Hypersomnia - Pipeline Insight, 2025

This “Hypersomnia - Pipeline Insight, 2025” report provides comprehensive insights about 3+ companies and 4+ 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.

Hypersomnia: Understanding

Hypersomnia: Overview

Hypersomnia is a condition characterized by excessive daytime sleepiness, which can significantly impair daily functioning, productivity, and quality of life. It often leads to unintended lapses into sleep or drowsiness, commonly known as sleep attacks, without prior warning signs of increasing sleepiness. This condition, which is a major public health concern due to its contribution to motor vehicle accidents and workplace injuries, can be caused by various factors. One specific form, Idiopathic Hypersomnia (IH), is a rare and chronic disorder characterized by an uncontrollable need for sleep, long and unrefreshing naps, and difficulty waking from sleep, despite getting adequate or prolonged nocturnal rest. IH, which was first described by Bedrich Roth in 1956, is thought to have a neurological origin, but its exact pathophysiology remains poorly understood, making both diagnosis and management challenging.

The exact etiology of Idiopathic Hypersomnia (IH) remains unclear, though several potential triggers and contributing factors have been identified. These include abrupt changes in sleep-wake patterns, overexertion, general anesthesia, viral illnesses, and mild head trauma. Recent research has suggested a possible genetic predisposition, with certain subgroups of IH linked to reduced signaling of orexin, caused by variants in the cleavage site of prepro-orexin, as well as a homozygous PER2 variant. Additionally, dysregulation of microRNAs (miRNAs) has been implicated in the development of central hypersomnias, including IH. Furthermore, studies have suggested that immune reactivity, such as a response between a vaccine antigen and neural cell antigens, may contribute to the condition, pointing to an abnormal immune process that could mimic the pathogenesis of narcolepsy.

The pathophysiology of Idiopathic Hypersomnia (IH) and other central hypersomnias remains largely unknown, although neurochemical studies have not provided clear conclusions. The primary feature of central hypersomnias is a defect in the arousal systems of the central nervous system, rather than hyperactivity of sleep centers. In narcolepsy with cataplexy (narcolepsy type 1), the impairment of orexin neurotransmission, a neuropeptide mainly produced in the lateral hypothalamus, is a key pathological finding, possibly linked to an autoimmune process. However, the specific mechanisms underlying IH and other central hypersomnias have yet to be fully understood.

Non-pharmacological treatments, such as prolonging sleep times, scheduled naps, and behavioral therapy, have generally shown limited effectiveness in managing Idiopathic Hypersomnia (IH). In contrast, pharmacological therapy has proven to be more effective, with modafinil being the first-line treatment recommended by the latest clinical practice guidelines from the American Academy of Sleep Medicine. Modafinil, which promotes alertness, has demonstrated efficacy similar to that in narcolepsy cases and is considered safe, even for those without prolonged sleep times. It has been shown to significantly improve self-reported sleepiness, as measured by the Epworth Sleepiness Scale, and enhance the ability to remain awake on the Maintenance of Wakefulness Test. Common side effects include headaches and gastrointestinal issues.

'Hypersomnia- Pipeline Insight, 2025' 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, 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, 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

FT218: Avadel

FT218 (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 development for the treatment of Hypersomnia.

ORX750: Centessa Pharmaceuticals (UK) Limited

ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1). ORX750 has been shown to potently activate the OX2R with an in vitro EC50 of 0.11 nM and 9,800-fold selectivity over the human orexin receptor (hOX1R). ORX750 is Centessa’s first orexin product candidate being developed for the treatment of narcolepsy with potential expansion into narcolepsy type 2 (NT2), idiopathic hypersomnia (IH) and other sleep-wake disorders. Currently, the drug is in Phase II stage of its clinical trial for the treatment of 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. 3+ 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, Avadel.

Phases

The 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) 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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

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 III, 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

• Avadel
• Centessa Pharmaceuticals (UK) Limited
• Takeda

Key Products

• FT218
• ORX750
• TAK-861

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