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Pitolisant - Bioprojet

Drug Profile

Pitolisant - Bioprojet

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

Latest Information Update: 24 Nov 2019

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At a glance

  • Originator Bioprojet; Ferrer
  • Developer Alium Medical; AOP Orphan Pharmaceuticals AG; Bioprojet; Ferox Therapeutics; Harmony Biosciences
  • 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
  • Phase III Hypersomnia
  • Phase I Type 1 diabetes mellitus; Unspecified
  • No development reported Attention-deficit hyperactivity disorder
  • Discontinued Epilepsy; Obesity

Most Recent Events

  • 06 Feb 2020 Harmony Biosciences plans a phase II trial for Prader-Willi syndrome (In children, In Adolescents, In Adults) in May 2020 (PO) (NCT04257929)
  • 26 Aug 2019 Harmony Biosciences completes an Expanded Access Program in Narcolepsy in USA (PO) (NCT03433131)
  • 15 Aug 2019 Registered for Narcolepsy in USA (PO)
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