SECTION 04 · THE BIBLIOGRAPHY
Twenty-seven primary sources, sortable and searchable
Every citation used elsewhere on the site, with DOI or registry identifier and a link to the source.
About the bibliography
The references on this page are the primary sources cited by the /index, /research, /dosage and /faq pages. They are listed below in citation-number order and rendered as a sortable, searchable table.
The sources fall into four groups. Biochemistry and mechanism papers from 1992 through 2011 establish the actin-binding, NF-κB and PINCH-ILK-Akt frameworks [1][2][6][11]. Preclinical efficacy papers from 1999 through 2025 cover dermal and corneal wound healing, cardiac repair, stroke, skeletal muscle and hair follicle, plus the recent hydrogel-delivery and hepatic-stellate-cell work [3][4][5][7][8][9][10][12][18][20][21]. Human clinical trial reports and registry entries cover the Phase I safety studies, the Phase III ophthalmic program, and the halted Phase II cardiac program [13][14][15][16][17]. The Esposito 2012 equine doping-control paper provides the only published PK data specific to the seven-residue fragment [22]. Two review papers organize the field [24][25]. The FDA Interim 503A Bulks List guidance and the 2024 PCAC briefing material define the current regulatory record [26][27].
All twenty-seven sources have a DOI or a registry identifier and link to the publisher, PubMed, PMC, or ClinicalTrials.gov.
The full list
The table is sortable by citation number, year, first author and journal, and searchable across the citation text. The default sort is by citation number.
- Cassimeris L, Safer D, Nachmias VT, Zigmond SH. Interaction of thymosin beta 4 with muscle and platelet actin: implications for actin sequestration in resting platelets. Biochemistry. 1992;31(20):4628-4632. ↗
- 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 Journal. 2004;23(18):3599-3608. ↗
- Malinda KM, Sidhu GS, Mani H, Banaudha K, Maheshwari RK, Goldstein AL, Kleinman HK. Thymosin β4 accelerates wound healing. Journal of Investigative Dermatology. 1999;113(3):364-368. ↗
- 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. Experimental Eye Research. 2002;74(2):293-299. ↗
- Philp D, Badamchian M, Scheremeta B, Nguyen M, Goldstein AL, Kleinman HK. Thymosin β4 and a synthetic peptide containing its actin-binding domain promote dermal wound repair in db/db diabetic mice and in aged mice. Wound Repair and Regeneration. 2003;11(1):19-24. ↗
- 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;432(7016):466-472. ↗
- 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;445(7124):177-182. ↗
- Hinkel R, El-Aouni C, Olson T, Horstkotte J, Mayer S, Müller S, Willhauck M, Spitzweg C, Gildehaus FJ, Münzing W, Hannappel E, Bock-Marquette I, DiMaio JM, Hatzopoulos AK, Boekstegers P, Kupatt C. Thymosin β4 is an essential paracrine factor of embryonic endothelial progenitor cell-mediated cardioprotection. Circulation. 2008;117(17):2232-2240. ↗
- Philp D, Nguyen M, Scheremeta B, St-Surin S, Villa AM, Orgel A, Kleinman HK, Elkin M. Thymosin β4 increases hair growth by activation of hair follicle stem cells. FASEB Journal. 2004;18(2):385-387. ↗
- Tokura Y, Nakayama Y, Fukada S, Nara N, Yamamoto H, Matsuda R, Hara T. Muscle injury-induced thymosin β4 acts as a chemoattractant for myoblasts. Journal of Biochemistry. 2011;149(1):43-48. ↗
- 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 Journal. 2011;25(6):1815-1826. ↗
- 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;169(2):674-682. ↗
- Ruff D, Crockford D, Girardi G, Zhang Y. A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin beta4 in healthy volunteers. Annals of the New York Academy of Sciences. 2010;1194:223-229. ↗
- 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. Journal of Cellular and Molecular Medicine. 2021;25(17):8222-8233. ↗
- ReGenTree LLC / RegeneRx Biopharmaceuticals (HLB Therapeutics). Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome (ARISE-3). ClinicalTrials.gov NCT03937882, 2020. ↗
- 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. International Journal of Molecular Sciences. 2022;24(1):554. ↗
- RegeneRx Biopharmaceuticals, Inc. A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction. ClinicalTrials.gov NCT01311518, 2011. ↗
- Stark C, Taimen P, Tarkia M, Pärkkä J, Saraste A, Bizzarro V, Saraste M, Savunen T, Koskenvuo JW. Thymosin β4 protects against cardiac damage and subsequent cardiac fibrosis in mice with myocardial infarction. Cardiovascular Therapeutics. 2022;2022:1308651. ↗
- Sosne G, et al. Engineered tandem thymosin peptide promotes corneal wound healing. International Journal of Molecular Sciences. 2024;25(19):10347. ↗
- 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. Materials Today Bio. 2025;31:101585. ↗
- 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;12(12):1658. ↗
- 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. Analytica Chimica Acta. 2012;752:97-104. ↗
- 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. Frontiers in Pharmacology. 2016;7:115. ↗
- Goldstein AL, Hannappel E, Sosne G, Kleinman HK. Thymosin β4: a multi-functional regenerative peptide. Basic properties and clinical applications. Expert Opinion on Biological Therapy. 2012;12(1):37-51. ↗
- Xing Y, Ye Y, Zuo H, Li Y. Progress on the function and application of thymosin β4. Frontiers in Endocrinology. 2021;12:767785. ↗
- U.S. Food and Drug Administration. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FD&C Act — Updated Categorization. September 29, 2023. Docket FDA-2017-D-1067. ↗
- U.S. Food and Drug Administration. Pharmacy Compounding Advisory Committee Meeting Briefing Materials, October 29 and December 4, 2024. Docket FDA-2017-D-1067. ↗
- Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Medicine. 2026. ↗
- Cha HJ, Jeong MJ, Kleinman HK. Role of thymosin beta4 in tumor metastasis and angiogenesis. Journal of the National Cancer Institute. 2003;95(22):1674-1680. ↗
- Wang WS, Chen PM, Hsiao HL, Wang HS, Liang WY, Su Y. Thymosin beta 4 is overexpressed in human pancreatic cancer cells and stimulates proinflammatory cytokine secretion and JNK activation. Cancer Biology & Therapy. 2008;7(3):450-457. ↗
- Cooper TM, Stevenson DA, Bassindale T, Jarvis AM, Robinson JL. 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. Journal of Chromatography A. 2012;1262:215-222. ↗
- Spurney CF, Cha HJ, Sali A, Pandey GS, Pistilli E, Guerron AD, Gordish-Dressman H, Hoffman EP, Bhatt DL. 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. ↗
- Thomas A, Thevis M, Polet M, Delahaut P, Schänzer W. TB500/TB1000 and SGF1000: A scientific approach for a better understanding of doping-relevant peptide preparations. Drug Testing and Analysis. 2023;15(3):303-313. ↗