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Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)

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Trial Profile

Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Jul 2026

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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

  • 16 Jul 2026 According to Mezzion media release, the results from the trial were published in the peer-reviewed journal Pediatric Cardiology.
  • 16 Jul 2026 Results presented in the Mezzion media release.
  • 05 Jun 2026 According to a Mezzion media release, company announced the results of a planned independent, blinded statistical review from this trial. The independent review determined that no increase in sample size was required and recommended that the study continue as planned with the enrollment of 436 patients. Moreover, no changes were recommended to the study design, primary endpoint, statistical analysis plan, or projected study timelines.

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