USFDAApr 30, 2026, 08:48 AM
CVKD Completes FDA End-of-Phase 2 Meeting for CAD-1005; Plans Phase 3
AI Summary
Cadrenal Therapeutics, Inc. announced the successful completion of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for CAD-1005, its investigational 12-lipoxygenase (12-LOX) inhibitor for heparin-induced thrombocytopenia (HIT). The FDA provided critical guidance on key elements for the Phase 3 pivotal trial, enabling the company to advance directly to a randomized, blinded, placebo-controlled Phase 3 study. This trial will involve approximately 120 patients across up to 50 global clinical centers, with a projected New Drug Application (NDA) submission in 2029.
Key Highlights
- Cadrenal Therapeutics completed its End-of-Phase 2 meeting with the FDA for CAD-1005.
- FDA provided critical guidance for the Phase 3 pivotal trial for CAD-1005 in HIT.
- Company plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study.
- The Phase 3 study will evaluate CAD-1005 in approximately 120 patients across up to 50 clinical centers worldwide.
- Projected NDA submission for CAD-1005 is in 2029.
- CAD-1005 is a first-in-class 12-LOX inhibitor for heparin-induced thrombocytopenia (HIT).
- Phase 2 data showed a greater than 25% absolute reduction in thrombotic events with CAD-1005.
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