Wednesday, October 15, 2025

Narcolepsy Pipeline Drugs 2025 Report: Emerging Drugs, Innovative Therapies, Clinical Trial Updates, and Top Companies

Narcolepsy Pipeline Drugs 2025 Report: Emerging Drugs, Innovative Therapies, Clinical Trial Updates, and Top Companies

DelveInsight’s “Narcolepsy Pipeline Insight 2025” report provides comprehensive insights about 10+ companies and 12+ pipeline drugs in the Narcolepsy pipeline landscape. It covers the Narcolepsy Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Narcolepsy Pipeline Therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Curious about the latest updates in the Narcolepsy Pipeline? Click here to explore the therapies and trials making headlines @ Narcolepsy Pipeline Outlook Report

Key Takeaways from the Narcolepsy Pipeline Report

  • On 14 October 2025, Alkermes Inc. announced a study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.
  • On 09 October 2025, Centessa Pharmaceuticals (UK) Limited conducted a Phase 2a Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects With Narcolepsy and Idiopathic Hypersomnia (CRYSTAL-1).
  • DelveInsight’s Narcolepsy Pipeline report depicts a robust space with 10+ active players working to develop 12+ pipeline therapies for Narcolepsy treatment.
  • The leading Narcolepsy Companies such as Axsome Therapeutics, Inc., Takeda, Centessa Pharmaceuticals (UK) Limited, Eisai Inc., Harmony Biosciences, NLS Pharmaceutics Ltd and others.
  • Promising Narcolepsy Therapies such as JZP258, TS-091 5mg, SUVN-G3031, Xyrem (sodium oxybate) oral solution, Modafinil, JZP-110, ADX-N05, Xyrem, Armodafinil and others.

Want to know which companies are leading innovation in Narcolepsy? Dive into the full pipeline insights @ Narcolepsy Clinical Trials Assessment

The Narcolepsy Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Narcolepsy Pipeline Report also highlights the unmet needs with respect to the Narcolepsy.

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.

Narcolepsy Emerging Drugs Profile

  • 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.

If you’re tracking ongoing Narcolepsy Clinical trials, this press release is a must-read. Tap to see the breakthroughs @ Narcolepsy Treatment Drugs

The Narcolepsy Pipeline report provides insights into:-

  • The report provides detailed insights about companies that are developing therapies for the treatment of Narcolepsy with aggregate therapies developed by each company for the same.
  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Narcolepsy Treatment.
  • Narcolepsy Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Narcolepsy Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Narcolepsy market.

Narcolepsy Companies

Axsome Therapeutics, Inc., Takeda, Centessa Pharmaceuticals (UK) Limited, Eisai Inc., Harmony Biosciences, NLS Pharmaceutics Ltd and others.

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

Narcolepsy Products have been categorized under various Molecule types such as,

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

From emerging drug candidates to competitive intelligence, the Narcolepsy Pipeline Report covers it all – check it out now @ Narcolepsy Market Drivers and Barriers, and Future Perspectives

Scope of the Narcolepsy Pipeline Report

  • Coverage- Global
  • Narcolepsy Companies- Axsome Therapeutics, Inc., Takeda, Centessa Pharmaceuticals (UK) Limited, Eisai Inc., Harmony Biosciences, NLS Pharmaceutics Ltd and others.
  • Narcolepsy Therapies- JZP258, TS-091 5mg, SUVN-G3031, Xyrem (sodium oxybate) oral solution, Modafinil, JZP-110, ADX-N05, Xyrem, Armodafinil and others.
  • Narcolepsy Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Narcolepsy Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Stay ahead in Healthcare Research – discover what’s next for the Narcolepsy Treatment landscape in this detailed analysis @ Narcolepsy Emerging Drugs and Major Players

Table of Contents

  1. Introduction
  2. Executive Summary
  3. Narcolepsy: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Narcolepsy– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. AXS-12: Axsome Therapeutics, Inc.
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. SUVN-G3031: Suven Life Sciences
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. E2086: Eisai Inc.
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. Drug Name: Company Name
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Narcolepsy Key Companies
  21. Narcolepsy Key Products
  22. Narcolepsy- Unmet Needs
  23. Narcolepsy- Market Drivers and Barriers
  24. Narcolepsy- Future Perspectives and Conclusion
  25. Narcolepsy Analyst Views
  26. Narcolepsy Key Companies
  27. Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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