narcolepsy pipeline insight

DelveInsight’s, “Narcolepsy - Pipeline Insight, 2025” report provides comprehensive insights about 10+ companies and 12+ pipeline drugs in Narcolepsy 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

 

Narcolepsy: Understanding

Narcolepsy: Overview

Narcolepsy is a long-term neurological condition that disrupts the brain’s ability to regulate sleep and wakefulness. Individuals with narcolepsy often wake up feeling refreshed but experience excessive daytime sleepiness that can interfere with everyday activities. They may unexpectedly fall asleep during routine tasks such as eating, talking, or driving. Sleep at night is often fragmented, with frequent awakenings. Common symptoms also include cataplexy—sudden episodes of muscle weakness triggered by strong emotions—vivid hallucinations during sleep-wake transitions, and episodes of sleep paralysis, where a person is temporarily unable to move when falling asleep or waking up. Management typically involves medications like stimulants, sodium oxybate, and certain antidepressants, along with lifestyle adjustments such as maintaining a consistent sleep routine, scheduling short daytime naps, and avoiding alcohol and caffeine.

 

Symptoms of narcolepsy typically include excessive daytime sleepiness, sudden sleep attacks, cataplexy, sleep paralysis, and hallucinations. Excessive daytime sleepiness is often the earliest and most persistent symptom, leading to overwhelming fatigue and difficulty staying awake during daily activities. Sleep attacks are sudden, uncontrollable episodes of falling asleep that can occur at any time, even during conversations, meals, or while driving. Cataplexy, which is unique to certain forms of narcolepsy, involves sudden muscle weakness triggered by strong emotions such as laughter or anger. This can range from mild slurring of speech to complete loss of muscle control, lasting from a few seconds to several minutes. Sleep paralysis, the temporary inability to move or speak while falling asleep or waking up, is also common and can be distressing. Hallucinations, which are often vivid and dream-like, may occur during sleep onset or upon awakening and can be especially confusing when not accompanied by sleep paralysis. These symptoms can significantly impact daily functioning, safety, and quality of life if left unmanaged.

 

Narcolepsy is diagnosed through a combination of clinical evaluation, a thorough review of the patient’s medical history, and specialized sleep studies. The diagnostic process includes monitoring sleep patterns, excluding other possible disorders, and conducting tests such as polysomnography to assess sleep stages and disturbances. In some cases, testing cerebrospinal fluid for hypocretin levels can provide additional confirmation, particularly for narcolepsy with cataplexy. Recognition of hallmark symptoms—such as excessive daytime sleepiness, sudden sleep episodes, cataplexy, sleep paralysis, and hallucinations—is central to making a diagnosis. However, narcolepsy can be difficult to identify because its symptoms often resemble those of other sleep disorders. As a result, the time from symptom onset to an accurate diagnosis can range from 8 to 22 years. 

 

Narcolepsy is a lifelong condition with no known cure, but its symptoms can be effectively managed through a combination of medications and lifestyle modifications. To address excessive daytime sleepiness, doctors often prescribe stimulants like modafinil, armodafinil, methylphenidate, or amphetamines. Sodium oxybate is another medication that can help reduce episodes of sudden muscle weakness (cataplexy) and improve nighttime sleep, which in turn may lessen daytime fatigue. Antidepressants are also used to manage cataplexy symptoms. In addition to medication, maintaining a consistent sleep schedule, taking short daytime naps, and avoiding substances like alcohol and caffeine can significantly improve symptom control and overall quality of life.

 

"Narcolepsy- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Narcolepsy pipeline landscape is provided which includes the disease overview and Narcolepsy treatment guidelines. The assessment part of the report embraces, in depth Narcolepsy 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, Narcolepsy 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 Narcolepsy R&D. The therapies under development are focused on novel approaches to treat/improve Narcolepsy.

 

Narcolepsy Emerging Drugs Chapters

This segment of the Narcolepsy 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.

 

Narcolepsy Emerging Drugs

• AXS-12: Axsome Therapeutics, Inc.

AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy. AXS-12 is thought to modulate noradrenergic activity to promote maintain tone during wakefulness, and noradrenergic and cortical dopamine signaling to promote wakefulness and enhance cognition. AXS-12 has been granted US Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of narcolepsy. AXS-12 is covered by issued patents providing protection to at least 2039. Currently, the drug is in the Phase III stage of its development for the treatment of Narcolepsy.

 

• SUVN-G3031: Suven Life Sciences

Samelisant is a novel, potent, and selective Histamine-3 (H3) receptor inverse agonist that is brain-penetrant and orally active. By blocking the H3 receptor, it elevates histamine, norepinephrine, and dopamine levels in the brain, making it a promising candidate for treating excessive daytime sleepiness (EDS) and cataplexy. In preclinical studies, samelisant demonstrated wake-promoting activity in orexin knock-out mice, an animal model for narcolepsy. Comprehensive preclinical and clinical investigations, including neurochemical, pharmacokinetic, safety studies, and Phase I trials in healthy subjects under a US IND, have been successfully completed. Currently, the drug is in Phase II stage of its clinical trial for the treatment of narcolepsy.

 

• E2086: Eisai Inc.

E2086 is a selective orexin-2 receptor agonist, potentially compensating for orexin loss. High levels of orexin are associated with wakefulness and suppress rapid eye movement (REM) sleep. Discovered by Eisai chemists, E2086 is a novel selective orexin-2 agonist.  Nonclinical studies have demonstrated statistically significant increases in time spent awake and significant reductions in rates of cataplexy. Currently, the drug is in Phase I stage of its development for the treatment of Narcolepsy.

Further product details are provided in the report……..

 

Narcolepsy: Therapeutic Assessment

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

Major  Players in Narcolepsy

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

 

Phases

DelveInsight’s report covers around 12+ 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

Narcolepsy 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.

 

Narcolepsy: Pipeline Development Activities 

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Narcolepsy 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 Narcolepsy drugs.

 

Narcolepsy Report Insights

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

 

Narcolepsy 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 Narcolepsy drugs?
• How many Narcolepsy drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Narcolepsy?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Narcolepsy 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 Narcolepsy and their status?
• What are the key designations that have been granted to the emerging drugs?