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Cell movement, supporting tissue and the work of repair

TB-500 references

The wound experiment is the beginning of this collection. The papers below follow repair into cell movement, blood supply, useful function and safety.

Begin with the rat woundsAbout this site

Wounds, actin and useful function

For the skin-wound findings, start with Malinda and colleagues’ rat experiment. For the underlying cell machinery, Irobi and colleagues’ actin structure is the more technical stop. I particularly value the muscle-function experiment because its tissue observations and strength findings resist an easy conclusion.

The healthy-volunteer safety study concerns full-length thymosin beta-4. For the regulatory record, consult FDA’s safety-risk entry alongside its Section 503A framework. The list includes reviews, cell and animal experiments, human parent-protein research and regulatory records; each source answers a particular question.

Sources

  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, Chopp M, Zhang L, 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. Grant DS, Kinsella JL, Kibbey MC, et al. Thymosin beta4 and angiogenesis: modes of action and therapeutic potential. Angiogenesis. 2007;10(2):137-145. ↗
  8. Jo JO, Kang YJ, Ock MS, et al. Thymosin β4 induces the expression of vascular endothelial growth factor (VEGF) in a hypoxia-inducible factor (HIF)-1α-dependent manner. Biochim Biophys Acta. 2010;1803(11):1244-1251. ↗
  9. Chen Y, Yang S, Yu W, et al. Thymosin β4 released from functionalized self-assembling peptide activates cardiac cells and promotes cardiac repair. Theranostics. 2021;11(9):4262-4280. ↗
  10. Guarnera G, DeRosa A, Camerini R. 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. ↗
  11. 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. ↗
  12. Goldstein AL, Kleinman HK. Thymosin beta4: actin-sequestering protein moonlights to repair injured tissues. Trends Mol Med. 2005;11(9):421-429. ↗
  13. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. ↗
  14. Zhang Y, et al. Tβ4-exosome-loaded hemostatic and antibacterial hydrogel to improve vascularized wound repair. Mater Today Bio. 2025;31:101585. ↗
  15. Stark C, Taimen P, Tarkia M, et al. Systemic Dosing of Thymosin Beta 4 before and after Ischemia Does Not Attenuate Global Myocardial Ischemia-Reperfusion Injury in Pigs. Front Pharmacol. 2016;7:115. ↗
  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'; effective 2023-09-29.) ↗
  17. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. ↗
  18. 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', BPC-157, KPV, and MOTs-C as bulk drug substances being considered for inclusion on the 503A Bulks List.) ↗
  19. Note on unconfirmed reports: commercial and clinic sources reporting an early-2026 reclassification of Category 2 peptides toward Category 1, or specific 2026 dates on which TB-500 was 'removed' from Category 2, could not be confirmed from an authoritative FDA source as of 2026-05-29 and are not treated here as completed FDA action. The site instead follows FDA's own page, current as of April 22, 2026, which no longer lists TB-500 in Category 2 and gives no date for that change. ↗
  20. Cha HJ, Jeong MJ, Kleinman HK. Role of thymosin beta4 in tumor metastasis and angiogenesis. J Natl Cancer Inst. 2003. ↗
  21. Zhang Y, et al.. Thymosin beta 4 is overexpressed in human pancreatic cancer cells and stimulates proinflammatory cytokine secretion and JNK activation. Cancer Biol Ther. 2008. ↗
  22. Ho EN, et al.. Doping control analysis of TB-500, a synthetic version of an active region of thymosin β4, in equine urine and plasma by liquid chromatography-mass spectrometry. J Chromatogr A. 2012. ↗
  23. Spurney CF, et al.. Evaluation of skeletal and cardiac muscle function after chronic administration of thymosin beta-4 in the dystrophin deficient mouse. PLoS One. 2010. ↗
  24. Delcourt V, et al.. TB500/TB1000 and SGF1000: A scientific approach for a better understanding of misbranded and adulterated drugs. Drug Test Anal. 2023. ↗