Pitolisant

Drug Profile

Pitolisant

Alternative Names: BF 2.649; BF-2649; Pitolisant hydrochloride; Tiprolisant; Wakix

Latest Information Update: 05 Jan 2017

Price : $50

At a glance

  • Originator Bioprojet; Ferrer
  • Developer Bioprojet
  • Class Nootropics; Piperidines; Sleep disorder therapies
  • Mechanism of Action Histamine H3 receptor inverse agonists
  • Orphan Drug Status

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

    Yes - Narcolepsy
  • 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 Narcolepsy
  • Phase III Hypersomnia
  • No development reported Attention-deficit hyperactivity disorder
  • Discontinued Epilepsy; Obesity

Most Recent Events

  • 31 Oct 2016 Bioprojet completes the phase-I HAROSA III trial in Hypersomnia in Bulgaria (PO) (NCT02739568)
  • 01 Aug 2016 Bioprojet completes a phase I bioavailability trial in Healthy volunteers in United Kingdom (PO) (NCT02929342)
  • 01 Jul 2016 Bioprojet initiates a phase I bioavailability trial in Healthy volunteers in United Kingdom (PO) (NCT02929342)
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