On November 9, 2026, the FDA approved Bayer's Sunharbo (asundexian) as a first-in-class Factor XIa inhibitor for secondary stroke prevention in adults following a noncardioembolic ischemic stroke or TIA. In the 12,327-patient OCEANIC-STROKE trial, once-daily Sunharbo combined with antiplatelet therapy reduced recurrent ischemic stroke risk by 26% without increasing overall major bleeding. Bayer plans a mid-November launch at $748.50 per month to offset declining revenues from older blockbuster Xarelto.
U.S. approval and launch details
- ▪Bayer set the list price for a 30-day supply of Sunharbo at $748.50, with a U.S. commercial launch planned for mid-November 2026
- ▪The U.S. FDA approved Bayer's asundexian, brand name Sunharbo as a first-in-class Factor XIa inhibitor for secondary stroke prevention
- ▪The FDA advised avoiding Sunharbo with strong CYP3A4 and P-glycoprotein inducers, and advised against its use in moderate-to-severe hepatic impairment or atrial fibrillation
- ▪Sunharbo is indicated for once-daily use alongside antiplatelet therapy to reduce recurrent stroke risk in adults following recent mild-to-moderate noncardioembolic ischemic stroke or high-risk TIA
Mechanism of action
- ▪Sunharbo inhibits Factor XIa to reduce thrombin generation and blood clotting while preserving the body's baseline ability to stop active bleeding
- ▪Factor XIa inhibitors differ from established anticoagulants like Xarelto and Eliquis, which target the blood-clotting protein Factor Xa
OCEANIC-STROKE trial results
- ▪In the OCEANIC-STROKE trial, overall major bleeding rates were similar between Sunharbo and placebo groups at 1.9% and 1.7% respectively, though bleeding increased in patients over age 75
- ▪In the Phase 3 OCEANIC-STROKE trial of 12,327 patients, Sunharbo reduced recurrent ischemic stroke risk by 26% compared to placebo when added to antiplatelet therapy
International regulatory status
- ▪China's drug regulator approved Sunharbo in late October 2026, marking Sunharbo's first regulatory approval worldwide prior to U.S. clearance
- ▪Sunharbo remains under regulatory review by health authorities in Europe and Japan
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