Mezzion Pharma Co. Ltd
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 Pharma Co. Ltd
Patents
Methods of improving myocardial performance in Fontan patients using udenafil compositions
US-12048701-B2
View DetailsMethods of improving myocardial performance in Fontan patients using udenafil compositions
US-10653698-B2
View DetailsMethods of improving myocardial performance in fontan patients using udenafil compositions
US-10137128-B2
View DetailsAgent for treatment of liver diseases containing pyrazolopyrimidinone derivative
US-8796286-B2
View DetailsAgent for the prevention and treatment of prostatic hyperplasia comprising pyrazolopyrimidinone compound
US-8148386-B2
View Details
Methods of improving myocardial performance in Fontan patients using udenafil compositions
US-12048701-B2
View DetailsMethods of improving myocardial performance in Fontan patients using udenafil compositions
US-10653698-B2
View DetailsMethods of improving myocardial performance in fontan patients using udenafil compositions
US-10137128-B2
View DetailsAgent for treatment of liver diseases containing pyrazolopyrimidinone derivative
US-8796286-B2
View DetailsAgent for the prevention and treatment of prostatic hyperplasia comprising pyrazolopyrimidinone compound
US-8148386-B2
View DetailsProducts
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
Sponsorship and management of clinical development programs including Phase 3 confirmatory trials, open-label safety extensions, protocol submission to regulators, and global site oversight.
Collaboration with patient organizations and community networks to support patient education, recruitment, and awareness for single ventricle/Fontan populations.
Sponsorship and management of clinical development programs including Phase 3 confirmatory trials, open-label safety extensions, protocol submission to regulators, and global site oversight.
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
News & Updates
Introduction of new ICD-10 diagnosis codes for Fontan-associated conditions in the U.S. CMS system, aiding clinical documentation, insurance reimbursement, and recognition of Fontan patients' needs.
Funding for the FUEL-2 phase-3 clinical trial of udenafil in adolescents with Fontan circulation, aiming to improve exercise capacity and long-term outcomes.
Study showing that udenafil administration results in small, clinically insignificant changes in heart rate and blood pressure, supporting its safety in Fontan patients.
FDA provided guidance that only one new clinical trial, FUEL-2, is needed for approval, with specific endpoints and population criteria, aiming to improve exercise capacity and delay morbidity.
Introduction of new ICD-10 diagnosis codes for Fontan-associated conditions in the U.S. CMS system, aiding clinical documentation, insurance reimbursement, and recognition of Fontan patients' needs.
Funding for the FUEL-2 phase-3 clinical trial of udenafil in adolescents with Fontan circulation, aiming to improve exercise capacity and long-term outcomes.
Study showing that udenafil administration results in small, clinically insignificant changes in heart rate and blood pressure, supporting its safety in Fontan patients.
FDA provided guidance that only one new clinical trial, FUEL-2, is needed for approval, with specific endpoints and population criteria, aiming to improve exercise capacity and delay morbidity.