Hypersomnia - Pipeline Insight, 2024

This “Hypersomnia - Pipeline Insight, 2024,” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Hypersomnia pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Cushing Syndrome Understanding

Hypersomnia: Overview

Hypersomnia, a complaint of excessive daytime sleep or sleepiness, affects 4% to 6% of the population, with an impact on the everyday life of the patient. The obvious main symptom of hypersomnia Is a constant complaint of excessive daytime sleep or sleepiness, which affects the everyday life of the patient. In our mechanized societies, It may Impair work performance and even be Involved In accidents at work or while driving. Although hypersomnia syndromes have been described for more than a century, starting with narcolepsy. Narcolepsy is a rare, chronic neurological disorder (0.026% of the general population) caused by the inability to regulate sleep-wake cycles normally. It is characterized by excessive diurnal sleepiness and cataplexy. The diagnosis of narcolepsy is essentially clinical, but also involves a nocturnal polysomnographic recording followed by an MSLT, during which sleep latency should be below 8 min with at least two SOREMPs.

Idiopathic hypersomnia is a rare condition and is 10 times less frequent than narcolepsy, although no prevalence study has ever been conducted. For a long time, it was confused with narcolepsy, but it was clearly individualized through polysomnographic studies. The International Classification of Sleep Disorders (ICSD) defines idiopathic hypersomnia as a normal or prolonged nocturnal sleep episode that is associated with excessive daytime sleepiness consisting of prolonged (1- to 2-h) sleep episodes of non-REM sleep.

Hypersomnia- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Hypersomnia pipeline landscape is provided which includes the disease overview and Hypersomnia treatment guidelines. The assessment part of the report embraces, in depth Hypersomnia commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence in Hypersomnia R&D. The therapies under development are focused on novel approaches to treat/improve in Hypersomnia.
• In Octomber 2021, Schrödinger and Centessa Pharmaceuticals together with subsidiary Orexia Therapeutics announced an exclusive collaboration focused on the discovery of novel therapeutics targeting the orexin-2 receptor (OX2R), which is known to play a role in a broad spectrum of sleep disorders, including narcolepsy. The collaboration provides Orexia with substantial access to Schrödinger’s entire computational platform as well as Schrödinger’s extensive expertise in ultra-large-scale deployment of its technology.
• In April 2021, KemPharm announced the submission of an Investigational New Drug (IND) application seeking authorization from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial evaluating KP1077 as a treatment for idiopathic hypersomnia (IH), a rare neurological sleep disorder. Upon IND clearance, KemPharm anticipates initiating KP1077 Phase 2 IH trial as early as the second half of 2022.

This segment of the Hypersomnia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Hypersomnia Emerging Drugs

Reboxetine: Axsome TherapeuticsReboxetine is a highly selective and potent norepinephrine reuptake inhibitor being developed for the treatment of narcolepsy. It is thought to modulate noradrenergic activity to promote wakefulness, maintain muscle tone and enhance cognition. Reboxetine has an extensive safety record in Europe and in over 40 countries where it’s approved for the treatment of depression. In narcolepsy, AXS-12 is supported by positive pre-clinical and Phase 2 clinical results. AXS-12 is an investigational drug not approved by the FDA and its safety and effectiveness have not been established.

Quilience: NLS PharmaceuticsQuilience, is a proprietary extended-release formulation of mazindol (mazindol ER) and is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders such as idiopathic hypersomnia. Quilience in adult subjects suffering from narcolepsy is currently ongoing in the United States.

Hypersomnia: Therapeutic Assessment

This segment of the report provides insights about the different Hypersomnia drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Hypersomnia

There are approx. 10+ key companies which are developing the therapies for Hypersomnia. The companies which have their Hypersomnia drug candidates in the most advanced stage, i.e. Phase III include, Axsome Therapeutics.

Phases

This 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) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

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

• Intravenous
• Oral
• Subcutaneous

Molecule Type

Products have been categorized under various Molecule types such as

• Small Molecule
• Antidepressants

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Hypersomnia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Hypersomnia therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Hypersomnia drugs.

Hypersomnia Report Insights

• Hypersomnia Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Hypersomnia Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Hypersomnia drugs?
• How many Hypersomnia drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Hypersomnia?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hypersomnia therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Hypersomnia and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Bioprojet
• Balance Therapeutics
• Gate Neurosciences
• NLS Pharmaceutics
• Takeda
• Axsome Therapeutics
• KemPharm
• Orexia Therapeutics
• Pfizer
• Eisai

Key Products

• Pitolisant
• BTD-001
• GATE-101
• Quilience
• Danavorexton
• Reboxetine
• KP 1077
• TAK 994

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