WAKIX (Pitolisant), Drug Insight and Market Forecast - 2032

“WAKIX (Pitolisant), Drug Insight and Market Forecast - 2032” report provides comprehensive insights about WAKIX (Pitolisant) for Excessive Daytime Sleepiness (EDS) in the 7MM. A detailed picture of the WAKIX (Pitolisant) for Excessive Daytime Sleepiness (EDS) in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2019-2032 is provided in this report along with a detailed description of the WAKIX (Pitolisant) for Excessive Daytime Sleepiness (EDS) . The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the WAKIX (Pitolisant) market forecast, analysis for Excessive Daytime Sleepiness (EDS) in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Excessive Daytime Sleepiness (EDS).

Drug Summary

Pitolisant, a Histamine H3 receptor (H3R) antagonist, was developed for its awakening effect in the treatment of narcolepsy with or without cataplexy. European marketing authorization was obtained for this indication in March 2016 (WAKIX). A pediatric investigation plan is underway, and studies are being carried out on narcoleptic children.

In October 2020, the US FDA also approved WAKIX (Pitolisant) for the treatment of cataplexy in adult patients with narcolepsy.

Pitolisant has also been developed for treating Excessive Daytime Sleepiness (EDS) related to Obstructive Sleep Apnea (OSA) and Parkinson's disease. It is the subject of several international multicenter Phase III studies. The Phase III clinical trial evaluating pitolisant for the treatment of EDS in OSA shows that treatment with pitolisant, compared with placebo, reduced EDS and improved several other outcomes among patients with obstructive sleep apnea who refuse Continuous Positive Airway Pressure (CPAP).

It was designed and developed by Bioprojet Societe Civile de Recherche (Bioprojet), which has marketed the product in Europe since its approval by the European Medicines Agency in 2016. Recently, the European Medicines Agency (EMA) has approved Bioprojet's pitolisant with the brand name Ozawade to treat EDS associated with OSA in adults.

Harmony has an exclusive license from Bioprojet to develop, manufacture, and commercialize pitolisant in the United States. It is in a Phase I study for Prader-Willi syndrome and has completed the pre-IND phase for myotonic dystrophy.

Mechanism of Action
The mechanism of action of pitolisant in EDS in adult patients with narcolepsy is unclear. However, its efficacy could be mediated by its antagonist/inverse agonist activity at histamine-3 (H3) receptors.

• Potent, highly selective histamine 3 (H3) receptor antagonist/inverse agonist
• Results in increased histaminergic transmission in the brain
• It activates other wake-promoting neurotransmitters (dopamine, norepinephrine, serotonin, acetylcholine)

It does not increase dopamine in the nucleus accumbens (consistent with its lack of abuse potential).

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the WAKIX (Pitolisant) description, mechanism of action, dosage and administration, research and development activities in Excessive Daytime Sleepiness (EDS).
• Elaborated details on WAKIX (Pitolisant) regulatory milestones and other development activities have been provided in this report.
• The report also highlights the WAKIX (Pitolisant) research and development activity in Excessive Daytime Sleepiness (EDS) in detail across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around WAKIX (Pitolisant).
• The report contains forecasted sales of WAKIX (Pitolisant) for Excessive Daytime Sleepiness (EDS) till 2032.
• Comprehensive coverage of the late-stage emerging therapies for Excessive Daytime Sleepiness (EDS).
• The report also features the SWOT analysis with analyst views for WAKIX (Pitolisant) in Excessive Daytime Sleepiness (EDS).

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by a team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

WAKIX (Pitolisant) Analytical Perspective

In-depth WAKIX (Pitolisant)Market Assessment

This report provides a detailed market assessment of WAKIX (Pitolisant) in Excessive Daytime Sleepiness (EDS) in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data from 2022 to 2032.

WAKIX (Pitolisant)Clinical Assessment

The report provides the clinical trials information of WAKIX (Pitolisant) in Excessive Daytime Sleepiness (EDS) covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for Excessive Daytime Sleepiness (EDS) is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence WAKIX (Pitolisant) dominance.
• Other emerging products for Excessive Daytime Sleepiness (EDS) are expected to give tough market competition to WAKIX (Pitolisant) and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of WAKIX (Pitolisant) in Excessive Daytime Sleepiness (EDS).
• Our in-depth analysis of the forecasted sales data of WAKIX (Pitolisant) from 2022 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the WAKIX (Pitolisant) in Excessive Daytime Sleepiness (EDS).

Key Questions Answered

• What is the product type, route of administration and mechanism of action of WAKIX (Pitolisant)?
• What is the clinical trial status of the study related to WAKIX (Pitolisant) in Excessive Daytime Sleepiness (EDS) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the WAKIX (Pitolisant) development?
• What are the key designations that have been granted to WAKIX (Pitolisant) for Excessive Daytime Sleepiness (EDS)?
• What is the forecasted market scenario of WAKIX (Pitolisant) for Excessive Daytime Sleepiness (EDS)?
• What are the forecasted sales of WAKIX (Pitolisant) in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What are the other emerging products available in Excessive Daytime Sleepiness (EDS) and how are they giving competition to WAKIX (Pitolisant) for Excessive Daytime Sleepiness (EDS)?
• Which are the late-stage emerging therapies under development for the treatment of Excessive Daytime Sleepiness (EDS)?