Narcolepsy - Pipeline Insight, 2024

This “Narcolepsy - Pipeline Insight, 2024,” report provides comprehensive insights about 15+ companies and 20+ 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 rare long-term brain condition that causes a person to suddenly fall asleep at inappropriate times. The brain is unable to regulate sleeping and waking patterns normally, which can result in: excessive daytime sleepiness - feeling very drowsy throughout the day and finding it difficult to concentrate and stay awake, sleep attacks - falling asleep suddenly and without warning, cataplexy - temporary loss of muscle control resulting in weakness and possible collapse, often in response to emotions such as laughter and anger, sleep paralysis - a temporary inability to move or speak when waking up or falling asleep, excessive dreaming and waking in the night - dreams often come as you fall asleep (hypnogogic hallucinations) or just before or during waking (hypnopompic hallucinations). Narcolepsy is often caused by a lack of the brain chemical hypocretin (also known as orexin), which regulates wakefulness. Narcolepsy is a fairly rare condition. It's difficult to know exactly how many people have narcolepsy because many cases are thought to go unreported. There's currently no cure for narcolepsy, but making changes to improve sleeping habits and taking medicine can help minimize the impact the condition has on your daily life.

Narcolepsy - Pipeline Insight, 2024 report 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 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

FT218: Avadel Pharmaceuticals FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel’s Micro Pump™ controlled-release (CR) technology. In December 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. The FDA assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of October 15,2021.

AXS-12: Axsome Therapeutics AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor being developed for the treatment of narcolepsy. It modulates 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 where it: Improved daytime sleepiness with reduced cataplexy (sudden loss of muscle control) in people with narcolepsy in an open-label pilot trial. AXS-12 has been granted U.S. Food and Drug Administration (FDA) Orphan Drug designation for the treatment of narcolepsy. The drug is currently being evaluated in Phase III stage of development.

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. 15+ key companies which are developing the therapies for Narcolepsy. The companies which have their Narcolepsy drug candidates in the most advanced stage, i.e. Preregistration include, Avadel Pharmaceuticals.

Phases

This report covers around 20+ 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
• Parenteral
• Intravenous
• Subcutaneous
• Topical.

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• 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 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?

Key Players

• Axsome Therapeutics, Inc.
• Avadel Pharmaceuticals
• Suven Life Sciences
• Takeda
• NLS Pharmaceutics
• Vallon Pharmaceuticals
• Alkermes
• Centessa Pharmaceuticals
• Ono Pharma
• Harmony Biosciences
• Reset Therapeutics
• XWPharma
• Sunovion Pharmaceuticals
• Otsuka Pharmaceutical
• Con SynanceTherapeutics
• Alkermes
• KemPharm

Key Products

• AXS-12
• FT218
• SUVN-G3031
• TAK-994
• Mazindol
• ADAIR

Research programme: Orexin 2 Receptor Agonist- ONO-2909

• HBS 102
• XW10172
• Ulotaront
• HBS 102
• ALKS 2680
• KP 1077

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