BPC157: An Evidence Map of 236 Publications, the Human Studies and Australian Regulation

By Dr. Sarah Chen, PhD Pharmacology

Abstract

Background. BPC157 (also written BPC 157 or BPC-157) is a synthetic 15-amino-acid peptide whose online reputation has grown far faster than its clinical record. Australian regulators added it to Schedule 4 of the Poisons Standard, with additional possession controls, from 1 June 2024, and in 2026 the TGA, the Chief Medical Officer and NSW Health issued repeated warnings about unapproved peptides [1, 2, 3, 4, 5]. Existing reviews either summarise the animal findings narratively or, in the two systematic reviews, cover only orthopaedic use or human studies [6, 7, 8]. No published work has mapped the whole BPC157 literature, measured how it is distributed across models, research groups and years, or audited how it is reported.

Objective. To build a reproducible evidence map of every PubMed-indexed BPC157 record; to classify each primary study by outcome domain, model and research group; to audit reporting quality in the open-access animal studies; to reconcile the human evidence across journals, meeting abstracts, trial registries and regulator reviews; and to set out a verified regulatory timeline for Australia, anti-doping and the United States.

Methods. A systematic evidence map with reporting informed by PRISMA 2020 [9]. PubMed was searched through NCBI E-utilities on 30 October 2026 (Australia/Brisbane) with a title/abstract block covering eight synonyms. Europe PMC and ClinicalTrials.gov were searched as cross-checks [10, 11, 12]. All 236 PubMed records were screened and classified by hand. Open-access full texts of in vivo animal studies published from 2013 were audited against core items from ARRIVE 2.0 and the SYRCLE risk-of-bias tool [13, 14]. Regulatory facts were read at the primary source.

Results. Of 236 records, 3 were excluded, 167 were primary studies and 66 were reviews, editorials or comments. Rodent models accounted for 144 of the 167 primary studies (86.2%), and only 4 (2.4%) reported data from people. Authors from the Zagreb group (any author named Sikirić, or any Zagreb affiliation) wrote 140 of 167 primary studies (83.8%) and 139 of 148 in vivo animal studies (93.9%). In 47 audited full texts, 42 (89.4%) said animals were randomised but only 3 (6.4%) described how. Three (6.4%) reported a sample-size calculation, 5 (10.6%) cited ARRIVE and 42 (89.4%) used male animals only. Human evidence comprised four uncontrolled published reports (33 people) and, outside PubMed, three meeting abstracts from 2002–2005 identified by the US FDA. One was a randomised, placebo-controlled trial in 53 people with ulcerative colitis whose between-group confidence interval included zero [15]. None of four ClinicalTrials.gov registrations has posted results, and three of the four were registered after the study had started. In 2025–26, secondary publications outnumbered primary studies by 33 to 16.

Conclusions. The BPC157 evidence base is large in count but narrow in origin and design: mostly short rodent studies from one research network, with low reporting of the safeguards that protect against bias and no peer-reviewed controlled human trial. Claims about effects in people are therefore not supported by the record. In Australia BPC-157 is a Schedule 4 substance listed in Appendix D, it is prohibited at all times in sport, and the TGA states that a “research use only” label does not change a product’s regulatory status [16, 17, 18].

What is new here. This is, to our knowledge, the first whole-corpus BPC157 evidence map: every PubMed record classified by domain, model and research group, with counts that can be reproduced from the published search strings. It adds a full-text reporting audit, a registry audit, a reconciliation of journal, meeting-abstract and regulator sources on human data, and a regulatory timeline checked against the legislation, TGA decisions and the 2027 WADA List. Top-ranking pages describe BPC157 in general terms. None of them quantifies how concentrated, how rodent-based or how incompletely reported the evidence is.

Contents

1. Introduction: why BPC157 needs an evidence map
2. What BPC157 is: identity, names and origin
3. Methods: search, classification and audits
4. Results: search yield and publication trends
5. Results: the BPC157 evidence map by domain and model
6. Results: concentration of BPC-157 research in one network
7. Results: reporting quality of BPC157 animal studies
8. Results: BPC-157 human studies, abstracts and registrations
9. Results: BPC-157 regulatory status in Australia, sport and the United States
10. Discussion
11. Gap analysis: research questions for BPC157
12. Limitations
13. Conclusion
14. Relevance to Eternal Peptides Wholesale
15. Frequently asked questions about BPC157
16. Glossary
17. References
18. Related research
19. About this article
20. About the author

Introduction: why BPC157 needs an evidence map

Few research peptides have drawn as much public attention as BPC157. Search interest, social media and online commentary often present it as well established. The scientific record is different. Most of the literature consists of short experiments in rats, most of those experiments come from one research network, and the human record is sparse enough that a systematic review published in 2026 found only three eligible human studies involving 30 people. That review rated the certainty of evidence as very low [6]. A 2025 systematic review limited to orthopaedic sports medicine reached a similar conclusion about the shortage of human data [7]. A narrative review of musculoskeletal healing set out the gap between preclinical promise and clinical uncertainty [8].

These reviews answer the question “what does the human evidence show?” They do not answer a prior question that matters just as much for anyone trying to interpret BPC157 research: what kind of evidence base is this? How many studies are there, in which models, from which groups, and how well were they reported? The answers determine how much weight any single finding can bear. A literature of 150 rat studies from many independent laboratories with transparent randomisation and adequate sample sizes would carry far more weight than the same number of studies from one network with sparse reporting of bias safeguards. Meta-research across preclinical science shows that unreported randomisation and blinding are associated with larger apparent effects [19], that small samples inflate effect sizes and reduce reproducibility [21], and that only a minority of highly cited animal findings translate into human benefit [22].

A second reason for an evidence map is regulatory. On 1 June 2024 Australia created a Schedule 4 entry for BPC-157 and listed it in Appendix D, clause 5, of the Poisons Standard. That listing places additional controls on possession, and the Explanatory Statement records that possession without authority is illegal [1, 2]. The TGA delegate’s reasons cited “a limited evidence base” made up of “a small number of peer-reviewed studies that largely originate from a single laboratory”, and “only a single registered phase 1 clinical trial conducted in 2015” [23]. Those are empirical statements about the literature. This review tests them with a full count.

A third reason is the quality of secondary literature. Between 2025 and October 2026, reviews, editorials and comments about BPC-157 outnumbered new primary studies two to one (33 versus 16 PubMed records; see Figure 1). As secondary publications multiply, errors can propagate. One 2025 literature and patent review stated that BPC-157 was not listed as banned by WADA [24]. Yet both the 2025 Prohibited List, in force when the review appeared, and the 2026 List name BPC-157 under S0 [25, 26]. A whole-corpus map gives readers a check against such drift.

This article therefore sets out to do five things: (1) report a reproducible search with real counts; (2) classify every primary BPC157 study by outcome domain, model, species and research group; (3) audit how the recent open-access animal studies report the safeguards that limit bias; (4) reconcile the human evidence across journals, meeting abstracts, trial registries and a regulator’s review; and (5) assemble a verified regulatory timeline for Australia, anti-doping and the United States. It does not assess whether BPC-157 works in people, and it makes no recommendation about use. The aim is to describe the evidence accurately, so that researchers, reviewers and regulators can see where its limits lie.

What BPC157 is: identity, names and origin

BPC-157 is a linear pentadecapeptide. PubChem lists it as compound CID 9941957 with molecular formula C₆₂H₉₈N₁₆O₂₂ and a molecular weight of about 1,419.5 g/mol [27]. Its sequence, Gly-Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val (GEPPPGKPADDAGLV), was confirmed by mass spectrometry in vials confiscated during an anti-doping investigation [28]. The name comes from “body protection compound”. The originating group described BPC as a new gastric juice peptide in a 1993 overview of its stomach-stress-organoprotection hypothesis [29], and later papers from the same group call BPC 157 a “stable gastric pentadecapeptide” [30]. The word “stable” refers to a reported resistance to hydrolysis in gastric juice. The FDA’s 2026 briefing document notes that, despite this, the reported half-life after injection in animals is short [15, 31].

The peptide appears under several names and development codes. The literature and regulators use BPC 157, BPC-157 and BPC157 interchangeably, as well as PL 14736 (also written PL14736), PL-10, PLD-116 and Bepecin [32, 20]. That spread of names matters for searching. A query for one spelling misses records that use another, so the search strategy in this review combined all of them (Table 1). Sport Integrity Australia lists the same aliases on its BPC-157 substance page [20].

BPC-157 is not an approved medicine in Australia. Sport Integrity Australia notes that it is not included on the Australian Register of Therapeutic Goods (ARTG) [20]. In the United States, the FDA’s 2026 briefing document records that it has no pharmacopeial monograph and is not a component of any FDA-approved drug [15]. For broader context on how signalling peptides relate to approved peptide medicines, see the EPW review What do peptides do? Signalling, receptors and approved medicines.

Methods: search, classification and audits

Design and reporting standards for the BPC157 evidence map

This is a systematic evidence map, a form of evidence synthesis that describes the extent and character of a literature rather than pooling effect sizes. Searching, screening and reporting followed the relevant items of PRISMA 2020 [9]. The audit of animal studies used core items from the ARRIVE 2.0 guidelines and the SYRCLE risk-of-bias tool for animal intervention studies [13, 14], together with the reporting items proposed by Landis and colleagues for preclinical research [33]. The review was not prospectively registered. That is a limitation, but because every search string and count is published here and every classification rule is stated, the work can be repeated. All searches were run on 30 October 2026 between about 04:00 and 04:20 Australia/Brisbane time (AEST).

Information sources and search strings

The primary source was PubMed, queried through the NCBI Entrez Programming Utilities (E-utilities) so that counts were captured exactly [10]. The core search combined eight title/abstract synonyms: “BPC 157”, “BPC-157”, “BPC157”, “body protection compound”, “pentadecapeptide BPC”, “PL 14736”, “PL14736” and “bepecin”. It was limited to publication dates up to 30 October 2026. The core search returned 236 records, and a re-run about 15 minutes later returned the same count. Standard PubMed filters were then applied as descriptive subsets (Table 1). Europe PMC was queried through its REST interface as a cross-check, returning 247 records for a title/abstract search and 325 for an all-fields search [11]. ClinicalTrials.gov was searched through its version 2 API for each synonym [12]. The Australian New Zealand Clinical Trials Registry could not be queried programmatically because it blocked automated requests (HTTP 403). This is recorded as a limitation.

Table 1. Reproducible search strings and record counts for BPC157, run 30 October 2026 (Australia/Brisbane).

The PubMed filter counts in Table 1 show why automated subsets cannot replace screening. The humans[mh] filter returned 59 records, yet only 4 primary studies reported data from people. The tag mostly attaches to reviews and to in vitro work on human cells or tissue. Conversely, the clinical trial and randomised controlled trial publication-type filters each returned zero records. That is the correct count for peer-reviewed trials, but it says nothing about trials reported only as conference abstracts, which PubMed does not index (see BPC-157 human studies).

Eligibility, screening and classification

Every one of the 236 records was screened on title, abstract and publication type. Records were classified as primary studies (reporting new data), secondary publications (reviews, editorials, comments, letters and replies) or excluded. Each primary study was assigned to one main outcome domain and one model category. The eight domains were gastrointestinal; vascular and cardiac; nervous system; musculoskeletal (muscle, tendon, ligament and bone); skin wounds and eye; liver, kidney and other organs; toxicity-antagonism models (studies in which BPC-157 was tested against injury caused by another drug or toxin); and chemistry, pharmacokinetics and safety. The six model categories were rodent in vivo, other animal in vivo, in vitro or ex vivo, nonclinical pharmacokinetic or safety study, chemistry or analytical study, and human report. Species were extracted from the title, abstract and MeSH terms. A study that spanned domains was counted once, in the domain of its primary outcome, so every count in this review refers to unique records.

Author-group attribution

A research group was treated as the Zagreb group when any author was named Sikirić (any spelling) or any author affiliation included Zagreb. Both were read from the PubMed XML record. The rule is deliberately broad, because the question is whether the evidence is independent of the originating network, not who led each paper. It may count a small number of unrelated Zagreb studies as part of the network. That would slightly overstate concentration, so the non-Zagreb records were also checked by hand.

Full-text reporting audit

Every primary in vivo animal study with a full text available as PubMed Central (PMC) XML was retrieved, with the reference lists removed: 47 studies published between 2013 and 2026, of which 42 were by the Zagreb group. Each was screened with predefined text patterns, and matching passages were then read to confirm eight reporting items: a statement that animals were randomised; a description of the randomisation method; a statement of blinding; a sample-size calculation; citation of ARRIVE; the sex of the animals; a conflict-of-interest statement; and a data-availability statement. These items map onto the core ARRIVE 2.0 set [13] and onto SYRCLE domains for selection, performance and detection bias [14]. Each item was scored present or absent from the text as published. Absence means “not reported”, which is not the same as “not done” [34].

Trial-registry audit

Each ClinicalTrials.gov record was retrieved as structured JSON. For each one, the review extracted phase, design, masking, planned or actual enrolment, country, overall status, start date, first-submitted date, primary completion date and whether results had been posted. A registration was classed as retrospective when its first-submitted date fell after its start date. Prospective registration has been a condition of publication in member journals of the International Committee of Medical Journal Editors since 2005, because it guards against selective reporting [35].

Verification of regulatory facts

Every regulatory statement in this review was read at the primary source on 30 October 2026. The sources were the TGA’s interim and final scheduling decisions [23, 1], the Explanatory Statement and text of the June 2024 Poisons Standard instrument [2, 36], the Poisons Standard in force from 1 October 2026 [16], TGA guidance and media releases [18, 3, 37, 4, 38, 39], the WADA Prohibited Lists for 2025, 2026 and 2027 [25, 26, 17, 40], Sport Integrity Australia [20], the US FDA [41, 15] and NSW Health [5]. Secondary commentary was not used as a source for any legal or regulatory fact. Where a TGA web page could not be rendered, the decision PDF was cited instead.

Results: search yield and publication trends

Screening flow from 236 records to 167 BPC157 primary studies

The core PubMed search returned 236 records. Three were excluded: a 2021 corrigendum, a 2025 article whose PubMed record is titled “Withdrawn”, and a 2025 paper on another class of compounded medicines in which BPC-157 was mentioned but not studied. Of the remaining 233 records, 167 were primary studies (71.7%; 167 ÷ 233) and 66 were secondary publications (28.3%). The earliest primary study in the set dates from 1992 [42]. Europe PMC returned slightly more records (247 by title and abstract) because it also indexes preprints and records outside MEDLINE [11]. Those extra records were not screened, which is a limitation discussed below.

Publication trend: the rise of secondary BPC-157 literature

The balance between new data and commentary has changed over time (Figure 1). In the 1990s the PubMed record held 22 primary studies and 2 secondary publications. In the 2000s it held 41 and 1, and in the 2010s 47 and 14. From 2020 to October 2026 there were 57 primary studies and 49 secondary publications. The sharpest shift came at the end of the period. In 2025 and 2026 combined, PubMed indexed 16 primary studies and 33 secondary publications, about 2.1 secondary records for every primary one (33 ÷ 16 = 2.06). Of those 33 secondary records, 24 came from authors outside the Zagreb group. The new commentary is coming largely from orthopaedics, sports medicine, pharmacy and public health [43, 44, 45, 46, 47, 48]. The record suggests that BPC-157 is now being written about much faster than it is being studied.

Results: the BPC157 evidence map by domain and model

Models and species: an overwhelmingly rodent BPC-157 literature

Of the 167 primary studies, 144 (86.2%; 144 ÷ 167) were in vivo rodent experiments (Table 2; Figure 2). Within those 144, rats alone were used in 122 studies (84.7%), mice alone in 10, both species in 9, and the species was not clear from the record in 3. Only four primary studies used another animal species. Two were in honeybees, investigating an apiculture parasite [49]. One was a 1999 rabbit bone-defect study [50], and one was a 1997 study in broiler chicks [51]. No efficacy study in a large mammal was identified. Six studies were in vitro or ex vivo, including tendon-fibroblast experiments [52, 53], isolated rat aorta and endothelial-cell work [54, 55] and an ex vivo study of human internal mammary artery segments obtained during surgery [56]. Two were nonclinical pharmacokinetic or safety studies [57, 31], seven were chemistry, analytical or formulation studies [28, 58, 59, 60, 61], and four reported data from people.

Table 2. BPC157 evidence map: 167 primary studies by main outcome domain and model (number of studies; Zagreb-group studies in brackets).

Source: author classification of the PubMed core search (Table 1). Each study is counted once. Row and column totals were checked by summation: 46 + 30 + 22 + 17 + 15 + 14 + 13 + 10 = 167, and 144 + 4 + 6 + 2 + 7 + 4 = 167.

Outcome domains: from gastric lesions to nearly every organ

The gastrointestinal domain was the largest (46 studies). It is also the oldest: work on gastric and duodenal lesion models began in 1992 and continued through fistula, oesophageal-sphincter and periodontitis models [42, 62, 63, 64]. The most recent gastrointestinal primary study in the PubMed set was published in 2024. The vascular and cardiac domain (30 studies) is now the second largest. Since 2018 it has been dominated by a series of rat “occlusion” models, in which major vessels are ligated and outcomes across several organs are recorded [65, 66, 67]. Earlier work examined bleeding after amputation in anticoagulated rats [68]. Nervous system studies (22) range from behavioural models involving dopamine-active drugs to traumatic brain and spinal cord injury in rodents [69, 70, 71]. Thirteen studies tested BPC-157 against injury caused by an overdose of another drug or a toxic exposure, such as paracetamol or electrolyte disturbance. All 13 came from the Zagreb group [72, 73, 74, 75].

The musculoskeletal domain is the one most often cited online, yet it is comparatively small. It contains 15 primary studies: 11 rodent experiments on transected or crushed muscle, tendon, ligament and bone [76, 77, 78, 79, 80, 81], one rabbit bone study [50], two tendon-fibroblast studies [52, 53] and one human chart review [82]. Only one musculoskeletal animal study came from an independent group. That 2026 rat study of Achilles tendon healing included a TB-500 arm and a combined arm, and it reported that BPC-157 alone produced numerically lower injury scores that were not statistically significant on total scores [83]. It is the only independent in vivo test of a tendon outcome in the PubMed record, and it did not reproduce a clear effect for BPC-157 alone. One study does not refute a literature. It does show why independent replication matters.

Results: concentration of BPC-157 research in one network

By the attribution rule set out in the Methods, the Zagreb group authored 140 of 167 primary studies (83.8%). Concentration was highest in exactly the categories that make up the efficacy literature. The group wrote 135 of 144 rodent studies (93.8%), all 4 other-animal studies, and 139 of 148 in vivo animal studies overall (93.9%; 139 ÷ 148). It wrote none of the 6 in vitro or ex vivo studies, none of the 2 nonclinical pharmacokinetic or safety studies, 1 of the 7 chemistry studies and none of the 4 human reports. The group also wrote 38 of the 66 secondary publications (57.6%), including several large narrative reviews of its own findings [30, 84, 85, 86].

Only nine in vivo animal efficacy studies in the PubMed record came from outside the Zagreb network, and all nine were in rodents. They covered a gastric ulcer model (2004) [87], an alkali-burn skin wound model (2015) [88], an angiogenesis and hind-limb ischaemia model (2017) [89], clopidogrel-induced gastric injury (2020) [90], incisional pain (2022) [91], radiation-induced liver injury (2022) [92], distant organ injury after limb ischaemia-reperfusion (2025) [93], lower-limb ischaemia (2026) [94] and Achilles tendon healing (2026) [83]. Each tested a different outcome, so none replicates another, and none was designed or reported as a direct replication of a specific Zagreb experiment. This review treats a finding as independently replicated when a second, unrelated group reproduces the same outcome in the same model and says so. By that standard, the review found no independently replicated BPC-157 finding in the PubMed record.

Concentration in one group is not evidence of error. Specialist laboratories often build large bodies of work on a single compound. But the TGA delegate’s 2024 observation that the studies “largely originate from a single laboratory” [23] is confirmed and quantified here. The lack of independent replication is directly relevant to the reproducibility concerns that meta-research has documented across preclinical science [21, 33]. A critical review of the rodent ischaemia-reperfusion literature published in 2026 reached a compatible conclusion. It found heterogeneous models and outcomes that precluded meta-analysis [95].

Results: reporting quality of BPC157 animal studies

The full-text audit covered 47 in vivo animal studies published between 2013 and 2026 (42 Zagreb, 5 other groups). Results are shown in Figure 3. Forty-two studies (89.4%; 42 ÷ 47) stated that animals were randomised, but only 3 (6.4%) described how the allocation sequence was generated. Thirty-nine (83.0%) stated that some assessment was blinded. Three (6.4%) reported a sample-size calculation, and 5 (10.6%) cited the ARRIVE guidelines. Forty-two (89.4%) used only male animals. Of the other five, four included female animals and one did not report sex. Conflict-of-interest statements were present in 44 (93.6%) and data-availability statements in 36 (76.6%). The three studies that described a randomisation method were also the three that reported a sample-size calculation, and all three were published in 2026 [96, 97, 98]. This suggests that reporting has recently begun to improve.

These figures matter because unreported randomisation and blinding are associated with inflated effect estimates in animal research [19, 34]. Small, underpowered studies also produce exaggerated and less reproducible effects [21]. A statement that animals were “randomly assigned”, with no method, does not let a reader judge whether allocation was truly random. SYRCLE rates such studies as “unclear” risk for sequence generation [14]. On the items that can be assessed from text, the recent BPC-157 animal literature would therefore be rated mostly unclear risk of selection bias. The near-universal use of male animals means that findings in female animals are largely untested.

Results: BPC-157 human studies, abstracts and registrations

Peer-reviewed human reports: four uncontrolled studies

Four primary records in the PubMed set reported data from people (Table 3). Two others involved human material but not people: the ex vivo artery study [56] and in vitro work on human cells. The first peer-reviewed human report was a 2021 retrospective chart review from a single clinic in Florida. Seventeen patients with knee pain were identified who had received intra-articular injections of BPC-157, alone or combined with thymosin beta-4. Sixteen were contacted, and 12 had received BPC-157 alone. Outcomes were gathered by telephone without a validated instrument, and there was no comparison group [82]. The second was a 2024 single-arm pilot study of 12 women with interstitial cystitis who were treated during a single procedure at a private clinic. It reported symptom change on the Global Response Assessment questionnaire and no adverse events, again with no control group [99]. The third, published in 2025, described intravenous infusion in two adults at a private clinic, both of whom had received intravenous BPC-157 before. Its title describes it as a study of safety, and its abstract concludes that the results “showed the safety of BPC-157 in humans” [100]. Two participants cannot characterise the safety of anything, and prior exposure selects for people who had already tolerated the substance. The fourth, published in 2026, was a case report with narrative review. It described three people with inferior alveolar nerve injury, a complication of oral and maxillofacial surgery, who were managed with peptide agents together with dexamethasone and local anaesthetic. Because several interventions were given at once, the authors’ framing as “hypothesis-generating” is the appropriate reading [101].

Together, these four reports describe 33 people (16 + 12 + 2 + 3). The 2026 systematic review by Poolton and colleagues, which searched to 1 June 2026 and so predated the case report, included the first three (30 people). It rated all three as poor quality and the certainty of evidence as very low on GRADE [6]. The 2025 systematic review by Vasireddi and colleagues, which searched to June 2024, also found very limited human data in orthopaedic sports medicine [7]. None of the four peer-reviewed reports randomised participants, used a control or comparison group, or blinded outcome assessment.

Meeting abstracts outside PubMed: the 2002–2005 enema studies

A whole-corpus search of PubMed misses one set of human data. In its July 2026 briefing document for the Pharmacy Compounding Advisory Committee, the US FDA searched PubMed and Embase and identified three conference abstracts from 2002, 2003 and 2005 [15]. The 2002 and 2003 abstracts described a placebo-controlled phase 1 tolerability and pharmacokinetic study of BPC-157 given by rectal enema to healthy male volunteers. Thirty-two people were randomised, 24 of whom received BPC-157. The most frequently reported adverse events were headache and flatulence, with no obvious difference from placebo, and BPC-157 was reported as not detected, or mostly below the limit of quantification, in plasma [15]. The 2005 abstract described a multicentre, randomised, double-blind, placebo-controlled trial in 53 people with mild to moderate ulcerative colitis, of whom 46 completed. The FDA reported that the confidence interval for the between-group difference in the primary disease-activity score included zero. It judged that, because the study existed only as a meeting abstract lacking key details, the data were “inadequate to support the efficacy and safety” of BPC-157 for that use [15].

These abstracts are the only randomised, placebo-controlled human data on BPC-157 that this review could find. None was followed by a peer-reviewed full paper indexed in PubMed. That matters in two ways. First, phrases such as “in trials for inflammatory bowel disease” in older review titles [32], or statements in primary papers that BPC-157 had been “successful” in clinical use for ulcerative colitis [64], have no peer-reviewed trial report behind them. Second, the one randomised result that is visible, through the FDA’s description, did not show a clear difference from placebo. Including the abstracts, the FDA counted 81 people exposed to BPC-157 across five human studies, with the longest treatment lasting two weeks [102]. Those five studies are the two studies described in the abstracts and the three peer-reviewed reports published from 2021 to 2025; the published analysis does not break the total down by study, and no serious adverse events were reported in them [102]. The FDA also found three reports in its adverse event reporting system (FAERS), and it stressed that such reports cannot establish causation or safety in either direction [15].

Trial registrations: none with results

ClinicalTrials.gov held four unique BPC-157 registrations on 30 October 2026 [12]. The oldest, NCT02637284, is a randomised, quadruple-masked phase 1 study in healthy volunteers in Mexico with an estimated enrolment of 42. It started in October 2015 and was first submitted in December 2015, about two months after it started. Its estimated completion was March 2016, its record was last updated in December 2015, and its status is “unknown”. No results have been posted in the roughly 10 years and 7 months since its estimated completion, and the FDA could not find an associated publication [103, 15]. This is the “single registered phase 1 clinical trial conducted in 2015” cited by the TGA delegate in 2024 [23].

Three more registrations appeared in 2026. NCT07437547 is a randomised, quadruple-masked phase 2 study of hamstring strain in China with an estimated enrolment of 120. It started on 2 February 2026, was first submitted on 22 February 2026 (20 days after it started), and was recruiting at the time of the search [104]. NCT07803250 is a randomised, quadruple-masked phase 1 study in people undergoing rotator cuff repair in the United States, with an estimated enrolment of 30. It was registered before its planned start in January 2027 [105]. NCT07752381 is an open-label, single-group study of 40 people in the United States testing an oral product that contains BPC-157. It was recorded as completed on 1 November 2025 but first submitted on 3 August 2026, about nine months after completion, and no results have been posted [106]. In summary, none of the four registrations has posted results, three of the four were registered after the study began, and only one was registered prospectively. Retrospective registration weakens the protection that registries offer against selective outcome reporting [35].

Table 3. BPC-157 human studies, meeting abstracts and trial registrations identified on 30 October 2026 (doses deliberately omitted).

Results: BPC-157 regulatory status in Australia, sport and the United States

Is BPC-157 legal in Australia? The Schedule 4 and Appendix D listing

BPC-157 entered the Poisons Standard through a scheduling process that ran from November 2023 to June 2024. The proposal was considered at the November 2023 meeting of the Advisory Committee on Medicines Scheduling. It cited 48 referrals for importation of BPC-157 received by the TGA since 1 July 2022 [23]. The delegate’s interim decision, published in April 2024, was to create a Schedule 4 entry and to list BPC-157 in Appendix D, clause 5. The decision document stated that the putative human benefits were “largely unsubstantiated”, that the toxicity profile was “largely uncharacterised”, and that marketing the substance as “not for therapeutic use” or “for research only” was “insufficient to deter consumer misuse” [23]. The final decision confirmed the listing with an implementation date of 1 June 2024 [1]. The legislative instrument’s Explanatory Statement records that the entry added BPC-157 to Schedule 4 for the first time, and that the Appendix D listing means possession without authority is illegal [2, 36].

The Poisons Standard that commenced on 1 October 2026 retains the Schedule 4 entry and the Appendix D, clause 5 listing [16]. Schedule 4 covers prescription-only medicines. Under the Therapeutic Goods Act 1989, medicines supplied in Australia must generally be included in the ARTG unless an exemption, approval or authority applies [107], and BPC-157 is not on the ARTG [20]. On the question “is BPC-157 legal in Australia?”, the primary sources therefore support a precise answer. BPC-157 is not an approved medicine in Australia. It is a Schedule 4 substance with additional possession controls, and the TGA states that labels such as “research use only” or “not for human use” do not change whether a product is regulated as a therapeutic good [18, 3]. This review does not offer legal advice. Anyone with a specific question should consult the TGA, the relevant state or territory health department, or a lawyer.

TGA and state action in 2026

Regulatory attention increased sharply in 2026 (Figure 4). On 13 April 2026 the TGA published guidance on responsibilities when importing, compounding, supplying and advertising peptides. It named BPC-157 among unapproved peptides and stated that research-use disclaimers do not make supply lawful [3]. On 10 June the TGA added unapproved peptide products to its compliance priorities [37]. On 19 June the TGA and Australia’s Chief Medical Officer issued a joint statement on public health risks. It named BPC-157 and noted that the TGA has no oversight of the composition of unapproved products [4]. On 20 July the TGA put promoters and suppliers of unapproved peptides on notice [38]. On 17 August it reported that more than $120,000 of goods had been seized in New South Wales after warrants were executed on 4 August 2026, including a combined BPC-157 and TB-500 product [39]. On 19 October NSW Health reported 1,180 emergency department presentations associated with peptide use between 1 July 2025 and 30 September 2026, rising from 5 in July 2025 to more than 217 in September 2026 [5]. Over those 15 months that is an average of about 79 presentations a month (1,180 ÷ 15 = 78.7). The release attributes presentations to peptide use generally, not to BPC-157 specifically, and should not be read as a BPC-157 harm estimate.

BPC-157 and WADA: prohibited at all times in sport

BPC-157 falls under section S0 (Non-Approved Substances) of the WADA Prohibited List. S0 covers pharmacological substances not approved by any government health authority for human therapeutic use, and they are prohibited at all times, in and out of competition. According to the TGA delegate, the listing applied from January 2022 [23]. BPC-157 is named as an example in the S0 text of the 2025 and 2026 Lists [25, 26]. The 2027 List, approved by WADA’s Executive Committee on 10 September 2026 and in force from 1 January 2027, retains it [17, 40]. Sport Integrity Australia states that BPC-157 is prohibited and that a Therapeutic Use Exemption would not be granted for it [20]. The United States Anti-Doping Agency describes it as an experimental peptide that creates risk for athletes [108, 109]. A validated urine detection method for BPC-157 was reported after the peptide was identified in confiscated vials [28]. A harmonised anti-doping workflow covering peptidic agents was published in 2026 [59], and in vitro metabolite profiling has also been reported [58].

United States: FDA safety concerns and the 2026 advisory committee

The US FDA lists BPC-157 on its page of bulk drug substances that may present significant safety risks in compounding. It states that the substance may pose a risk for immunogenicity and for peptide-related impurities, and that the agency lacks sufficient information to know whether it would cause harm when administered to humans [41]. In July 2026 the FDA’s Pharmacy Compounding Advisory Committee considered whether BPC-157 should be added to the list of bulk substances eligible for compounding. FDA scientists proposed that it should not. They cited inadequate physicochemical characterisation, insufficient safety and immunogenicity information, insufficient evidence of effectiveness, and the fact that its molecular targets had not been identified [15]. According to a published analysis of the meeting, 15 members voted on BPC-157: 8 supported adding it, 6 voted against and 1 abstained. That recommendation is advisory and does not itself change BPC-157’s status [102]. The FDA had not announced a final decision in the sources reviewed on 30 October 2026.

Table 4. BPC-157 regulatory and anti-doping status, verified at primary sources on 30 October 2026.

Discussion: what the BPC157 evidence map shows

A large animal literature with almost no human translation

The central finding of this review is the gap between the volume and the type of BPC157 evidence. The corpus is large, with 167 primary records over 34 years, and it covers almost every organ system. It is also almost entirely preclinical: 86% of primary records are rodent studies, and only four peer-reviewed reports describe data from people. Those four reports are uncontrolled and together describe 33 people. The only randomised, placebo-controlled human data are three meeting abstracts from 2002 to 2005, which were never published as full papers and are visible today only through the FDA’s description of them [15]. The one randomised efficacy comparison reported in those abstracts did not show a clear difference from placebo. On the question “what do BPC-157 human studies show?”, this is the most accurate one-sentence answer the record supports: very little, and nothing from a peer-reviewed controlled trial.

This gap is not unusual in itself. Most compounds that look promising in rodents never show a benefit in people. Systematic reviews of animal research have repeatedly found that poor reporting of randomisation, blinding and sample size is associated with larger estimated effects [34, 21]. What is unusual about BPC-157 is the combination of three features: the length of time the animal record has grown without a clinical programme reaching publication, the concentration of that record in one group, and the extent to which the substance is promoted online as though human efficacy had been established. The TGA delegate made the same observation in 2024, describing a small number of peer-reviewed studies “that largely originate from a single laboratory” and “only a single registered phase 1 clinical trial conducted in 2015” [23]. Two years later, the number of registrations has risen to four, but none has posted results.

Why concentration in one group matters

The single-group pattern is the most distinctive feature of this literature. Of the 167 primary studies, 140 (83.8%) came from the Zagreb group, and the proportion was higher still among in vivo animal studies (139 of 148, 93.9%). The group has been prolific and consistent, and its papers describe a coherent mechanistic programme centred on nitric oxide, angiogenesis and a proposed “cytoprotective” action [30, 86, 85]. Concentration is not evidence of error. It does mean, however, that the credibility of almost every BPC-157 finding depends on the methods of one laboratory. It also means that the field has had little of the independent testing that normally separates robust effects from chance or method-specific results.

The few independent studies identified here are informative precisely because they are independent. A 2026 rat study of Achilles tendon healing from an independent group reported that BPC-157 alone produced numerically lower injury scores that were not statistically significant on total scores [83]. Work from a Taiwanese group on tendon fibroblasts and vessel tone added mechanistic detail but did not test the Zagreb in vivo models [52, 53, 54]. A pharmacokinetic and toxicology programme in China reported data from mice, rats, rabbits and dogs, and it remains the most systematic published safety work [57, 31]. None of these studies was designed as a replication. The field therefore still lacks the most basic test of robustness: an independent laboratory, using a pre-registered protocol and blinded assessment, repeating a key Zagreb experiment.

Reporting quality and what it implies

The reporting audit in this review (Figure 3) found that randomisation was stated in 42 of 47 full texts, but its method was described in only 3. Blinding was mentioned in 39, a sample size calculation was reported in only 3, and only 5 referred to the ARRIVE guidelines. These are not trivial omissions. ARRIVE 2.0 places randomisation, blinding and sample size among its “essential 10” items because inadequate reporting of them is associated with biased estimates [13, 34]. The audit also found that 42 of the 47 studies used male animals only. That limits generalisability, and it means that any sex differences in response have not been examined. The improvements seen in 2026, when three Zagreb papers described their randomisation method or sample size, are welcome. They are also recent, few and not yet the norm.

How errors propagate in secondary literature

Secondary literature now outnumbers new primary research: in 2025 and 2026, this review counted 33 secondary records against 16 primary studies. That shift matters because errors in reviews tend to be copied. Three examples emerged from this review. First, older review titles describe BPC-157 as being “in trials for inflammatory bowel disease” [32, 110], and a 2008 primary paper describes it as “in clinical trials” [111]. Some primary papers go further and describe clinical use in ulcerative colitis as successful [64]. The only trial-level data visible today are meeting abstracts, and the FDA judged them inadequate [15]. Second, a 2025 literature and patent review states that BPC-157 is “not currently listed as banned by the WADA” [24]. The 2025 Prohibited List names BPC-157 in S0 [25], as do the 2026 and 2027 Lists [26, 17]. Third, online commentary often treats the 2015 registration NCT02637284 as evidence of human testing. Its record shows no results, an unknown status and no update since 2015 [103]. Each of these points can be checked in minutes against a primary source. Each is also repeated widely, which is why this review verified every regulatory and registry statement at source.

The secondary literature is also contested. In 2025, the Zagreb group published a commentary on the Józwiak review, followed by the authors’ reply [112, 113], and a separate commentary responded to a lengthy 2024 Zagreb review [114]. Several reviews written for clinicians in 2026 emphasise limited clinical validation, product quality concerns, regulatory status and anti-doping implications [48, 46, 47, 43, 45]. One, searching to June 2026, found that human musculoskeletal evidence was limited to one small retrospective uncontrolled case series [47]. A 2026 review from a drug-development perspective noted that BPC-157 has no approved formulation and no completed phase II clinical trial, and that its pharmaceutical development remains rudimentary [115].

How this review differs from earlier BPC-157 reviews

Four recent reviews are the closest to this one. The systematic review by Vasireddi and colleagues searched to 3 June 2024 and included 36 studies relevant to orthopaedic sports medicine, of which 35 were preclinical and one was clinical [7]. The systematic review by Poolton and colleagues searched to 1 June 2026, included only human studies, and found three (30 people) of poor quality, with very low certainty of evidence [6]. The narrative review by McGuire and colleagues considered musculoskeletal healing and framed the question as regeneration or risk [8]. The critical review by Demirtaş, published in September 2026, examined rodent ischaemia–reperfusion models and concluded that the evidence was heterogeneous, often relied on short observation periods and single-dose designs, and supported BPC-157 only as a “hypothesis-generating” preclinical candidate [95].

This review adds four things those reviews do not provide. It counts the whole PubMed corpus with a reproducible search and classifies every record. It quantifies the single-group concentration rather than describing it. It audits reporting quality across all open-access full texts. And it reconciles the peer-reviewed human reports with the meeting abstracts, the trial registrations and the FDA’s 2026 count of exposed participants, all checked against primary sources. Its conclusions are consistent with the earlier reviews. They also show that the pattern those reviews describe in specific fields, mostly animal data from one group with very little human evidence, holds across the whole literature.

BPC-157 side effects and safety: what the evidence can and cannot say

Questions about BPC-157 side effects and safety are common, and the honest answer is that its safety in people has not been characterised. The preclinical safety work by Xu and colleagues reported that the peptide was well tolerated in mice, rats, rabbits and dogs, with no genetic or embryo-fetal toxicity observed [57]. Pharmacokinetic work in rats and dogs reported an elimination half-life of under 30 minutes and rapid metabolism [31]. These data are useful, but they cannot be extrapolated to people, to repeated or long-term exposure, or to products of unknown composition. The human reports are too small and too poorly controlled to detect anything but the most common adverse effects. A study of two people cannot establish safety, even when its title says otherwise [100], and the Poolton review rated the overall certainty as very low [6].

Regulators have reached the same conclusion. The TGA delegate described the toxicity profile as “largely uncharacterised” [23]. The FDA states that it lacks sufficient information to know whether BPC-157 would cause harm when administered to humans, and it has raised concerns about immunogenicity and peptide-related impurities [41]. A published analysis of the 2026 advisory committee materials noted that certificates of analysis for these products lacked peptide-specific testing [102]. The TGA has warned that it has no oversight of the composition of unapproved peptide products [4], and NSW Health has reported a rise in emergency department presentations associated with peptide use in general [5]. None of these sources establishes a specific harm from BPC-157. Together they show that the absence of reported harm in small studies is not evidence of safety.

What “research use only” does and does not mean

Products containing BPC-157 are often labelled “for research use only” or “not for human consumption”. The regulatory position on this point is clear. The TGA delegate noted in 2024 that such disclaimers were used “to circumvent existing controls on therapeutic goods” [23]. In 2026 the TGA stated that wording such as “research use only” does not change whether a product is a therapeutic good or whether its supply is lawful [18, 3]. A label describes intended use. It does not change a substance’s scheduling, approval status or anti-doping status. For an Australian reader, the relevant facts are that BPC-157 is a Schedule 4 substance listed in Appendix D, that it is not on the ARTG, and that it is prohibited at all times in sport [16, 20, 17].

Human-evidence gap analysis: research questions for BPC-157

The evidence map points to specific, answerable questions. Table 5 sets out seven of them, the gap each addresses, and the type of study that could answer it. The table deliberately specifies designs and outcomes, not doses or protocols. Any human study would need ethics approval and, in Australia, would need to operate within the clinical trial and scheduling frameworks that apply to an unapproved Schedule 4 substance [107, 16].

Table 5. Priority research questions arising from the BPC-157 evidence map (designs only; no doses or protocols).

Questions 1, 3 and 4 could be answered without exposing anyone to BPC-157. Publishing the 2002–2005 data and the outcome of NCT02637284 would provide the first peer-reviewed randomised human evidence on BPC-157, of which there is currently none. Independent preclinical replication would show whether the large Zagreb literature is reproducible. Question 6 reflects the FDA’s view that immunogenicity has not been addressed [41], and question 7 reflects the TGA’s warning about the composition of unapproved products [4].

Limitations of this review

This review has several limitations. The main corpus came from PubMed, so studies indexed only in Embase, Scopus or regional databases may have been missed. The Europe PMC count was used as a cross-check [11], and the FDA’s PubMed and Embase search identified the meeting abstracts that PubMed alone misses [15]. Records were screened and classified by one reviewer using a pre-specified scheme, without independent duplicate screening. Classification of study models and domains involved judgement, and a second reviewer might classify some records differently. Affiliation-based attribution relied on author and affiliation data and may misattribute some collaborative studies. The reporting audit was limited to 47 open-access full texts, which may not represent studies without open full text, and it recorded whether items were reported, not whether they were done well. The Australian New Zealand Clinical Trials Registry blocked automated access, so registrations there could not be checked systematically. Regulatory sources change. Every regulatory statement here was checked on 30 October 2026, and later changes are not reflected. Finally, this review did not assess risk of bias in individual studies or pool effect sizes, because the heterogeneity of models and outcomes would make a pooled estimate misleading.

Conclusion: the state of BPC157 evidence in 2026

BPC157 has one of the largest single-group literatures of any investigational peptide. That literature is overwhelmingly preclinical, concentrated in one laboratory, poorly reported on the items most linked to bias, and largely untested in female animals. In people, the peer-reviewed record consists of four uncontrolled reports describing 33 people. The only randomised data are meeting abstracts from 20 years ago, and four trial registrations have produced no results. In Australia, BPC-157 is a Schedule 4 substance listed in Appendix D and is not on the ARTG. In sport, it is prohibited at all times under the WADA S0 category, including in the 2027 List. In the United States, it is unapproved and the FDA has raised safety and quality concerns. Labels such as “research use only” change none of this. Until independent replications and controlled human trials are completed and fully reported, statements that BPC-157 has been shown to have specific effects in people are not supported by the evidence.

Relevance to Eternal Peptides Wholesale

Eternal Peptides Wholesale distributes research peptides in wholesale boxes of 10 vials, for laboratory research use only and not for human consumption (company background). It publishes this review because BPC157 is one of the most searched peptide names, and an accurate summary of its evidence and regulatory position is more useful to researchers than marketing claims. As this review shows, a “research use only” label is not legal clearance, and BPC-157 is a Schedule 4 and Appendix D substance in Australia.

What the site documents is analytical, not biological. Its certificate of analysis library transcribes batch-specific reports from Janoshik Analytical, an independent laboratory, and the testing standards page explains how identity, purity and content results are read. Those reports bear on the analytical gap identified in question 7 of Table 5. They say nothing about effects in people and do not establish regulatory approval, clinical suitability or safety for human use. Related evidence reviews from Eternal Peptides Wholesale are on the blog, including an analysis of peptides for muscle gain and a guide to reading peptide research claims.

Glossary

• Appendix D (clause 5): part of the Poisons Standard listing poisons for which possession without authority is illegal; BPC-157 is item 5.
• ARRIVE 2.0: reporting guidelines for animal research, including an “essential 10” set of items such as randomisation, blinding and sample size.
• ARTG: Australian Register of Therapeutic Goods, the TGA’s register of goods that can be lawfully supplied in Australia.
• BPC157 (BPC-157, BPC 157): a synthetic 15-amino-acid peptide (GEPPPGKPADDAGLV), also coded PL 14736, studied mainly in rat injury models.
• Evidence map: a systematic description of what research exists on a topic, by design, model and domain, without pooling results.
• FAERS: the FDA Adverse Event Reporting System, a database of voluntary reports that cannot establish causation.
• GRADE: a framework for rating the certainty of a body of evidence as high, moderate, low or very low.
• Meeting abstract: a short summary presented at a conference, usually not peer reviewed in full and often lacking methods and results detail.
• PCAC: the FDA’s Pharmacy Compounding Advisory Committee, whose recommendations are advisory.
• Prospective registration: registering a trial before its first participant is enrolled, so that planned outcomes are on record.
• S0 (Non-Approved Substances): the WADA Prohibited List section for substances with no current approval for human therapeutic use; prohibited at all times.
• Schedule 4: the Poisons Standard schedule for prescription-only medicines.
• Zagreb group: the University of Zagreb research network that has produced most BPC-157 studies, defined for this review by the attribution rule in the Methods.

BPC157 frequently asked questions

What is BPC157?

BPC157, also written BPC-157 or BPC 157, is a synthetic peptide of 15 amino acids. It was first described in the early 1990s by researchers in Zagreb in connection with a peptide found in gastric juice. Almost all research on it consists of rodent studies, and 83.8% of primary studies come from one research group in Zagreb. It is not an approved medicine in Australia or the United States.

Is BPC-157 legal in Australia?

BPC-157 is not an approved medicine in Australia and is not on the ARTG. Since 1 June 2024 it has been a Schedule 4 (prescription-only) substance, and it is listed in Appendix D, clause 5, which makes possession without authority illegal. The current Poisons Standard, in force from 1 October 2026, retains both entries. This summary is not legal advice.

Why is BPC-157 Schedule 4?

The TGA delegate’s 2024 reasons cited putative human benefits that were “largely unsubstantiated”, a toxicity profile that was “largely uncharacterised”, a limited evidence base largely from a single laboratory, and the risk of misuse, particularly among athletes. The proposal followed 48 import referrals for BPC-157 received by the TGA since 1 July 2022.

Is BPC-157 banned by WADA?

Yes. BPC-157 is prohibited at all times, in and out of competition, under section S0 (Non-Approved Substances) of the WADA Prohibited List. It is named in the 2025, 2026 and 2027 Lists. Sport Integrity Australia states that a Therapeutic Use Exemption would not be granted for it.

Are there BPC-157 human studies?

Very few. Four peer-reviewed reports describe 33 people, and none had a control group. Randomised, placebo-controlled data exist only as meeting abstracts from 2002 to 2005, which the FDA judged inadequate. Four trials are registered on ClinicalTrials.gov, and none has posted results.

What is known about BPC-157 side effects and safety?

Its safety in people has not been established. Animal toxicology reported it was well tolerated, but the human reports are too small to characterise side effects. The TGA described its toxicity profile as largely uncharacterised, and the FDA has raised concerns about immunogenicity and impurities. The absence of reported harm in small studies is not evidence of safety.

Is BPC-157 approved by the FDA?

No. The FDA lists BPC-157 among bulk drug substances that may present significant safety risks in compounding. In July 2026 FDA scientists proposed that it should not be made eligible for compounding. An advisory committee vote of 8 in favour, 6 against and 1 abstention is advisory only, and no final FDA decision had been announced by 30 October 2026.

Does a “research use only” label change the legal status of BPC 157?

No. The TGA states that wording such as “research use only” or “not for human use” does not change whether a product is regulated as a therapeutic good or make its supply lawful. BPC 157 remains a Schedule 4 and Appendix D substance whatever the label says.

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About this article

This article is an educational evidence review of published research and of Australian and international regulatory documents. It is not medical or regulatory advice, and it does not describe or recommend any use of BPC-157 or other peptides in people or animals. Database searches were run, and every reference and link was checked against its source, on 30 October 2026 (Australia/Brisbane). Sources that block automated access were verified through DOI and NCBI records or indexed page text, as noted in the reference list.

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About the author

Dr. Sarah Chen, PhD Pharmacology. Author and reviewer attribution for this article is as confirmed by Eternal Peptides Wholesale.