Flibanserin

Drug Profile

Flibanserin

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

Latest Information Update: 12 Nov 2016

Price : $50

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.

    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
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Female sexual dysfunction
  • Discontinued Major depressive disorder

Most Recent Events

  • 19 Oct 2015 Launched for Female sexual dysfunction in USA (PO) - First global launch
  • 18 Aug 2015 Registered for Female sexual dysfunction in USA (PO) - first global approval
  • 04 Jun 2015 The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommend approval of flibaserin for Hypoactive Sexual Desire Disorder, with a risk management option beyond labelling, in USA
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