NOV 18 2026
Bayer — asundexian
for Secondary prevention after non-cardioembolic ischemic stroke or TIA
Accepted MAY 18 2026.
About
Ischemic stroke occurs when a blood clot blocks an artery in the brain, starving cells of oxygen and causing lasting damage, while transient ischemic attacks (TIAs) are temporary blockages that signal high stroke risk. Asundexian is a pill that blocks Factor XIa, a protein involved in blood clot formation. By targeting this specific clotting pathway, the drug may help prevent repeat strokes while potentially causing less bleeding than traditional blood thinners.
Pivotal trial
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
Drug Watch — recent news on asundexian
- New Drug Asundexian Reduces Secondary Stroke Risk by 26% Without Bleeding Concerns - AOL.com
- FDA Accepts NDA for Asundexian, Dysport Noninferior Botox in Safety Profile, gMG Bridging the Gaps Discussion - Neurology Live
- Bayer wins FDA priority review for asundexian in stroke and TIA patients - MSN
- FDA Grants Priority Review to Asundexian for Secondary Stroke Prevention - Patient Care Online
- Bayer granted priority review by US FDA for secondary stroke prevention with asundexian - NeuroNews International