Mezzion Pharmaceuticals, Inc
Mezzion Pharmaceuticals is dedicated to improving outcomes for patients with rare congenital heart diseases, particularly those with single ventricle heart disease and Fontan circulation. The company focuses on discovering, developing, and delivering new treatments, including the drug JURVIGO® (udenafil), which aims to enhance exercise capacity and quality of life for Fontan patients. With a history of regulatory progress and clinical trials, Mezzion strives to provide innovative solutions and expand treatment options for the Fontan community.
Industries
Nr. of Employees
medium (51-250)
Mezzion Pharmaceuticals, Inc
Products
Oral PDE5 inhibitor candidate (udenafil) for Fontan physiology
An orally administered, long-acting, selective phosphodiesterase type 5 inhibitor under clinical investigation to improve pulmonary vasodilation and exercise capacity in patients with Fontan circulation.
Oral PDE5 inhibitor candidate (udenafil) for Fontan physiology
An orally administered, long-acting, selective phosphodiesterase type 5 inhibitor under clinical investigation to improve pulmonary vasodilation and exercise capacity in patients with Fontan circulation.
Services
Sponsor-led clinical development for rare congenital heart disease
Sponsorship and management of clinical development programs including Phase 3 confirmatory trials, open-label safety extensions, protocol submission to regulators, and global site oversight.
Patient advocacy and community partnership programs
Collaboration with patient organizations and community networks to support patient education, recruitment, and awareness for single ventricle/Fontan populations.
Sponsor-led clinical development for rare congenital heart disease
Sponsorship and management of clinical development programs including Phase 3 confirmatory trials, open-label safety extensions, protocol submission to regulators, and global site oversight.
Patient advocacy and community partnership programs
Collaboration with patient organizations and community networks to support patient education, recruitment, and awareness for single ventricle/Fontan populations.
Expertise Areas
- Clinical trial management
- Pediatric cardiology clinical research
- Rare disease drug development
- Regulatory affairs and FDA interactions
Key Technologies
- Cardiopulmonary exercise testing (CPET)
- Oral small-molecule PDE5 inhibitor pharmacology
- Randomized double-blind placebo-controlled trial methodology
- Interim analysis and adaptive sample size re-estimation