TB-500 Legit

READOUT / 07 — CITATION REGISTER

TB-500 references and citations, indexed to source.

Every quantitative claim on this site maps to an entry below. Parent-protein studies are noted as such where the distinction matters.

Back to the researchLegal status sources

How to read this register

These TB-500 references are the full source list for the digest. Entries 1 through 17 are the compound corpus — structural, mechanistic, wound-healing, cardiac, neurological, and human Phase 1 studies of thymosin beta-4 and its Ac-LKKTETQ fragment, plus the 2025-2026 literature. Entries 18 through 22 are the audited regulatory and access sources behind the TB-500 legal status and FDA 503A category page.

Where a study used full-length thymosin beta-4 rather than the seven-residue fragment, that is the parent protein the marketing borrows from — the single most important thing this register is built to keep visible. Each entry below carries its DOI, PMID, or NCT identifier and a resolving link.

  1. TB-500 compound corpus (rev. 2): synthesis of the thymosin beta-4 / Ac-LKKTETQ research record, including the identity caveat (fragment ~889 Da vs full-length protein ~4963 Da), the absence of completed controlled clinical trials of the heptapeptide, the mdx muscular-dystrophy finding (regenerating fibers up, no strength gain), the porcine ischemia-reperfusion negative result, the medial collateral ligament rat finding, the hair-follicle stem-cell finding, the WADA-prohibited and detection context, and the research-grade purity concern. ↗
  2. Irobi E, et al. Structural basis of actin sequestration by thymosin-beta4: implications for WH2 proteins. EMBO J. 2004;23(18):3599-3608. ↗
  3. Malinda KM, et al. Thymosin beta4 accelerates wound healing. J Invest Dermatol. 1999;113(3):364-368. ↗
  4. 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. ↗
  5. 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. ↗
  6. 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.' List entry effective September 29, 2023; verified 2026-05-29. ↗
  7. U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee — agenda listing BPC-157, KPV, TB-500, and MOTs-C as bulk drug substances 'being considered for inclusion on the 503A Bulks List.' Verified 2026-05-29. ↗
  8. Jo JO, 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. ↗
  9. 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. ↗
  10. 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. ↗
  11. RegeneRx (sponsor). A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Stroke. ClinicalTrials.gov (2011) — trial withdrawn. ↗
  12. Sosne G, et al. Thymosin beta 4 promotes corneal wound healing and decreases inflammation in vivo following alkali injury. Exp Eye Res. 2002;74(2):293-299. ↗
  13. Kim S, Kwon J. Thymosin beta 4 improves dermal burn wound healing via downregulation of receptor for advanced glycation end products in db/db mice. Biochim Biophys Acta. 2014;1840(12):3452-3459. ↗
  14. Guarnera G, et al. Thymosin beta-4 and venous ulcers: clinical remarks on a European prospective, randomized study of safety, tolerability, and enhancement of healing. Ann N Y Acad Sci. 2007;1112:407-412. ↗
  15. El-Sayed N, et al. The combined impact of thymosin beta 4 and selenium on diabetic ulcers: a comparative study. Discover Biotechnology. 2025. ↗
  16. Kim TI, et al. Engineered Tandem Thymosin Peptide Promotes Corneal Wound Healing. Invest Ophthalmol Vis Sci. 2025;66(14):31. ↗
  17. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. ↗
  18. U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee — public calendar listing 'TB-500 (free base)' / 'TB-500 acetate' (with BPC-157, KPV, and MOTs-C) as substances 'being considered for inclusion on the 503A Bulks List.' A scheduled discussion, not a decision. Verified 2026-05-29. ↗
  19. 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 bulks-list / nomination framework, and the role of the Pharmacy Compounding Advisory Committee. Verified 2026-05-29. ↗
  20. 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,' citing potential immunogenicity for certain routes and a lack of important safety information; effective with the September 29, 2023 nominated-substances update. Verified 2026-05-29. ↗
  21. U.S. Food and Drug Administration, human drug compounding (Sections 503A and 503B): the lawful compounded-medication access pathway — licensed-prescriber evaluation (telehealth as a possible front-end channel), valid patient-specific prescription, 503A compounding pharmacy or 503B outsourcing facility, with bulk-substance eligibility limits (USP/NF monograph, component of an approved drug, or on the FDA bulks list). Verified 2026-05-29. ↗
  22. World Anti-Doping Agency. Prohibited List — TB-500 and thymosin beta-4 fall under prohibited peptide, growth-factor, and tissue-repair categories; banned in and out of competition for the relevant classes and detectable by LC-MS anti-doping assays. ↗