Cadrenal Therapeutics wins FDA alignment on Phase 3 CAD-1005 trial design in heparin-induced thrombocytopenia
CVKD•FDA aligns with Phase 3 CAD-1005 trial design
Cadrenal Therapeutics reported a positive FDA Type D meeting supporting its Phase 3 registration study plan for CAD-1005 in heparin-induced thrombocytopenia (HIT).
No clinical results were presented; the update outlined regulatory alignment ahead of the Phase 3 trial.
FDA backed the primary endpoint approach focused on whether patients develop new or worsening clot-related events during treatment.
The Phase 3 study will use placebo alongside standard anticoagulation in both arms, supporting a controlled readout for potential approval.
Management cited a $2 billion peak annual revenue opportunity for CAD-1005, targeting about 50,000 acute HIT diagnoses annually in the U.S.
