References · The record, indexed

TB-500 References: The Citations Behind Every Number

Every quantitative claim on this site maps to a numbered entry below. Most efficacy studies used full-length thymosin beta-4; the regulatory entries are FDA primary sources.

How to read this list

These are the TB-500 references that ground the digest. Entries 1–15 are the thymosin beta-4 and TB-500 research record — biochemistry, cardiac, wound, stroke, and the 2024–2026 updates — and most of the efficacy work was conducted with the full-length parent protein, which the digest flags wherever it applies [5]. Entries 16–19 are the regulatory record: a 2026 peptide review and three FDA primary sources for the 503A standing and the July 2026 PCAC evaluation [16][17][18][19]. Each entry carries a DOI or PubMed link so the source can be checked directly.

  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. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance (review noting mixed and negative preclinical results, including the mdx-mouse and porcine ischemia-reperfusion findings). Sports Med. 2026.
  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. Smart N, et al. Thymosin β4 is an essential paracrine factor of embryonic endothelial progenitor cell-mediated vasculogenesis. Circulation. 2008.
  8. Bock-Marquette I, et al. Thymosin beta4 is cardioprotective after myocardial infarction. Ann N Y Acad Sci. 2007;1112:51-62.
  9. Stark C, et al. Cardioprotection by systemic dosing of thymosin beta four following ischemic myocardial injury. Front Pharmacol. 2013;4:149.
  10. Peng H, et al. Thymosin-β4 prevents cardiac rupture and improves cardiac function in mice with myocardial infarction. Am J Physiol Heart Circ Physiol. 2014;307(5):H741-H751.
  11. Srivastava D, Saxena A, Dimaio JM, Bock-Marquette I. Thymosin beta4 and cardiac repair. Ann N Y Acad Sci. 2010;1194:87-96.
  12. Sosne G, et al. Activation of pro-resolving pathways mediate the therapeutic effects of thymosin beta-4. Front Immunol. 2024;15:1458684.
  13. 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.
  14. Zhang Y, et al. Tβ4-exosome-loaded hemostatic and antibacterial hydrogel to improve vascularized wound repair. Mater Today Bio. 2025;31:101585.
  15. Wang L, et al. Thymosin β4 improves the survival of cutaneous flaps of rat and activates Wnt/β-catenin signaling. Arch Med Sci. 2024.
  16. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance (lists TB-500/thymosin β4 and BPC-157 among unapproved peptides; notes scarce human safety data and WADA-prohibited standing). Sports Med. 2026.
  17. 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. FDA.gov (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, the 503A/503B framework, the bulks-list and PCAC nomination process, and the January 7, 2025 interim-policy revision. FDA.gov (verified 2026-05-29).
  19. 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' (with BPC-157, KPV, and MOTs-C) as bulk drug substances 'being considered for inclusion on the 503A Bulks List.' FDA.gov (verified 2026-05-29).