Prasterone vaginal - Bayer/Endoceutics

Drug Profile

Prasterone vaginal - Bayer/Endoceutics

Alternative Names: Dehydroepiandrosterone; DHEA; INTRAROSA; Intravaginal dehydroepiandrosterone; Intravaginal prasterone; Prasterone vaginal ovule; Vaginorm

Latest Information Update: 23 May 2018

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At a glance

  • Originator Endoceutics
  • Developer AMAG Pharmaceuticals; Bayer HealthCare Pharmaceuticals Inc.; Endoceutics
  • Class Androstenols; Hormonal replacements; Small molecules; Testosterone congeners
  • Mechanism of Action Testosterone congener stimulants; Testosterone replacements
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Dyspareunia
  • Phase III Atrophic vaginitis; Decreased libido

Most Recent Events

  • 20 May 2018 Prasterone vaginal licensed to Mundipharma International in Middle East and Africa
  • 10 Jan 2018 Registered for Dyspareunia in Liechtenstein, Iceland, Norway and European Union (Vaginal)
  • 09 Nov 2017 Preregistration for Dyspareunia in European Union prior to November 2017 (Vaginal)
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