Bayer's Asundexian Reduces Stroke Risk

Bayer announced highly positive results from its global, pivotal Phase III OCEANIC-STROKE study for Asundexian, an investigational once-daily, oral Factor XIa inhibitor. The study demonstrated that Asundexian significantly reduced ischemic stroke by 26% in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack, when combined with antiplatelet therapy. Crucially, these benefits were achieved with no increase in the risk of major bleeding, a common concern with anticoagulant therapies. The findings were consistent across various patient subgroups, including age, sex, and stroke subtype. Asundexian had previously received Fast Track Designation from the United States===Food and Drug Administration. These results, presented at the International Stroke Conference 2026, mark a significant milestone as OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor to show superiority in reducing recurrent ischemic stroke compared to placebo.