US FDA Approves Sunharbo, First Factor XIa Inhibitor to Reduce Risk of Recurrent Stroke
November 14, 2026
The United States Food and Drug Administration (US FDA) has approved Sunharbo (asundexian) 50 mg tablets, the first Factor XIa (FXIa) inhibitor, to reduce the risk of stroke in certain adults following a recent non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).
The United States Food and Drug Administration (US FDA) has approved Sunharbo (asundexian) 50 mg tablets, the first Factor XIa (FXIa) inhibitor, to reduce the risk of stroke in certain adults following a recent non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). The approval was announced on November 9, 2026, and was granted to Bayer HealthCare Pharmaceuticals Inc.
Sunharbo is approved for use in combination with antiplatelet therapy in adults who have experienced a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk TIA. A non-cardioembolic ischemic stroke occurs when a blood clot blocks blood flow to the brain but does not originate in the heart. A TIA, commonly called a mini-stroke, causes temporary stroke-like symptoms due to a brief interruption in blood supply to the brain.
The approval was supported by findings from the Phase 3 OCEANIC-STROKE clinical trial, which enrolled 12,327 adults. Participants received Sunharbo or placebo alongside antiplatelet therapy within 72 hours of symptom onset. Over a median treatment period of 14.2 months, Sunharbo 50 mg once daily reduced the risk of ischemic stroke by 26% compared with placebo.
The FDA reported that overall major bleeding rates were similar between the Sunharbo and placebo groups. However, major bleeding was more frequent among patients older than 75 years and during the first 90 days of treatment. Gastrointestinal bleeding was also reported more commonly with Sunharbo, while diarrhoea was the most frequently reported adverse reaction.
Sunharbo is not recommended for patients with moderate or severe hepatic impairment and is not approved for stroke prevention in people with atrial fibrillation. The FDA also advises caution regarding interactions with certain medicines, including combined P-glycoprotein and strong CYP3A4 inducers. The approval introduces a new treatment approach for secondary stroke prevention in eligible patients.
Source: https://news.docthub.com/us-fda-approves-sunharbo-first-factor-xia-inhibitor-to-reduce-risk-of-recurrent-stroke-N2714
