Cadrenal Therapeutics Announces FDA Guidance for Pivotal Phase 3 Trial of CAD-1005 in HIT

On April 30, 2026, Cadrenal Therapeutics, Inc. announced the successful completion of an End-of-Phase 2 (EOP2) meeting with the FDA regarding CAD-1005, its first-in-class 12-lipoxygenase (12-LOX) inhibitor for heparin-induced thrombocytopenia (HIT). Following FDA guidance on protocol design, dosing, and safety, the company plans to skip further Phase 2 testing and advance directly into a pivotal Phase 3 registration trial. The planned Phase 3 study will be a randomized, blinded, placebo-controlled trial enrolling approximately 120 patients across 50 clinical centers worldwide. It will evaluate CAD-1005 as an add-on to the current standard of care, with a primary endpoint of new or worsening thrombotic events. This trial is intended to support a projected New Drug Application (NDA) submission in 2029. CAD-1005 previously demonstrated a greater than 25% absolute reduction in thrombotic events during Phase 2. The drug has already received Orphan Drug and Fast Track designations from the FDA.