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Pitolisant - Bioprojet

Drug Profile

Pitolisant - Bioprojet

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

Latest Information Update: 17 Sep 2021

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At a glance

  • Originator Bioprojet; Ferrer
  • Developer Alium Medical; AOP Orphan Pharmaceuticals AG; Bioprojet; Citrine Medicine; Ferox Therapeutics; Harmony Biosciences; Paladin Labs
  • Class Chlorobenzenes; Ethers; Nootropics; Piperidines; Sleep disorder therapies; Small molecules
  • 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
  • Registered Cataplexy; Hypersomnia
  • Phase II Myotonic dystrophy
  • Phase I Type 1 diabetes mellitus
  • No development reported Attention-deficit hyperactivity disorder; Unspecified
  • Discontinued Epilepsy; Obesity

Most Recent Events

  • 03 Sep 2021 Registered for Hypersomnia (In adults) in European Union, Iceland, Liechtenstein, Norway (PO)
  • 01 Sep 2021 Biomarkers information updated
  • 21 Jul 2021 Preregistration for Narcolepsy in China (PO)
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