Frunexian: A Next-Generation intravenous (IV) Factor XIa Inhibitor for Acute and Critical Care
Cadrenal’s recent acquisition of the eXIthera Pharmaceuticals portfolio expanded its pipeline with a series of investigational Factor XIa inhibitors.
The lead asset in this new portfolio is frunexian, a small molecule fast-on, fast-off parenteral Phase 2-ready potent intravenous (IV) Factor XIa inhibitor designed for acute care settings, especially where contact activation of coagulation by medical devices or artificial surfaces plays a significant role.
Unlike oral anticoagulants developed for chronic use, Frunexian is purpose-built for environments requiring rapid, controllable, and reversible anticoagulation, such as complex cardiac surgeries. It is currently the only IV small-molecule Factor XIa inhibitor in active development exclusively targeting acute indications.
In recent years, considerable attention has been focused on the Factor XIa pathway, with data strongly supporting the ability of Factor XIa inhibitors to selectively interfere with clot formation without significantly increasing the risk of bleeding.
Factor XIa: A Proven Target for Safer Anticoagulation
Epidemiological data and studies in established animal models suggest Factor XIa plays a fundamental role in thrombosis but only a minor role in normal hemostasis.
Elevated Factor XI levels have been associated with higher incidences of deep venous thrombosis, myocardial infarction, and stroke, while individuals with Factor XI deficiency show significantly lower rates of ischemic stroke and venous thromboembolism without spontaneous bleeding.
This evidence supports Factor XIa inhibition as a promising strategy to reduce clotting risk while minimizing bleeding complications.
Designed for Precision and Safety in Critical Care
Frunexian is a fast-on/fast-off inhibitor that binds rapidly and avidly to Factor XIa, producing predictable, dose-proportional anticoagulant effects. Its pharmacokinetic and pharmacodynamic profile—marked by rapid onset, short half-life, and limited renal dependence—makes it well-suited for use in critical care environments requiring precise control.
In vivo animal studies with frunexian have demonstrated the ability of the molecule to inhibit thrombosis while minimizing the risk of unwanted bleeding. Overall, frunexian administered as a single intravenous bolus or with continuous infusions over 5 consecutive days in healthy subjects has been generally well tolerated, and the AE profile did not suggest any increased risk of bleeding events.