Sleep Apnea - Pipeline Insight, 2025

DelveInsight’s, “Sleep Apnea - Pipeline Insight, 2025” report provides comprehensive insights about 10+ companies and 14+ pipeline drugs in Sleep Apnea 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

Sleep Apnea: Understanding

Sleep Apnea: Overview

Sleep apnea is a common sleep disorder characterized by repeated interruptions in breathing during sleep, leading to fragmented and poor-quality rest. These interruptions, called apneas, occur when the airway becomes partially or completely blocked or when the brain fails to send signals to the muscles that control breathing. Sleep apnea can lead to excessive daytime sleepiness, cognitive impairments, and an increased risk of serious health conditions such as cardiovascular disease, diabetes, and stroke. It is a significant public health concern, affecting millions of individuals worldwide, with many cases remaining undiagnosed.

There are three primary types of sleep apnea: obstructive sleep apnea (OSA), central sleep apnea (CSA), and complex (mixed) sleep apnea. OSA, the most prevalent type, occurs when throat muscles relax excessively, causing airway collapse. CSA arises from a failure of the brain to signal proper breathing control. Complex sleep apnea syndrome is diagnosed when OSA persists despite appropriate treatment, often indicating a combination of obstructive and central factors. Obesity, older age, and male gender are strong risk factors for OSA, while CSA is more commonly associated with neurological or heart conditions.

The symptoms of sleep apnea can vary but typically include loud snoring, choking or gasping during sleep, morning headaches, and persistent daytime fatigue. Individuals with sleep apnea may also experience mood disturbances, memory issues, and reduced concentration. For many, these symptoms severely impact quality of life and productivity. In severe cases, untreated sleep apnea significantly increases the risk of accidents, particularly when driving or operating machinery.

Diagnosis usually involves a sleep study, known as polysomnography, conducted either in a sleep clinic or at home with portable monitoring devices. Treatment for sleep apnea depends on its severity and underlying causes. Continuous positive airway pressure (CPAP) therapy is the gold standard for managing OSA, delivering steady air pressure through a mask to keep airways open. Alternative treatments include oral appliances, lifestyle changes such as weight loss and avoiding alcohol, and surgical interventions for anatomical abnormalities. For CSA, addressing the underlying condition, using supplemental oxygen therapy may be necessary.

Advances in medical research and technology have significantly improved the management of sleep apnea. Despite this progress, raising awareness about the condition and improving access to diagnostic and therapeutic resources remain critical challenges. Early identification and treatment are essential to reduce the long-term health risks associated with this condition and improve overall well-being.

""Sleep Apnea- Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Sleep Apnea pipeline landscape is provided which includes the disease overview and Sleep Apnea treatment guidelines. The assessment part of the report embraces, in depth Sleep Apnea 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, Sleep Apnea 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 Sleep Apnea R&D. The therapies under development are focused on novel approaches to treat/improve Sleep Apnea.

Sleep Apnea Emerging Drugs Chapters

This segment of the Sleep Apnea 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.

Sleep Apnea Emerging Drugs

• AD109: Apnimed

AD109 is an investigational oral therapy, a pill designed to target the underlying neuromuscular dysfunction in people living with mild, moderate, and severe obstructive sleep apnea (OSA). This novel treatment targets the hypoglossal motor nucleus (HMN) to increase signals in the upper airway dilator muscles during sleep to limit or prevent airway collapse. It is a potential first-in-class, novel, investigational combination dosed once daily at bedtime, designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines company’s novel selective antimuscarinic (aroxybutynin) with a selective norepinephrine reuptake inhibitor (atomoxetine). AD109 targets key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. AD109 has the potential to become a safe, effective, and convenient treatment for OSA, addressing some of the key limitations of current standard of care treatments that can be poorly tolerated (e.g., CPAP and oral devices) and/or invasive (e.g., surgery or implanted devices). Currently, the drug is in the Phase III stage of its development for the treatment of Obstructive Sleep Apnea.

• Dronabinol: RespireRx Phamaceuticals

Dronabinol is a synthetic form of tetrahydrocannabinol (THC), the active compound in cannabis, primarily used to treat nausea, vomiting, and appetite loss. Research has shown potential for dronabinol in treating sleep apnea by stimulating the body's endocannabinoid receptors, which may help reduce apnea episodes and stabilize breathing during sleep. While not yet FDA-approved for sleep apnea, clinical studies suggest it could be beneficial in managing obstructive sleep apnea (OSA) symptoms. Currently, the drug is in the Phase II stage of its development for the treatment of Sleep Apnea.

• Gal 475: Neurim Pharmaceuticals

GAL-475 is a novel therapeutic agent for the treatment of sleep apnea syndromes. In a series of in vitro and in vivo studies in various animal models it demonstrated improvements in sleep apnea indices with reductions in both the frequency and severity of events, without stimulating minute ventilation or disturbing sleep. Preclinical pharmacology studies with GAL-475 suggest that the compound acts predominantly as a peripheral chemoreception modulator, and indicate that the compound is effective in increasing respiratory drive to the upper airways and ameliorating obstructive apneas and their attendant sequelae in rodent models of obstructive apnea at relatively low plasma levels. The primary site of action for GAL-475 appears to be at the level of the carotid body, a peripheral polymodal chemosensory organ, located at the carotid bifurcation, responsible for sensing changes in partial pressures of O2, CO2 or pH, and activating the brainstem respiratory center to produce hyperventilation. Currently, the drug is in the Phase I stage of its development for the treatment of Sleep Apnea.

Further product details are provided in the report……..

Sleep Apnea: Therapeutic Assessment

This segment of the report provides insights about the different Sleep Apnea drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Sleep Apnea
• There are approx. 10+ key companies which are developing the therapies for Sleep Apnea. The companies which have their Sleep Apnea drug candidates in the most advanced stage, i.e. Phase III include, Apnimed.
• Phases

DelveInsight’s report covers around 14+ 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

Sleep Apnea 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
• Molecule Type

Products have been categorized under various Molecule types such as

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

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Sleep Apnea: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Sleep Apnea 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 Sleep Apnea drugs.

Sleep Apnea Report Insights

• Sleep Apnea Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Sleep Apnea 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 Sleep Apnea drugs?
• How many Sleep Apnea drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Sleep Apnea?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Sleep Apnea 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 Sleep Apnea and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Apnimed
• Incannex Healthcare
• Fujian Shengdi Pharmaceutical
• Eli Lilly and Company
• RespireRx Phamaceuticals
• Neurim Pharmaceuticals

Key Products

• AD109
• IHL-42X
• HRS9531
• Orforglipron
• Dronabinol
• Gal 475