New Stroke Drug Cuts Recurrence Risk 26% Without Bleeding Danger

In a groundbreaking development for stroke prevention, the investigational medication asundexian has demonstrated significant promise in reducing the risk of recurrent strokes without increasing bleeding risks, according to preliminary findings presented at the American Stroke Association’s International Stroke Conference 2026. The Phase III OCEANIC-STROKE trial, involving over 12,300 stroke survivors across 37 countries, revealed that adding daily asundexian to standard antiplatelet therapy like aspirin reduced the occurrence of ischemic stroke by 26% and lowered cardiovascular death, stroke, heart attack, and major bleeding events. This novel Factor XI inhibitor, developed by Bayer, represents a potential major advance as it targets a specific clotting protein involved in large blood clots while avoiding the bleeding complications that have limited previous anti-clotting medications.

The study, led by principal investigator Dr. Mike Sharma of McMaster University and the Population Health Research Institute, focused on patients who had experienced a mild-to-moderate ischemic stroke or high-risk transient ischemic attack (TIA) not caused by heart conditions. Participants received either asundexian plus standard therapy or a placebo, with neither patients nor researchers aware of the treatment during the trial. Results showed consistent benefits across all participant groups regardless of age, sex, stroke cause, or severity, with no increase in brain bleeding or serious adverse effects. The research highlights the critical need for better secondary stroke prevention, as nearly one in four stroke survivors will experience another stroke, according to the American Stroke Association.

While these findings are promising, researchers caution that the study is a preliminary research abstract that hasn't yet undergone peer review, and further analysis of brain imaging data from the trial is pending. The medication has received fast-track designation from the U.S. Food and Drug Administration for stroke prevention but hasn't been approved in any country. If ultimately approved, asundexian could become a widely used treatment for preventing recurrent strokes in patients who have experienced non-cardioembolic ischemic strokes or high-risk TIAs, addressing a significant gap in current stroke prevention strategies that balance effectiveness with safety concerns.