PONTE VEDRA, Fla. – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) is seeking out-licensing or co-development partners for CAD-1005, a 12-LOX inhibitor it describes as Phase 3-ready, after a competitor's late-stage trial in cardiac surgery-associated acute kidney injury (CSA-AKI) was discontinued for lack of efficacy.
Cadrenal extends CAD-1005 from HIT to a $1 billion-plus U.S. CSA-AKI market
The company is consolidating its Cardiac Acute Critical Care franchise around a dual-indication plan. CAD-1005 will be developed for heparin-induced thrombocytopenia (HIT) and for CSA-AKI, which Cadrenal sizes at more than $1 billion in the U.S. It claims first-in-class positioning in CSA-AKI following the competitor's Phase 3 discontinuation. The source does not name the competitor or the failed mechanism.
CAD-1005 inhibits 12-lipoxygenase (12-LOX), an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT. Cadrenal says the same mechanism targets platelet hyperactivation in HIT and reduces inflammation-driven injury in CSA-AKI. The drug is intended for use alongside existing standards of care.
Phase 2 data at ISTH 2026 show thrombotic events cut by more than 25%
Late-breaking Phase 2 data presented at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris showed an absolute reduction in thrombotic events of more than 25%. Cadrenal also reports a favorable safety and renal-protective baseline.
CAD-1005 holds Orphan Drug and Fast Track designations from the U.S. FDA and orphan drug status from the European Medicines Agency.
CEO Pham pitches transaction-ready asset as no drug class has shown CSA-AKI prevention
CEO Quang X. Pham said the trial termination underscores that "no single drug class has yet demonstrated clear preventive efficacy" for CSA-AKI. He called for novel upstream targets such as 12-LOX.
Cadrenal is marketing CAD-1005 as part of a critical care asset package. The package builds on shared in-hospital ICU infrastructure and an intravenous presentation. The company is also evaluating second-generation oral 12-LOX therapeutics for chronic indications.
Frunexian and tecarfarin fill out the cardiovascular pipeline
The Cardiac Acute Critical Care portfolio also includes frunexian, an investigational intravenous Factor XIa inhibitor for anticoagulation in major cardiac surgery. Cadrenal recently asked the FDA for Rare Pediatric Disease Designation for tecarfarin, an oral vitamin K antagonist, in preventing blood clots inside coronary artery aneurysms in children with Kawasaki disease.