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Flibanserin - Sprout Pharmaceuticals

Drug Profile

Flibanserin - Sprout Pharmaceuticals

Alternative Names: Addyi; BIMT 17; BIMT 17 BS; Girosa®

Latest Information Update: 09 Sep 2019

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At a glance

  • Originator Boehringer Ingelheim
  • Developer Boehringer Ingelheim; Sprout Pharmaceuticals
  • Class Antidepressants; Anxiolytics; Benzimidazoles; Ketones; Small molecules
  • Mechanism of Action Serotonin 1A receptor agonists; Serotonin 2A receptor antagonists
  • Orphan Drug Status

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

  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Female sexual dysfunction
  • Discontinued Major depressive disorder

Most Recent Events

  • 04 Sep 2019 Sprout Pharmaceuticals plans to change labelling elements for flibanserin under US FDA's Risk Evaluation and Mitigation Strategy programme
  • 12 Apr 2019 US FDA relaxes restrictions on alcohol use in women taking flibanserin for treatment of Female sexual dysfunction
  • 21 Mar 2019 Safety results from three clinical trials in Healthy volunteers released by Sprout Pharmaceuticals
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