Overview
- Researchers randomized 12,327 adults within 72 hours of noncardioembolic ischemic stroke or high‑risk TIA to asundexian 50 mg daily or placebo on top of antiplatelet therapy across 702 sites in 37 countries.
- Asundexian reduced recurrent ischemic stroke to 6.2% vs 8.4% with placebo (hazard ratio 0.74) over follow-up up to 31 months, with benefits emerging early and persisting.
- Major bleeding occurred in 1.9% of patients on asundexian vs 1.7% on placebo (HR 1.10), with similar rates of intracranial hemorrhage and no excess in other bleeding measures.
- Key secondary outcomes favored asundexian, including a significant reduction in disabling or fatal strokes (2.1% vs 3.0%) and improvements in composite cardiovascular endpoints, with consistent effects across subgroups and antiplatelet regimens.
- As an oral Factor XIa inhibitor designed to limit clotting without impairing normal hemostasis, asundexian holds FDA fast‑track status, and competitors such as milvexian and abelacimab have not yet reported late‑stage stroke‑prevention success.