The Food and Drug Administration approved Sunharbo (asundexian) on November 9, 2026, clearing the first factor XIa inhibitor to lower recurrent stroke risk in eligible high-risk adults.
Sunharbo is taken as a once-daily 50-milligram pill alongside standard antiplatelet therapy such as aspirin. Regulatory clearance applies specifically to patients recovering from a recent mild-to-moderate non-cardioembolic ischemic stroke with a National Institutes of Health Stroke Scale score of 15 or lower, or a high-risk transient ischemic attack.
Eligibility Limits and Bleeding Profile
The FDA explicitly excluded patients whose strokes stem from atrial fibrillation or heart valve conditions. In addition, the agency does not recommend the medication for individuals with moderate or severe liver impairment.
In the phase 3 OCEANIC-STROKE trial of 12,327 participants across 37 nations, adding 50 mg of daily asundexian to antiplatelet drugs reduced the risk of recurrent ischemic stroke by 26 percent compared to placebo over a median 14.2 months. Participants began therapy within 72 hours of symptom onset. While overall major bleeding did not show a statistically significant increase, bleeding rates were elevated among patients older than 75, during the initial 90 days, and in the digestive tract. Diarrhea was the most common side effect, affecting 3.4 percent of patients on the drug compared to 2.8 percent on placebo.
Bayer stated that shipments to U.S. hospitals and pharmacies are scheduled to begin in mid-to-late November 2026. Stroke survivors should consult their hospital neurology team or prescribing physician to evaluate individual eligibility and monitor bleeding risks.
