Hypersomnia - Pipeline Insight, 2024

DelveInsight's, "Hypersomnia - Pipeline Insight, 2024" report provides comprehensive insights about 8+ 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

Hypersomnia: Understanding

Hypersomnia: Overview

Hypersomnia is a state of excessive sleepiness which can result in decreased functioning and affect performance adversely. Hypersomnolence is defined as an inability to stay awake and alert during major waking episodes, resulting in periods of irrepressible need for sleep or unintended lapses into drowsiness or sleep. Lapses into sleep without prodromal symptoms of increasing sleepiness are called sleep attacks. Excessive daytime sleepiness (EDS) is one of the big public health problem. Patients with EDS have decreased workplace productivity, lower quality of life and increased risk of work-related injury.

The causes of hypersomnia can be diverse and include various factors such as sleep disorders like narcolepsy and sleep apnea, insufficient sleep, idiopathic hypersomnia, being overweight, drug or alcohol abuse, head injuries, neurological diseases like multiple sclerosis or Parkinson's disease, certain medications, genetics, and depression. Other potential causes may involve autonomic nervous system dysfunction, tumors, encephalitis, epilepsy, and chronic sleep deprivation, among others.

The exact etiology of idiopathic hypersomnia (IH) remains unclear, but several potential triggers and contributing factors have been identified. Abrupt changes in sleep-wake habits, overexertion, general anesthesia, viral illnesses, and mild head trauma have been associated with the development of IH symptoms. Rare genetic predispositions may also play a role, with subgroups of IH linked to reduced signaling of the neuropeptide orexin due to variants in the prepro-orexin gene.

Excessive daytime sleepiness and associated symptoms (such as automatic behaviors) can lead to danger to self and others, including an increased risk of motor vehicle accidents. Due to the potential for diversion as a "date rape" drug, access to oxybate is regulated in the United States and is controlled under Schedule III.

Non-pharmacologic treatments for hypersomnia focus on improving sleep quality and quantity. Good sleep hygiene practices, such as avoiding stimulants before bed, maintaining a regular sleep schedule, and keeping the sleeping environment comfortable, can help enhance night time sleep. Scheduled daytime naps of 15-20 minutes have been shown to reduce daytime sleepiness without negatively impacting nighttime sleep quality, though their effectiveness has been more extensively studied in narcolepsy compared to other hypersomnia. Regular physical activity can also be beneficial for improving sleep.

"Hypersomnia - Pipeline Insight, 2024" report by DelveInsight 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, Hypersomnia 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 Hypersomnia R&D. The therapies under development are focused on novel approaches to treat/improve Hypersomnia.

Hypersomnia Emerging Drugs Chapters

This segment of the Hypersomnia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II/III, 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

• Lumryz: Avadel Pharmaceuticals

LUMRYZ is an extended-release sodium oxybate medication designed for the treatment of cataplexy and excessive daytime sleepiness (EDS) in adults with narcolepsy. The drug operates as a central nervous system depressant, acting on gamma-aminobutyric acid (GABA) receptors to help regulate sleep-wake cycles and manage symptoms associated with narcolepsy. By providing a once-at-bedtime dosing regimen, LUMRYZ enhances patient convenience and adherence compared to traditional twice-nightly oxybate treatments, which require nocturnal arousal for a second dose. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Idiopathic Hypersomnia.

• KP1077: Zevra Therapeutics

KP1077 (serdexmethylphenidate or SDX) is Zevra's proprietary prodrug of d-methylphenidate (d-MPH) and its sole active pharmaceutical ingredient (API). KP1077 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA), and by the European Commission, for the treatment of IH. The U.S. Drug Enforcement Agency (DEA) has classified SDX, the sole API in KP1077, as a Schedule IV controlled substance based on evidence suggesting SDX has a lower potential for abuse when compared to d-MPH, a Schedule II controlled substance. In addition, KP1077 has intellectual property protection through 2037 and potentially beyond. Currently, the drug is in Phase II stage of its development for the treatment of Idiopathic Hypersomnia at sleep.

• ALKS 2680: Alkermes

ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy. Orexin neuropeptides are important regulators of the sleep/wake cycle through OX2R activation, and loss of orexinergic neurons in the brain is associated with excessive daytime sleepiness and cataplexy in narcolepsy.2 ALKS 2680 was designed to address the underlying pathology of narcolepsy with the goal of improving duration of wakefulness and providing cataplexy control. Once-daily oral administration of ALKS 2680 was evaluated in a phase I study in healthy volunteers and people living with narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia.

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. 8+ 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

DelveInsight's 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
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• 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

• Axsome Therapeutics
• Alkermes
• Zevra Therapeutics
• Takeda
• Aexon Labs

Key Products

• Reboxetine
• ALKS 2680
• KP1077
• TAK-861
• AEX-19