Udenafil Clinical Program
Mezzion is evaluating the safety and efficacy of udenafil in adolescents with single ventricle heart disease who have undergone Fontan surgical palliation.
Udenafil is an orally administered, long acting, highly selective phosphodiesterase type 5 inhibitor (PDE5). Inhibition of PDE5 results in the relaxation of pulmonary vascular smooth muscle cells and vasodilation of the pulmonary vascular bed.
The clinical program has included a 400-subject, randomized, double-blind, placebo-controlled trial, a long-term, open-label, safety study in approximately 300 subjects, and a long-term, open-label study evaluating the effect of udenafil on Fontan-associated liver disease. The current clinical program is designed as a 400+ -subject double-blind, placebo-controlled confirmatory phase 3 clinical trial.
