# TB-500 References: The Thymosin Beta-4 Literature, Cited in Full

> The full TB-500 reference list — every thymosin beta-4 study cited across this dossier, with DOIs, PubMed and ClinicalTrials.gov links, plus the FDA regulatory sources for the 503A status.

Every study and source cited across this dossier, numbered and linked. The thymosin beta-4 literature dominates by design — the fragment has little of its own.

## How to read this list

These are the TB-500 references behind every numbered claim on this site. Almost all are studies of full-length thymosin beta-4; that is the point the dossier keeps making. Where a citation is a clinical-trial registry entry or an FDA page, that is noted in the entry. The regulatory sources (prefixed reg) underpin [TB-500 legal status and 503A category](/legal-status) and are drawn from FDA's own pages, verified loading and containing the cited text. For the narrative reading of these sources, see [the research evidence on TB-500](/research).

## 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, et al. 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] RegeneRx / ReGenTree. 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
[8] Sosne G, Qiu P, Kurpakus-Wheater M. Thymosin beta 4 suppression of corneal NFkappaB: a potential anti-inflammatory pathway. Exp Eye Res. 2007;84(4):663-669. https://pubmed.ncbi.nlm.nih.gov/17254567/
[9] Sosne G, et al. RGN-259 (thymosin β4) ophthalmic solution clinical program for dry eye disease (ARISE). ClinicalTrials.gov (topical thymosin β4 dry-eye trials). 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. 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] 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/
[13] Qiu P, Wheater MK, Qiu Y, Sosne G. Thymosin beta4 inhibits TNF-alpha-induced NF-kappaB activation, IL-8 expression, and the sensitizing effects by its partners PINCH-1 and ILK. FASEB J. 2011;25(6):1815-1826. https://pubmed.ncbi.nlm.nih.gov/21343177/
[14] Sosne G, et al. Activation of pro-resolving pathways mediate the therapeutic effects of thymosin beta-4. Front Immunol. 2024;15:1458684. https://pubmed.ncbi.nlm.nih.gov/39380984/
[15] Kim J, et al. Targeted Deletion of Thymosin Beta 4 in Hepatic Stellate Cells Ameliorates Liver Fibrosis. Cells. 2023;12(12):1658. https://doi.org/10.3390/cells12121658
[16] Lee Y, et al. Thymosin β4 Regulates Tissue Inflammatory Response in Mouse Nonalcoholic Fatty Liver Disease. J Inflamm Res. 2025;18. https://pubmed.ncbi.nlm.nih.gov/40322536/
[reg1] 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 substance; entry effective September 29, 2023). FDA.gov. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
[reg2] U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (agenda lists 'TB-500 (free base)' / 'TB-500 acetate', BPC-157, KPV, and MOTs-C as substances being considered for inclusion on the 503A Bulks List). FDA.gov. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
[reg3] U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 1 and Category 2 definitions; 503A/503B framework; bulks-list and PCAC nomination process). FDA.gov. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
[reg4] U.S. Food and Drug Administration. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FD&C Act (guidance underlying the compounding access pathway and ingredient-eligibility framework). FDA.gov. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/interim-policy-compounding-using-bulk-drug-substances-under-section-503a-federal-food-drug-and

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A cinematic dark-folio reading of the thymosin beta-4 literature, kept honest about where the Ac-LKKTETQ fragment's human data stop — an editorial dossier, never a clinic and nothing dispensed.