Issue No. 02 · independently reviewed source log

The BPC-157 Evidence Audit: source log.

The inspectable claim ledger behind Issue 02. Every number, attribution, limitation, and link passed independent review on July 18, 2026.

12claims in the reviewed ledger

5primary or official sources

3claims cut or narrowed

0products or vendors recommended

Claim ledger

C-01

The 2025 review screened 544 papers.

Use only with the review's own screening description; do not call all 544 clinical studies.

Vasireddi et al., 2025

C-02

The review identified one human musculoskeletal study.

The statement is scoped to that systematic review and musculoskeletal evidence.

Vasireddi et al., 2025

C-03

The knee report was retrospective and uncontrolled.

No randomized comparison group or blinding was described.

Lee & Padgett, 2021

C-04

Sixteen of seventeen identified patients were reached.

Twelve received BPC-157 alone; four received BPC-157 plus TB4.

Lee & Padgett, 2021

C-05

The report did not document structural tendon or cartilage repair.

No standardized functional tool or follow-up imaging was used to establish repair.

Lee & Padgett, 2021

C-06

NCT02637284 was canceled in 2016; the registry status now displays “Unknown.”

A canceled study without posted results is not a positive or negative efficacy result.

ClinicalTrials.gov

C-07

FDA's 2026 review evaluated BPC-157 for ulcerative colitis.

Do not generalize that regulatory review to tendon repair or every marketed use.

FDA briefing

C-08

FDA found no UC studies using the proposed oral, subcutaneous, nasal, or transdermal routes.

The route and population are part of the claim.

FDA briefing

C-09

FDA identified limited rectal-enema research.

FDA said the evidence did not support effectiveness and was inadequate for long-term safety characterization.

FDA briefing

C-10

FDA staff recommended against 503A Bulks List inclusion.

Label explicitly as staff position before the committee meeting, not a committee vote or final determination.

FDA briefing · briefing introduction

C-11

No controlled human tendon-repair trial was identified.

This is an inference from the cited review and FDA record, scoped to the searches they report.

Systematic review · FDA briefing

C-12

Regulatory status and evidence volume are separate.

An administrative category change or advisory vote does not add clinical participants to the literature.

FDA briefing introduction

Primary and official sources

Vasireddi et al., 2025

Systematic review of emerging orthopedic and sports-medicine use. PubMed record →

Lee & Padgett, 2021

Retrospective knee-pain report. PubMed record →

ClinicalTrials.gov NCT02637284

PCO-02 / Bepecin study canceled in 2016; current registry status displays “Unknown.” Registry record →

FDA BPC-157 briefing, July 2026

Official staff review of chemistry, history, effectiveness, safety, and 503A criteria. FDA PDF →

FDA PCAC briefing introduction, July 2026

Explains that briefing packages seek advisory input and precede a final FDA determination. FDA PDF →

Claims considered, then cut or narrowed

Cut: “BPC-157 has never been tested in humans.”

False as written. Limited human reports and short rectal-enema studies exist. The defensible claim is that controlled human evidence for the common recovery and tendon claims is missing.

Cut: “BPC-157 is unsafe.”

The available human record is too small to characterize safety confidently. Insufficient safety evidence is not proof of harm or proof of safety.

Narrowed: “544 studies prove nothing.”

Overbroad and dismissive. The preclinical literature can support biological hypotheses. It does not by itself establish human clinical outcomes.

Counting boundary: These counts describe this source log. Sitewide trust totals are calculated separately from the verification-log recipe, so overlapping claims and sources are not double-counted.