# FDA approves Bayer's asundexian to prevent repeat strokes

_Published Thursday, November 12, 2026 at 10:07 PM EST · Policy · Latest · Tier 2 — Notable_

![FDA approves Bayer's asundexian to prevent repeat strokes — Primary](https://assets.newatlas.com/dims4/default/22b3992/2147483647/strip/true/crop/2048x1075+0+145/resize/1200x630!/quality/90/?url=https%3A%2F%2Fnewatlas-brightspot.s3.ap-southeast-2.amazonaws.com%2F5f%2Fbf%2F34b540d24769bcb10267b6a8a41b%2Fstroke.jpeg&na.image_optimisation=0)

The US Food and Drug Administration approved Bayer's asundexian, branded Sunharbo, to prevent repeat strokes, New Atlas reported. The approval followed positive results from a global Phase 3 study and introduces the first approved drug in the Factor XIa inhibitor class worldwide, according to Bayer.

The oral, once-daily treatment blocks Factor XIa, a protein involved in blood clotting, rather than Factor Xa, which existing medicines target. It is used in combination with antiplatelet therapy to reduce the risk of a secondary stroke.

## Sources

- [New Atlas: Technology-Innovation-Outdoor News](https://newatlas.com/stroke/stroke-prevention-approved-fda/)

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Canonical: https://techandbusiness.org/newswire/mQGe31Y92tb6H-JpvJq0Ay
Published: 2026-11-13T03:07:03.330Z
Story chronology: 2026-11-13T01:46:43.535Z
Retrieved: 2026-11-13T05:50:59.012Z
Publisher: Tech & Business (techandbusiness.org)