Bayer’s SUNHARBO becomes first and only Factor XIa inhibitor approved by FDA

Nov 10, 2026 01:11 (3h ago)

Bayer’s SUNHARBO was approved by the U.S. FDA to reduce stroke risk.
SUNHARBO is a 50 mg tablet containing asundexian.
SUNHARBO is indicated for adults with recent non-cardioembolic ischemic stroke or high-risk transient ischemic attack.

Bayer’s SUNHARBO (asundexian), a 50 mg tablet, has been approved by the U.S. FDA (Food and Drug Administration) to reduce the risk of stroke in adults with a recent non-cardioembolic ischemic stroke or high-risk transient ischemic attack. Bayer describes SUNHARBO as the first and only Factor XIa inhibitor, a medicine designed to block factor XIa in the blood-clotting process, approved for this use.