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XYWAV, Drug Insight and Market Forecast - 2032

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    Report

  • 30 Pages
  • August 2022
  • Region: Global
  • DelveInsight
  • ID: 5680344
“XYWAV, Drug Insight and Market Forecast - 2032” report provides comprehensive insights about XYWAV for Excessive Daytime Sleepiness (EDS) in the 7MM. A detailed picture of the XYWAV 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 XYWAV 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 XYWAV 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

XYWAV, also known as JZP-258, is approved by the US Food and Drug Administration (FDA) to treat cataplexy or Excessive Daytime Sleepiness (EDS) in patients 7 years of age and older with narcolepsy and for the treatment of idiopathic hypersomnia in adults. XYWAV is comprised of a unique composition of cations resulting in 92% less sodium, or approximately 1,000-1,500 mg/night, than sodium oxybate at the recommended dosage range of 6-9 g. XYWAV has the same oxybate concentration as sodium oxybate and includes a mix of calcium, magnesium, potassium, and sodium cations. While the exact mechanism of action of XYWAV is unknown, it is hypothesized that the therapeutic effects of XYWAV on cataplexy and EDS are mediated through GABAB actions during sleep at noradrenergic and dopaminergic neurons as well as at thalamocortical neurons.

Dosage
Dosage for Adult Patients
  • Initiate dosage at 4.5 g per night orally, divided into two doses
  • Titrate to effect in increments of up to 1.5 g per night per week
  • Recommended dosage range: 6-9 g per night orally
Dosage for Pediatric Patients (7 years of age and older)
  • The recommended starting dosage, titration regimen, and maximum total nightly dosage are based on body weight.
Mechanism of Action
XYWAV is a CNS depressant. The exact mechanism of action of XYWAV in the treatment of narcolepsy is unknown. XYWAV is a mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate (gamma-hydroxybutyrate). Gamma-hydroxybutyrate (GHB) is an endogenous compound and metabolite of the neurotransmitter GABA. It is hypothesized that the therapeutic effects of XYWAV on cataplexy and EDS are mediated through GABAB actions during sleep at noradrenergic and dopaminergic neurons as well as at thalamocortical neurons.

Scope of the Report

The report provides insights into:
  • A comprehensive product overview including the XYWAV description, mechanism of action, dosage and administration, research and development activities in Excessive Daytime Sleepiness (EDS).
  • Elaborated details on XYWAV regulatory milestones and other development activities have been provided in this report.
  • The report also highlights the XYWAV 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 XYWAV.
  • The report contains forecasted sales of XYWAV 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 XYWAV 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.

XYWAV Analytical Perspective

In-depth XYWAV Market Assessment

This report provides a detailed market assessment of XYWAV 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.

XYWAV Clinical Assessment

The report provides the clinical trials information of XYWAV 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 XYWAV dominance.
  • Other emerging products for Excessive Daytime Sleepiness (EDS) are expected to give tough market competition to XYWAV 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 XYWAV in Excessive Daytime Sleepiness (EDS).
  • Our in-depth analysis of the forecasted sales data of XYWAV from 2022 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the XYWAV in Excessive Daytime Sleepiness (EDS).

Key Questions Answered

  • What is the product type, route of administration and mechanism of action of XYWAV?
  • What is the clinical trial status of the study related to XYWAV in Excessive Daytime Sleepiness (EDS) and study completion date?
  • What are the key collaborations, mergers and acquisitions, licensing and other activities related to the XYWAV development?
  • What are the key designations that have been granted to XYWAV for Excessive Daytime Sleepiness (EDS)?
  • What is the forecasted market scenario of XYWAV for Excessive Daytime Sleepiness (EDS)?
  • What are the forecasted sales of XYWAV 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 XYWAV for Excessive Daytime Sleepiness (EDS)?
  • Which are the late-stage emerging therapies under development for the treatment of Excessive Daytime Sleepiness (EDS)?

Table of Contents

1. Report Introduction
2. XYWAV Overview
2.1. Product Detail
2.2. Clinical Development
2.2.1. Clinical Studies
2.2.2. Clinical Trials Information
2.2.3. Safety and Efficacy
2.3. Regulatory Milestones
2.4. Other Developmental Activities
2.5. Product Profile
3. Competitive Landscape (Marketed Therapies)4. Competitive Landscape (Late-stage Emerging Therapies) *
5. XYWAV Market Assessment
5.1. Market Outlook of XYWAV for Excessive Daytime Sleepiness (EDS)
5.2. 7MM Market Analysis
5.2.1. Market Size of XYWAV in the 7MM for Excessive Daytime Sleepiness (EDS)
5.3. Country-wise Market Analysis
5.3.1. Market Size of XYWAV in the United States for Excessive Daytime Sleepiness (EDS)
5.3.2. Market Size of XYWAV in Germany for Excessive Daytime Sleepiness (EDS)
5.3.3. Market Size of XYWAV in France for Excessive Daytime Sleepiness (EDS)
5.3.4. Market Size of XYWAV in Italy for Excessive Daytime Sleepiness (EDS)
5.3.5. Market Size of XYWAV in Spain for Excessive Daytime Sleepiness (EDS)
5.3.6. Market Size of XYWAV in the United Kingdom for Excessive Daytime Sleepiness (EDS)
5.3.7. Market Size of XYWAV in Japan for Excessive Daytime Sleepiness (EDS)
6. SWOT Analysis7. Analysts’ Views
8. Appendix
8.1. Bibliography
8.2. Report Methodology
9. Publisher Capabilities10. Disclaimer11. About the Publisher12. Report Purchase Options
List of Tables
Table 1: XYWAV, Clinical Trial Description, 2022
Table 2: XYWAV: General Description
Table 3: Competitive Landscape (Marketed Therapies)
Table 4: Competitive Landscape (Late-stage Emerging Therapies)
Table 5: XYWAV Market Size in the 7MM, in USD million (2019-2032)
Table 6: XYWAV Market Size in the US, in USD million (2019-2032)
Table 7: XYWAV Market Size in Germany, in USD million (2019-2032)
Table 8: XYWAV Market Size in France, in USD million (2019-2032)
Table 9: XYWAV Market Size in Italy, in USD million (2019-2032)
Table 10: XYWAV Market Size in Spain, in USD million (2019-2032)
Table 11: XYWAV Market Size in the UK, in USD million (2019-2032)
Table 12: XYWAV Market Size in Japan, in USD million (2019-2032)
List of Figures
Figure 1: XYWAV Market Size in the 7MM, USD million (2019-2032)
Figure 2: XYWAV Market Size in the United States, USD million (2019-2032)
Figure 3: XYWAV Market Size in Germany, USD million (2019-2032)
Figure 4: XYWAV Market Size in France, USD million (2019-2032)
Figure 5: XYWAV Market Size in Italy, USD million (2019-2032)
Figure 6: XYWAV Market Size in Spain, USD million (2019-2032)
Figure 7: XYWAV Market Size in the United Kingdom, USD million (2019-2032)
Figure 8: XYWAV Market Size in Japan, USD million (2019-2032)