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Udenafil - Dong-A ST/Mezzion

Drug Profile

Udenafil - Dong-A ST/Mezzion

Alternative Names: DA-8159; ME-3113; MZ101; Udzire; WC-3043; WC-3055; Zydena

Latest Information Update: 23 Feb 2023

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At a glance

  • Originator Dong-A Pharmaceutical
  • Developer Abdi Ibrahim Pharmaceuticals; Dong-A Pharmaceutical; Dong-A ST; Dr Falk Pharma; Meiji Seika Pharma; Mezzion; National Heart, Lung and Blood Institute; Seoul National University Hospital; Valenta; Zydus Urosciences
  • Class Antihypertensives; Erectile dysfunction therapies; Pyrazolones; Pyrimidinones; Pyrrolidines; Small molecules; Sulfonamides
  • Mechanism of Action Type 5 cyclic nucleotide phosphodiesterase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Congenital heart defects
  • New Molecular Entity Yes
  • Available For Licensing Yes - Benign prostatic hyperplasia; Erectile dysfunction; Portal hypertension; Pulmonary hypertension

Highest Development Phases

  • Marketed Erectile dysfunction
  • Preregistration Congenital heart defects
  • Phase II/III Pulmonary arterial hypertension
  • Phase II Benign prostatic hyperplasia; Portal hypertension
  • No development reported Overactive bladder
  • Discontinued Heart failure; Pulmonary hypertension

Most Recent Events

  • 21 Feb 2023 Mezzion submits protocol for the phase confirmatory pivotal phase III FUEL-2 trial to the US FDA for Congenital heart defects
  • 02 Jun 2022 Mezzion Pharma plans a phase III FUEL-2 trial in Congenital heart defects in 2022
  • 31 May 2022 US FDA gives positive review over re-submitted NDA of initiating an additional clinical trial for the regulatory approval of udenafil in Congenital heart disorders
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