Cadrenal gains FDA alignment on CAD-1005 trial

• Cadrenal Therapeutics reported FDA alignment on key elements of its Phase 3 CAD-1005 registration study.
• The trial will use a placebo-controlled design with standard anticoagulation in both treatment groups.
• The FDA and Cadrenal agreed on a composite primary endpoint focused on thromboembolic events in HIT patients.

Cadrenal Therapeutics (NASDAQ:CVKD) reported a positive outcome from a July 28, 2026 FDA Type D meeting regarding the planned Phase 3 registration study of CAD-1005 for heparin-induced thrombocytopenia.

The company said the meeting provided alignment on key protocol and Statistical Analysis Plan elements for evaluating CAD-1005, a 12-lipoxygenase inhibitor designed for HIT treatment.

Cadrenal said the FDA agreed with an optimized composite primary endpoint based on adjudicated new or worsening thromboembolic events in Serotonin Release Assay-positive patients through Day 14 or hospital discharge.

The company said the FDA also supported a placebo-controlled design with standard anticoagulation in both study arms and evaluation of bleeding as a major safety endpoint using International Society on Thrombosis and Haemostasis criteria.

Cadrenal Therapeutics develops therapies targeting cardiovascular and hematologic conditions, including CAD-1005 for heparin-induced thrombocytopenia.

The FDA alignment provides additional regulatory clarity for the Phase 3 program, with the company continuing preparations for the registration study design and execution.