Bayer Posts Strong Phase III Results for Asundexian in Stroke Prevention

Bayer has shared encouraging topline results from its OCEANIC-STROKE Phase III trial, testing asundexian, a once-daily oral FXIa inhibitor. The investigational therapy met both primary efficacy and safety endpoints, marking a major step forward in secondary stroke prevention.

What the Study Found?

Asundexian delivered meaningful clinical impact:

• 50 mg once daily cut the risk of ischemic stroke vs. placebo
• No increase in ISTH major bleeding
• Benefits observed even alongside antiplatelet therapy
• Target patients: those recovering from a non-cardioembolic ischemic stroke or high-risk TIA

More than 12,300 patients participated in this global, randomized, double-blind study.
Full results will be shared at an upcoming scientific congress.

Why This Matters: The Stroke Burden Is Enormous?

Stroke remains one of the world’s biggest health threats:

• 12 million strokes occur each year
• 20–30% are recurrent
• 1 in 5 survivors will have another stroke within five years
• Recurrent strokes are often more disabling and carry a higher mortality risk

Existing treatments help but leave a large gap. Asundexian may help close part of that gap.

What the Experts Are Saying?

Dr. Mike Sharma captured the urgency well:

“Recurrent strokes are devastating. Even with current therapies, the risk stays high.
The OCEANIC-STROKE results show that asundexian may offer a new way to reduce that risk.”

Bayer’s R&D head, Christian Rommel, emphasized the significance:

“These findings spotlight the promise of FXIa inhibition as a new method to protect patients.”

A New Mechanism With Big Promise

FXIa is an interesting target. It plays a small role in normal clotting but a larger role in pathological clot formation. By blocking FXIa, asundexian may reduce harmful clotting without raising major bleeding risk. This approach could reshape thrombosis prevention.

The FDA has already granted the drug Fast Track Designation.

Inside the OCEANIC-STROKE Trial

Structure of the trial:

• International, multicenter, event-driven
• Randomized and placebo-controlled
• Double-blind, parallel-group design
• Patients received asundexian 50 mg or placebo
• All participants were on antiplatelet therapy

The trial was built to answer one critical question:
Can we prevent a second stroke without raising bleeding risk?
Early signs say yes.

Bayer’s Cardiovascular Push

Bayer continues strengthening its leadership in cardiology. The company is expanding its portfolio around major unmet cardiovascular needs. This trial marks another move in that direction.

The Bottom Line

Asundexian’s Phase III success offers real hope for stroke survivors. If the full data holds, clinicians may soon have a safer, targeted strategy to prevent recurrent strokes. The field of thrombosis prevention may be entering a new era.

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