Milvexian Fails to Cut Recurrent Events in ACS, Safety Profile Holds

In the LIBREXIA ACS trial, milvexian did not reduce the composite of cardiovascular death, myocardial infarction, or ischemic stroke compared with placebo in patients with recent acute coronary syndrome on antiplatelet therapy. The trial was halted early for futility, but the drug did not increase major bleeding. The safety finding is reassuring for ongoing trials of milvexian in atrial fibrillation and stroke prevention.

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The trial enrolled patients within seven days of an ACS event, with 92% undergoing revascularization and most receiving prolonged dual antiplatelet therapy. Median follow-up lasted 12.2 months. The data and safety monitoring board halted enrollment in November 2025 after determining the primary endpoint was unlikely to be met.

Milvexian's safety profile remains relevant because the drug is still being tested in two ongoing phase III programs: LIBREXIA AF for atrial fibrillation and LIBREXIA STROKE for secondary stroke prevention. The DSMB recommended those trials continue as planned, with results expected in 2026. A related factor XIa inhibitor, asundexian