Prasterone vaginal - Endoceutics

Drug Profile

Prasterone vaginal - Endoceutics

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

Latest Information Update: 11 Oct 2018

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At a glance

  • Originator Endoceutics
  • Developer AMAG Pharmaceuticals; Bayer HealthCare Pharmaceuticals Inc.; Endoceutics
  • Class Androstenols; Hormonal replacements; Small molecules
  • Mechanism of Action Dehydroepiandrosterone-replacements
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Marketed Dyspareunia
  • Phase III Atrophic vaginitis; Decreased libido

Most Recent Events

  • 04 Oct 2018 Pooled efficacy data from two clinical trials in Dyspareunia presented at the Annual Meeting of The North American Menopause Society (NAMS-2018)
  • 07 Aug 2018 EndoCeutics in collaboration with AMAG Pharmaceuticals plans the Second phase III trial for Decreased-libido in September 2018 (NCT03619005)
  • 19 Jul 2018 Prasterone licensed to Theramex in Australia, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Serbia, Slovakia, Slovenia, United Kingdom, Russia, Kazakhstan and Ukraine
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