FDA Press Releases·Nov 9, 2026, 5:15 PM ET

FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High Risk

The FDA approved Sunharbo (asundexian) 50 mg tablets on November 9, 2026, as the first factor XIa inhibitor for reducing stroke risk in adults following a recent mild-to-moderate non-cardioembolic ischemic stroke or high-risk TIA.
Sunharbo is indicated for use in combination with antiplatelet therapy & was granted Fast Track & Priority Review designations.
Approval was based on the OCEANIC-STROKE phase 3 study involving 12,327 adults, which showed a 26% significant reduction in ischemic stroke risk compared to placebo over a median treatment of 14.2 months.
While overall major bleeding rates were similar to placebo, risks were increased for patients older than 75 years & during the first 90 days of treatment.
Gastrointestinal bleeding occurred more frequently with Sunharbo than placebo, & diarrhea was the most common adverse reaction.
Concomitant use with combined P-gp & strong CYP3A4 inducers is not recommended due to decreased effectiveness.
Sunharbo is contraindicated in patients with moderate or severe hepatic impairment & is not approved for stroke prevention in patients with atrial fibrillation.
The drug should be withheld at least 24 hours before elective surgery or invasive procedures & for at least 24 hours after thrombolysis for acute ischemic stroke.
The approval was granted to Bayer HealthCare Pharmaceuticals Inc.