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Where each fact came from

TB-500 claims on this site lead back to these sources.

The list includes lab and animal work, a Phase 1 early safety trial, and thymosin beta-4 studies. PubMed holds study summaries, ClinicalTrials.gov holds trial records, DOI pages lead to papers, and FDA.gov holds agency pages.

Return to the studiesReturn to FDA facts

The number beside a claim matches the same number here

Every source used on the TB-500 pages appears here. When you see a number beside a claim, match that number with the entry below. The note tells you whether scientists used full thymosin beta-4 or the short TB-500 piece. It also names whom they studied: people, test animals, or cells kept alive in a lab. Newer TB-500 and thymosin beta-4 work comes near the end, followed by FDA pages.

  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. RegeneRx / ReGenTree. Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye (ARISE-3). ClinicalTrials.gov identifier NCT03937882. 2020. ↗
  8. Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction. ClinicalTrials.gov identifier NCT05984134. 2023. ↗
  9. RegeneRx. A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction (withdrawn). ClinicalTrials.gov identifier NCT01311518. 2011. ↗
  10. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. ↗
  11. Gonzalez-Franquesa A, et al. Discovery of thymosin β4 as a human exerkine and growth factor. Am J Physiol Cell Physiol. 2021;321(5):C770-C778. ↗
  12. Zhang Y, et al. Tβ4-exosome-loaded hemostatic and antibacterial hydrogel to improve vascularized wound repair. Mater Today Bio. 2025;31:101585. ↗
  13. El-Sayed N, et al. The combined impact of thymosin beta 4 and selenium on diabetic ulcers: a comparative study. Discover Biotechnology. 2025. ↗
  14. Rahaman KA, et al. Simultaneous quantification of TB-500 and its metabolites in in-vitro experiments and rats by UHPLC-Q-Exactive orbitrap MS/MS and their screening by wound healing activities in-vitro. J Chromatogr B Analyt Technol Biomed Life Sci. 2024;1235:124033. ↗
  15. Kim TI, et al. Engineered Tandem Thymosin Peptide Promotes Corneal Wound Healing. Invest Ophthalmol Vis Sci. 2025;66(14):31. ↗
  16. U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (agenda lists TB-500, BPC-157, KPV, and MOTs-C as bulk drug substances being considered for inclusion on the 503A Bulks List). Verified 2026-05-29. ↗
  17. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (entry for "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500": Category 2 effective 2023-09-29, a withdrawn nomination on the page current as of 2026-04-22). 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; January 7, 2025 revised interim policy; 503A/503B framework). Verified 2026-05-29. ↗
  19. Cha HJ, Jeong MJ, Kleinman HK. Role of thymosin beta4 in tumor metastasis and angiogenesis. J Natl Cancer Inst. 2003. ↗
  20. 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. ↗
  21. 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. ↗
  22. 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. ↗
  23. Delcourt V, et al. TB500/TB1000 and SGF1000: A scientific approach for a better understanding of misbranded and adulterated drugs. Drug Test Anal. 2023. ↗