Asundexian 50 mg for stroke prevention: a systematic review and meta-analysis of 14,031 patients

Asundexian, a novel oral factor XIa inhibitor, may prevent thrombosis without increasing bleeding. We evaluated its efficacy for stroke prevention in high-risk patients. We systematically searched PubMed, Scopus, Cochrane, and Web of Science through March 2026 for randomized controlled trials comparing asundexian 50 mg daily versus placebo for secondary stroke prevention. Primary outcomes were ischemic stroke, any stroke, and all-cause mortality. Risk ratios (RR) with 95% confidence intervals (CI) were pooled using random-effects models. Three trials comprising 14,031 patients were included. Asundexian significantly reduced ischemic stroke (RR 0.74, 95% CI 0.63-0.88; p = 0.01; I² = 0%) and any stroke (RR 0.75, 95% CI 0.62-0.90; p = 0.02; I² = 0%) versus placebo. All-cause mortality did not differ between groups (RR 1.14, 95% CI 0.56-2.32; p = 0.50). Evidence certainty was high for stroke outcomes. Heterogeneity was negligible across analyses. Asundexian 50 mg daily significantly reduces ischemic and total stroke risk without affecting mortality in high-risk patients. These findings support factor XIa inhibition as a promising therapeutic strategy, though confirmation in additional large-scale trials is warranted.