A new once-daily pill has won federal approval to help prevent another stroke in certain adults who recently suffered an ischemic stroke or a high-risk “mini-stroke.”

The FDA today approved Sunharbo, also known as asundexian, a 50-milligram tablet used alongside antiplatelet therapy. The approval went to Bayer HealthCare Pharmaceuticals in Whippany, New Jersey.

The treatment is intended for adults following a recent mild-to-moderate non-cardioembolic ischemic stroke, meaning a stroke caused by a clot that did not originate in the heart, or a high-risk transient ischemic attack, known as a TIA.

For stroke survivors, the approval offers a new treatment option to discuss with their doctors. It is not an approval for every type of stroke, and Sunharbo is not approved to prevent strokes in patients with atrial fibrillation.

In a study involving 12,327 adults, participants received Sunharbo or a placebo within 72 hours of symptom onset, with both groups also receiving antiplatelet treatment. The FDA said Sunharbo reduced the risk of ischemic stroke by 26% compared with the placebo over a median treatment period of 14.2 months. That is a relative reduction, not a 26-percentage-point reduction in an individual patient’s risk.

The FDA also flagged limits and risks. Major bleeding rates were similar overall, but were higher with Sunharbo among patients older than 75 and during the first 90 days of treatment. Gastrointestinal bleeding was more common with the drug, and diarrhea was the most frequently reported adverse reaction.

The medicine is not recommended for patients with moderate or severe liver impairment. Certain drug combinations can reduce its effectiveness, and treatment must be paused around some surgeries, procedures and clot-dissolving treatment.

The announcement did not establish a retail price or a local pharmacy availability date. Patients should not start, stop or change stroke-prevention medication without their treating clinician.