Reviews TB-500

EXHIBIT No. 07 // THE SOURCE REGISTER

TB-500 references and citations

Every study cited in this case review, with journal, year, DOI, and PubMed or source link.

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How to read this register

These are the sources behind every quantitative claim in this file. Where a finding was generated on the full-length parent protein, thymosin beta-4, rather than the TB-500 heptapeptide, the body text says so — and most of them were. The regulatory sources are FDA primary pages and one secondary legal analysis. The TB-500 references and citations below carry the journal, year, and a resolvable DOI or URL for each entry.

  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, Girard 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. Sosne G, Szliter EA, Barrett R, Kernacki KA, Kleinman H, Hazlett LD. Thymosin beta 4 promotes corneal wound healing and decreases inflammation in vivo following alkali injury. Exp Eye Res. 2002;74(2):293-299. ↗
  8. Sosne G, Qiu P, Christopherson PL, Wheater MK. Thymosin β4 Promotes Dermal Healing. Vitam Horm. 2016;102:251-275. ↗
  9. Qiu P, Wheater MK, Qiu Y, Sosne G. Thymosin beta4 promotes matrix metalloproteinase expression during wound repair. J Cell Physiol. 2006;208(2):447-456. ↗
  10. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. ↗
  11. El-Sayed N, et al. The combined impact of thymosin beta 4 and selenium on diabetic ulcers: a comparative study. Discover Biotechnology. 2025. ↗
  12. Kim TI, et al. Engineered Tandem Thymosin Peptide Promotes Corneal Wound Healing. Invest Ophthalmol Vis Sci. 2025;66(14):31. ↗
  13. Sosne G, et al. Activation of pro-resolving pathways mediate the therapeutic effects of thymosin beta-4. Front Immunol. 2024;15:1458684. ↗
  14. Wang L, et al. Thymosin β4 improves the survival of cutaneous flaps of rat and activates Wnt/β-catenin signaling. Arch Med Sci. 2024. ↗
  15. Zhang Y, et al. Tβ4-exosome-loaded hemostatic and antibacterial hydrogel to improve vascularized wound repair. Mater Today Bio. 2025;32:101585. ↗
  16. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (entry: "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500"; Category 2, effective with the September 29, 2023 nominated-substances update). FDA.gov. ↗
  17. U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (agenda listing "TB-500 (free base)" / "TB-500 acetate," alongside BPC-157, KPV, and MOTs-C, as substances being considered for inclusion on the 503A Bulks List). FDA.gov. ↗
  18. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (definitions of Category 1 and Category 2; the 503A/503B framework; the January 7, 2025 change to categorization of newly nominated substances). FDA.gov. ↗
  19. U.S. Food and Drug Administration. Human Drug Compounding (the lawful access pathway: licensed-prescriber evaluation and patient-specific prescription, dispensed by a state-licensed 503A pharmacy or an FDA-registered 503B outsourcing facility; ingredient-eligibility under the bulk-substance rules). FDA.gov. ↗
  20. McDermott Will & Emery. End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists (analysis of the January 7, 2025 FDA action; existing Category 1 substances retain enforcement discretion, Category 2 substances do not regain it). ↗