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Sources

TB-500 source bibliography

The dose-response paper offers the clearest entry into this collection. The full source list also includes experiments with very different questions and very different molecules.

Dose response and exposure

Morris and colleagues’ rat stroke dose-response study is the starting point for this site. The intravenous healthy-volunteer study describes human exposure to full-length thymosin beta-4, while the chronic mdx mouse experiment tests muscle and cardiac function. Each makes a different comparison.

The rat study frustrates my wish for a tidy repair story. The larger tested amount gave no significant benefit. That fact deserves to remain attached to the positive lower-dose result.

Molecules and tissues

The actin-complex structure, equine TB-500 analysis and preparation-characterization study address different aspects of substance identity and action. The wound, cardiac and follicle papers extend the parent-protein record across tissues. The tumor-metastasis study and pancreatic cancer-cell study explain the preclinical safety concern.

The complete audited citations are listed below, including their original titles and identifiers. A paper's title can use broader language than the particular result discussed in an article.

FDA documents

The FDA safety-risk page with the withdrawn nomination, 503A bulk-substance framework and July 2026 advisory-committee agenda support the legal-status discussion. The dates retained in the citations describe the recorded FDA material; they supply no date for an unannounced removal decision or an unpublished committee vote.

  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. Cha HJ, Jeong MJ, Kleinman HK. Role of thymosin beta4 in tumor metastasis and angiogenesis. J Natl Cancer Inst. 2003;95(22):1674-1680. ↗
  8. 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;7(3):419-423. ↗
  9. 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;5(1):e8976. ↗
  10. Goldstein AL, Kleinman HK. Thymosin beta4: actin-sequestering protein moonlights to repair injured tissues. Trends Mol Med. 2005;11(9):421-429. ↗
  11. Sosne G, Qiu P, Christopherson PL, Wheater MK. Thymosin β4 Promotes Dermal Healing. Vitam Horm. 2016;102:251-275. ↗
  12. Gao X, et al. Thymosin Beta-4 Induces Mouse Hair Growth. PLoS One. 2015;10(6):e0130040. ↗
  13. Xiao X, et al. Multiple potential roles of thymosin β4 in the growth and development of hair follicles. J Cell Mol Med. 2021;25(3):1350-1358. ↗
  14. Philp D, et al. Thymosin beta4 promotes angiogenesis, wound healing, and hair follicle development. Mech Ageing Dev. 2004;125(2):113-115. ↗
  15. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. ↗
  16. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. Lists "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500" under "Bulk drug substances nominated but withdrawn," after its Category 2 entry dated 2023-09-29; content current 2026-04-22 and checked 2026-09-17. ↗
  17. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Source for the Category 1 / Category 2 definitions and the bulks-list nomination framework; 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 / acetate), BPC-157, KPV, and MOTs-C as bulk substances being considered for inclusion on the 503A Bulks List; verified 2026-05-29. ↗
  19. 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. ↗
  20. Delcourt V, et al.. TB500/TB1000 and SGF1000: A scientific approach for a better understanding of misbranded and adulterated drugs. Drug Test Anal. 2023. ↗