# TB-500 References: The Cited Thymosin Beta-4, Clinical, and Regulatory Sources

> TB-500 references: the peer-reviewed thymosin beta-4 studies, the human clinical trials, the recent reviews, and the FDA 503A regulatory sources cited across this site, with DOIs and PMIDs.

Every TB-500 and thymosin beta-4 citation used across the binder, with DOI, PMID or NCT identifiers and the FDA regulatory sources.

## How to read this register

These are the sources cited across TB-500 Dr. Entries 1–12 are the peer-reviewed mechanistic, animal and human studies and the doping-reference synthesis; 13–16 are the recent (2021–2026) studies and reviews; 17 is the analytical fragment-characterization reference; 18–20 are the FDA regulatory sources behind the [FDA 503A status of TB-500](/legal-status). Where a finding used full-length thymosin beta-4 rather than the TB-500 fragment, the body text says so at the point of citation. The numbered list is rendered below.

## References

[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. https://pubmed.ncbi.nlm.nih.gov/15329672/
[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. https://pubmed.ncbi.nlm.nih.gov/15565145/
[3] Malinda KM, Sidhu GS, Mani H, et al. Thymosin beta4 accelerates wound healing. J Invest Dermatol. 1999;113(3):364-368. https://pubmed.ncbi.nlm.nih.gov/10469335/
[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. https://pubmed.ncbi.nlm.nih.gov/25060418/
[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. https://pubmed.ncbi.nlm.nih.gov/22074294/
[6] Ruff D, Crockford D, Girardi 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. https://pubmed.ncbi.nlm.nih.gov/20536472/
[7] Sosne G, Dunn SP, Kim C. Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE) model. Clin Ophthalmol. 2015;9:877-884. https://pubmed.ncbi.nlm.nih.gov/26056426/
[8] Sosne G, Kleinman HK, et al. 0.1% RGN-259 (Thymosin β4) Ophthalmic Solution Promotes Healing and Improves Corneal Integrity. Int J Mol Sci. 2022;24(1):554. https://doi.org/10.3390/ijms24010554
[9] RegeneRx / ReGenTree (sponsor). Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye (ARISE-3). ClinicalTrials.gov identifier NCT03937882; 2020. https://clinicaltrials.gov/study/NCT03937882
[10] Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction. ClinicalTrials.gov identifier NCT05984134; 2023. https://clinicaltrials.gov/study/NCT05984134
[11] RegeneRx (sponsor). A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Stroke (withdrawn). ClinicalTrials.gov identifier NCT01311518; 2011. https://clinicaltrials.gov/study/NCT01311518
[12] TB-500 (Ac-LKKTETQ), the synthetic N-acetylated heptapeptide fragment (residues 17-23) of thymosin beta-4; parent protein thymosin beta-4 / TMSB4X, UniProt P62328. Reference identity entry. https://en.wikipedia.org/wiki/TB-500
[13] Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. https://pubmed.ncbi.nlm.nih.gov/41966639/
[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. https://doi.org/10.5114/aoms/186188
[15] U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. FDA.gov (verified 2026-05-29). https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
[16] Chen Y, et al. Thymosin β4 released from functionalized self-assembling peptide activates cardiac cells and promotes cardiac repair. Theranostics. 2021;11(10):4631-4647. https://pubmed.ncbi.nlm.nih.gov/33754060/
[17] Esposito S, et al. Synthesis and characterization of the N-terminal acetylated 17-23 fragment of thymosin beta 4 identified in TB-500, a product suspected to possess doping potential. Drug Test Anal. 2012;4(9):733-738. https://doi.org/10.1002/dta.1402
[18] 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; list entry effective 2023-09-29). FDA.gov (verified 2026-05-29). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
[19] U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act — Category 1 / Category 2 definitions and the January 7, 2025 revised interim policy. FDA.gov (verified 2026-05-29). https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
[20] 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. FDA.gov (verified 2026-05-29). https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026

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A tabbed research binder on TB-500 and thymosin beta-4 — each evidence class filed behind its own divider and cited to source, the fragment kept apart from its parent protein, with no clinic behind the binder and nothing here dispensed or prescribed.