TB-500 Compound

Reference designator · U07 · References

TB-500 references and citations, every claim soldered to its source

The full citation register behind this board — peer-reviewed thymosin β4 studies and the authoritative FDA regulatory sources — with DOIs, PubMed IDs, and the FDA URLs.

Back to the researchRead the legal status

How to read this register

Every TB-500 references and citations entry below maps to an inline marker used across the site. Each carries its identifier — a DOI and PubMed ID for the peer-reviewed work, a publisher URL for the FDA sources. Where a finding was measured on full-length thymosin β4 rather than the Ac-LKKTETQ fragment, the body text says so; the citation itself is listed here unchanged. The regulatory entries [16]–[18] are FDA pages verified loading and containing the cited text as of the dates noted.

Peer-reviewed literature

The mechanistic, preclinical, and clinical studies on thymosin β4 and its actin-binding fragment, in citation order. These are the sources behind the mechanism, repair, and safety claims throughout the board.

Regulatory sources

The FDA pages establishing TB-500's 503A Category 2 standing, the compounding framework, and the scheduled 2026 advisory-committee agenda. These support the TB-500 legal status and 503A category page and are the only basis on which this site states regulatory facts.

  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. 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. ↗
  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. Cha HJ, Jeong MJ, Kleinman HK. Role of thymosin beta4 in tumor metastasis and angiogenesis. J Natl Cancer Inst. 2003;95(22):1674-1680. ↗
  8. Wang WS, et al. Thymosin beta 4 is overexpressed in human pancreatic cancer cells and stimulates proinflammatory cytokine secretion and JNK activation. Cancer Biol Ther. 2008;7(3):419-423. ↗
  9. Spurney CF, 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. Goldstein AL, Kleinman HK. Thymosin beta4: actin-sequestering protein moonlights to repair injured tissues. Trends Mol Med. 2005;11(9):421-429. ↗
  11. Sosne G, Qiu P, Christopherson PL, Wheater MK. Thymosin β4 Promotes Dermal Healing. Vitam Horm. 2016;102:251-275. ↗
  12. Gao X, et al. Thymosin Beta-4 Induces Mouse Hair Growth. PLoS One. 2015;10(6):e0130040. ↗
  13. Xiao X, et al. Multiple potential roles of thymosin β4 in the growth and development of hair follicles. J Cell Mol Med. 2021;25(3):1350-1358. ↗
  14. Philp D, et al. Thymosin beta4 promotes angiogenesis, wound healing, and hair follicle development. Mech Ageing Dev. 2004;125(2):113-115. ↗
  15. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. ↗
  16. 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 Category 2 bulk substance; entry effective 2023-09-29; page verified 2026-05-29. ↗
  17. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Source for the Category 1 / Category 2 definitions and the bulks-list nomination framework; verified 2026-05-29. ↗
  18. U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. Published agenda lists TB-500 (free base / acetate), BPC-157, KPV, and MOTs-C as bulk substances being considered for inclusion on the 503A Bulks List; verified 2026-05-29. ↗