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Asundexian

Updated ยทnext FDA decision on the calendar

Asundexian is a Bayer AG program in Prevention of secondary stroke in patients after a non-cardioembolic ischemic stroke or transient ischemic attack (OCEANIC-STROKE). It is under FDA review; the agency's action date has not been publicly disclosed. Every date links its source.

BAYRY catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Prevention of secondary stroke in patients after a non-cardioembolic ischemic stroke or transient ischemic attack (OCEANIC-STROKE). Sponsor: Bayer AG (BAYRY). Review status: Bayer announced on May 19, 2026 that the FDA accepted the New Drug Application for asundexian, an oral Factor XIa inhibitor, and granted Priority Review. The application rests on the Phase 3 OCEANIC-STROKE trial, which met its primary efficacy outcome (time to first ischemic stroke) and its primary safety outcome (time to ISTH major bleeding); results were presented at the International Stroke Conference 2026 and published in the New England Journal of Medicine. Asundexian received Fast Track designation in 2023. Bayer has not publicly disclosed the PDUFA goal date, so no date is stated here. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · NDA accepted with Priority Review 2026-05-19; goal date not disclosedBAYRY

Questions

When is Asundexian's next FDA decision or readout?

Asundexian is under FDA review, but no action date has been publicly disclosed (NDA accepted with Priority Review 2026-05-19; goal date not disclosed). The review status row below links the sponsor's own announcement; this page updates when a date becomes public.

What happened at Asundexian's most recent FDA decision?

No FDA decision for Asundexian is in our archive yet.

What is Asundexian used for?

In our records Asundexian is under review or in development for Prevention of secondary stroke in patients after a non-cardioembolic ischemic stroke or transient ischemic attack (OCEANIC-STROKE).

Who makes Asundexian?

Bayer AG (BAYRY).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.
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