Trial Profile

Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 30 Oct 2025

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At a glance

Drugs Udenafil (Primary)
Indications Ventricular dysfunction
Focus Registrational; Therapeutic Use
Acronyms FUEL-2
Sponsors Mezzion

Most Recent Events

31 Jul 2025 According to a Mezzion media release, trial is being conducted at more than 30 children's hospitals across the United States and South Korea.
31 Jul 2025 According to a Mezzion media release, to ensure the highest data quality, all cardiopulmonary exercise testing (CPET) in FUEL-2 is centrally reviewed by The Lundquist Institute, an internationally recognized leader in cardiopulmonary diagnostics.
31 Jul 2025 According to a Mezzion media release, trial has surpassed a key enrollment milestone randomizing approximately 50% of the planned 400+ participants and to enter the second half of enrollment.

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