Hypersomnia Clinical Trials and Pipeline 2025: EMA, PDMA, FDA Approvals, Medication, IND, NDA Approval, Therapies, Mechanism of Action, Route of Administration and Companies by DelveInsight

(Albany, United States) "Hypersomnia Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Hypersomnia Market.

As per DelveInsight's assessment, globally, Hypersomnia pipeline constitutes 8+ key companies continuously working towards developing 10+ Hypersomnia treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

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.

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Some of the key takeaways from the Hypersomnia Pipeline Report:
• Hypersomnia 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 September 2024, Alkermes plc (Nasdaq: ALKS) announced its plans to present clinical data from the Phase 1b study of ALKS 2680 in patients with narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) at the European Sleep Research Society (ESRS) conference, scheduled for September 24-27, 2024, in Seville, Spain. ALKS 2680 is an investigational, oral, selective orexin 2 receptor (OX2R) agonist being developed as a once-daily treatment for narcolepsy, a chronic neurological disorder marked by excessive daytime sleepiness
• In September2024, Takeda (TSE:4502/NYSE:TAK) will present additional data from its Phase 2b trials (TAK-861-2001, TAK-861-2002) and the long-term extension (LTE) study (TAK-861-2003) evaluating TAK-861 in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society (ESRS), taking place from September 24-27, 2024, in Seville, Spain. TAK-861 is an investigational oral orexin receptor 2 (OX2R) selective agonist designed to address orexin deficiency in NT1 by specifically stimulating the orexin receptor 2. It has the potential to become the first treatment targeting the underlying pathophysiology of NT1.
• In September 2024, Zevra Therapeutics, Inc. (NasdaqGS: ZVRA), a commercial-stage company specializing in rare disease therapeutics, announced that Rene Braeckman, Ph.D., Senior Vice President of Clinical Development, will present top-line results from the Phase 2 placebo-controlled, double-blind, randomized withdrawal clinical trial (NCT05668754) evaluating the safety and tolerability of KP1077 (serdexmethylphenidate, or SDX) in patients with idiopathic hypersomnia (IH). The data will be presented at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society (ESRS), in Seville.

Hypersomnia Overview
Hypersomnia refers to excessive daytime sleepiness or prolonged nighttime sleep, which can interfere with daily functioning. It can be categorized into primary and secondary types. Primary hypersomnia, also known as idiopathic hypersomnia, has no identifiable cause, while secondary hypersomnia is a result of underlying conditions such as sleep apnea, narcolepsy, or psychiatric disorders.
Common symptoms of hypersomnia include prolonged sleep episodes, difficulty waking up, and grogginess upon awakening. Individuals may struggle with concentration and memory, leading to a decline in performance at work or school. The causes of hypersomnia can be multifactorial, including genetic factors, neurological issues, and environmental influences like irregular sleep patterns.
Diagnosis involves a comprehensive evaluation, including sleep studies (polysomnography) and the Multiple Sleep Latency Test (MSLT). Treatment may include addressing underlying causes, such as managing sleep apnea or depression, and lifestyle adjustments like maintaining a consistent sleep schedule. Medications like stimulants may also be prescribed to manage excessive daytime sleepiness.
If left untreated, hypersomnia can affect quality of life, leading to social isolation, relationship difficulties, and impaired cognitive function. Managing the condition effectively requires a tailored approach based on the individual's specific needs and causes.

Get a Free Sample PDF Report to know more about Hypersomnia Pipeline Therapeutic Assessment- https://www.delveinsight.com/sample-request/hypersomnia-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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 10+ 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/report-store/hypersomnia-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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=apr

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

Request for Sample PDF Report for Hypersomnia Pipeline Assessment and clinical trials - https://www.delveinsight.com/sample-request/hypersomnia-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
1. Hypersomnia Report Introduction
2. Hypersomnia Executive Summary
3. Hypersomnia Overview
4. Hypersomnia- Analytical Perspective In-depth Commercial Assessment
5. Hypersomnia Pipeline Therapeutics
6. Hypersomnia Late Stage Products (Phase II/III)
7. Hypersomnia Mid Stage Products (Phase II)
8. Hypersomnia Early Stage Products (Phase I)
9. Hypersomnia Preclinical Stage Products
10. Hypersomnia Therapeutics Assessment
11. Hypersomnia Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Hypersomnia Key Companies
14. Hypersomnia Key Products
15. Hypersomnia Unmet Needs
16 . Hypersomnia Market Drivers and Barriers
17. Hypersomnia Future Perspectives and Conclusion
18. Hypersomnia Analyst Views
19. Appendix
20. About DelveInsight

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