Thymosin beta-4 — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Cutaneous wound healing and tissue repair
Anchor outcome. Time to complete closure.
Effect as recorded. Phase 2 trials in dry-eye disease, epidermolysis bullosa and venous stasis ulcers reported signals on some secondary endpoints without meeting primary endpoints consistently; heterogeneous; no confirmatory result.[1,2]
Certainty. Low certainty A genuine phase 2 clinical programme exists, which distinguishes this compound from most of the repair peptides in this series. It did not produce a confirmatory result and no marketing authorisation followed.
Contributing trials. TB4-PH2-EPIDERMOLYSIS · TB4-PH2-DRYEYE · TB4-PH2-VENOUSULCER. Full structured abstracts are published for each.
Full evidence extract for cutaneous wound healing and tissue repair · Indication assessment
§3.2Atherosclerotic cardiovascular disease and cardiovascular risk reduction
Anchor outcome. Three-point major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke).
Effect as recorded. Phase 1 safety study completed; no efficacy conclusion; —.[2,3]
Certainty. Very low certainty Preclinical cardiac-repair findings were not confirmed clinically.
Contributing trials. TB4-PH1-CARDIAC. Full structured abstracts are published for each.
Full evidence extract for atherosclerotic cardiovascular disease and cardiovascular risk reduction · Indication assessment
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Goldstein AL, Hannappel E, Sosne G, Kleinman HK. Thymosin β4: a multi-functional regenerative peptide. Basic properties and clinical applications. Expert Opinion on Biological Therapy 2012;12(1):37–51. doi:10.1517/14712598.2012.634793 · PMID 22074294
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
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