Hypersomnia Pipeline 2026: MOA, ROA, FDA-Approved Drugs, and Clinical Trial Progress Assessment by DelveInsight

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Hypersomnia pipeline constitutes 3+ key companies continuously working towards developing 4+ Hypersomnia treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Hypersomnia Pipeline Insight, 2026" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Hypersomnia Market.

The Hypersomnia Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Hypersomnia Pipeline Report: https://www.delveinsight.com/sample-request/hypersomnia-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Hypersomnia treatment therapies with a considerable amount of success over the years.
• Hypersomnia companies working in the treatment market are Avadel Pharmaceuticals, Zevra Therapeutics, Alkermes, and others, are developing therapies for the Hypersomnia treatment
• Emerging Hypersomnia therapies in the different phases of clinical trials are- Lumryz, KP1077, ALKS 2680, and others are expected to have a significant impact on the Hypersomnia market in the coming years.
• In November 2024, Axsome Therapeutics reported that its investigational narcolepsy treatment, AXS-12 (reboxetine), successfully met the primary endpoint in a Phase III ENCORE trial (NCT05059223). As a norepinephrine reuptake inhibitor and cortical dopamine modulator, AXS-12 demonstrated a 72% reduction in cataplexy attacks after one month and an 82% reduction at six months.
• In June 2025, Avadel Pharmaceuticals announced that the FDA has granted orphan drug designation to Lumryz, its extended-release sodium oxybate therapy, for the treatment of idiopathic hypersomnia (IH). This designation offers development incentives for drugs and biologics intended to address rare diseases.
• In April 2025, Irish biopharmaceutical firm Alkermes initiated a randomized Phase II study to evaluate the safety and efficacy of ALKS 2680 in adults with idiopathic hypersomnia (IH). The double-blind, placebo-controlled Vibrance-3 trial plans to enroll approximately 96 IH patients across sites in the US, Europe, and Australia. Participants will be randomly assigned to receive either 10 mg, 14 mg, or 18 mg of ALKS 2680, or a placebo, once daily for a duration of eight weeks.
• In April 2025, iNGENū CRO, a specialized Contract Research Organization with extensive experience in sleep medicine, announced that two clinical trials for rare and severe sleep disorders-Idiopathic Hypersomnia and Narcolepsy-have obtained ethics approval and are now open for patient enrollment. These key studies are being led by Dr. Sud Agarwal, Specialist Anaesthesiologist and Clinical Research Physician at iNGENū CRO.

Hypersomnia Overview
Hypersomnia is a sleep disorder characterized by excessive daytime sleepiness (EDS) despite getting adequate or prolonged sleep at night. Individuals with hypersomnia often struggle to stay awake during the day, leading to difficulties in work, school, and daily activities. The condition can be primary (idiopathic hypersomnia) or secondary to other medical conditions such as sleep apnea, narcolepsy, depression, or neurological disorders. Treatment typically involves lifestyle modifications, stimulant medications, or addressing underlying causes.

Get a Free Sample PDF Report to know more about Hypersomnia Pipeline Therapeutic Assessment-
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Emerging Hypersomnia Drugs Under Different Phases of Clinical Development Include:
• Lumryz: Avadel Pharmaceuticals
• KP1077: Zevra Therapeutics
• ALKS 2680: Alkermes

Hypersomnia Route of Administration
Hypersomnia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Hypersomnia Molecule Type
Hypersomnia Products have been categorized under various Molecule types, such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Hypersomnia Pipeline Therapeutics Assessment
• Hypersomnia Assessment by Product Type
• Hypersomnia By Stage and Product Type
• Hypersomnia Assessment by Route of Administration
• Hypersomnia By Stage and Route of Administration
• Hypersomnia Assessment by Molecule Type
• Hypersomnia by Stage and Molecule Type

DelveInsight's Hypersomnia Report covers around 4+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Hypersomnia product details are provided in the report. Download the Hypersomnia pipeline report to learn more about the emerging Hypersomnia therapies
https://www.delveinsight.com/sample-request/hypersomnia-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key companies in the Hypersomnia Therapeutics Market include:
Key companies developing therapies for Hypersomnia are - Axsome Therapeutics, Alkermes, Zevra Therapeutics, Takeda, Aexon Labs, and others.

Hypersomnia Pipeline Analysis:
The Hypersomnia pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Hypersomnia with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hypersomnia Treatment.
• Hypersomnia key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Hypersomnia Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Hypersomnia market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Hypersomnia drugs and therapies
https://www.delveinsight.com/sample-request/hypersomnia-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Hypersomnia Pipeline Market Drivers
• Increased Awareness and Diagnosis, Unmet Medical Need, Rising Prevalence, Advances in Neuroscience and Drug Development, Growing Investment in Research and Development (R&D), Supportive Regulatory Environment, are some of the important factors that are fueling the Hypersomnia Market.

Hypersomnia Pipeline Market Barriers
• However, Lack of Clear Biomarkers, High Clinical Trial Costs, Regulatory Hurdles, Limited Patient Population, Efficacy and Safety Concerns, Market Competition, and other factors are creating obstacles in the Hypersomnia Market growth.

Scope of Hypersomnia Pipeline Drug Insight
• Coverage: Global
• Key Hypersomnia Companies: Avadel Pharmaceuticals, Zevra Therapeutics, Alkermes, and others
• Key Hypersomnia Therapies: Lumryz, KP1077, ALKS 2680, and others
• Hypersomnia Therapeutic Assessment: Hypersomnia current marketed and Hypersomnia emerging therapies
• Hypersomnia Market Dynamics: Hypersomnia market drivers and Hypersomnia market barriers

Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-service

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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