In short
Clinical trials are studying Asundexian in people with stroke risk, atrial fibrillation, and in healthy volunteers. These studies look at how well it may prevent blood clots and stroke, and how safe it is compared with other treatments or placebo. One trial also checks how food and a pediatric formulation affect blood levels.
Key points
- Clinical trials of Asundexian are studying ways to prevent stroke and other clot-related events in people at high risk. Two large Phase 3 trials focus on patients after ischemic stroke or high-risk transient ischemic attack, and on people with atrial fibrillation. A smaller Phase 1 study in healthy participants looks at blood levels after a single dose and the effect of food. The main outcomes include time to first ischemic stroke, stroke or systemic embolism, and major bleeding. The trials use placebo or apixaban as comparators in the Phase 3 studies. One study is authorised, while the two large studies are completed.
Clinical trials overview
These studies are testing Asundexian in different groups of people who may have a higher risk of clot-related problems. The trial data include two large Phase 3 studies and one smaller Phase 1 study.
The main research goal in the Phase 3 trials is to see whether Asundexian can help prevent stroke or related clot events better than the comparison treatment, while also checking major bleeding. The Phase 1 study looks at blood levels after a single dose and how food changes those levels.
Stroke and TIA study
NCT05686070 is a completed Phase 3 trial called OCEANIC-STROKE. It studied people after an acute non-cardioembolic ischemic stroke or a high-risk transient ischemic attack, which is a short-lasting stroke-like event often called a mini stroke.
The study compared oral BAY 2433334, which is Asundexian, with placebo on top of background antiplatelet therapy. The brief summary says the trial wanted to see whether Asundexian was superior to placebo in reducing ischemic stroke in these patients.
The main outcomes were time to first ischemic stroke and time to first ISTH major bleeding, which means serious bleeding defined by the International Society on Thrombosis and Hemostasis.
Atrial fibrillation study
NCT05643573 is another completed Phase 3 trial. It studied people with atrial fibrillation, a heart rhythm problem that can raise the risk of stroke, and who were at risk for stroke.
This study compared Asundexian with apixaban, a standard blood-thinning treatment used in this setting. The trial also used placebo versions of the study treatments to keep the comparison fair and blinded.
The trial aimed to show that Asundexian was at least not worse than apixaban for preventing stroke or systemic embolism, and it also measured whether Asundexian reduced major bleeding. A composite outcome, meaning a combined result, also looked at stroke, systemic embolism, or major bleeding together.
Healthy participant study
Trial 2025-523677-41-00 is an authorised Phase 1 study in healthy participants. It is much smaller than the Phase 3 studies and includes 18 people.
This study looks at the amount of Asundexian in the blood after a single oral dose and compares a pediatric formulation with the tablet form in the fasted state. It also checks how a high-fat, high-calorie meal changes the blood levels of the pediatric formulation.
The main measurements are Cmax, which is the highest blood level reached, and AUC, which shows total drug exposure over time. The study also measures AUC(0-tlast), which is exposure from the start until the last measured time point.
Endpoints and measures
The stroke and TIA trial focused on the time until the first ischemic stroke and the time until the first ISTH major bleeding event. These endpoints help researchers understand both benefit and safety in the same study.
The atrial fibrillation trial used a combined endpoint of stroke or systemic embolism, plus major bleeding outcomes, to balance effectiveness and safety. This design helps show whether a treatment lowers clot risk without causing too much serious bleeding.
The Phase 1 study used blood-level measurements instead of clinical outcomes like stroke, because early studies often focus on how the body handles a treatment. The food-effect part is important because meals can sometimes change how much of a treatment reaches the blood.
Trial status and size
The two large studies, NCT05686070 and NCT05643573, are both listed as completed. They enrolled 12,008 and 17,460 participants, respectively, showing that these were very large stroke-prevention trials.
The healthy participant study is authorised and much smaller, with 18 participants. Together, these trials show that Asundexian has been studied both in patients with serious clot-related risks and in healthy volunteers for early blood-level testing.