FDA Approves Bayer's Sunharbo After It Cut Stroke Risk 26%

The US Food and Drug Administration has approved Bayer's asundexian, sold as Sunharbo, for adults who recently had a mild to moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA). The 50 mg tablet is taken once a day with antiplatelet therapy. The FDA announced the approval on November 9, 2026, HCPLive reported.

What happened

Bayer said Sunharbo is the first approved medicine in the US that targets Factor XIa, a protein involved in blood clotting. The FDA based its decision on the phase 3 OCEANIC-STROKE trial, according to HCPLive and NeurologyLive.

• Trial size: 12,327 adults were randomized within 72 hours of their stroke or TIA. 6,162 received asundexian and 6,165 received placebo, both on top of antiplatelet therapy.
• Main result: ischemic stroke occurred in 6.2% of the asundexian group versus 8.4% on placebo. The FDA described this as a 26% lower risk over a median of 14.2 months of treatment.
• Bleeding: major bleeding was 1.9% with asundexian and 1.7% with placebo, a difference that was not statistically significant. Gastrointestinal bleeding was higher with the drug, RTTNews reported.

The label has limits. The drug is not approved for stroke prevention in atrial fibrillation. It is not recommended for people with moderate or severe liver impairment, according to NeurologyLive. The FDA also flagged higher major bleeding in patients older than 75, HCPLive reported.

Why it matters

The FDA called it the first Factor XIa inhibitor approved in the US for this use, HCPLive reported. In the trial it lowered ischemic stroke without a statistically significant rise in major bleeding, NeurologyLive reported. The approval comes after an earlier phase 2b study of asundexian missed its main goal. NeurologyLive reported that the phase 2b results shaped the dose and patient selection used in the larger trial.

The patient group is large. Bayer estimates that about 795,000 people in the US have a stroke each year. About 87% of those strokes are ischemic and 23% are repeat strokes, the company said, according to RTTNews.

China's regulator approved Sunharbo on October 26, 2026, RTTNews reported. Reviews are under way in the European Union and Japan.

What it means for people in the industry

Bayer expects to start shipping the drug in mid to late November 2026. Hospitals and pharmacies across the US should be able to order it shortly after, according to RTTNews. The sources did not say whether Bayer will add US staff for the launch. Watch for the decisions in Europe and Japan, and for any filing with Health Canada.

This story reports regulatory news and is not medical advice.

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Sources

• Asundexian Receives FDA Approval for Secondary Stroke Prevention, HCPLive
• FDA Approves Factor XIa Inhibitor Asundexian for Secondary Stroke Prevention, NeurologyLive
• Bayer Secures FDA Nod For SUNHARBO In Secondary Stroke Prevention, RTTNews