FDA Approves Bayer’s New Drug for Secondary Stroke Reduction

Bayer announced approval of new drug Sunharbo (Asundexian) by USFDA to reduce the risk of stroke in adults following a recent mild-to-moderate non-cardioembolic ischemic stroke or or high-risk transient ischemic attack (TIA). 

Asundexian, is an oral, once-daily, 50mg tablet, a Factor XIa inhibitor which reduces the risk of secondary stroke, in combination with antiplatelet therapy. Asundexian is the first factor XIa (FXIa) inhibitor to be approved by FDA. Factor XIa (FXIa) is a protein in the blood coagulation pathway and Asundexian selectively inhibits FXIa, allowing to reduce pathological clot formation.

As per a Bayer press release Asundexian is already approved by China’s National Medical Products Administration (NMPA) and undergoing regulatory review for marketing authorisation in multiple markets around the world.

• FDA Press Release on Approval of Asundexian (November 9, 2026)
• Bayer Press note on approval of asundexian first FXIa inhibitor approved by U.S. FDA for secondary stroke risk reduction