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Section 07 · References

The cited record behind the BPC-157 TB-500 digest

Peer-reviewed single-compound studies and the FDA regulatory sources, listed with DOIs and PubMed links.

Back to the researchThe regulatory & access record

Full reference list

Every quantitative and regulatory claim in this BPC-157 TB-500 digest resolves to one of the references below. Citations 1-8 are the peer-reviewed single-compound literature on BPC-157 and Thymosin Beta-4 / TB-500; citations 9-11 are the U.S. Food and Drug Administration sources behind the Wolverine legal status and FDA 503A compounding facts. The blend itself has no controlled trial to cite — that absence is the central finding of this record.

  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. 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. ↗
  6. Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review. HSS J. 2025. (36 studies; 35 preclinical, 1 human; no clinical safety data; no TB-500 or combination mention.) ↗
  7. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. ↗
  8. Regeneration or Risk? A Narrative Review of BPC-157 for Musculoskeletal Healing. Curr Rev Musculoskelet Med. 2025. ↗
  9. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. (Category 2 entries for BPC-157 and for “Thymosin beta-4, fragment (LKKTETQ), also known as TB-500”; effective with the September 29, 2023 update.) ↗
  10. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. (Definitions of Category 1 and Category 2; the 503A bulks-list and nomination framework.) ↗
  11. U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. (Calendar listing BPC-157, KPV, TB-500, and MOTs-C as substances “being considered for inclusion on the 503A Bulks List.” A scheduled discussion, not a decision.) ↗
  12. Cha HJ, Jeong MJ, Kleinman HK. Role of thymosin beta4 in tumor metastasis and angiogenesis. J Natl Cancer Inst. 2003. ↗
  13. 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. ↗
  14. Ruff D, et al. A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin beta4 in healthy volunteers. Ann N Y Acad Sci. 2010. ↗
  15. et al. A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin beta4 in healthy Chinese volunteers. J Cell Mol Med. 2021. ↗