FDA approves first-in-class drug for secondary stroke prevention
The U.S. Food and Drug Administration (FDA) has approved the first factor XIa (FXIa) inhibitor drug, asundexian, for secondary stroke prevention. It is being sold under the brand name Sunharbo by Bayer HealthCare Pharmaceuticals. The oral, once-daily drug is indicated to be used in combination with antiplatelet therapy to reduce stroke risk in adults following a recent mild-to-moderate noncardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).
“Stroke is a leading cause of disability and death in the United States, and survivors are at risk of having another stroke,” Hylton V. Joffe, MD, MMSc, director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the FDA’s Center for Drug Evaluation and Research, said in an agency statement. “Today’s approval represents a meaningful advance for patients and healthcare providers seeking a new option for secondary stroke prevention.”
The approval comes days after the pivotal OCEANIC-STROKE trial was presented as a late-breaker at the American Heart Association Scientific Sessions 2026. The multicenter, randomized, double-blind, placebo-controlled phase 3 study enrolled 12,327 patients who had a recent noncardioembolic ischemic stroke (NIH Stroke Scale ≤15) or high-risk TIA and were randomly assigned to the drug or a placebo within 72 hours of symptom onset. Both groups also received antiplatelet therapy. The data show that asundexian significantly reduced the risk of ischemic stroke by 26% compared to placebo over a median treatment of 14.2 months.
“For those who survive a stroke, the risk of another potentially devastating event is highest in the days and weeks after the initial event, and that risk persists over time,” Ashkan Shoamanesh, MD, co-principal investigator of the OCEANIC-STROKE clinical study and senior scientist at Population Health Research Institute, a Joint Institute of Hamilton Health Sciences and McMaster University, Ontario, Canada, said in a separate statement. “I believe asundexian introduces an important new addition to post-stroke care that can be used to help patients reduce the risk of a secondary stroke.”
The trial showed the rate of major bleeding was similar between the asundexian and placebo groups. However, an increase was observed in the drug group in patients older than 75 during the first 90 days of treatment. Gastrointestinal bleeding was also more common than with a placebo. Diarrhea, meanwhile, was reported as the most common side effect, occurring in at least 3% of asundexian patients.
The FDA said the FXIa inhibitor should not be used with medicines that combined P-gp and strong CYP3A4 inducers, because these might decrease the drug's effectiveness. Also, asundexian is not recommended in patients with moderate or severe hepatic impairment. The drug needs to be stopped at least 24 hours before elective surgery or invasive procedures, or for at least 24 hours after thrombolysis for acute ischemic stroke.
Asundexian is not approved for stroke prevention in patients with atrial fibrillation. In fact, Bayer terminated its asundexian clinical trial for atrial fibrillation in 2024 based on recommendations from the Independent Data Monitoring Committee.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]