Drug Profile


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

Latest Information Update: 17 May 2017

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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
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 15 Mar 2017 Phase-I clinical trials in Drug abuse (In volunteers) in Canada (PO) (NCT03152123)
  • 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)
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