Pharmacy TB-500

Citations · 07

TB-500 References and Citations

Every quantitative claim on this site resolves to a numbered entry below, with a DOI or PubMed link and, for regulatory facts, the FDA page verified to contain the entry.

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How to read these TB-500 references

These TB-500 references are the source for every numbered marker in the digest. Entries 1–10 are the peer-reviewed mechanistic and tissue-repair literature, including the human Phase 1 safety study [6]. Entries 11–16 are the recent 2021–2026 thymosin beta-4 studies and the 2026 Sports Medicine review. Entries 17–19 are the FDA regulatory sources behind the legal-status page, each verified on 2026-05-29 to load and to contain the cited entry.

The single most important note carries across the whole list: where an entry describes work on full-length thymosin beta-4 (~4963 Da) rather than the TB-500 heptapeptide (Ac-LKKTETQ, ~889 Da), that is the molecule the finding belongs to. The full citation list follows.

  1. Irobi E, 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, et al. Thymosin beta4 activates integrin-linked kinase and promotes cardiac cell migration, survival and cardiac repair. Nature. 2004;432(7016):466-472. ↗
  3. Malinda KM, et al. Thymosin beta4 accelerates wound healing. J Invest Dermatol. 1999;113(3):364-368. ↗
  4. Morris DC, 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, et al. 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. Guarnera G, et al. Thymosin beta-4 and venous ulcers: clinical remarks on a European prospective, randomized study of safety, tolerability, and enhancement of healing. Ann N Y Acad Sci. 2007;1112:407-412. ↗
  8. Kim S, Kwon J. Thymosin beta 4 improves dermal burn wound healing via downregulation of receptor for advanced glycation end products in db/db mice. Biochim Biophys Acta. 2014;1840(12):3452-3459. ↗
  9. Goldstein AL, Kleinman HK. Thymosin beta4: actin-sequestering protein moonlights to repair injured tissues. Trends Mol Med. 2005;11(9):421-429. ↗
  10. TB-500 (Thymosin beta-4 fragment, Ac-LKKTETQ). Compound overview and identifiers (parent protein thymosin beta-4 / TMSB4X, UniProt P62328). ↗
  11. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. ↗
  12. Chen Y, et al. Thymosin β4 released from functionalized self-assembling peptide activates cardiac cells and promotes cardiac repair. Theranostics. 2021;11(10):4720-4740. ↗
  13. Wei Y, et al. Inhaled exogenous thymosin beta 4 suppresses bleomycin-induced pulmonary fibrosis. J Pharm Pharmacol. 2024. ↗
  14. Su Y, et al. Thymosin β4 promotes zebrafish Mauthner axon regeneration by facilitating actin dynamics. BMC Biol. 2024;22(1):241. ↗
  15. Lee Y, et al. Thymosin β4 Regulates Tissue Inflammatory Response in Mouse Nonalcoholic Fatty Liver Disease. J Inflamm Res. 2025;18:5879-5894. ↗
  16. Kim TI, et al. Engineered Tandem Thymosin Peptide Promotes Corneal Wound Healing. Invest Ophthalmol Vis Sci. 2025;66(14):31. ↗
  17. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks — list entry 'Thymosin beta-4, fragment (LKKTETQ), also known as TB-500,' Category 2 (effective 2023-09-29). Page verified 2026-05-29. ↗
  18. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act — Category 1 / Category 2 definitions, the 503A/503B framework, and the PCAC nomination process. Page verified 2026-05-29. ↗
  19. U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee — public agenda listing 'TB-500 (free base)' / 'TB-500 acetate' (with BPC-157, KPV, MOTs-C) as substances being considered for inclusion on the 503A Bulks List. Scheduled discussion, not a decision. Page verified 2026-05-29. ↗