Cadrenal Therapeutics
Cadrenal Therapeutics is a biopharmaceutical company focused on developing tecarfarin, a novel and safer oral anticoagulant designed to improve outcomes for patients with rare cardiovascular conditions and those with implanted cardiac devices. The company aims to address unmet needs in anticoagulation therapy, with a focus on conditions such as end-stage kidney disease, atrial fibrillation, and patients with left ventricular assist devices. Tecarfarin has received orphan drug and fast-track designations from the FDA, and the company is advancing its clinical development with plans for pivotal trials and strategic partnerships. Recently, Cadrenal expanded its focus to include patients with implanted medical devices for heart diseases, such as LVADs, where tecarfarin could provide a more reliable anticoagulant option due to warfarin's limitations.
Industries
Nr. of Employees
small (1-50)
Cadrenal Therapeutics
Patents
Products
Oral reversible vitamin K antagonist candidate
A late-stage oral, reversible vitamin K antagonist drug candidate designed with an alternate metabolic pathway to reduce susceptibility to common drug–drug interactions and exposure variability; evaluated in multiple human clinical trials.
Oral reversible vitamin K antagonist candidate
A late-stage oral, reversible vitamin K antagonist drug candidate designed with an alternate metabolic pathway to reduce susceptibility to common drug–drug interactions and exposure variability; evaluated in multiple human clinical trials.
Services
Protocol design, trial planning, investigator outreach, site identification, and execution support for late-stage clinical trials in specialized cardiovascular and device-associated populations.
Coordination of cGMP technical transfer to contract manufacturers and management of manufacturing scale-up and supply chain milestones to support clinical trial readiness.
Development and execution of regulatory engagement plans including pursuit of orphan/fast-track designations and formal agency meetings to align on pivotal trial pathways.
Assessment of additional clinical indications and estimation of target patient populations to support strategic development decisions for device-associated and rare cardiovascular indications.
Support for investor relations and corporate communications, including preparation for and participation in industry conferences and investor partner meetings to communicate clinical and regulatory plans.
Protocol design, trial planning, investigator outreach, site identification, and execution support for late-stage clinical trials in specialized cardiovascular and device-associated populations.
Coordination of cGMP technical transfer to contract manufacturers and management of manufacturing scale-up and supply chain milestones to support clinical trial readiness.
Development and execution of regulatory engagement plans including pursuit of orphan/fast-track designations and formal agency meetings to align on pivotal trial pathways.
Assessment of additional clinical indications and estimation of target patient populations to support strategic development decisions for device-associated and rare cardiovascular indications.
Support for investor relations and corporate communications, including preparation for and participation in industry conferences and investor partner meetings to communicate clinical and regulatory plans.
Expertise Areas
- Pivotal clinical trial design and execution (Phase 3)
- Clinical pharmacology and PK/PD assessment in renal impairment
- Anticoagulation therapy development for device-associated and rare cardiovascular populations
- Regulatory strategy and management of orphan/fast-track designations
Key Technologies
- Retrometabolic small-molecule design
- Pharmacokinetic/pharmacodynamic clinical studies
- Clinical trial design and adaptive pivotal trial planning
- cGMP drug substance and drug product technical transfer