
Bayer’s OCEANIC-STROKE trial found asundexian cut recurrent ischemic stroke, secondary stroke, by 26% without significantly raising bleeding risk, revealed a study, published April 15, 2026. After these encouraging study results, on May 19, 2026, Bayer announced the U.S. Food and Drug Administration granted priority review for asundexian, an investigational once-daily pill, for patients following a non-cardioembolic ischemic stroke* or transient ischemic attack**.
Stroke is an acquired brain injury and surviving one does not eliminate the danger. The CDC estimates stroke costs the U.S. $56.2 billion annually, straining Medicare and Medicaid. Federal programs like Million Hearts, co-led by CDC and CMS, reflect Washington’s focus on this crisis.”Secondary stroke remains a serious and persistent challenge, and the FDA’s Priority Review designation underscores the urgency of advancing potential new approaches,” said Yesmean Wahdan, M.D., of U.S. Medical Affairs at Bayer. Affecting roughly one in ten survivors within one year, a secondary stroke occurs when the same underlying conditions that caused the first, such as arterial damage and clot formation, go unresolved. Recurrences are often more severe, causing greater disability or death.
Reserved for treatments that could improve care for serious conditions, the designation accelerates the FDA’s review from ten months to six.
*Per NIH: A non-cardioembolic ischemic stroke occurs when a blood clot blocks an artery supplying blood to the brain, but the clot originates locally (e.g., from narrowed neck arteries or plaque rupture) rather than traveling from the heart.
**Per NIH: A transient ischemic attack (TIA) is a medical emergency. It is defined as a transient episode of neurologic dysfunction due to the focal brain, spinal cord, or retinal ischemia without acute infarction or tissue injury.










