# TB-500 References: The Thymosin Beta-4 Studies Cited Here

> The full reference list behind this TB-500 digest — the thymosin beta-4 structural, wound, cardiac, neuro, Phase 1, and 2024–2026 studies, plus the FDA 503A and PCAC sources, with DOIs, PMIDs, and NCTs.

Structural, preclinical, Phase 1, and recent thymosin beta-4 work, plus the FDA regulatory sources — linked to PubMed, ClinicalTrials.gov, DOIs, and FDA.gov.

## How to read this list

This is the full reference list behind the TB-500 digest. Each entry is numbered to match the inline citation markers across the research, tissue-repair, dosage, legal-status, and FAQ pages. 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 distinction is preserved throughout rather than collapsed in this list. The latest TB-500 and thymosin beta-4 studies sit toward the end, alongside the FDA regulatory sources behind the legal-status page.

## 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] 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] Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction. ClinicalTrials.gov identifier NCT05984134. 2023. https://clinicaltrials.gov/study/NCT05984134
[9] 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
[10] 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/
[11] Gonzalez-Franquesa A, et al. Discovery of thymosin β4 as a human exerkine and growth factor. Am J Physiol Cell Physiol. 2021;321(5):C770-C778. https://pubmed.ncbi.nlm.nih.gov/34495765/
[12] Zhang Y, et al. Tβ4-exosome-loaded hemostatic and antibacterial hydrogel to improve vascularized wound repair. Mater Today Bio. 2025;31:101585. https://doi.org/10.1016/j.mtbio.2025.101585
[13] El-Sayed N, et al. The combined impact of thymosin beta 4 and selenium on diabetic ulcers: a comparative study. Discover Biotechnology. 2025. https://doi.org/10.1007/s44340-025-00015-0
[15] Rahaman KA, et al. Simultaneous quantification of TB-500 and its metabolites in in-vitro experiments and rats by UHPLC-Q-Exactive orbitrap MS/MS and their screening by wound healing activities in-vitro. J Chromatogr B Analyt Technol Biomed Life Sci. 2024;1235:124033. https://pubmed.ncbi.nlm.nih.gov/38382158/
[16] Kim TI, et al. Engineered Tandem Thymosin Peptide Promotes Corneal Wound Healing. Invest Ophthalmol Vis Sci. 2025;66(14):31. https://pubmed.ncbi.nlm.nih.gov/41235866/
[17] U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (agenda lists TB-500, BPC-157, KPV, and MOTs-C as bulk drug substances being considered for inclusion on the 503A Bulks List). Verified 2026-05-29. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
[18] U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (Category 2 entry: "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500"; effective 2023-09-29). 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; January 7, 2025 revised interim policy; 503A/503B framework). Verified 2026-05-29. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

---

A soft-paneled research desk on the TB-500 and thymosin beta-4 literature — each finding set in its own panel, the fragment-versus-full-length caveat and the FDA 503A status pressed in before anything else, and no clinic, vendor, or prescription behind the surface.