FDA approves Sunharbo to prevent stroke in certain high-risk adults

The Food and Drug Administration approved Sunharbo (asundexian) 50 mg tablets on Monday 09 November 2026. The drug is the first factor XIa inhibitor for use with antiplatelet therapy to reduce stroke risk in adults after a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack.

The agency said the approved use applies to adults who have had a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack, or TIA. Treatment is intended for secondary stroke prevention. It is not approved for stroke prevention in patients with atrial fibrillation.

The effectiveness of Sunharbo was shown in the OCEANIC-STROKE study, a multicenter, randomized, double-blind, placebo-controlled phase 3 study that enrolled 12,327 adults. Participants had a recent non-cardioembolic ischemic stroke with an NIH Stroke Scale ≤15 or a high-risk TIA. They were assigned to Sunharbo or placebo within 72 hours of symptom onset, and both groups received antiplatelet therapy.

Sunharbo 50 mg once daily significantly reduced the risk of ischemic stroke by 26% compared to placebo over a median treatment period of 14.2 months. The FDA said this was the first approval of a factor XIa inhibitor for this use.

Overall major bleeding rates were similar between the Sunharbo and placebo groups. Bleeding increased with Sunharbo in patients older than 75 years and during the first 90 days of treatment. Gastrointestinal bleeding occurred more often with Sunharbo than with placebo. Diarrhea was the most frequently reported adverse reaction, occurring in 3% or greater of Sunharbo-treated patients.

The agency said concomitant use with medicines that are combined P-gp and strong CYP3A4 inducers, including carbamazepine, is not recommended because they may reduce Sunharbo's effectiveness. Sunharbo is not recommended for patients with moderate or severe hepatic impairment. It should be withheld at least 24 hours before elective surgery or invasive procedures and for at least 24 hours after thrombolysis for acute ischemic stroke.

The FDA granted Sunharbo Fast Track and Priority Review designations. The approval was granted to Bayer HealthCare Pharmaceuticals Inc. in Whippany, N.J.