Related names in cited records: Body protection compound 157↗
A research peptide represented by FDA compounding-review material and one selected trial-registry record.↗↗↗
Citation markers ↗ open the public records supporting the adjacent statements.
Profile update · July 29, 2026
We added the July 2026 FDA advisory-committee meeting context and clarified that both the committee process and the selected trial record have limited implications. 14
Not an FDA-approved drug. FDA presented BPC-157 briefing material at its July 2026 pharmacy-compounding advisory-committee meeting. Committee recommendations are nonbinding and FDA's final determination remains pending; the cited trial registration also does not establish safety or effectiveness.↗↗↗
Review source snapshots checked August 18, 2026 · Integrity checked August 19, 2026.
A bounded review of one human safety pilot, one literature-and-patent review, and one current human trial protocol.↗↗↗
What the reviewed sources report
This source set contains a two-person uncontrolled safety pilot, a narrative review dominated by preclinical research, and a recruiting Phase 2 protocol with no posted results. It does not establish human efficacy.↗↗↗
What remains unresolved?
Do adequately powered controlled human trials reproduce any claimed benefit and characterize harms over meaningful follow-up?↗↗
FDA evaluated BPC-157 free base and acetate separately for ulcerative colitis. The briefing recommended against their inclusion on the 503A bulks list. It explicitly precedes a final agency determination; this summary does not report a final ruling. FDA PDF pp. 1, 5, 8, 9 ↗FDA PDF pp. 43, 44, 45, 46, 47 ↗
More findings and the sources behind them
Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.
The human trial evidence was limited
FDA identified a 53-participant, two-week randomized study reported only in a meeting abstract. Missing endpoint, eligibility, statistical and follow-up details prevented it from supporting efficacy and safety conclusions for ulcerative colitis. FDA PDF pp. 25, 27, 28, 29 ↗
Formulation and duration limit extrapolation
The reviewed trial used a rectal enema, not the nominated suppository. FDA found no ulcerative-colitis studies using the proposed oral, subcutaneous, nasal or transdermal routes. These findings cannot establish effectiveness for tendon or sports injuries. FDA PDF pp. 1, 5, 8, 9 ↗FDA PDF pp. 25, 27, 28, 29 ↗
Safety remains inadequately characterized
FDA described insufficient clinical safety information, limited long-term data and concerns involving peptide impurities, aggregation and immune responses. Its adverse-event reports could not establish causality. FDA PDF pp. 43, 44, 45, 46, 47 ↗
Rectal-enema findings do not validate other formulations
The briefing distinguishes the studied rectal enema from the nominated suppository and other routes. FDA found no human pharmacokinetic data for oral, subcutaneous, nasal or transdermal administration in its reviewed sources. FDA PDF pp. 27, 40 ↗
Assay experiments are not human treatment studies
FDA identified laboratory plasma-metabolism reports used for anti-doping detection in which BPC-157 was not administered to people. Such work must not be counted as a clinical exposure study. FDA PDF pp. 40 ↗
Reported adverse events cannot establish causation or incidence
FDA discussed injection-related reports but noted incomplete information and concomitant substances. Those reports neither prove that BPC-157 caused each event nor establish a reliable adverse-event rate. FDA PDF pp. 41, 44 ↗
What remains to be checked
Check subsequent advisory records and any final FDA action separately from the staff briefing.
Retrieve and appraise the original human reports and proposed formulation or route; agency search findings are dated and do not establish a complete worldwide literature review.
Source dates and review coverage
PDF citations use file page numbers. Named webpage sections and registry fields identify the portions read. These are selected readings, not complete source coverage.
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Catalog-name and calibrated alias discovery for human evidence review. Complete query retrieval is separate from clinical eligibility, study-family linkage and appraisal.
219 retrieved · 2 included · 0 excluded · 217 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"BPC-157"[Title/Abstract] OR "BPC 157"[Title/Abstract] OR "Body protection compound 157"[Title/Abstract]
Retrieved IDs completely represent this query response, not all relevant literature. Additional aliases, references and non-PubMed sources require separate searches.
Unscreened records may include animal or cell experiments, reviews, secondary analyses, mixtures, protocols and unrelated name matches.
Study-family mappings use available declared registry IDs; unresolved mappings do not create independent trial counts. Full-text, corrections and registry comparison remain separate work.
Showing 25 of 219 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 40131143 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: bpc-157-PMID40131143-registry-linkage-unresolved.Bibliographic record recheck · 2026-09-15
The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗
PubMed 40005999 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: bpc-157-PMID40005999-registry-linkage-unresolved.Bibliographic record recheck · 2026-09-15
The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗
PubMed 42667535 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42635865 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42578445 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42555375 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42542926 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42533460 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42385164 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42356491 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42328738 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42278509 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42222211 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42204242 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42198317 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42160466 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42123471 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42123221 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42021992 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 41966639 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 41901308 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 41898733 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 41832718 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 41754849 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 41754776 — not screened: Name-query match awaiting clinical eligibility screening.
FDA search
Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov search
ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.
4 retrieved · 0 included · 0 excluded · 4 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"BPC-157" OR "Body protection compound 157" OR "BPC 157"
Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
Other registries, unregistered studies and additional aliases remain outside this query.
Showing 4 of 4 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT07437547 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07752381 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02637284 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07803250 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
Read the full Human Evidence Review
Supervised synthesis
What do selected human studies report about BPC-157?
A bounded review of one human safety pilot, one literature-and-patent review, and one current human trial protocol.213
Bottom line from this bounded source set
This source set contains a two-person uncontrolled safety pilot, a narrative review dominated by preclinical research, and a recruiting Phase 2 protocol with no posted results. It does not establish human efficacy.213
Reviewed study record
Two-person human safety pilot
Design
An IRB-approved, uncontrolled pilot measured selected laboratory values, vital signs, and participant-reported side effects over a short observation window.2
Population
Two healthy adults at one private clinic participated; both had previously received BPC-157.2
Outcomes reported
The authors reported no measurable changes in the tested biomarkers and no participant-reported side effects during the observation window.2
Limitations
Two previously exposed participants, no comparator, one site, and short follow-up cannot establish general safety or any treatment effect.2
Reviewed study record
Current hamstring-strain protocol
Design
A randomized, parallel, quadruple-masked Phase 2 protocol is listed as recruiting. The registry currently posts a study plan, not results.3
Population
The protocol estimates 120 adults with an acute MRI-confirmed grade II hamstring strain.3
Outcomes reported
Return to unrestricted sport and change in MRI-assessed injury volume are registered primary outcomes; no outcome data are posted.3
Limitations
Recruitment status and planned outcomes do not demonstrate completion, safety, or effectiveness.3
Reviewed study record
Review-level context
Design
A narrative literature-and-patent review summarizes proposed mechanisms, preclinical models, patents, toxicity discussion, and limited clinical context.1
Population
The reviewed activity is primarily drawn from preclinical models rather than controlled human trials.1
Outcomes reported
The review describes favorable findings reported across preclinical models while stating that comprehensive human clinical studies are insufficient.1
Limitations
Narrative synthesis and preclinical findings cannot substitute for controlled human evidence, and the review does not establish clinical benefit.1
No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.3390/ph18020185. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Crossref check unavailableThe reviewed PubMed payload did not include a DOI, so this source could not be matched to a Crossref work endpoint.
ClinicalTrials.gov · NCT07437547BPC 157 for Acute Hamstring Muscle Strain Repair ↗ClinicalTrials.gov history entry 1 · API v2 protocol payload · ETag 883b003/0.34.1/msyfmeiw · reviewed 2026-08-18 · payload SHA-256 12bfc8e25e906a301d3386e85ec82800566378a3b8e16cfcf78075175c8b5e57
Explore status sources, recent additions, and coverage gaps
Living status brief
What is the current status of BPC-157?
Not an FDA-approved drug. FDA presented BPC-157 briefing material at its July 2026 pharmacy-compounding advisory-committee meeting. Committee recommendations are nonbinding and FDA's final determination remains pending; the cited trial registration also does not establish safety or effectiveness.↗↗↗
The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.
PeptideScanner currently has no selected safety records connected to this profile. That is a collection gap, not evidence that no such records exist.
PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.
This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.
1 of 2 selected trial records include at least one phase value; 1 of 2 include a status value in the retained structured contract.
PhasesPhase 1 1
Status at observationNot yet recruiting 1
A phase value is unavailable here for 1 selected record; this is not counted as “no phase.”
A status value is unavailable here for 1 selected record; this is not counted as a trial status.
PubMed bibliography
Publication composition
23 of 48 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Publication typesJournal Article 23Review 8Research Support, Non-U.S. Gov't 3Comparative Study 2Validation Study 1
Bibliography fields unavailable here for 25 selected records; the records remain visible as metadata observations.
Regulatory and publication surfaces
What is structurally connected?
Drugs@FDA applications
0
FDA Federal Register documents
1
DailyMed SPL versions
0
Canonical profile
Published
Profile structured data
Published
Linked dated records
52
Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.
PeptideScanner retained ClinicalTrials.gov record NCT07803250 at 2026-09-09T19:17:17.410Z. Its registry update date was 2026-09-03, and PeptideScanner's reviewed identity mapping was bpc-157.
PubMed lists PMID 33251034 in World journal of gastrointestinal pharmacology and therapeutics as Journal Article, with publication-date metadata of 2020-11-08 (day precision). PeptideScanner associated the retained record with the identity slug bpc-157. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.
The Federal Register published notice 2026-07361, attributed to FDA and its parent HHS department, on 2026-04-16. Its official title is “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List,” and PeptideScanner's exact reviewed identity mapping connects the document to BPC-157, Emideltide, Epitalon, KPV, MOTS-c, Semax and TB-500.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.
These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.
Evidence summary
What the cited records say
FDA presented BPC-157 briefing material at its July 2026 pharmacy-compounding advisory-committee meeting. Committee recommendations are nonbinding and FDA's final determination remains pending; the cited trial registration also does not establish safety or effectiveness.↗↗↗
This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.
PeptideScanner retained ClinicalTrials.gov record NCT07803250 at 2026-09-09T19:17:17.410Z. Its registry update date was 2026-09-03, and PeptideScanner's reviewed identity mapping was bpc-157.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42555375 at 2026-08-10T10:49:12.992Z. PubMed recorded a metadata revision date of 2026-08-05 and an Entrez history date of 2026-08-05. PeptideScanner associated this retained record with the identity slug bpc-157. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 40756949 at 2026-08-10T10:49:06.956Z. PubMed recorded a metadata revision date of 2026-08-01 and an Entrez history date of 2025-08-04. PeptideScanner associated this retained record with the identity slug bpc-157. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42278509 at 2026-08-10T18:13:52.250Z. PubMed recorded a metadata revision date of 2026-07-26 and an Entrez history date of 2026-06-12. PeptideScanner associated this retained record with the identity slug bpc-157. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42356491 at 2026-08-10T18:13:53.763Z. PubMed recorded a metadata revision date of 2026-07-26 and an Entrez history date of 2026-06-26. PeptideScanner associated this retained record with the identity slug bpc-157. These dates describe PubMed metadata history, not the article's original publication date.↗
FDA convened its Pharmacy Compounding Advisory Committee on July 23-24, 2026, to discuss free-base and acetate bulk drug substances across seven peptide-related groups.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41898733 at 2026-08-10T18:13:46.758Z. PubMed recorded a metadata revision date of 2026-07-13 and an Entrez history date of 2026-03-28. PeptideScanner associated this retained record with the identity slug bpc-157. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42385164 at 2026-07-30T16:11:44.943Z. PubMed recorded a metadata revision date of 2026-07-01 and an Entrez history date of 2026-07-01. PeptideScanner associated this retained record with the identity slug bpc-157. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 40789979 at 2026-07-30T16:14:11.079Z. PubMed recorded a metadata revision date of 2026-06-26 and an Entrez history date of 2025-08-11. PeptideScanner associated this retained record with the identity slug bpc-157. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42198317 at 2026-07-30T16:20:45.939Z. PubMed recorded a metadata revision date of 2026-05-29 and an Entrez history date of 2026-05-27. PeptideScanner associated this retained record with the identity slug bpc-157. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42123221 at 2026-07-30T16:20:45.661Z. PubMed recorded a metadata revision date of 2026-05-15 and an Entrez history date of 2026-05-13. PeptideScanner associated this retained record with the identity slug bpc-157. These dates describe PubMed metadata history, not the article's original publication date.↗
The Federal Register published notice 2026-07361, attributed to FDA and its parent HHS department, on 2026-04-16. Its official title is “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List,” and PeptideScanner's exact reviewed identity mapping connects the document to BPC-157, Emideltide, Epitalon, KPV, MOTS-c, Semax and TB-500.↗