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Report Overview

Hypersomnia is a neurological sleep disorder characterized by excessive daytime sleepiness and prolonged nighttime sleep despite adequate rest. According to the University Hospitals data (2025), the global prevalence of narcolepsy, a central hypersomnia disorder, ranges from 25 to 50 per 100,000, while idiopathic hypersomnia (IH) affects approximately 2 to 10.3 per 100,000 individuals. According to the hypersomnia pipeline analysis by Expert Market Research, current therapeutic approaches include stimulants, wake-promoting agents, and novel orexin receptor agonists. Growing research focus, increased diagnosis rates, and advancements in sleep medicine are expected to drive market growth in the coming years.

  • Major companies involved in the hypersomnia pipeline analysis include Avadel, Alkermes, Inc., Takeda, and others.

  • Leading drugs currently in the pipeline include FT218, ALKS 2680, ORX750, and others.

  • The pipeline growth is driven by increasing clinical trials targeting orexin and GABA receptor pathways, rising prevalence of sleep disorders, and enhanced research funding supporting novel therapeutic development.

Report Coverage

The Hypersomnia Pipeline Analysis Report by Expert Market Research gives comprehensive insights into hypersomnia therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for hypersomnia. The hypersomnia report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The hypersomnia pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with hypersomnia treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to hypersomnia.

Hypersomnia Pipeline Analysis By Drug Class

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Hypersomnia Pipeline Outlook

Hypersomnia is a neurological sleep disorder characterized by excessive daytime sleepiness despite sufficient or extended nighttime rest. It occurs due to dysfunction in the brain regions regulating the sleep–wake cycle, often linked to genetic, neurological, or idiopathic factors. Individuals may struggle to wake up, experience confusion after sleep, and feel unrefreshed after naps.

Hypersomnia treatment focuses on symptom management through behavioral therapies, stimulant medications, and lifestyle adjustments to improve wakefulness, sleep quality, and cognitive functioning. In August 2021, Jazz Pharmaceuticals received FDA approval for Xywav (JZP258) as the first treatment for idiopathic hypersomnia in adults. This lower sodium oxybate therapy demonstrated strong efficacy and safety in Phase 3 trials.

Hypersomnia Epidemiology

According to University Hospitals data, 2025, hypersomnia disorders such as narcolepsy and idiopathic hypersomnia show varied global prevalence. Narcolepsy affects between 25 and 50 per 100,000 individuals, while idiopathic hypersomnia ranges from 2 to 10.3 per 100,000. As per Yu-Shu Huang et al., 2025, the prevalence of narcolepsy varies significantly across regions, with rates as high as 590 per 100,000 in Japan and as low as 0.23 per 100,000 in Israel. In the United States, estimates range between 37.7 and 79.4 per 100,000, while Asian studies report 15 to 37.5 per 100,000. These findings highlight substantial regional variation, emphasizing the need for improved diagnosis and consistent epidemiological research.

Hypersomnia – Pipeline Therapeutic Assessment

This section of the report covers the analysis of hypersomnia drug candidates based on several segmentations, including:

By Phase

The pipeline assessment report covers 50+ drug analyses based on phase:

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

The hypersomnia pipeline analysis report covers 50+ drug analyses based on drug classes:

  • Small Molecules
  • Monoclonal Antibodies
  • Gene Therapies
  • Peptides
  • Polymers

By Route of Administration

The pipeline assessment report covers 50+ drug analyses based on the route of administration.

  • Oral
  • Parenteral
  • Others

Hypersomnia Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total hypersomnia clinical trials, at 56%. It is followed by phase III at 28% and phase IV at 11%. The strong presence of late-stage trials underscores significant clinical progress, expected to drive therapeutic innovation and growth in the hypersomnia drug market.

Hypersomnia Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the hypersomnia pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides, and polymers. The hypersomnia report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for hypersomnia. Sodium oxybate-based therapies are gaining prominence in the hypersomnia drug pipeline due to their effectiveness in managing excessive daytime sleepiness and sleep inertia. In June 2025, Avadel Pharmaceuticals announced that Lumryz, its extended-release sodium oxybate formulation, received orphan drug designation from the FDA for idiopathic hypersomnia. The once per night dosing of Lumryz improves treatment adherence and patient convenience compared to traditional twice-nightly regimens.

Hypersomnia Clinical Trials – Key Players

The EMR report for the hypersomnia pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed hypersomnia therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in hypersomnia clinical trials:

  • Avadel
  • Alkermes, Inc.
  • Takeda
  • Centessa Pharmaceuticals (UK) Limited
  • Harmony Biosciences Management, Inc.
  • Axsome Therapeutics, Inc.
  • Masimo Corporation
  • Millennium Pharmaceuticals, Inc.
  • Jazz Pharmaceuticals
  • Zevra Therapeutics

Hypersomnia – Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for hypersomnia. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of hypersomnia drug candidates.

Drug: FT218

FT218, developed by Avadel, is an investigational once-nightly extended-release formulation of sodium oxybate designed to treat idiopathic hypersomnia. The ongoing Phase 3 trial (REVITALYZ) is evaluating its safety and efficacy through a double-blind, placebo-controlled, randomized withdrawal design. The study is enrolling approximately 150 participants to determine FT218’s ability to improve excessive daytime sleepiness and overall functioning, potentially offering a more convenient therapeutic option for patients with idiopathic hypersomnia.

Drug: ALKS 2680

ALKS 2680 is an investigational, oral, selective orexin 2 receptor (OX2R) agonist being developed by Alkermes, Inc. for the treatment of narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. This Phase 2/3 study is examining the long-term safety, tolerability, and durability of treatment effects of ALKS 2680 in patients. The drug aims to restore wakefulness by activating orexin pathways, which regulate alertness and reduce excessive daytime sleepiness across hypersomnolence disorders.

Drug: ORX750

ORX750 is an investigational oral drug developed by Centessa Pharmaceuticals (UK) Limited, currently in Phase 2a of the CRYSTAL-1 study. This phase is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ORX750 in participants with narcolepsy Type 1, narcolepsy Type 2, and idiopathic hypersomnia. Designed as a highly potent and selective orexin receptor 2 (OX2R) agonist, ORX750 mimics the natural action of orexin, promoting wakefulness and reducing excessive daytime sleepiness.

*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*

Key Questions Answered in the Hypersomnia Pipeline Insight Report

  • Which companies/institutions are leading the hypersomnia drug development?
  • What is the efficacy and safety profile of the hypersomnia pipeline drugs?
  • Which company is leading the hypersomnia pipeline development activities?
  • What is the current hypersomnia commercial assessment?
  • What are the opportunities and challenges present in the hypersomnia pipeline landscape?
  • Which company is conducting major trials for hypersomnia drugs?
  • Which companies/institutions are involved in hypersomnia collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in Hypersomnia?

Reasons To Buy This Report

The Hypersomnia Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for hypersomnia. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into hypersomnia collaborations, regulatory environments, and potential growth opportunities.

Related Reports

Global Clinical Trials Market

Hypersomnia Epidemiology Forecast

Narcolepsy Drugs Market

Narcolepsy Pipeline Analysis Report

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

Scope of the Report

Details

Drug Pipeline by Clinical Trial Phase

  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

Route of Administration

  • Oral
  • Parenteral
  • Others

Drug Classes

  • Small Molecules
  • Monoclonal Antibodies
  • Gene Therapies
  • Peptides
  • Polymers

Leading Sponsors Covered

  • Avadel
  • Alkermes, Inc.
  • Takeda
  • Centessa Pharmaceuticals (UK) Limited
  • Harmony Biosciences Management, Inc.
  • Axsome Therapeutics, Inc.
  • Masimo Corporation
  • Millennium Pharmaceuticals, Inc.
  • Jazz Pharmaceuticals
  • Zevra Therapeutics

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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