Thymosin beta-4 in cutaneous wound healing and tissue repair: effect on the anchor outcome
In the population defined for cutaneous wound healing and tissue repair, what is the effect of Thymosin beta-4 compared with the comparator used in its contributing trials on the anchor outcome for this indication?
Templated review frame. This review question was generated by crossing an indication with a compound for which contributing trials exist. Its prose frame is templated and is shared with other questions of the same shape. Its included studies, its summary of findings and its certainty rating are computed from the underlying records and are not templated. The Institute publishes these questions because the alternative is to leave a question the document set can answer unanswered, and it labels them because the alternative is to present a templated frame as an authored one.
§1Abstract
§1.1Review question
In the population defined for cutaneous wound healing and tissue repair, what is the effect of Thymosin beta-4 compared with the comparator used in its contributing trials on the anchor outcome for this indication?
§1.2PICO frame
Table 1. The registered PICO frame. Any change made after protocol registration is recorded in the amendment log at §5 and is identified there as post hoc.
| Element | As registered |
|---|---|
| Population | Restoration of epithelial and dermal integrity following injury, assessed by closure rate, area reduction and scar quality. |
| Intervention | Thymosin beta-4 administered as intravenous, subcutaneous or topical in clinical studies. |
| Comparator | The comparator used in each contributing trial, reported per trial rather than pooled across comparator types. |
| Outcomes | Anchor outcome for this indication: Time to complete closure. Additional outcomes: Percentage area reduction; Scar assessment scale; Infection rate. |
§1.3Method in brief
A review of the effects of an intervention on pre-specified outcomes, with a quantitative synthesis where the contributing studies are sufficiently similar. The protocol was registered with the Institute's secretariat before the search was executed. The search was run on 28 August 2025 across 8 sources and is reproduced in full at §2. Screening, extraction and certainty assessment were performed independently by two members of the secretariat with disagreement resolved by a third.[1,2]
§1.4Conclusion
Low certainty evidence from 3 contributing trials bears on the effect of Thymosin beta-4 on the anchor outcome for cutaneous wound healing and tissue repair. The estimate the Institute carries in the monograph is: Phase 2 trials in dry-eye disease, epidermolysis bullosa and venous stasis ulcers reported signals on some secondary endpoints without meeting primary endpoints consistently. 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.
The conclusion rests on 3 contributing studies, listed with their extracted data at §3 and summarised outcome by outcome at §4.
§1.5Limitations
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
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.