Clinical Research

The efficacy and safety of thymosin alpha1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial

Wu J, Pei F, Zhou L, et al. (2025). BMJ.

Summary

The largest trial of thymosin alpha-1 to date, and a negative one. Adults with sepsis at 22 Chinese centres were randomised to thymosin alpha-1 or placebo by subcutaneous injection for up to seven days. Death from any cause within 28 days occurred in 23.4 percent of the treated group and 24.1 percent of the placebo group, a difference that was not statistically significant, and no secondary or safety outcome differed either. Prespecified subgroup analysis hinted at different effects by age and by diabetes status, which the authors treat as hypothesis-generating. The conclusion is that there is no clear evidence the drug reduces 28-day mortality in sepsis.