Population Pharmacokinetics of Asundexian in People at Risk for Thromboembolic/Cardiovascular Events.

ABSTRACT: Asundexian is a potent, selective, and reversible inhibitor of activated clotting Factor XI currently under development for secondary prevention of recurrent ischemic stroke in the ongoing Phase III OCEANIC-STROKE study (NCT05686070). Here, we report the development of a population pharmacokinetic (popPK) model for asundexian. Plasma concentration data were available from 2914 participants enrolled in nine Phase I and II studies of asundexian. The pharmacokinetics (PK) of asundexian were well described by the popPK model. Within the investigated dose range of asundexian 10-100 mg once daily, the PK of asundexian was dose-proportional. The systemic apparent clearance (CL/F) of asundexian was estimated to be 2.25 L/h and the central volume of distribution (V_C/F) was 35.3 L. Body w

SUBMITTER: Yassen A 

PROVIDER: S-EPMC12823300 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature