KEY POINTS
- Bayer’s asundexian reduced the risk of repeat stroke by 26% in a large Phase III trial.
- The drug was tested in more than 12,000 patients alongside standard antiplatelet therapy.
- Results showed no increase in major bleeding, highlighting a balanced safety profile.
Bayer on Thursday reported that its experimental blood thinner asundexian significantly lowered the risk of stroke recurrence in patients.
The Phase III Oceanic-Stroke trial showed a 26% reduction in repeat strokes when compared with standard antiplatelet therapy alone.
The study enrolled over 12,000 adults who had suffered a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).
Participants received either asundexian plus antiplatelet drugs or antiplatelet therapy with a placebo.
Patients taking asundexian were significantly less likely to experience another stroke compared with the placebo group.
This benefit was consistent regardless of age, sex, type of prior stroke or baseline risk.
A major concern with blood thinners is bleeding risk, particularly major hemorrhages that can offset benefits.
The trial’s safety data showed no increase in serious bleeding for asundexian versus placebo.
The drug belongs to a class called Factor XIa inhibitors, designed to prevent harmful blood clots while minimising bleeding complications.
This mechanism differs from some traditional anticoagulants, potentially offering a better safety balance.
Bayer presented the full results at the International Stroke Conference 2026 in New Orleans.
The positive data marked a successful completion of a pivotal Phase III study for this indication.
Stroke remains a leading cause of death and disability globally, with recurrent events tied to higher risk and worse outcomes.
Around one in five stroke survivors will experience another within five years, underscoring the need for effective secondary prevention.
The Oceanic-Stroke results suggest asundexian could be an important option to reduce repeat events without heightened bleeding risk.
Bayer plans to submit the data to regulators to seek approval for asundexian’s use in stroke prevention.
The company’s chief executive has pushed innovation amid broader challenges, including legal and financial pressures.
Success in this trial bolsters the drugmaker’s portfolio with potential growth beyond existing products.
Rival medications in the same drug class have faced mixed results in trials for stroke or cardiovascular disease.
But asundexian’s positive outcomes could position it as a leading option in its category.
If approved, asundexian would join therapies aimed at reducing the global burden of stroke recurrence, particularly in high-risk patients.
It would provide physicians and patients a new tool to prevent debilitating follow-up strokes.
