Drug Profile


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

Latest Information Update: 15 Feb 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.

  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 13 Feb 2017 The Scottish Medicines Consortium does not recommend pitolisant for the treatment of Narcolepsy for use within NHS Scotland
  • 11 Jan 2017 Bioprojet withdraws the phase II PoC Alcohol trial before enrolment due to the sponsor decision for Alcoholism in Bulgaria (NCT02800083)
  • 15 Nov 2016 Launched for Narcolepsy in United Kingdom (PO)
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