Product
Pitolisant
Aliases
Pitolisant Oral Tablet, Pitolisant tablet, Wakix
Name
Wakix
INN Name
PITOLISANT HYDROCHLORIDE
FDA Approved
Yes
9 clinical trials
1 organization
9 indications
1 document
Indication
Idiopathic HypersomniaIndication
Excessive Daytime SleepinessIndication
Pregnancy RelatedIndication
NarcolepsyIndication
Myotonic Dystrophy 1Indication
Prader-Willi SyndromeIndication
Alcohol Use DisorderIndication
Alcohol consumptionIndication
Autism Spectrum DisorderClinical trial
WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their OffspringStatus: Recruiting, Estimated PCD: 2030-06-30
Clinical trial
An Open-Label Study to Evaluate the Long-Term Safety and Effectiveness of Pitolisant in Adult Patients With Idiopathic Hypersomnia Who Completed Study HBS-101-CL-010Status: Active (not recruiting), Estimated PCD: 2025-08-01
Clinical trial
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic HypersomniaStatus: Completed, Estimated PCD: 2023-09-08
Clinical trial
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1, Followed by an Open-Label ExtensionStatus: Active (not recruiting), Estimated PCD: 2023-10-06
Clinical trial
A Phase 3, Randomized, Double-Blind, Placebo-controlled, Efficacy and Safety Study of Pitolisant Followed by an Open-Label Extension in Patients With Prader-Willi SyndromeStatus: Recruiting, Estimated PCD: 2026-07-01
Clinical trial
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label ExtensionStatus: Active (not recruiting), Estimated PCD: 2022-08-17
Clinical trial
A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep ApneaStatus: Completed, Estimated PCD: 2023-07-18
Clinical trial
The Effects of the Histamine-3 Receptor Inverse Agonist Pitolisant on Alcohol Self-Administration in Heavy DrinkersStatus: Terminated, Estimated PCD: 2023-02-03
Clinical trial
An Exploratory, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect and Safety of Pitolisant in Children and Adolescents With Autism Spectrum DisordersStatus: Not yet recruiting, Estimated PCD: 2025-01-01
Document
DailyMed Label: WakixOrganization
Harmony Biosciences, LLC