Bayer's asundexian reduces stroke risk by 26% in phase III trial

Bayer announced that its investigational drug asundexian demonstrated a 26% reduction in ischemic stroke compared to placebo in patients who had experienced a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. The results come from the OCEANIC-STROKE Phase III study, which enrolled 12,327 patients worldwide.

The study evaluated asundexian 50mg taken once daily compared to placebo, both combined with antiplatelet therapy. Patients receiving asundexian showed significantly lower rates of secondary stroke (csHR 0.74; 95% CI 0.65–0.84; p<.0001). The drug also reduced the risk of any stroke type by 26% (6.6% vs. 8.8%).

Safety data showed no increase in major bleeding risk according to International Society of Thrombosis and Hemostasis criteria, with rates of 1.9% for asundexian versus 1.7% for placebo (HR 1.10; 95% CI, 0.85–1.44). Bleeding risks for minor bleeding, hemorrhagic stroke, and fatal bleeding remained similar to placebo levels.

The effectiveness remained consistent across patient subgroups regardless of age, sex, stroke cause, or severity. Results were presented at the International Stroke Conference 2026 in New Orleans.

Asundexian is a Factor XIa inhibitor that has received Fast Track Designation from the U.S. Food and Drug Administration for potential stroke prevention treatment. The compound remains investigational and has not received approval from any health authority.

Approximately 12 million people worldwide experience stroke annually, with 20-30% representing recurrent events. One in five stroke survivors will experience another stroke within five years, according to the press release.

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