# TB-500 References and Citations: The Thymosin Beta-4 Literature and FDA Sources

> TB-500 references and citations — the peer-reviewed thymosin beta-4 literature behind every claim on this site, plus the FDA 503A and PCAC sources, with DOIs, PubMed links, and identifiers.

The full citation register behind this board — peer-reviewed thymosin β4 studies and the authoritative FDA regulatory sources — with DOIs, PubMed IDs, and the FDA URLs.

## How to read this register

Every TB-500 references and citations entry below maps to an inline marker used across the site. Each carries its identifier — a DOI and PubMed ID for the peer-reviewed work, a publisher URL for the FDA sources. Where a finding was measured on full-length thymosin β4 rather than the Ac-LKKTETQ fragment, the body text says so; the citation itself is listed here unchanged. The regulatory entries [16]–[18] are FDA pages verified loading and containing the cited text as of the dates noted.

## Peer-reviewed literature

The mechanistic, preclinical, and clinical studies on thymosin β4 and its actin-binding fragment, in citation order. These are the sources behind the mechanism, repair, and safety claims throughout the board.

## Regulatory sources

The FDA pages establishing TB-500's 503A Category 2 standing, the compounding framework, and the scheduled 2026 advisory-committee agenda. These support the [TB-500 legal status and 503A category](/legal-status) page and are the only basis on which this site states regulatory facts.

## References

[1] Irobi E, 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, 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, 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, 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, et al. 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] Cha HJ, Jeong MJ, Kleinman HK. Role of thymosin beta4 in tumor metastasis and angiogenesis. J Natl Cancer Inst. 2003;95(22):1674-1680. https://pubmed.ncbi.nlm.nih.gov/14625258/
[8] Wang WS, et al. Thymosin beta 4 is overexpressed in human pancreatic cancer cells and stimulates proinflammatory cytokine secretion and JNK activation. Cancer Biol Ther. 2008;7(3):419-423. https://pubmed.ncbi.nlm.nih.gov/18094619/
[9] Spurney CF, et al. 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. https://pubmed.ncbi.nlm.nih.gov/20126456/
[10] Goldstein AL, Kleinman HK. Thymosin beta4: actin-sequestering protein moonlights to repair injured tissues. Trends Mol Med. 2005;11(9):421-429. https://pubmed.ncbi.nlm.nih.gov/16099219/
[11] Sosne G, Qiu P, Christopherson PL, Wheater MK. Thymosin β4 Promotes Dermal Healing. Vitam Horm. 2016;102:251-275. https://pubmed.ncbi.nlm.nih.gov/27450738/
[12] Gao X, et al. Thymosin Beta-4 Induces Mouse Hair Growth. PLoS One. 2015;10(6):e0130040. https://pubmed.ncbi.nlm.nih.gov/26083021/
[13] Xiao X, et al. Multiple potential roles of thymosin β4 in the growth and development of hair follicles. J Cell Mol Med. 2021;25(3):1350-1358. https://pubmed.ncbi.nlm.nih.gov/33393222/
[14] Philp D, et al. Thymosin beta4 promotes angiogenesis, wound healing, and hair follicle development. Mech Ageing Dev. 2004;125(2):113-115. https://pubmed.ncbi.nlm.nih.gov/15037013/
[15] 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/
[16] 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 bulk substance; entry effective 2023-09-29; 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. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Source for the Category 1 / Category 2 definitions and the bulks-list nomination framework; verified 2026-05-29. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
[18] U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. Published agenda lists TB-500 (free base / acetate), BPC-157, KPV, and MOTs-C as bulk 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

---

A cool-green research board for the TB-500 record — the Ac-LKKTETQ fragment routed as its own net apart from the full-length thymosin beta-4 it is sold as, the empty human-trial pad left open, the tumor-angiogenesis trace flagged and the FDA 503A standing read first; no clinic solders this board and nothing here is dispensed or sold.
