TB-500 — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Atherosclerotic 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. No randomised controlled human trial identified; —.[1,2]
Certainty. Very low certainty Preclinical cardiac-repair work used the full-length protein.
Contributing trials. None identified. The rating reflects an absence of controlled evidence rather than conflicting evidence.
Full evidence extract for atherosclerotic cardiovascular disease and cardiovascular risk reduction · Indication assessment
§3.2Cutaneous wound healing and tissue repair
Anchor outcome. Time to complete closure.
Effect as recorded. Clinical trials of the full-length thymosin beta-4 protein were conducted in epidermolysis bullosa and in dry-eye disease; results did not support marketing authorisation; not reportable for the fragment.[2,3]
Certainty. Very low certainty Critically, those trials used the full-length 43-residue protein, not the heptapeptide fragment. Their results do not transfer to TB-500 in either direction.
Contributing trials. TB4-PH2-EPIDERMOLYSIS · TB4-PH2-DRYEYE. Full structured abstracts are published for each.
Full evidence extract for cutaneous wound healing and tissue repair · Indication assessment
§3.3Tendon, ligament and musculoskeletal soft-tissue injury
Anchor outcome. Time to return to activity.
Effect as recorded. No randomised controlled human trial identified; —.[3,4]
Certainty. Very low certainty Preclinical rodent and equine work only.
Contributing trials. None identified. The rating reflects an absence of controlled evidence rather than conflicting evidence.
Full evidence extract for tendon, ligament and musculoskeletal soft-tissue injury · 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
- Thevis M, Thomas A, Schänzer W. Detecting peptidic drugs, drug candidates and analogs in sports doping: current status and future directions. Expert Review of Proteomics 2019;11(6):663–673. doi:10.1586/14789450.2014.965158
- 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
- Bhattacharyya S, Wang J, Kaplan RM. Quality of peptide products obtained from unregulated online suppliers: an analytical survey. Journal of Pharmaceutical Sciences 2024;113(4):1102–1110. doi:10.1016/j.xphs.2023.11.021 Cited by the Institute as an indicative analytical survey; sample frame was not random.
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