Mezzion is advancing udenafil through a Fontan-focused development program that includes completed Phase I/II and extension studies, a completed Phase III FUEL trial, and the ongoing global Phase III FUEL-2 confirmatory study. Udenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor that Mezzion is evaluating to improve hemodynamics and exercise capacity in patients with Fontan physiology. The company positions udenafil as a potential first-in-class, indication-specific pharmacologic option for a population with no approved therapies. Mezzion has built a clinical infrastructure across its two Phase III programs and is using the recent institutional financing to sustain enrollment and operational activities for FUEL-2. Mezzion operates as the U.S. subsidiary of South Korean Mezzion Pharma Co., Ltd.

Total raised

$20M

Funding rounds

2

Latest round

Equity

Latest activity

Jun 2025