Mezzion is focused on advancing treatment options for individuals living with Fontan circulation, particularly through their clinical program evaluating the safety and efficacy of udenafil. Udenafil is a long-acting, highly selective phosphodiesterase type 5 (PDE5) inhibitor that is administered orally. The mechanism of action involves the inhibition of PDE5, which leads to the relaxation of pulmonary vascular smooth muscle cells and subsequent vasodilation of the pulmonary vascular bed. This innovative approach aims to address the unique challenges faced by adolescents with single ventricle heart disease who have undergone Fontan surgical palliation.

The clinical program for udenafil includes a comprehensive series of studies, such as a randomized, double-blind, placebo-controlled trial involving 400 subjects, as well as a long-term open-label safety study with approximately 300 participants. Additionally, there is a focus on understanding the effects of udenafil on Fontan-associated liver disease. The current phase of the clinical program is designed as a confirmatory phase 3 trial, which aims to further validate the findings and ensure the safety and efficacy of udenafil for this specific patient population.

United States

Mezzion is a rare disease company focused on discovering, developing, and delivering new treatments for people living with Fontan circulation. Since its founding in South Korea in 2002, Mezzion has remained dedicated to developing new hope for rare disease patients.

Mezzion

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