The U.S. Food and Drug Administration has granted marketing approval to Bayer's asundexian, branded as Sunharbo, making it the first Factor XIa inhibitor cleared worldwide to prevent repeat strokes. Sunharbo 50 mg tablets are approved for use alongside antiplatelet therapy in adults who recently suffered a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. Stroke affects roughly 12 million people globally each year, including 795,000 in the United States. Stroke ranks as the second leading cause of death globally and the third leading cause of combined death and disability.
Clinical Trial Cuts Repeat Stroke Risk by 26%
Approval rests on results from the pivotal global Phase III Oceanic-stroke study, published in The New England Journal of Medicine. Adding asundexian 50 mg to standard antiplatelet therapy reduced recurrent ischemic stroke by 26% compared with antiplatelet therapy alone. The trial showed similar rates of major bleeding between the asundexian and placebo groups, as defined by the International Society on Thrombosis and Hemostasis. The treatment benefit remained consistent across patient age, sex, stroke severity, and background antiplatelet therapy.
Uncoupling Clots From Bleeding Risk
Factor XIa is a blood coagulation protein involved in forming pathological clots that block vessels, while playing only a minor role in normal wound sealing. By selectively inhibiting Factor XIa, asundexian limits dangerous thrombosis without sharply raising major hemorrhage rates. Ashkan Shoamanesh, co-principal investigator of Oceanic-stroke and senior scientist at the Population Health Research Institute in Ontario, said the drug fills an urgent clinical gap and emphasized that persistent post-stroke risk requires safer long-term options.
Alongside the U.S. clearance, asundexian recently won approval from China's National Medical Products Administration. Bayer has also submitted marketing applications in other global markets. Sunharbo is specifically indicated for patients with a National Institutes of Health Stroke Scale score of 15 or lower.
