Cadrenal reports FDA alignment on Phase 3 design for HIT drug CAD-1005

Cadrenal Therapeutics said on August 31, 2026 that it received positive feedback from the FDA during a Type D meeting held July 28, 2026, covering the protocol and Statistical Analysis Plan for a Phase 3 registrational study of CAD-1005, the company's 12-lipoxygenase inhibitor being developed to treat heparin-induced thrombocytopenia, known as HIT.¹

HIT is described in the release as a potentially life-threatening immune reaction to heparin, a widely used blood thinner, that can lead to dangerous blood clots.¹ The company said the condition affects approximately 50,000 patients with acute HIT each year in the U.S.¹

At the meeting, the FDA agreed to a revised definition of worsening HIT for use as the primary endpoint, tied to progression of thrombotic events through Day 14 of treatment or hospital discharge.¹ To standardize measurement across trial sites, the worsening component will also count extension of an existing thrombus into a new vascular segment or bed, a change meant to reduce variability from manual size measurements.¹ The company summarized the resulting measure as tracking, in its words, the share of "Serotonin Release Assay-positive (SRA+) participants" with new or worsening clot-related events through Day 14 or discharge, as described in the release's endpoint definition. Additionally, the FDA agreed to placebo control for the Phase 3 trial, with standard anticoagulation given to both the CAD-1005 and placebo arms.¹

The trial will also track bleeding as a major safety endpoint using ISTH criteria, with all safety analyses conducted in patients who received at least one dose of study drug.¹

CAD-1005 already carries Orphan Drug Designation and FDA Fast Track designation for HIT, along with an orphan designation from the European Medicines Agency for platelet-activating factor 4 disorders.¹