PAGE 05 · CUSTOMS MANIFEST

Every citation, sortable.

The full reference list — twenty-four entries from in vitro biochemistry to regulatory enforcement.

About this manifest

Every claim made on this site is sourced to one or more of the entries below. The manifest spans the foundational biochemistry of Thymosin Beta-4 — actin sequestration, HIF-1α and VEGF, NF-κB inhibition, PINCH–ILK–Akt cardiac signaling, AcSDKP antifibrotic activity — through the preclinical record in mouse, rat, pig, and equine models, into the Phase I and Phase II/III clinical-development programs for the full-length recombinant peptide. It includes the regulatory enforcement record (FDA 503A Category 2 placement; WADA 2025 Prohibited List entries; USADA athlete sanction) and the validated equine doping-control detection method.

Where multiple citations bear on a single topic, the most-cited or most-recent primary source is given preference. Where a regulatory finding is the citation, the original agency document is linked directly. DOIs are provided where available; PubMed, PMC, and ClinicalTrials.gov URLs are provided for primary research; agency URLs are provided for regulatory entries.

The table is sortable, searchable, and filterable by year, species, journal, and authority. The customs-manifest treatment is intentional: a single document of record.

The citation list

The full reference list appears below, organized as a single sortable manifest. Each entry includes the citation, DOI or identifier, and a direct URL to the primary source.

  1. Jo JO, Kim SR, Bae MK, Kang YJ, Ock MS, Kleinman HK, Cha HJ. Thymosin β4 induces the expression of vascular endothelial growth factor (VEGF) in a hypoxia-inducible factor (HIF)-1α-dependent manner. Biochim Biophys Acta Mol Cell Res. 2010.
  2. Ryu YK, Kang JH, Moon EY. The Actin-Sequestering Protein Thymosin Beta-4 Is a Novel Target of Hypoxia-Inducible Nitric Oxide and HIF-1α Regulation. PLoS One. 2014.
  3. Kim S, Kwon J. Thymosin beta4 induces angiogenesis through Notch signalling in endothelial cells. Cell Signal. 2013.
  4. Qiu P, Wheater MK, Qiu Y, Sosne G. Thymosin β4 inhibits TNF-α-induced NF-κB activation, IL-8 expression, and the sensitizing effects of its partners PINCH-1 and ILK. FASEB J. 2011.
  5. Yang HM, Kang SW, Sung J, Kim K, Kleinman HK. Purinergic Signaling Involvement in Thymosin β4-mediated Corneal Epithelial Cell Migration. Curr Eye Res. 2020.
  6. 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.
  7. Xiong Y, Zhang Y, Mahmood A, Meng Y, Zhang ZG, Morris DC, Chopp M. Neuroprotective and neurorestorative effects of thymosin beta4 treatment initiated 6 hours post injury following traumatic brain injury in rats. J Neurosurg. 2012.
  8. Morris DC, Chopp M, Zhang L, Lu M, Zhang ZG. Thymosin β4 improves functional neurological outcome in a rat model of embolic stroke. Neuroscience. 2010.
  9. Smart N, Risebro CA, Melville AAD, Moses K, Schwartz RJ, Chien KR, Riley PR. Thymosin β4 induces adult epicardial progenitor mobilization and neovascularization. Nature. 2007.
  10. Bock-Marquette I, Saxena A, White MD, DiMaio JM, Srivastava D. Thymosin β4 activates integrin-linked kinase and promotes cardiac cell migration, survival and cardiac repair. Nature. 2004.
  11. Wei C, Kumar S, Kim IK, Gupta S. Systemic dosing of thymosin beta 4 before and after ischemia does not attenuate global myocardial ischemia-reperfusion injury in pigs. Front Pharmacol. 2016.
  12. 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.
  13. Beijing Northland Biotech. Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction. ClinicalTrials.gov NCT05984134. 2023.
  14. Sosne G, Kleinman HK, Springs C, Gross RH, Sung J, Kang S. 0.1% RGN-259 (Thymosin β4) Ophthalmic Solution Promotes Healing and Improves Comfort in Neurotrophic Keratopathy Patients in a Randomized, Placebo-Controlled, Double-Masked Phase III Clinical Trial. Int J Mol Sci. 2022.
  15. Esposito S, Deventer K, Goeyens L, Van Eenoo P. Doping control analysis of TB-500, a synthetic version of an active region of thymosin β4, in equine urine and plasma by liquid chromatography–mass spectrometry. Anal Chim Acta. 2012.
  16. Sosne G, Kleinman HK, et al. Engineered Tandem Thymosin Peptide Promotes Corneal Wound Healing. Int J Mol Sci. 2024.
  17. Yu H, Wang B, Li Z, et al. Tβ4-exosome-loaded hemostatic and antibacterial hydrogel to improve vascular regeneration and modulate macrophage polarization for diabetic wound treatment. Mater Today Bio. 2025.
  18. Lee S, Lee H, Bae S, Kim E, Oh GT, Park H, Yeon JE, Byun KS, Kim K. Targeted deletion of thymosin beta 4 in hepatic stellate cells ameliorates liver fibrosis in a transgenic mouse model. Cells. 2023.
  19. Conte E, Genovese T, Gili E, Esposito E, Iemmolo M, Fruciano M, Fagone E, Pistorio MP, Crimi N, Cuzzocrea S, Vancheri C. Tβ4–Ac-SDKP pathway: Any relevance for the cardiovascular system? Can J Physiol Pharmacol. 2019.
  20. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. 21 CFR Part 216. 2023.
  21. World Anti-Doping Agency. The World Anti-Doping Code International Standard — Prohibited List 2025. WADA, 2024.
  22. Irobi E, Aguda AH, Larsson M, Guerin C, Yin HL, Burtnick LD, Blanchoin L, Robinson RC. Structural basis of actin sequestration by thymosin-β4: implications for WH2 proteins. EMBO J. 2004.
  23. Wang X, Liu L, Qi L, Lei C, Li P, Wang Y, Liu C, Bai H, Han C, Sun Y, Liu J. A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy Chinese volunteers. J Cell Mol Med. 2021.
  24. Xing Y, Ye Y, Zuo H, Li Y. Progress on the function and application of thymosin β4. Front Endocrinol. 2021.
  25. U.S. Anti-Doping Agency. Michael Nackoul Accepts Doping Sanction. USADA Sanction Notice, 2018.
  26. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026.
  27. Cha HJ, Jeong MJ, Kleinman HK. Role of thymosin beta4 in tumor metastasis and angiogenesis. J Natl Cancer Inst. 2003.
  28. 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.
  29. Cooper TM, et al. Doping control analysis of TB-500, a synthetic version of an active region of thymosin β4, in equine urine and plasma by liquid chromatography-mass spectrometry. J Chromatogr A. 2012.
  30. 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.
  31. 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.
  32. Thomas A, et al. TB500/TB1000 and SGF1000: A scientific approach for a better understanding of doping-relevant peptide preparations. Drug Test Anal. 2023.