The hypersomnia treatment landscape is experiencing significant growth with multiple promising therapies in development, according to a new report from DelveInsight. The "Hypersomnia Pipeline Insight, 2025" assessment identifies 8+ companies actively developing 10+ treatment therapies for this sleep disorder that causes excessive daytime sleepiness and prolonged nighttime sleep.
Pipeline Overview and Recent Developments
The hypersomnia pipeline currently features several advanced candidates that could substantially impact treatment options for patients. Key therapies in development include:
- Lumryz (Avadel Pharmaceuticals)
- KP1077 (Zevra Therapeutics)
- ALKS 2680 (Alkermes)
Several significant clinical developments have occurred in recent months. In November 2024, Axsome Therapeutics reported that its investigational narcolepsy treatment, AXS-12 (reboxetine), successfully met the primary endpoint in a Phase III ENCORE trial. As a norepinephrine reuptake inhibitor and cortical dopamine modulator, AXS-12 demonstrated a 72% reduction in cataplexy attacks after one month and an impressive 82% reduction at six months.
In September 2024, Alkermes announced plans to present clinical data from its Phase 1b study of ALKS 2680 in patients with narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) at the European Sleep Research Society conference. ALKS 2680 is an investigational, oral, selective orexin 2 receptor (OX2R) agonist being developed as a once-daily treatment for narcolepsy.
That same month, Takeda revealed it would present additional data from its Phase 2b trials evaluating TAK-861 in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). TAK-861 is an investigational oral orexin receptor 2 selective agonist designed to address orexin deficiency in NT1 by specifically stimulating the orexin receptor 2. It has the potential to become the first treatment targeting the underlying pathophysiology of NT1.
Also in September, Zevra Therapeutics announced that its Senior Vice President of Clinical Development would present top-line results from the Phase 2 clinical trial evaluating KP1077 (serdexmethylphenidate) in patients with idiopathic hypersomnia.
Understanding Hypersomnia
Hypersomnia refers to excessive daytime sleepiness or prolonged nighttime sleep that interferes with daily functioning. It can be categorized into primary and secondary types. Primary hypersomnia, also known as idiopathic hypersomnia, has no identifiable cause, while secondary hypersomnia results from underlying conditions such as sleep apnea, narcolepsy, or psychiatric disorders.
Common symptoms include prolonged sleep episodes, difficulty waking up, and grogginess upon awakening. Individuals may struggle with concentration and memory, leading to a decline in performance at work or school. The causes can be multifactorial, including genetic factors, neurological issues, and environmental influences like irregular sleep patterns.
Diagnosis involves a comprehensive evaluation, including sleep studies (polysomnography) and the Multiple Sleep Latency Test (MSLT). Current treatment approaches may include addressing underlying causes and lifestyle adjustments like maintaining a consistent sleep schedule. Medications such as stimulants may also be prescribed to manage excessive daytime sleepiness.
Therapeutic Assessment and Development Stages
The hypersomnia pipeline includes therapies at various stages of development:
- Late-stage products (Phase III)
- Mid-stage products (Phase II)
- Early-stage products (Phase I)
- Pre-clinical and discovery stage candidates
These therapies utilize various routes of administration, including:
- Oral
- Parenteral
- Intravenous
- Subcutaneous
- Topical
The molecular types being investigated include:
- Monoclonal antibodies
- Peptides
- Polymers
- Small molecules
- Gene therapies
Market Dynamics
Several factors are driving growth in the hypersomnia treatment market:
- Increased awareness and diagnosis
- Significant unmet medical needs
- Rising prevalence of sleep disorders
- Advances in neuroscience and drug development
- Growing investment in research and development
- Supportive regulatory environment
However, challenges remain that could impede market growth:
- Lack of clear biomarkers
- High clinical trial costs
- Regulatory hurdles
- Limited patient population
- Efficacy and safety concerns
- Market competition
Key Companies in the Space
Several pharmaceutical companies are at the forefront of hypersomnia treatment development:
- Avadel Pharmaceuticals
- Zevra Therapeutics
- Alkermes
- Axsome Therapeutics
- Takeda
- Aexon Labs
"The hypersomnia pipeline shows significant promise with multiple therapies targeting different aspects of the condition," said Dr. James Reynolds, a sleep medicine specialist not affiliated with the report. "The focus on orexin receptor agonists is particularly exciting as it represents a more targeted approach to addressing the underlying neurological mechanisms of certain sleep disorders."
As these therapies progress through clinical development, they have the potential to address significant unmet needs in the treatment of hypersomnia and related sleep disorders, potentially improving quality of life for millions of patients worldwide who struggle with excessive sleepiness and its consequences.
