Gepirone ER

Drug Profile

Gepirone ER

Alternative Names: BMY 13805; MJ 13805; Org 33062; TGFK07AD; Travivo; Variza™

Latest Information Update: 21 Sep 2017

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At a glance

  • Originator Bristol-Myers Squibb
  • Developer Fabre-Kramer Pharmaceuticals
  • Class Antidepressants; Anxiolytics; Hypnosedatives; Pyrimidines; Small molecules
  • Mechanism of Action Serotonin 1A receptor agonists
  • 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

  • Preregistration Major depressive disorder

Most Recent Events

  • 21 Sep 2017 Gepirone ER is still preregistered for Major depressive disorder in USA (Fabre-Kramer Pharmaceuticals pipeline, September 2017)
  • 17 Mar 2016 US FDA Office of New Drugs rule favourably on efficacy of Gepirone ER
  • 02 Dec 2015 The US FDA completes review of the amended NDA submitted by Fabre-Kramer for Major depressive disorder
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