# TB-500 References: The Thymosin Beta-4 Studies and FDA Sources Cited

> TB-500 references: the full citation list behind this digest — the thymosin beta-4 mechanism, wound, stroke, cardiac and recent studies, plus the FDA compounding sources, with DOIs and PubMed links.

Every figure on this site maps to one of these. Peer-reviewed studies on thymosin beta-4 and its actin-binding fragment, plus the FDA regulatory sources.

## How to read these TB-500 references

These are the references for every quantitative claim in this TB-500 digest, numbered to match the inline markers across the site. They divide into two groups. References one through fifteen are the peer-reviewed scientific literature on thymosin beta-4 and its `Ac-LKKTETQ` fragment — structure, mechanism, wound, cardiac, neurological, and recent work. References sixteen through eighteen are the authoritative FDA sources behind the regulatory and access statements on the [TB-500 legal status and FDA 503A category](/legal-status) page; each was verified against a live FDA.gov page.

One note carries across the whole list, as it does across the whole site: where a study used full-length thymosin beta-4 rather than the TB-500 heptapeptide, the digest says so in the running text. The citation list does not relitigate that each time — the distinction lives in how each finding is described. Where a primary identifier is available it is a PubMed link; where the canonical record is a journal landing page, a DOI is given instead.

If you find a figure on this site that does not match its cited source, the [contact](/contact) page is the channel for a correction. Accuracy against the published record is the only thing this digest is for.

## 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] Xiong Y, Mahmood A, Meng Y, et al. Neuroprotective and neurorestorative effects of thymosin β4 treatment following experimental traumatic brain injury. J Neurosurg. 2012;116(5):1081-1092. https://pubmed.ncbi.nlm.nih.gov/22324420/
[8] Morris DC, Chopp M, Zhang L, et al. Thymosin beta4 improves functional neurological outcome in a rat model of embolic stroke. Neuroscience. 2010;169(2):674-682. https://pubmed.ncbi.nlm.nih.gov/20627173/
[9] Sosne G, Rimmer D, Kleinman HK, Ousler G. 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
[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] Su Y, Xu J, Zhu Z, et al. Thymosin β4 promotes zebrafish Mauthner axon regeneration by facilitating actin dynamics. BMC Biol. 2024;22(1):238. https://pubmed.ncbi.nlm.nih.gov/39443925/
[12] Kim J, Hwang S, Lee S, 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
[13] Sosne G, Qiu P, Kurpakus-Wheater M, 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/
[14] Zhang Y, Li L, Wang J, et al. Tβ4-exosome-loaded hemostatic and antibacterial hydrogel to improve vascularized wound repair. Mater Today Bio. 2025;30:101585. https://doi.org/10.1016/j.mtbio.2025.101585
[15] Wang L, Chen X, Liu Y, 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
[16] U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. (List entry: "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500," placed in 503A Category 2; effective with the September 29, 2023 nominated-substances update; page verified 2026-05-29.) https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
[17] U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. (Published agenda listing "TB-500 (free base)" / "TB-500 acetate," alongside BPC-157, KPV, and MOTs-C, as bulk drug substances being considered for inclusion on the 503A Bulks List; a scheduled discussion, not a decision; 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. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. (Definitions of 503A/503B and Category 1/Category 2; the bulks-list and nomination framework; the role of the Pharmacy Compounding Advisory Committee; verified 2026-05-29.) https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

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The TB-500 record drawn as a comic page — each repair figure, stroke dose and safety signal inked into its own panel and logged to its study, the fragment-versus-full-length caveat stamped on every page, with no clinic behind the gutters and nothing here dispensed or sold.