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Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)

Trial Profile

Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Jun 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

  • 11 Jun 2025 According to a Mezzion media release, company announced a major milestone in their clinical development program, having secured approximately $20 million USD in strategic funding to support the ongoing global Phase 3 FUEL-2 trial of udenafil for patients with Fontan circulation.
  • 01 Mar 2024 According to a Mezzion media release, currently, 22 sites in the U.S. are enrolling or will begin enrolling in the coming weeks.
  • 01 Mar 2024 According to a Mezzion media release, the company has announced Dr. Rahul Rathod, as the Global Principal Investigator of FUEL-2.He will lead the study analysis and contribute to reporting the results to the Food and Drug Administration (FDA).

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