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Manifest / 07

BPC-157 TB-500 references: the cited source register

Every quantitative claim on this site resolves to an entry below — peer-reviewed studies, reviews, and FDA primary sources, with DOI or PubMed and FDA URLs.

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The cited source register

This register lists every source cited across the manifest. Entries 1-13 are the peer-reviewed literature for the two constituents; entries 14-16 are the WADA and FDA regulatory record; entries P1-P4 are the audited FDA compounding sources used on the Wolverine legal status and 503A compounding page. The full citation detail is in the references index below.

  1. Staresinic M, et al. Gastric pentadecapeptide BPC 157 accelerates healing of transected rat Achilles tendon and in vitro stimulates tendocytes growth. J Orthop Res. 2003;21(6):976-983. ↗
  2. Hsieh MJ, et al. Therapeutic potential of pro-angiogenic BPC157 is associated with VEGFR2 activation and up-regulation. J Mol Med (Berl). 2017;95:323-333. ↗
  3. Irobi E, et al. Structural basis of actin sequestration by thymosin-beta4: implications for WH2 proteins. EMBO J. 2004. ↗
  4. Goldstein AL, Hannappel E, Sosne G, Kleinman HK. Thymosin beta4: a multi-functional regenerative peptide. Basic properties and clinical applications. Expert Opin Biol Ther. 2012. ↗
  5. Composition and handling note: commercial 'Wolverine' research products pair BPC-157 and TB-500 at fixed combined masses (e.g. 10 mg + 10 mg per vial) with no standardized, clinically validated composition or ratio; both constituents are supplied as lyophilized powders for research use. Identity, purity, and ratio in unregulated material are not guaranteed. (Editorial summary of the research-product record.)
  6. Ho ENM, et al. Doping control analysis of TB-500, a synthetic version of an active region of thymosin beta4, in equine urine and plasma by liquid chromatography-mass spectrometry. J Chromatogr A. 2012. ↗
  7. Tumor/angiogenesis safety consideration: thymosin beta-4 is overexpressed in several cancers and implicated in metastasis and tumor angiogenesis; the same pro-migratory, pro-angiogenic properties that aid repair could theoretically support tumor progression — a documented consideration, not a demonstrated human outcome. (As consolidated in Goldstein AL, et al. Expert Opin Biol Ther. 2012; PMID 22074294.) ↗
  8. Negative/null preclinical result: chronic thymosin beta-4 in dystrophin-deficient mdx mice increased the number of regenerating muscle fibers but did not improve strength, cardiac function, or fibrosis (dosing 150 microg twice weekly IP over 6 months). (As summarized in the thymosin beta-4 regenerative-peptide literature; Goldstein AL, et al. Expert Opin Biol Ther. 2012; PMID 22074294.) ↗
  9. Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review. HSS J. 2025. Included 36 studies (35 preclinical, 1 human); found no clinical safety data; level IV-V evidence; no mention of TB-500 or combination use. ↗
  10. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. Narrative review of BPC-157 and TB-500/thymosin beta-4: favorable tissue-repair outcomes in animal models, scarce rigorous human safety data, potential for serious harm, largely outside regulatory oversight; no defined combination synergy. ↗
  11. Regeneration or Risk? A Narrative Review of BPC-157 for Musculoskeletal Healing. Curr Rev Musculoskelet Med. 2025. Concludes human data for BPC-157 are extremely limited (three pilot studies), rigorous large-scale trials are lacking, and BPC-157 should be considered investigational; also bounds the human reference points for full-length thymosin beta-4. ↗
  12. Esposito S, et al. Synthesis and characterization of the N-terminal acetylated 17-23 fragment of thymosin beta 4 identified in TB-500, a product suspected to possess doping potential. Drug Test Anal. 2012. (Anchors TB-500 = Ac-LKKTETQ identity; non-monotonic thymosin beta-4 dose-response is reported in the rat embolic-stroke literature consolidated in PMID 22074294.) ↗
  13. World Anti-Doping Agency Prohibited List: BPC-157 falls under the S0 non-approved-substances category; TB-500 / thymosin beta-4 falls under prohibited peptide, growth-factor, and tissue-repair categories. Detection methods for TB-500 in equine plasma/urine (LOD ~0.01-0.02 ng/mL) reported in Ho ENM, et al. J Chromatogr A. 2012; PMID 23084823. ↗
  14. Regulatory status summary: neither BPC-157 nor TB-500 is approved by the FDA for human use, and the blend has no approved therapeutic indication; both constituents are WADA-prohibited. TB-500 reference standard synthesis/characterization in Esposito S, et al. Drug Test Anal. 2012; PMID 22962027. ↗
  15. U.S. FDA. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. FDA placed BPC-157 and 'Thymosin beta-4, fragment (LKKTETQ), also known as TB-500' in Category 2 (significant safety risks; not within FDA's enforcement-discretion policy for 503A compounding), effective with the September 29, 2023 update to the nominated-substances list. ↗
  16. U.S. FDA. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Definitions of the 503A/503B framework and Category 1 (covered by FDA's enforcement-discretion policy while under evaluation) versus Category 2 (identified as raising significant safety risks; not afforded that discretion); the bulks-list / nomination process informed by the Pharmacy Compounding Advisory Committee. ↗
  17. U.S. FDA. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. BPC-157 ('BPC-157 (free base)' / 'BPC-157 acetate') and 'Thymosin beta-4, fragment (LKKTETQ), also known as TB-500' placed in Category 2, effective with the September 29, 2023 update, citing potential immunogenicity for certain routes and peptide impurity/characterization complexities. ↗
  18. U.S. FDA. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. Public calendar listing BPC-157, KPV, TB-500, and MOTs-C as bulk drug substances 'being considered for inclusion on the 503A Bulks List' to be discussed at this scheduled meeting — a scheduled discussion, not a decision or outcome. ↗
  19. U.S. FDA. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (lawful access pathway). A legally compounded medication is prepared only after a licensed prescriber evaluates an individual patient (in person or via compliant telehealth), determines a compounded preparation is appropriate, and issues a valid patient-specific prescription; dispensed by a state-licensed 503A pharmacy or sourced from an FDA-registered 503B outsourcing facility, and only when the active ingredient is eligible under the 503A/503B bulk-substance rules. ↗