Prescribed TB-500

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TB-500 References and Sources

The full citation register behind every figure on this site — the peer-reviewed thymosin beta-4 literature and the FDA regulatory record, each resolvable by DOI, PMID or URL.

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How to read this register

Every quantitative claim on this site maps to a numbered entry below. The list covers the structural and biochemical work that establishes the actin-binding mechanism, the animal and human studies behind the researched effects, the 2024-2026 recent literature, and the FDA sources behind the legal-status page. Where a finding used full-length thymosin beta-4 rather than the Ac-LKKTETQ fragment, the body text says so — the studies cited on this site are listed here in full so any claim can be checked at the source. Entries 16-18 are the primary FDA pages behind the 503A and PCAC statements.

  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. Philp D, Badamchian M, Scheremeta B, et al. Thymosin beta 4 and a synthetic peptide containing its actin-binding domain promote dermal wound repair in db/db diabetic mice and in aged mice. Wound Repair Regen. 2003;11(1):19-24. ↗
  8. Safer D, Elzinga M, Nachmias VT. Interaction of thymosin beta 4 with muscle and platelet actin: implications for actin sequestration in resting platelets. Biochemistry. 1992;31(28):6360-6365. ↗
  9. Goldstein AL, Kleinman HK. Thymosin beta4: actin-sequestering protein moonlights to repair injured tissues. Trends Mol Med. 2005;11(9):421-429. ↗
  10. Morris DC, Chopp M, Zhang L, Lu M, Zhang ZG. Thymosin beta4 improves functional neurological outcome in a rat model of embolic stroke. Neuroscience. 2010;169(2):674-682. ↗
  11. Sosne G, Rimmer D, Kleinman HK, Ousler G. 0.1% RGN-259 (Thymosin β4) Ophthalmic Solution Promotes Healing and Improves Corneal Integrity. Int J Mol Sci. 2022;24(1):554. ↗
  12. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. ↗
  13. Sosne G, Qiu P, Kurpakus-Wheater M, Matthew HL. Activation of pro-resolving pathways mediate the therapeutic effects of thymosin beta-4. Front Immunol. 2024;15:1458684. ↗
  14. Zhang Y, et al. Tβ4-exosome-loaded hemostatic and antibacterial hydrogel to improve vascularized wound repair. Mater Today Bio. 2025;32:101585. ↗
  15. Wang L, et al. Thymosin β4 improves the survival of cutaneous flaps of rat and activates Wnt/β-catenin signaling. Arch Med Sci. 2024. ↗
  16. 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 with the September 29, 2023 nominated-substances update.) Verified 2026-05-29. ↗
  17. 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/503B framework and PCAC nomination process.) Verified 2026-05-29. ↗
  18. U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. (Published agenda lists 'TB-500 (free base)' / 'TB-500 acetate', BPC-157, KPV, and MOTs-C as bulk drug substances being considered for inclusion on the 503A Bulks List — a scheduled discussion, not a decision.) Verified 2026-05-29. ↗