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FDA Approves Sunharbo for Stroke Risk Reduction

lite News Desk 2 min read

Sunharbo (asundexian), a 50 mg tablet, received U.S. Food and Drug Administration approval on November 9, 2026, to reduce stroke risk alongside antiplatelet treatment. According to the FDA, the approval covers adults following a recent non-cardioembolic ischemic stroke of mild-to-moderate severity or a transient ischemic attack (TIA) classified as high-risk.

The FDA granted the approval to Bayer HealthCare Pharmaceuticals Inc. and identified Sunharbo as its first approved inhibitor of factor XIa. In the agency’s definition, a non-cardioembolic stroke involves a clot originating somewhere other than the heart. The FDA said Sunharbo has no approval for stroke prevention in people with atrial fibrillation.

Bayer said asundexian selectively inhibits factor XIa, a protein involved in blood coagulation. According to the company, that protein is thought to contribute to abnormal clot enlargement and blood-vessel blockage, with a smaller role in producing the plug that closes an injured vessel.

In published results from the OCEANIC-STROKE trial, the proportion experiencing ischemic stroke was 6.2% among participants receiving daily asundexian at 50 mg, compared with 8.4% among those receiving placebo. Both groups also received antiplatelet treatment. The cause-specific hazard ratio in the results was 0.74, with a 95% confidence interval ranging from 0.65 to 0.84. Separately, the FDA put the relative reduction against placebo at 26%, with treatment lasting a median of 14.2 months.

The agency’s study summary describes OCEANIC-STROKE as a phase 3 trial involving 12,327 adults across multiple centers, using random assignment, double blinding and a placebo control. Eligibility included a recent non-cardioembolic ischemic stroke scoring no higher than 15 on the National Institutes of Health Stroke Scale, or a high-risk TIA. Assignment to asundexian or placebo occurred within 72 hours after symptoms began.

According to the FDA, major bleeding occurred at similar rates overall across the two groups. However, rates with asundexian were higher among those over 75 and during treatment’s first 90 days. Gastrointestinal bleeding was also more frequent with asundexian. Diarrhea, reported in at least 3% of treated participants, was the most common adverse reaction.

The FDA said Sunharbo is not recommended in cases of moderate or severe hepatic impairment. It also advised against combining the drug with medicines, including carbamazepine, that induce both P-glycoprotein and CYP3A4, with strong induction of CYP3A4, because those medicines may make Sunharbo less effective.

For elective surgery or invasive procedures, the FDA said Sunharbo should be withheld for a minimum of 24 hours beforehand. The agency also specified withholding it for at least 24 hours following thrombolysis for acute ischemic stroke.

* This article is based on publicly available information at the time of writing.

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