Hypersomnia Overview:
Hypersomnia is a disorder marked by excessive daytime sleepiness, which can greatly disrupt daily activities, productivity, and overall quality of life. It often results in sudden, unplanned episodes of sleep or drowsiness, known as sleep attacks, without obvious signs of tiredness beforehand. As a significant public health issue, hypersomnia is linked to increased risks of motor vehicle accidents and workplace injuries. Among its forms, Idiopathic Hypersomnia (IH) stands out as a rare, chronic condition characterized by an uncontrollable urge to sleep, prolonged and non-refreshing naps, and difficulty waking up, even after sufficient or extended nighttime sleep. First described by Bedrich Roth in 1956, IH is believed to have a neurological basis, though its exact underlying mechanisms are still not well understood, posing challenges for both diagnosis and treatment.
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“Hypersomnia Pipeline Insight 2025” report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Hypersomnia Therapeutics Market.
Key Takeaways from the Hypersomnia Pipeline Report
DelveInsight’s Hypersomnia pipeline report depicts a robust space with 3+ active players working to develop 4+ pipeline therapies for Hypersomnia treatment.
YOLT-203 received Rare Pediatric Disease Designation in September 2024. This in vivo gene-editing therapy has initiated patient dosing, with a Phase 1 study expected to conclude by January 2026.
The FDA granted Rare Pediatric Disease Designation to META-001-PH in August 2024. Preclinical studies indicated up to an 80% reduction in urinary oxalate excretion. A Phase 1 trial is planned for early 2025.
In December 2024, the FDA approved a Phase 1/2 clinical trial for ABO-101, a gene-editing therapy targeting the HAO1 gene. This liver-directed treatment aims to provide a one-time solution by reducing oxalate production. The redePHine trial is expected to commence in the first half of 2025.
In October 2023, the FDA approved Rivfloza for patients aged 9 and older with PH1 and relatively preserved kidney function. This once-monthly subcutaneous RNAi therapy inhibits lactate dehydrogenase, a key enzyme in oxalate production. The approval was based on the PHYOX2 trial, which showed significant reductions in 24-hour urinary oxalate excretion.
Key Hypersomnia companies such as Avadel, Centessa Pharmaceuticals (UK) Limited, Takeda, and others are evaluating new drugs for Hypersomnia to improve the treatment landscape.
Hypersomnia Pipeline Analysis
The report provides insights into:
The report provides detailed insights into the key companies that are developing therapies in the Hypersomnia Market.
The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hypersomnia treatment.
It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
It navigates the emerging 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 Hypersomnia market.
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Hypersomnia Emerging Drugs
FT218: Avadel
FT218 (LUMRYZ) is an extended-release formulation of sodium oxybate developed to treat cataplexy and excessive daytime sleepiness (EDS) in adults with narcolepsy. It functions as a central nervous system depressant, targeting gamma-aminobutyric acid (GABA) receptors to help regulate the sleep-wake cycle and alleviate narcolepsy symptoms. Unlike conventional twice-nightly oxybate therapies, LUMRYZ offers the convenience of a single, bedtime-only dose, improving patient compliance. The drug is currently in Phase III development for the treatment of hypersomnia.
ORX750: Centessa Pharmaceuticals (UK) Limited
ORX750 is an experimental, orally administered drug that acts as a highly potent and selective agonist of the orexin receptor 2 (OX2R), specifically developed to address the underlying cause of orexin neuron loss in narcolepsy type 1 (NT1). In laboratory studies, ORX750 demonstrated strong activation of OX2R with an in vitro EC50 of 0.11 nM and showed 9,800 times greater selectivity for OX2R over the human orexin receptor 1 (hOX1R). ORX750 is Centessa’s first orexin-targeting candidate, currently under development for treating narcolepsy, with potential applications for narcolepsy type 2 (NT2), idiopathic hypersomnia (IH), and other sleep-wake disorders. The drug is currently in Phase II clinical trials for hypersomnia treatment.
Hypersomnia Companies
There are around three or more major companies working on developing therapies for Hypersomnia. Among them, Avadel has a drug candidate currently in the most advanced stage, specifically Phase III of clinical development.
DelveInsight’s 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
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
Intravenous
Subcutaneous
Oral
Intramuscular
Hypersomnia Products have been categorized under various Molecule types such as
Monoclonal antibody
Small molecule
Peptide
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Hypersomnia Pipeline Therapeutic Assessment
• Hypersomnia Assessment by Product Type
• Hypersomnia By Stage
• Hypersomnia Assessment by Route of Administration
• Hypersomnia Assessment by Molecule Type
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Table of Content
1. Report Introduction
2. Executive Summary
3. Hypersomnia Current Treatment Patterns
4. Hypersomnia – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
6. Hypersomnia Late-Stage Products (Phase-III)
7. Hypersomnia Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Hypersomnia Discontinued Products
13. Hypersomnia Product Profiles
14. Hypersomnia Key Companies
15. Hypersomnia Key Products
16. Dormant and Discontinued Products
17. Hypersomnia Unmet Needs
18. Hypersomnia Future Perspectives
19. Hypersomnia Analyst Review
20. Appendix
21. Report Methodology
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