Medicine TB-500

THE RECORD · CITED

TB-500 references: the sources behind every claim

The full citation register for this digest — peer-reviewed studies on TB-500 and thymosin beta-4, plus the FDA and anti-doping sources for the legal and regulatory facts. Each numbered marker on the site resolves here.

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About this reference list

These are the TB-500 references behind every cited claim on this site. Entries 1–18 are peer-reviewed studies and reviews on TB-500 and thymosin beta-4, with DOIs and PubMed identifiers where available. Entries 19–22 are the authoritative FDA and regulatory sources behind the TB-500 legal status page. Where a study used full-length thymosin beta-4 rather than the seven-mer heptapeptide, the body text says so at the point of citation; this list records the source, and the pages record the identity caveat.

  1. Irobi E, Aguda AH, Larsson M, et al. Structural basis of actin sequestration by thymosin-beta4: implications for WH2 proteins. EMBO J. 2004;23(18):3599-3608. ↗
  2. Bock-Marquette I, Saxena A, White MD, DiMaio JM, Srivastava D. Thymosin beta4 activates integrin-linked kinase and promotes cardiac cell migration, survival and cardiac repair. Nature. 2004;432(7016):466-472. ↗
  3. Malinda KM, Sidhu GS, Mani H, et al. Thymosin beta4 accelerates wound healing. J Invest Dermatol. 1999;113(3):364-368. ↗
  4. Morris DC, Cui Y, Cheung WL, et al. A dose-response study of thymosin β4 for the treatment of acute stroke. J Neurol Sci. 2014;345(1-2):61-67. ↗
  5. Goldstein AL, Hannappel E, Sosne G, Kleinman HK. Thymosin β4: a multi-functional regenerative peptide. Basic properties and clinical applications. Expert Opin Biol Ther. 2012;12(1):37-51. ↗
  6. Ruff D, Crockford D, Girardi G, Zhang Y. A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin β4 in healthy volunteers. Ann N Y Acad Sci. 2010;1194:223-229. ↗
  7. Qiu P, Wheater MK, Qiu Y, Sosne G. Thymosin beta4 inhibits TNF-alpha-induced NF-kappaB activation, IL-8 expression, and the sensitizing effects by its partners PINCH-1 and ILK. FASEB J. 2011;25(6):1815-1826. ↗
  8. Sosne G, Qiu P, Christopherson PL, Wheater MK. Thymosin beta 4 suppression of corneal NFkappaB: a potential anti-inflammatory pathway. Exp Eye Res. 2007;84(4):663-669. ↗
  9. Kumar S, Vijayan M, Bhatti JS, et al. Thymosin β4 alleviates renal fibrosis and tubular cell apoptosis through TGF-β pathway inhibition in UUO rat models. BMC Nephrol. 2017;18(1):314. ↗
  10. Evans MA, Smart N, Dubé KN, et al. Thymosin β4: A Multi-Faceted Tissue Repair Stimulating Protein in Heart Injury. Curr Med Chem. 2020;27(37):6294-6305. ↗
  11. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. ↗
  12. Zhu J, et al. Mechanism of thymosin β4 in ameliorating liver fibrosis via the MAPK/NF-κB signaling pathway. J Biochem Mol Toxicol. 2023;37(8):e23338. ↗
  13. Anti-doping LC-MS characterization of TB-500 (the Ac-LKKTETQ thymosin β4 fragment) and its metabolites in equine plasma and urine for detection (representative of the WADA-prohibited / detection literature; see Goldstein 2012 [5] and the Sports Med review [11] for the regulatory framing). ↗
  14. Kim J, et al. Targeted Deletion of Thymosin Beta 4 in Hepatic Stellate Cells Ameliorates Liver Fibrosis. Cells. 2023;12(12):1658. ↗
  15. Wei Y, et al. Inhaled exogenous thymosin beta 4 suppresses bleomycin-induced pulmonary fibrosis. J Pharm Pharmacol. 2024;76(12):1631-1642. ↗
  16. Sosne G, Dunn SP, Kim C. Thymosin β4 and the eye: the journey from bench to bedside (clinical-grade topical thymosin β4, RGN-259, in corneal healing and dry-eye trials). Reviewed in Goldstein AL et al., Expert Opin Biol Ther. 2012;12(1):37-51. ↗
  17. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance (on the scarcity of human safety data, the regulatory-oversight gap, and research-material quality concerns for unapproved peptides). Sports Med. 2026. ↗
  18. Xing Y, Ye Y, Zuo H, Li Y. Progress on the Function and Application of Thymosin β4. Front Endocrinol (Lausanne). 2021;12:767785. ↗
  19. 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 bulk drug substances being considered for inclusion on the 503A bulks list). ↗
  20. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 1 and Category 2 definitions; enforcement-discretion policy; January 7, 2025 finalized interim policy on categorization). ↗
  21. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (Category 2 entry for 'Thymosin beta-4, fragment (LKKTETQ), also known as TB-500'; effective with the September 29, 2023 update; safety rationale including potential immunogenicity for certain routes and a lack of important safety information). ↗
  22. U.S. Food and Drug Administration. Compounding and the FDA: 503A compounding pharmacies and 503B outsourcing facilities; the prescriber-evaluation and valid-prescription pathway, and the bulk-substance eligibility requirement (USP/NF monograph, component of an approved drug, or on the applicable bulks list). ↗