Bayer Posts Positive Phase III Results for Asundexian in Stroke Prevention

German pharmaceutical leader Bayer has reported encouraging Phase III results for asundexian, its next-generation anticoagulant. The update marks a significant comeback two years after a major clinical setback for the same drug.

A Strong Phase III Win

Bayer announced that a daily 50 mg dose of asundexian significantly reduced the risk of ischemic stroke compared with placebo.

These results come from the OCEANIC-STROKE study. Full data will be shared at an upcoming scientific congress. Bayer also plans to engage with regulatory authorities worldwide to prepare for marketing authorisation submissions.

Why This Matters?

Asundexian has long been positioned as one of Bayer’s most promising pipeline assets.
The company previously estimated peak sales of over €5 billion, potentially making it the most valuable drug in its portfolio.

A Comeback After a Major Setback

In late 2023, asundexian failed a pivotal clinical trial involving patients with atrial fibrillation who were at risk of stroke. That outcome raised doubts about the drug’s future.

The new findings from OCEANIC-STROKE restore momentum and suggest a possible path forward for the anticoagulant.

What’s Next

Bayer aims to:

• Present full Phase III results at a scientific congress
• Begin global discussions with regulators
• Prepare formal marketing authorisation applications

If approvals follow, asundexian could still become a major entrant in the global anticoagulant market.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!