The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
NOV 18 2026
UPCOMING · 110 DAYS TO PDUFA

Bayer asundexian

for Secondary prevention after non-cardioembolic ischemic stroke or TIA

NDA · Priority Review

Accepted MAY 18 2026.

About

Ischemic stroke is a sudden loss of brain function caused by a blood clot blocking an artery in the brain, and a transient ischemic attack (TIA) is a similar, temporary event that signals a high risk of a full stroke soon after. Asundexian is an oral drug designed to block a specific blood-clotting protein called Factor XIa. By selectively inhibiting this clotting factor, asundexian may prevent dangerous clots from forming in the brain while potentially preserving the body's essential ability to stop bleeding from injuries.

Pivotal trial

OCEANIC-STROKE Phase 3 completed NCT05686070

Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: * an acute stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or * TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Acute ischemic strokes or TIA/mini-stroke result from a b...

Source: ClinicalTrials.gov

Also in development