Corrected TESTS sepsis trial findings
The 2025 TESTS trial found no clear evidence that thymosin-alpha1 reduced 28-day mortality in adults with sepsis. Its published correction gives a hazard ratio of 0.97, with a 95% confidence interval from 0.76 to 1.24. Those sepsis results do not establish a broad immune benefit for the supplier's Thymosin Alpha-1 10mg Pen. Published correction, TESTS sepsis trial.
The phase 3 trial randomized 1,106 adults with sepsis to thymosin-alpha1 or placebo. TESTS sepsis trial.
Compounded thymosin alpha-1 safety concerns
FDA's December 2024 briefing describes an N-terminal-acetylated 28-amino-acid peptide. Its separate compounding safety communication identifies peptide-characterization and potential immune-response concerns, and says safety information is inadequate to understand the extent of issues raised by the proposed compounded drug. FDA thymosin-alpha-1 assessment, FDA compounding safety communication.
Those concerns remain distinct from the mortality analysis. The catalogue identifies a 10mg pre-filled pen, not a verified clinical formulation. The separately listed Thymosin Alpha-1 vial provides a literal presentation comparison; neither product name resolves the safety-information limitation. FDA compounding safety communication.
