TB-500 Medicinal

READOUT / 07 · CITATION REGISTER

TB-500 references and citations: the source record behind every datum.

Each finding logged on this console resolves to one of these primary sources — peer-reviewed studies and FDA pages, with DOIs, PMIDs, and the cardiac-trial registry code.

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The source record

This is the full reference register for the TB-500 references and citations used across the site. Every quantitative claim — the actin-sequestration structure, the wound re-epithelialization figures, the non-monotonic stroke dosing, the human Phase 1 intravenous safety data, the cardiac mechanism and the completed acute-MI trial, and the FDA 503A standing — resolves to a numbered entry below. Where a finding used full-length thymosin beta-4 rather than the 7-mer fragment, the research and cardiac pages carry that tag inline. Regulatory facts are sourced to FDA pages verified loading and containing the cited text. The numbered list is rendered on the page from this register.

  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 beta4 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 beta4: 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 beta4 in healthy volunteers. Ann N Y Acad Sci. 2010;1194:223-229. ↗
  7. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. ↗
  8. 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. ↗
  9. Srivastava D, Saxena A, Dimaio JM, Bock-Marquette I. Thymosin beta4 and cardiac repair. Ann N Y Acad Sci. 2010;1194:87-96. ↗
  10. Peng H, Xu J, Yang XP, et al. Thymosin-beta4 prevents cardiac rupture and improves cardiac function in mice with myocardial infarction. Am J Physiol Heart Circ Physiol. 2014;307(5):H741-H751. ↗
  11. Smart N, Risebro CA, Melville AA, et al. Thymosin beta4 induces adult epicardial progenitor mobilization and neovascularization. Nature. 2007;445(7124):177-182. ↗
  12. TB-500 (thymosin beta-4 fragment) overview: human clinical-data status, pharmacokinetics, anti-doping (WADA) classification, and research/veterinary regulatory context. Compound corpus reference summary (tb-500, revision 2), drawing on the Ruff 2010 Phase 1 study (PMID 20536472), the ClinicalTrials.gov acute-MI registration NCT05984134, and the Mendias & Awan 2026 Sports Med review (PMID 41966639). ↗
  13. Wang Z, Su X, Ashraf M, et al. Thymosin beta4 increases cardiac cell proliferation, cell engraftment, and the reparative potency of mesenchymal stromal cells in a porcine model of myocardial infarction. Theranostics. 2021;11(16):7879-7895. ↗
  14. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (Category 2 entry: 'Thymosin beta-4, fragment (LKKTETQ), also known as TB-500'; effective with the September 29, 2023 nominated-substances update) and the July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting agenda listing 'TB-500 (free base)' and 'TB-500 acetate' as substances being considered for inclusion on the 503A Bulks List. Verified 2026-05-29. ↗
  15. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, and Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (Category 1 and Category 2 definitions; January 7, 2025 revised interim policy under which newly nominated substances are no longer placed in numbered categories and Category 2 substances are not afforded enforcement discretion). Verified 2026-05-29. ↗
  16. U.S. Food and Drug Administration. Human Drug Compounding: the 503A patient-specific and 503B outsourcing-facility framework and the bulk-substance eligibility requirement (lawful access via licensed-prescriber evaluation, valid patient-specific prescription, and a 503A pharmacy or 503B facility; ingredients flagged for significant safety risks are not eligible for routine 503A compounding). Verified 2026-05-29. ↗