FDA Clears Bayer’s SUNHARBO for Secondary Stroke Prevention
Key Points
- FDA approved SUNHARBO (asundexian), a once-daily oral Factor XIa inhibitor, to lower recurrent stroke risk after non-cardioembolic ischemic stroke or high-risk TIA, alongside antiplatelet therapy.
- In the Phase 3 OCEANIC-STROKE trial of 12,327 adults, SUNHARBO reduced ischemic stroke rate by 26% versus placebo (6.2% vs 8.4%), with similar major bleeding rates.
- Bayer expects U.S. shipments to begin in mid-to-late November 2026; the drug is also under review in Europe and Japan and was approved in China on October 26, 2026.
Bayer has received FDA approval for SUNHARBO (asundexian), a once-daily oral Factor XIa inhibitor intended to lower the risk of recurrent stroke in adults following a recent non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). The 50-mg tablet is approved for use alongside antiplatelet therapy.
The decision introduces the first Factor XIa inhibitor approved in the U.S. and a new approach to secondary stroke prevention. By inhibiting Factor XIa, asundexian reduces the amplification of thrombin generation, targeting clot formation while potentially having less effect on normal blood clotting.
Approval was supported by results from the Phase 3 OCEANIC-STROKE trial, which enrolled 12,327 adults. Participants received either asundexian or placebo, in both cases alongside antiplatelet therapy. The primary endpoint was the time to first ischemic stroke.
Patients receiving SUNHARBO experienced a 26% lower rate of ischemic stroke than those in the placebo group, with events reported in 6.2% and 8.4% of patients, respectively. Major bleeding rates were similar between the groups, at 1.6 and 1.5 events per 100 person-years.
The trial also found reductions in all strokes and in a composite measure of cardiovascular death, heart attack or stroke. However, gastrointestinal bleeding was more frequent with asundexian, and elevated liver enzymes were reported; most liver enzyme increases were classified as mild. Diarrhea was the most commonly reported adverse reaction, occurring in 3.4% of treated patients compared with 2.8% of those receiving placebo.
Bayer said the approval provides a new option for patients who remain at risk of another stroke after an initial event. The company expects U.S. shipments to begin in mid-to-late November 2026, with availability for hospitals and pharmacies to follow.
As of November 2026, SUNHARBO is also under review by regulators in Europe and Japan. China approved the medicine on October 26, 2026.
Total Page Views: 3
