PONTE VEDRA, Fla. – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) reached agreement with the FDA on the primary endpoint and placebo-controlled design of its Phase 3 registration study of CAD-1005, a first-in-class 12-lipoxygenase (12-LOX) inhibitor for heparin-induced thrombocytopenia (HIT). The agreement came at a Type D meeting held July 28, 2026.
FDA accepts thrombus-extension definition of worsening HIT
The agency agreed to define worsening HIT as progression of thrombotic events through Day 14 of treatment or hospital discharge. Worsening will also include extension of an existing thrombus into a new vascular segment or bed. Cadrenal said this avoids site-to-site variability from manual size measurements.
The composite primary endpoint will measure the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events through Day 14 or hospital discharge.
The FDA also agreed to a placebo control, with standard anticoagulation in both the CAD-1005 and placebo arms. CEO Quang X. Pham said the agreement provides "greater clarity on the regulatory path forward." Cadrenal has incorporated the agency's recommendations into its Phase 3 protocol and Statistical Analysis Plan.
Cadrenal projects $2 billion peak sales in a 50,000-patient U.S. market
About 50,000 patients in the U.S. are diagnosed with acute HIT each year. Current options rely on standard anticoagulants, which Cadrenal says do not target the underlying immune mechanisms of the disease. CAD-1005 is designed as an add-on to standard anticoagulation, and the company projects peak annual revenue of $2 billion.
CAD-1005 holds FDA Orphan Drug Designation for prophylaxis of thrombosis in HIT patients and FDA Fast Track designation for treatment and prevention of HIT. It also has a European Medicines Agency orphan designation for platelet-activating factor 4 disorders.
Trial to assess bleeding as major safety endpoint under ISTH criteria
The Phase 3 design will evaluate bleeding using International Society on Thrombosis and Haemostasis criteria. All safety analyses will cover patients who receive at least one dose of the study drug.