Narcolepsy Treatments
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Brand Name
Wakix
Generic Name
Pitolisant
View Brand Information FDA approval date: August 14, 2019
Classification: Histamine-3 Receptor Antagonist/Inverse Agonist
Form: Tablet
What is Wakix (Pitolisant)?
WAKIX is indicated for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy. WAKIX is a histamine-3 receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy
Approved To Treat
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Related Clinical Trials
WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring
Summary: The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
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 Syndrome
Summary: This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome. The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome. Secondary objectives inc...