Monday, May 20, 2024

Narcolepsy Pipeline and Clinical Trials Assessment 2024: FDA Approvals, Therapies and Key Companies involved by DelveInsight | Novartis, Shionogi Inc., Takeda Pharma, Avadel Pharma, Harmony Bioscience

Narcolepsy Pipeline and Clinical Trials Assessment 2024: FDA Approvals, Therapies and Key Companies involved by DelveInsight | Novartis, Shionogi Inc., Takeda Pharma, Avadel Pharma, Harmony Bioscience
(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Narcolepsy pipeline constitutes 15+ key companies continuously working towards developing 20+ Narcolepsy treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Narcolepsy Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

 

Narcolepsy Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Narcolepsy Market.

 

Some of the key takeaways from the Narcolepsy Pipeline Report:

  • Companies across the globe are diligently working toward developing novel Narcolepsy treatment therapies with a considerable amount of success over the years. 

  • Narcolepsy companies working in the treatment market are Orexia, Merck Sharp & Dohme, Jazz Pharmaceuticals, Takeda, Suven Life Sciences, Axsome Therapeutics, NLS Pharmaceutics Ltd, Taisho Pharmaceutical, Suven Life Sciences Limited, Alza Corporation, DE, USA, Cephalon, Orphan Medical, Theranexus, NLS Pharmaceutics, Takeda, Alkermes, Inc., Pfizer, Balance Therapeutics, Avadel, and others, are developing therapies for the Narcolepsy treatment 

  • Emerging Narcolepsy therapies in the different phases of clinical trials are- ORX-750, MK 6552, JZP-441, TAK-925, SUVN-G3031, AXS 12, NLS-2, JZP258, TS-091, SUVN-G3031, JNJ-17216498, Modafinil, sodium oxybate, THN102 300/3, Mazindol, TAK-861, ALKS 2680, PF-03654746, BTD-001, FT218, and others are expected to have a significant impact on the Narcolepsy market in the coming years. 

  • In February 2024, Takeda has released encouraging topline results from its Phase IIb clinical trial of TAK-861, an oral orexin receptor 2 agonist, intended for the treatment of narcolepsy type 1 (NT1). Named TAK-861-2001, the trial involved 112 participants diagnosed with NT1, a chronic and rare neurological condition characterized by excessive daytime sleepiness.

  • In April 2024, Alkermes plc (Nasdaq: ALKS) announced the commencement of the Vibrance-1 study, a phase 2 clinical trial aimed at assessing the safety and effectiveness of ALKS 2680 compared to a placebo in patients diagnosed with narcolepsy type 1 (NT1). ALKS 2680 represents the company's innovative, investigational, oral orexin 2 receptor (OX2R) agonist under development as a once-daily therapy for narcolepsy, a chronic neurological condition characterized by excessive daytime sleepiness. NT1 is linked with a deficiency or absence of orexin levels and the occurrence of cataplexy, sudden muscle tone loss triggered by intense emotions.

  • In July 2023, NLS Pharmaceutics disclosed that the protocol for the phase 3 clinical trial (the AMAZE Program) to assess the safety and effectiveness of Mazindol ER in individuals with narcolepsy type 1 has obtained approval from the independent institutional review board (IRB). The AMAZE Program comprises two nearly identical double-blind phase 3 studies, each involving 50 participants, examining Mazindol ER versus a placebo in adult narcolepsy patients.  

 

Narcolepsy Overview

Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness, sudden and uncontrollable episodes of falling asleep during the day, and disrupted nighttime sleep patterns. People with narcolepsy often experience sudden loss of muscle tone (cataplexy), vivid hallucinations while falling asleep or waking up (hypnagogic and hypnopompic hallucinations), and temporary paralysis when falling asleep or waking up (sleep paralysis).

 

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Emerging Narcolepsy Drugs Under Different Phases of Clinical Development Include:

  • ORX-750: Orexia

  • MK 6552: Merck Sharp & Dohme

  • JZP-441: Jazz Pharmaceuticals

  • TAK-925: Takeda

  • SUVN-G3031: Suven Life Sciences

  • AXS 12: Axsome Therapeutics

  • NLS-2: NLS Pharmaceutics Ltd

  • JZP258: Jazz Pharmaceuticals

  • TS-091: Taisho Pharmaceutical

  • SUVN-G3031: Suven Life Sciences Limited

  • JNJ-17216498: Alza Corporation, DE, USA

  • Modafinil: Cephalon

  • sodium oxybate: Orphan Medical

  • THN102 300/3: Theranexus

  • Mazindol: NLS Pharmaceutics

  • TAK-861: Takeda

  • ALKS 2680: Alkermes, Inc.

  • PF-03654746: Pfizer

  • BTD-001: Balance Therapeutics

  • FT218: Avadel

 

Narcolepsy 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

 

Narcolepsy Molecule Type

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

  • Monoclonal Antibody

  • Peptides

  • Polymer

  • Small molecule

  • Gene therapy 

 

Narcolepsy Pipeline Therapeutics Assessment

  • Narcolepsy Assessment by Product Type

  • Narcolepsy By Stage and Product Type

  • Narcolepsy Assessment by Route of Administration

  • Narcolepsy By Stage and Route of Administration

  • Narcolepsy Assessment by Molecule Type

  • Narcolepsy by Stage and Molecule Type

 

DelveInsight's Narcolepsy 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)

  • Pre-clinical and Discovery stage candidates

  • Discontinued & Inactive candidates

  • Route of Administration

 

Further Narcolepsy product details are provided in the report. Download the Narcolepsy pipeline report to learn more about the emerging Narcolepsy therapies

 

Some of the key companies in the Narcolepsy Therapeutics Market include:

Key companies developing therapies for Narcolepsy are - Novartis AG, Shionogi Inc., Takeda Pharmaceutical, Avadel Pharmaceuticals, Harmony Biosciences (BIOPROJET), Jazz Pharmaceuticals PLC, Ligand Pharmaceuticals Inc, Teva Pharmaceuticals, Axsome Therapeutics Inc., XWPharma Ltd., and others.

 

Narcolepsy Pipeline Analysis:

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 key 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.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

 

Download Sample PDF Report to know more about Narcolepsy drugs and therapies

 

Narcolepsy Pipeline Market Drivers

  • Need for disease-specific treatment options, increasing research and developmental activities are some of the important factors that are fueling the Narcolepsy Market.

 

Narcolepsy Pipeline Market Barriers

  • However, No standard specific cure for Narcolepsy and other factors are creating obstacles in the Narcolepsy Market growth.

 

Scope of Narcolepsy Pipeline Drug Insight    

  • Coverage: Global

  • Key Narcolepsy Companies: Orexia, Merck Sharp & Dohme, Jazz Pharmaceuticals, Takeda, Suven Life Sciences, Axsome Therapeutics, NLS Pharmaceutics Ltd, Taisho Pharmaceutical, Suven Life Sciences Limited, Alza Corporation, DE, USA, Cephalon, Orphan Medical, Theranexus, NLS Pharmaceutics, Takeda, Alkermes, Inc., Pfizer, Balance Therapeutics, Avadel, and others

  • Key Narcolepsy Therapies: ORX-750, MK 6552, JZP-441, TAK-925, SUVN-G3031, AXS 12, NLS-2, JZP258, TS-091, SUVN-G3031, JNJ-17216498, Modafinil, sodium oxybate, THN102 300/3, Mazindol, TAK-861, ALKS 2680, PF-03654746, BTD-001, FT218, and others

  • Narcolepsy Therapeutic Assessment: Narcolepsy current marketed and Narcolepsy emerging therapies

  • Narcolepsy Market Dynamics: Narcolepsy market drivers and Narcolepsy market barriers 

 

Request for Sample PDF Report for Narcolepsy Pipeline Assessment and clinical trials

 

Table of Contents

1. Narcolepsy Report Introduction

2. Narcolepsy Executive Summary

3. Narcolepsy Overview

4. Narcolepsy- Analytical Perspective In-depth Commercial Assessment

5. Narcolepsy Pipeline Therapeutics

6. Narcolepsy Late Stage Products (Phase II/III)

7. Narcolepsy Mid Stage Products (Phase II)

8. Narcolepsy Early Stage Products (Phase I)

9. Narcolepsy Preclinical Stage Products

10. Narcolepsy Therapeutics Assessment

11. Narcolepsy Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Narcolepsy Key Companies

14. Narcolepsy Key Products

15. Narcolepsy Unmet Needs

16 . Narcolepsy Market Drivers and Barriers

17. Narcolepsy Future Perspectives and Conclusion

18. Narcolepsy Analyst Views

19. Appendix

20. About DelveInsight

 

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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