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Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Compound monograph · evidence extract

TB-500 in atherosclerotic cardiovascular disease and cardiovascular risk reduction — evidence extract

No eligible study has been identified for TB-500 in atherosclerotic cardiovascular disease and cardiovascular risk reduction. The Institute records the question as not assessed and states what would change that.

Document identifier
CEI-MN-031/EV-CVD
Series
Evidence extract
Version
4.1
Published
13 Oct 2025
Last reviewed
13 Oct 2025
Next review
13 Oct 2027
Identifier
10.71829/cei.mono.31
Certainty
Not rated
Cycle
2025 Q4

§1Evidence extract: Atherosclerotic cardiovascular disease and cardiovascular risk reduction

§1.1Question and anchor outcome

Population
Established atherosclerotic disease of the coronary, cerebral or peripheral arterial beds, or a risk profile sufficient for enrolment in a cardiovascular outcome trial.
Intervention
TB-500, subcutaneous or intramuscular in research contexts
Comparator
As used in each contributing trial; reported per trial rather than pooled across comparator types
Anchor outcome
Three-point major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)

Additional outcomes the Institute extracts for this indication: Cardiovascular death; All-cause death; Hospitalisation for heart failure.

§1.2Contributing trials

No trial has been identified for TB-500 in atherosclerotic cardiovascular disease and cardiovascular risk reduction. No certainty rating is issued where that is so, for the reason given at §1.3.

§1.3Why no certainty rating is issued

The Institute rates certainty in a body of evidence. Where no eligible study has been identified there is no such body, and the domain-by-domain assessment used elsewhere in this series is not rendered: an inconsistency judgement requires two estimates to be inconsistent with one another, and an imprecision judgement requires an interval. Neither exists here.

The outcome is therefore recorded as not assessed. It is listed in the certainty index under that heading rather than at the lowest rating, because a rating of very low certainty says that evidence was found and is weak, and that is not what has happened.

What would change this: a controlled study in the population stated at §1.1, reporting the anchor outcome, retrievable in a form the Institute can appraise. The evidence gaps recorded in the monograph at §9 state what such a study would need to measure.

§1.4What this extract does not establish

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.

  1. 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
  2. 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 2014;11(6):663–673. doi:10.1586/14789450.2014.965159 · PMID 25382550
  3. 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.

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