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: 18 Nov 2016

Price : $50

At a glance

  • Originator Endoceutics
  • Class Androstenols; Hormonal replacements; Small molecules; Testosterone congeners
  • Mechanism of Action Testosterone congener stimulants
  • Orphan Drug Status

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

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Atrophic vaginitis

Most Recent Events

  • 17 Nov 2016 Registered for Atrophic vaginitis in USA (Vaginal) - First global approval
  • 12 May 2015 Prasterone vaginal is still in phase-III development for Vaginal atrophy in USA and Canada
  • 01 Feb 2015 EndoCeutics completes a phase III trial in Atrophic vaginitis (In adults, In the elderly, In postmenopausal women) in USA and Canada (NCT02013544)
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