Pitolisant

Drug Profile

Pitolisant

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

Latest Information Update: 11 Oct 2017

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At a glance

  • Originator Bioprojet; Ferrer
  • Developer 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

  • 06 Oct 2017 Pitolisant acquired by Harmony Biosciences in USA
  • 06 Oct 2017 Investigation in Narcolepsy in USA (PO)
  • 06 Oct 2017 Harmony Biosciences announces intention to submit NDA to US FDA for Narcolepsy in the first half of 2018
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