracting NSAID toxicity across stomach, intestine, liver and brain models in rats, using 10 ug or 10 ng/kg parenterally or per-orally.","source_url":"https://pubmed.ncbi.nlm.nih.gov/22950504/","grade":"animal","grade_label":"Animal"},{"id":"clm-060","text":"In rat spinal cord compression injury, a single BPC-157 dose (200 or 2 ug/kg i.p., 10 min post-injury) was followed by better tail motor function, resolved spasticity by day 15, and counteracted axonal and neuronal loss in arms out to 360 days.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC6604284/","grade":"animal","grade_label":"Animal"},{"id":"clm-061","text":"In rat sciatic nerve transection, BPC-157 (10 ug or 10 ng/kg, by ip, intragastric, or local routes) was associated with faster axonal regeneration, higher motor action potentials, and improved sciatic functional index.","source_url":"https://pubmed.ncbi.nlm.nih.gov/19903499/","grade":"animal","grade_label":"Animal"},{"id":"clm-062","text":"In rat perforating corneal injury, BPC-157 eye drops (2 ug/mL and 2 ng/mL every 8 h) closed epithelial defects by 72-96 h with regained corneal transparency; control eyes closed poorly and grew vessels toward the wound.","source_url":"https://pubmed.ncbi.nlm.nih.gov/25912999/","grade":"animal","grade_label":"Animal"},{"id":"clm-063","text":"In mouse traumatic brain injury (falling weight), BPC-157 (10 ug or 10 ng/kg i.p.) attenuated hemorrhage and edema and improved the conscious/unconscious/death ratio across graded force impulses in the 24 h post-injury window.","source_url":"https://pubmed.ncbi.nlm.nih.gov/19931318/","grade":"animal","grade_label":"Animal"},{"id":"clm-064","text":"In rats given heparin, warfarin, or aspirin, BPC-157 shortened bleeding time after amputation, reduced blood loss and platelet-count falls, and did not affect heparin anti-Xa activity.","source_url":"https://pubmed.ncbi.nlm.nih.gov/21840572/","grade":"animal","grade_label":"Animal"},{"id":"clm-065","text":"In burned mice with corticosteroid impairment, topical BPC-157 cream improved burn repair by microscopy and tensiometry and counteracted the corticosteroid effect.","source_url":"https://pubmed.ncbi.nlm.nih.gov/12781609/","grade":"animal","grade_label":"Animal"},{"id":"clm-066","text":"In alloxan-hyperglycemic rats (PLIVA institute study), topical PL 14736 gel (10-1000 ug/wound) dose-dependently accelerated excisional wound closure, equivalent at the highest doses to becaplermin gel.","source_url":"https://pubmed.ncbi.nlm.nih.gov/16785777/","grade":"animal","grade_label":"Animal"},{"id":"clm-070","text":"A randomized, quadruple-masked phase 1 safety and PK study of BPC-157 (as PCO-02/Bepecin) in 42 healthy volunteers was registered in December 2015 (PharmaCotherapia d.o.o.); its overall status is listed as unknown and no results are posted.","source_url":"https://clinicaltrials.gov/study/NCT02637284","grade":"registry","grade_label":"Registry record"},{"id":"clm-071","text":"A single-arm 40-person study of an oral BPC-157 gummy (500 ug per serving, 8 weeks, inflammation and recovery markers) is registered as completed in 2026 by a supplement company; no results are posted or published.","source_url":"https://clinicaltrials.gov/study/NCT07752381","grade":"registry","grade_label":"Registry record"},{"id":"clm-080","text":"No adequately characterized human pharmacokinetic study of BPC-157 has been published; its human PK profile is critically undercharacterized.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13210877/","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"clm-081","text":"In rats and beagle dogs, the elimination half-life of BPC-157 was under 30 minutes with linear kinetics; a preliminary two-subject human IV pilot echoed the sub-30-minute half-life.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9794587/","grade":"animal-pk","grade_label":"Animal PK"},{"id":"clm-082","text":"Intramuscular bioavailability of BPC-157 was approximately 14-19% in rats and 45-51% in beagle dogs.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9794587/","grade":"animal-pk","grade_label":"Animal PK"},{"id":"clm-083","text":"Radiolabel tracing showed BPC-157 is rapidly metabolized into small peptide fragments and then single amino acids, with excretion mainly via urine and bile.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9794587/","grade":"animal-pk","grade_label":"Animal PK"},{"id":"clm-084","text":"There is an unexplained PK-PD disconnect: a plasma half-life under 30 minutes versus biological effects reported to last hours to days.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13210877/","grade":"animal-pk","grade_label":"Animal PK"},{"id":"clm-085","text":"BPC-157 is repeatedly described in the literature as stable in gastric juice; this is a chemical characterization, not evidence of human oral absorption.","source_url":"https://pubmed.ncbi.nlm.nih.gov/22300085/","grade":"in-vitro","grade_label":"In vitro"},{"id":"clm-086","text":"Systemic oral bioavailability of BPC-157 in humans has never been measured; the peptide lacks BCS classification and permeability characterization, and no pharmaceutical-grade formulation has been developed or validated for any route.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13210877/","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"clm-090","text":"Gray-market BPC-157 is sold as lyophilized vials for injection, oral capsules, and branded gummies.","source_url":"https://clinicaltrials.gov/study/NCT07752381","grade":"registry","grade_label":"Registry record"},{"id":"clm-091","text":"Intraperitoneal injection is the dominant route in the animal musculoskeletal literature; topical creams, drinking-water dosing, and eye drops were used in specific models.","source_url":"https://pubmed.ncbi.nlm.nih.gov/14554208/","grade":"animal","grade_label":"Animal"},{"id":"clm-092","text":"The single published human study route was intra-articular knee injection.","source_url":"https://pubmed.ncbi.nlm.nih.gov/34324435/","grade":"human-uncontrolled","grade_label":"Uncontrolled human series"},{"id":"clm-100","text":"There is no established human dose of BPC-157; no human dose-finding study has been published.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13210877/","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"clm-101","text":"The standard regimens in the originating group's rodent studies are 10 ug/kg and 10 ng/kg body weight, typically intraperitoneal, once daily (10 pg/kg arms also appear).","source_url":"https://pubmed.ncbi.nlm.nih.gov/14554208/","grade":"animal","grade_label":"Animal"},{"id":"clm-102","text":"Per-oral BPC-157 was reported active in rodent models: 0.16 ug/mL in drinking water in the ligament study, and per-oral regimens across GI models.","source_url":"https://pubmed.ncbi.nlm.nih.gov/20225319/","grade":"animal","grade_label":"Animal"},{"id":"clm-103","text":"The 2026 head-to-head rat study dosed BPC-157 at 10 ug/kg/day intraperitoneally for four weeks.","source_url":"https://pubmed.ncbi.nlm.nih.gov/42542926/","grade":"animal","grade_label":"Animal"},{"id":"clm-104","text":"The rabbit bone-defect study used 10 ug/kg locally into the defect or 10 ug or 10 ng/kg intramuscularly.","source_url":"https://pubmed.ncbi.nlm.nih.gov/10071911/","grade":"animal","grade_label":"Animal"},{"id":"clm-110","text":"The originating group reports no observed toxicity in animal work, with LD1 not achieved, and describes BPC-157 as safe in its (unpublished) IBD trials.","source_url":"https://pubmed.ncbi.nlm.nih.gov/22300085/","grade":"animal","grade_label":"Animal"},{"id":"clm-111","text":"A 2025 systematic review found preclinical safety studies showed no adverse effects across organ systems, and stated that no clinical safety data were found.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12313605/","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-112","text":"The three small human pilots reported no major adverse effects; reviewers caution this cannot establish safety.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13026520/","grade":"human-uncontrolled","grade_label":"Uncontrolled human series"},{"id":"clm-113","text":"FDA states it lacks sufficient information to know whether compounded BPC-157 would cause harm when administered to humans.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-114","text":"Unregulated manufacturing and contamination are flagged as adverse-effect pathways for gray-market BPC-157; no pharmaceutical-grade formulation or quality standard exists for sold vials.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12313605/","grade":"regulatory","grade_label":"Regulatory record"},{"id":"clm-120","text":"Rat studies report BPC-157's effects are modified by nitric oxide system agents (L-arginine, L-NAME); no human interaction data exist.","source_url":"https://pubmed.ncbi.nlm.nih.gov/22950504/","grade":"animal","grade_label":"Animal"},{"id":"clm-121","text":"In rat models, BPC-157 counteracted corticosteroid-impaired muscle and tendon-to-bone repair.","source_url":"https://pubmed.ncbi.nlm.nih.gov/16583442/","grade":"animal","grade_label":"Animal"},{"id":"clm-122","text":"In rats, BPC-157 altered bleeding outcomes in the presence of heparin, warfarin, and aspirin without changing heparin anti-Xa activity; human relevance unknown.","source_url":"https://pubmed.ncbi.nlm.nih.gov/21840572/","grade":"animal","grade_label":"Animal"},{"id":"clm-123","text":"No studies exist in pregnant or breastfeeding people, children, people with cancer history, or people on anticoagulants; the pro-angiogenic mechanism is a specific reason those groups have been called out for caution.","source_url":"https://pubmed.ncbi.nlm.nih.gov/27847966/","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"clm-140","text":"All site-count statistics (study rows, species census, citation totals, percentage peer-reviewed or governmental) are computed mechanically from this pack's studies[] and citations[] arrays at build time and are recomputable by counting the rendered page.","source_url":"https://bpc157co.com","grade":"internal-measurement","grade_label":"Internal measurement"}]}