THE RECORD -- PANEL No.7

References behind the TB-500 digest.

Every figure on this site maps to one of these. Peer-reviewed studies on thymosin beta-4 and its actin-binding fragment, plus the FDA regulatory sources.

How to read these TB-500 references

These are the references for every quantitative claim in this TB-500 digest, numbered to match the inline markers across the site. They divide into two groups. References one through fifteen are the peer-reviewed scientific literature on thymosin beta-4 and its Ac-LKKTETQ fragment — structure, mechanism, wound, cardiac, neurological, and recent work. References sixteen through eighteen are the authoritative FDA sources behind the regulatory and access statements on the TB-500 legal status and FDA 503A category page; each was verified against a live FDA.gov page.

One note carries across the whole list, as it does across the whole site: where a study used full-length thymosin beta-4 rather than the TB-500 heptapeptide, the digest says so in the running text. The citation list does not relitigate that each time — the distinction lives in how each finding is described. Where a primary identifier is available it is a PubMed link; where the canonical record is a journal landing page, a DOI is given instead.

If you find a figure on this site that does not match its cited source, the contact page is the channel for a correction. Accuracy against the published record is the only thing this digest is for.

  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, 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, 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. Xiong Y, Mahmood A, Meng Y, et al. Neuroprotective and neurorestorative effects of thymosin β4 treatment following experimental traumatic brain injury. J Neurosurg. 2012;116(5):1081-1092.
  8. Morris DC, Chopp M, Zhang L, et al. Thymosin beta4 improves functional neurological outcome in a rat model of embolic stroke. Neuroscience. 2010;169(2):674-682.
  9. 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.
  10. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026.
  11. Su Y, Xu J, Zhu Z, et al. Thymosin β4 promotes zebrafish Mauthner axon regeneration by facilitating actin dynamics. BMC Biol. 2024;22(1):238.
  12. Kim J, Hwang S, Lee S, et al. Targeted Deletion of Thymosin Beta 4 in Hepatic Stellate Cells Ameliorates Liver Fibrosis. Cells. 2023;12(12):1658.
  13. Sosne G, Qiu P, Kurpakus-Wheater M, et al. Activation of pro-resolving pathways mediate the therapeutic effects of thymosin beta-4. Front Immunol. 2024;15:1458684.
  14. Zhang Y, Li L, Wang J, et al. Tβ4-exosome-loaded hemostatic and antibacterial hydrogel to improve vascularized wound repair. Mater Today Bio. 2025;30:101585.
  15. Wang L, Chen X, Liu Y, 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," placed in 503A Category 2; effective with the September 29, 2023 nominated-substances update; page verified 2026-05-29.)
  17. U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. (Published agenda listing "TB-500 (free base)" / "TB-500 acetate," alongside 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.)
  18. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. (Definitions of 503A/503B and Category 1/Category 2; the bulks-list and nomination framework; the role of the Pharmacy Compounding Advisory Committee; verified 2026-05-29.)