TB-500 MD

RECORD / 07

TB-500 references and source record

Every quantitative claim on this site resolves to one of these entries — peer-reviewed studies, a major review, and the FDA regulatory record, with DOIs and PubMed links.

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How to read these references

These TB-500 references are the source record for the dossier. Most concern thymosin beta-4, the parent protein, because that is where the efficacy literature lives; the entries are labeled so you can see at a glance which findings used the full-length protein versus the heptapeptide. The peptide research is cited from the peer-reviewed literature; the regulatory facts are cited to the FDA pages verified for this build. Full citations, DOIs, and PubMed or FDA URLs are listed below.

  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. Tokura Y, Nakayama Y, Fukada S, et al. Muscle injury-induced thymosin β4 acts as a chemoattractant for myoblasts. J Biochem. 2011;149(1):43-48. ↗
  8. Xiong Y, Mahmood A, Meng Y, et al. Thymosin β4 enhances the healing of medial collateral ligament injury in rats. Regul Pept. 2013;184:1-8. ↗
  9. Spurney CF, Cha HJ, Sali A, 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. 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. ↗
  11. Qiu P, Wheater MK, Qiu Y, Sosne G. Thymosin beta4 promotes matrix metalloproteinase expression during wound repair. J Cell Physiol. 2006;220(3):778-786. ↗
  12. Sosne G, Qiu P, Christopherson PL, Wheater MK. Thymosin beta 4 suppression of corneal NFkappaB: a potential anti-inflammatory pathway. Exp Eye Res. 2007;84(4):663-669. ↗
  13. Stark C, Taimen P, Tarkia M, et al. Cardioprotection by systemic dosing of thymosin beta four following ischemic myocardial injury. Front Pharmacol. 2013;4:149. ↗
  14. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. ↗
  15. Gonzalez-Franquesa A, Gama-Perez P, Kud O, et al. Discovery of thymosin β4 as a human exerkine and growth factor. Am J Physiol Cell Physiol. 2021;321(5):C770-C778. ↗
  16. U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. FDA Advisory Committee Calendar. Lists BPC-157, KPV, TB-500, and MOTs-C as bulk drug substances being considered for inclusion on the 503A Bulks List (scheduled discussion; not a decision). ↗
  17. 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' as a 503A Category 2 substance, effective with the September 29, 2023 update. ↗
  18. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Defines the 503A/503B framework, the bulk-substance eligibility rule (USP/NF monograph, component of an approved drug, or on the FDA bulks list), the Category 1 and Category 2 distinction, and the January 7, 2025 change under which newly nominated substances are no longer placed into numbered categories. ↗