Cadrenal Therapeutics, Inc. announced on August 5, 2025, its plans to initiate a clinical trial for its lead late-stage drug candidate, tecarfarin, in patients with End-Stage Kidney Disease (ESKD) who are transitioning to dialysis. This study will include patients with and without atrial fibrillation (AFib), with enrollment planned to begin later this year.
The company highlighted a critical need for safe and effective anticoagulants for ESKD patients, noting that tecarfarin holds Orphan Drug and Fast Track designations for ESKD patients with AFib. Patients with severe kidney disease face a high risk for thrombotic cardiovascular events, and the transition to dialysis further increases risks of myocardial infarction, stroke, and mortality.
Quang X. Pham, Chairman and CEO, emphasized that this study represents an important step forward for tecarfarin's continued development in ESKD and other areas. Tecarfarin, a next-generation Vitamin K antagonist, has a unique metabolism pathway not significantly affected by kidney impairment, offering potential promise in this area of unmet need where current anticoagulant therapies have limitations.
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