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Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)

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Trial Profile

Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2023

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At a glance

  • Drugs Udenafil (Primary)
  • Indications Congenital heart defects; Ventricular dysfunction
  • Focus Registrational; Therapeutic Use
  • Acronyms FUEL
  • Sponsors Mezzion

Most Recent Events

  • 30 Oct 2023 Results evaluating the effects of udenafil on vital signs, published in the American Journal of Cardiology
  • 21 Dec 2021 According to a Mezzion media release, new data from its Phase 3 efficacy and safety trial (FUEL Trial) and its open label extension trial (FUEL OLE Trial) was presented to the U.S. Food and Drug Administration (FDA) in a Type C meeting held on December 16, 2021.
  • 25 May 2021 According to a Mezzion Pharma media release, The FDA also advised in the FDA Notice that the FDA is not currently planning to hold an advisory committee meeting to discuss Mezzion's NDA.Company fully expects that, upon FDA approval of its NDA for the treatment of SVHD patients, a rare pediatric disease, it will be awarded a PRV, at which time the PRV will be fully redeemable and/or transferrable.

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