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A new weapon against recurrent stroke just got the green light. The FDA has approved asundexian (Sunharbo), the first factor XIa inhibitor cleared for secondary stroke prevention in adults following a noncardioembolic ischemic stroke or high-risk TIA. Based on the phase 3 OCEANIC-STROKE trial, the once-daily oral pill cut ischemic stroke risk by 26% compared to placebo when added to antiplatelet therapy — without a significant increase in major bleeding.
A new weapon against recurrent stroke just got the green light. The FDA has approved Bayer's asundexian (Sunharbo), making it the first factor XIa (FXIa) inhibitor approved for secondary stroke prevention. The oral, once-daily 50 mg tablet is indicated for adults who have experienced a noncardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), and is meant to be used alongside antiplatelet therapy.
The approval was driven by data from the pivotal phase 3 OCEANIC-STROKE trial, which enrolled over 12,000 patients. Asundexian reduced ischemic stroke risk by 26% compared to placebo over a median treatment period of about 14 months — a meaningful win in a population where roughly 1 in 10 patients suffers another stroke within a year despite existing therapies.
By the Numbers:
Why it matters: Recurrent stroke remains a major cause of disability and death, and current therapies leave a significant gap in protection. Asundexian's approval offers clinicians a new, targeted option that reduces stroke recurrence without meaningfully raising bleeding risk — a long-standing trade-off challenge in this space.
