Research index
Neutral one-line summaries with a link to each primary source. Null and negative findings are listed alongside positive ones.
- A new gastric juice peptide, BPC. An overview of the stomach-stress-organoprotection hypothesis and beneficial effects of BPC — The originating 1993 paper from the University of Zagreb. It reports the isolation of BPC, a gastric juice peptide of relative molecular mass 40,000, and the characterisation of a 15-amino-acid fragment of it designated BPC 157. It is a hypothesis-and-overview paper describing results across many animal lesion models rather than a controlled study of a single endpoint, and it is the source of the distinction between the parent protein and the pentadecapeptide that later literature routinely collapses. source
- Pharmacokinetics, distribution, metabolism, and excretion of body-protective compound 157, a potential drug for treating various wounds, in rats and dogs — The first pharmacokinetic characterisation of BPC-157, in Sprague Dawley rats and beagle dogs. Elimination half-life of the parent peptide was under 30 minutes by both intravenous and intramuscular routes, with linear kinetics at all doses. Mean absolute intramuscular bioavailability was roughly 14 to 19 percent in rats and 45 to 51 percent in dogs. Tritium labelling identified urine and bile as the main excretory pathways and showed rapid breakdown into small peptide fragments and then into single amino acids. Animal data only. source
- Preclinical safety evaluation of body protective compound-157, a potential drug for treating various wounds — A toxicology package in mice, rats, rabbits and dogs. The single-dose study showed no effects attributable to the test article. In repeated-dose evaluation the substance was tolerated in dogs, with a fall in creatinine at the 2 mg/kg dose but not at lower doses, reversing after two weeks off the substance. A local tolerance test showed mild irritation, and no genetic or embryo-fetal toxicity was found. FDA's reviewers note that the published manuscript does not include the histopathological data, that dosing was intramuscular only, and that the package covers neither a complete reproductive cycle nor carcinogenicity. source
- Detection and in vitro metabolism of the confiscated peptides BPC 157 and MGF R23H — An anti-doping laboratory characterised BPC 157 from vials confiscated from athletes. In vitro plasma metabolism experiments showed BPC 157 forms a stable metabolite that should be detectable in urine, and a validated solid-phase extraction method reached a limit of detection of 0.1 ng/mL with good linearity. BPC 157 was stable in urine for at least 4 days. This is analytical chemistry for doping control, not a study of any effect in a person. source
- Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review — A systematic review of English-language literature from database inception to June 3, 2024 across PubMed, Cochrane and Embase. 544 articles were screened and 36 studies included: 35 preclinical and 1 clinical. The authors characterise the included work as level IV and level V evidence and state that no clinical safety data were found. The single clinical study was a retrospective report on chronic knee pain. source
- Effect of BPC-157 on Symptoms in Patients with Interstitial Cystitis: A Pilot Study — A single-arm pilot study in 12 women aged 39 to 76 at a private clinic, none of whom had responded to pentosan polysulfate. A total of 10 mg of BPC-157, compounded by a 503A pharmacy, was placed around the inflamed area of the bladder wall during a single cystoscopy. Outcome was measured by a self-rated Global Response Assessment questionnaire. There was no control group and no blinding, and the authors report no adverse events and no dropouts. source
- Multifunctionality and Possible Medical Application of the BPC 157 Peptide—Literature and Patent Review — A narrative literature and patent review. It records that human studies are scarce and that the studies reporting consistently positive effects were performed in animal models, particularly rodents; that the knee-pain report lacked any survey instrument by which improvement could be defined; and that the 2015 phase 1 study in 42 healthy volunteers (NCT02637284) was begun and its result submission cancelled in 2016. Its own abstract illustrates the conflation warning at the top of this file, describing the pentadecapeptide as "isolated from human gastric juice", and it makes a claim about current WADA status that the anti-doping bodies contradict. source
What the research does not show
- There is no published, adequately reported, randomised controlled trial of BPC-157 in people for any condition. The single randomised comparison that exists was published only as a conference abstract, and FDA states the data presented there are inadequate to support either efficacy or safety.
- FDA's regulatory evaluation found only five clinical studies of BPC-157 in the entire published medical literature. Two of them are meeting abstracts rather than full papers. FDA describes the set as short in duration, small in sample size, exploratory in the doses used, and limited in the safety information the authors provided, and notes that safety monitoring is unclear for most of them. source
- An independent systematic review of the orthopaedic literature screened 544 articles published between 1993 and 2024 and included 36 studies, of which 35 were preclinical and 1 was clinical. Its authors classify the body of work as level IV and level V evidence and state plainly that no clinical safety data were found. source
- Route of administration in the published human studies does not match how the substance is actually supplied and used. FDA states it identified no study that gave BPC-157 to humans by the oral, subcutaneous, nasal or transdermal route. The two human studies FDA identified in which the substance was given repeatedly both used a rectal enema, a route almost nobody buying this compound uses.
- The same gap exists in the animal safety work. FDA states that neither the nominators submitted, nor did FDA identify, nonclinical pharmacokinetic, acute toxicity, repeat-dose toxicity or developmental toxicity studies by any of the oral, rectal, transdermal, subcutaneous or nasal routes. The available animal toxicology used the intramuscular route, and because the absolute bioavailability of the other routes in rats and dogs is unknown, FDA states the intramuscular no-observed- adverse-effect levels cannot be used to estimate levels for those routes. source
- The animal pharmacology does not establish a dose-response relationship. Across the rodent studies FDA reviewed, doses separated by three orders of magnitude (nanograms per kilogram versus micrograms per kilogram) produced effects of the same magnitude, so no dose-response could be established. FDA states the molecular targets of BPC-157 have not been identified and its mechanism of action remains poorly understood, which makes the biological plausibility of the reported effects difficult to assess. source
- The 28-day animal toxicology carries unresolved signals rather than a clean result. FDA summarises the repeat-dose intramuscular studies in rats and dogs as showing clinically relevant safety signals including shortened and prolonged activated partial thromboplastin time, suggestive of altered clotting properties, and liver-associated signals comprising raised serum ALT, glucose and triglyceride levels. FDA states longer repeat-dose studies were unavailable to show whether those findings reproduce or whether further signals emerge, and that no carcinogenicity study exists. source
- The published human studies that report favourable outcomes are uncontrolled and rely on self-report. The interstitial cystitis study cited here enrolled 12 women at a single private clinic, had one arm and no control group or blinding, and measured outcome with a self-rated Global Response Assessment questionnaire. The knee-pain report is a retrospective chart review in which some participants received BPC-157 combined with a second peptide, so nothing in it can be attributed to BPC-157 alone. source
- A registered phase 1 study in healthy volunteers (NCT02637284) was started in 2015 and its results were never posted; FDA searched and was unable to find an associated published study. An independent review records that the researchers cancelled submission of the results in 2016. The trials that would characterise this substance in people were begun and then not reported. source
- The evidence base is concentrated in a very small number of authors. A news investigation quotes a review team's count that the vast majority of the roughly 200 BPC-157 studies listed on PubMed include either Predrag Sikiric or Sven Seiwerth, both of the University of Zagreb, as a main author. That is a reported count from journalism rather than a published bibliometric analysis, and is recorded here as such. What can be checked directly is that the originating 1993 paper came from that same department, and that the reference list of FDA's own evaluation is dominated by papers from it. source
- Nobody has measured what BPC-157 does in a person's bloodstream. FDA states there is no information with which to assess its human pharmacokinetics. The half-life, bioavailability and excretion figures on this page are from rats and dogs, and the route that produced them is not a route anyone has studied in people.
- FDA considers the substance itself poorly characterised. Its evaluation concludes that both BPC-157 (free base) and BPC-157 acetate are "not well-characterized from the physical and chemical characterization perspective", citing naming conventions that do not follow USAN, INN or IUPAC standards, and missing or inadequate data on peptide-related impurities and aggregates, microbial quality, bacterial endotoxins and particle size. FDA notes that inconsistent naming is itself a safety risk because a patient may receive a different substance from the one intended. source
- Commercial certificates of analysis for this substance generally report purity and nothing else. FDA reviewed the certificates supplied with both nominations and searched the literature for others, and found that most contain only purity testing results, with no impurity limits or results that would demonstrate control of the impurity profile, and no bioburden or bacterial endotoxin testing. FDA states that because of this it cannot rule out the potential for immunogenicity from those impurities and from peptide-related aggregates. source
- The storage and solubility figures published on this site, and on every other site that carries them, trace back through FDA's evaluation to supplier product pages rather than to a published stability study. They are recorded here because FDA recorded them, with that provenance stated. No peer-reviewed shelf-life determination for this compound was located.
- Much of the literature does not say which substance it studied. FDA notes repeatedly that published articles do not clearly identify whether the BPC-157 used was the free base or the acetate salt, and that it is often unclear whether a product described in a source was compounded at all. Findings reported for "BPC-157" therefore cannot always be assigned to a specific substance.
- Adverse events reported to FDA exist but cannot be attributed. Every case FDA retrieved was confounded — by a second peptide given at the same time, by missing information about duration and concomitant medicines, or by use within a multi-ingredient product. Absence of a clean signal in a database this sparse is not evidence of safety.
- The published research does not establish a dose, a route, a schedule, a duration, or a formulation for any use in a person, and it does not establish what happens with long-term use, because no long-term human study has been published.