Bayer AG is initiating a large Phase III clinical trial program enrolling more than 30,000 patients to investigate its next-generation Factor XIa inhibitor asundexian, with the goal of developing an effective oral anticoagulant with an improved safety profile over the current standard of care, its own Xarelto (rivaroxaban) and Bristol Myers Squibb Company/Pfizer Inc.'s Eliquis (apixaban).
Bayer Outlines Asundexian Phase III Plan, Hoping To Prove Safety Benefit Over Eliquis
The Factor XIa inhibitor could be an effective anticoagulant without the increased risk in bleeding associated with current Factor Xa inhibitors, but the profile will need to be confirmed in Phase III.

More from Blood and Clotting
The small interference RNA therapeutic can be used by patients regardless of inhibitor status.
Taiwan-based PharmaEssentia hopes to add essential thrombocytopenia to the label for its pegylated interferon product, already approved to treat polycythemia vera.
With successful Phase II data versus active comparators for both REGN7508 and REGN9933, Regeneron hopes to position the candidates to compete against existing factor X products.
Hematologists’ concerns about hepatoxicity with hemophilia A gene therapies may limit use, but Phase III data for Pfizer’s candidate at ASH show a lower rate of ALT increases than seen with BioMarin’s Roctavian.
More from Therapy Areas
After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.
The firm has lofty ambitions for the aldosterone synthase inhibitor to treat hypertension and kidney disease.
The ZENITH study is a landmark for Merck’s first-in-class activin signalling inhibitor and pulmonary arterial hypertension treatment.