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Pitolisant - Bioprojet

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Drug Profile

Pitolisant - Bioprojet

Alternative Names: BF-2.649; BF-2649; HBS-201; Ozawade; Pitolisant delayed-release (DR); Pitolisant hydrochloride; Pitolisant-HD; Tiprolisant; Wakix

Latest Information Update: 13 Aug 2025

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At a glance

  • Originator Bioprojet; INSERM
  • Developer Aculys Pharma; AOP Orphan Pharmaceuticals AG; Bioprojet; Citrine Medicine; Ferox Therapeutics; Harmony Biosciences; Paladin Labs
  • Class Antiepileptic drugs; Antihyperglycaemics; Behavioural disorder therapies; Chlorobenzenes; Ethers; Nootropics; Obesity therapies; 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; Idiopathic hypersomnia; Prader-Willi syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Hypersomnia; Narcolepsy
  • Registered Cataplexy
  • Phase III Idiopathic hypersomnia; Prader-Willi syndrome
  • Phase II Attention-deficit hyperactivity disorder; Autism spectrum disorder; Myotonic dystrophy
  • Discontinued Epilepsy; Obesity; Type 1 diabetes mellitus

Most Recent Events

  • 05 Aug 2025 FDA assigns PDUFA action date in 2026 for Pitolisant GR for Narcolepsy
  • 05 Jun 2025 Bioprojet completes a phase III clinical trials in Narcolepsy (In children, In adolescents) in Finland, France, Italy, Russia and Netherlands (PO) (NCT02611687)
  • 05 Jun 2025 Harmony Biosciences announces a settlement agreement with Lupin Limited, resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application (ANDA) for a generic version of WAKIX® (pitolisant hydrochloride)

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