Drug Profile
Pitolisant - Bioprojet
Alternative Names: BF-2.649; BF-2649; Ozawade; Pitolisant hydrochloride; Tiprolisant; WakixLatest Information Update: 29 Feb 2024
Price :
$50
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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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Hypersomnia; Narcolepsy
- Registered Cataplexy
- Phase III Idiopathic hypersomnia
- Phase II Attention-deficit hyperactivity disorder; Myotonic dystrophy; Prader-Willi syndrome
- Discontinued Epilepsy; Obesity; Type 1 diabetes mellitus
Most Recent Events
- 22 Feb 2024 FDA assigns PDUFA action date of 21/06/2024 for pitolisant for Narcolepsy
- 20 Feb 2024 Pitolisant - Bioprojet receives Orphan Drug status for Prader-Willi syndrome in USA
- 08 Jan 2024 Harmony Biosciences anticipates to meet with the US FDA to discuss the development of pitolisant in Idiopathic hypersomnia, in Q1 2024