Pitolisant - Bioprojet

Drug Profile

Pitolisant - Bioprojet

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

Latest Information Update: 24 May 2018

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At a glance

  • Originator Bioprojet; Ferrer
  • Developer Alium Medical; Bioprojet; Harmony Biosciences
  • Class Nootropics; Piperidines; Sleep disorder therapies
  • Mechanism of Action Histamine H3 receptor antagonists; 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

  • 22 May 2018 Harmony Biosciences intends to market pitolisant for excessive daytime sleepiness and cataplexy in patients with Narcolepsy in USA in 2019
  • 21 May 2018 Pitolisant - Bioprojet receives Breakthrough Therapy status for Narcolepsy in USA (9241409; 9241470)
  • 21 May 2018 Pitolisant - Bioprojet receives Fast Track designation for Narcolepsy (excessive daytime sleepiness and cataplexy in patients with narcolepsy) [PO,Tablet] in USA
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