Drug Profile


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

Latest Information Update: 02 Aug 2017

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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
  • Phase III Congenital heart defects
  • Phase II/III Pulmonary arterial hypertension
  • Phase II Benign prostatic hyperplasia; Portal hypertension
  • Discontinued Heart failure; Pulmonary hypertension

Most Recent Events

  • 31 Jul 2017 Tabuk Pharmaceutical Manufacturing acquires marketing license for udenafil in Saudi Arabia, Bahrain, Iraq, Kuwait, Oman, Qatar and the United Arab Emirates
  • 01 Jan 2017 Mezzion Pharma initiates a phase III extension trial in Congenital heart disorders (In adolescents) in USA (NCT03013751)
  • 15 Dec 2016 Biomarkers information updated
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