Obstructive Sleep Apnea (OSA) - Pipeline Insight, 2025

DelveInsight's, "Obstructive Sleep Apnea (OSA) - Pipeline Insight, 2025" report provides comprehensive insights about 18+ companies and 20+ pipeline drugs in Obstructive Sleep Apnea (OSA) 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

Obstructive Sleep Apnea (OSA): Understanding

Obstructive Sleep Apnea (OSA): Overview

Obstructive sleep apnea (OSA) is a sleep disorder characterized by repeated episodes of partial or complete airway collapse during sleep, leading to oxygen desaturation and frequent awakenings. These interruptions result in fragmented and nonrestorative sleep, often accompanied by loud snoring, observed apneas, and excessive daytime sleepiness. OSA significantly impacts various aspects of health, including cardiovascular function, behavior, overall quality of life, and driving safety. While other forms of sleep-disordered breathing, such as central sleep apnea, upper airway resistance, and obesity hypoventilation, are distinct conditions, they share similar features with OSA and will be addressed separately.

The symptoms of obstructive sleep apnea (OSA) are diverse and can significantly affect daily life. Common signs include excessive daytime sleepiness, loud snoring, and witnessed episodes of stopped breathing during sleep. Individuals may also experience waking up at night gasping or choking, morning headaches, and a dry mouth or sore throat upon awakening. Other symptoms include difficulty focusing during the day, mood changes like irritability or depression, high blood pressure, and a reduced interest in sex. These symptoms can greatly impair both physical health and quality of life.

The pathophysiology of obstructive sleep apnea (OSA) is primarily driven by upper airway obstruction during sleep, which occurs due to negative collapsing pressure during inspiration. However, progressive expiratory narrowing, particularly in the retropalatal area, also plays a significant role in airway blockage. The degree of airway narrowing during sleep is closely linked to body mass index (BMI), suggesting that both anatomical factors, such as airway size, and neuromuscular control contribute to the obstruction. The pressure-flow relationship through collapsible airways is crucial for understanding the mechanisms behind OSA, as these pressures determine how easily the airway collapses during sleep. Additional risk factors, including anatomical variations and muscle tone, further influence the severity of the condition. Understanding these factors is essential for effective diagnosis and management of OSA.

The management of obstructive sleep apnea (OSA) involves a multifaceted approach tailored to the individual patient's needs, with treatment options ranging from lifestyle changes to advanced surgical interventions. For patients with mild-to-moderate OSA, lifestyle modifications such as weight loss, sleep hygiene, and avoidance of alcohol or sedatives are crucial. Continuous positive airway pressure (CPAP) therapy remains the most effective treatment for moderate-to-severe OSA, although patient adherence to CPAP can be challenging. For those unable to tolerate CPAP, oral appliances, particularly mandibular advancement devices, can help alleviate airway obstruction, especially in cases of mild-to-moderate OSA. Surgical options, including uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), and hypoglossal nerve stimulation (HNS), offer potential relief for patients with more severe cases. In certain cases, a tracheostomy may be considered for extreme OSA, though it is typically reserved for patients with multiple comorbidities requiring specialized care. Ultimately, a comprehensive, individualized treatment plan that may combine several modalities is essential for improving patient outcomes, reducing symptoms, and enhancing quality of life.

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

Obstructive Sleep Apnea (OSA) Emerging Drugs Chapters

This segment of the Obstructive Sleep Apnea (OSA) report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, 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.

Obstructive Sleep Apnea (OSA) 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. AD109 could be the first pharmacological treatment to improve oxygenation during sleep by directly addressing the underlying neuromuscular cause of upper airway collapse in people with obstructive sleep apnea. It is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective noradrenaline reuptake inhibitor (NRI). Their combined pharmacological synergy targets the root neuromuscular cause of OSA. The US Food and Drug Administration (FDA) has also granted Fast Track designation to AD109 for the treatment of OSA. Currently, the drug is in Phase III stage of its development for the treatment of Obstructive Sleep Apnea (OSA).

• IHL-42X: Incannex Healthcare Ltd

IHL-42X is designed to treat OSA by targeting its underlying pathophysiology. An oral fixed-dose combination of dronabinol and acetazolamide, IHL-42X is currently advancing through late clinical stages for the treatment of OSA. Designed to act synergistically, IHL-42X uniquely targets two physiological pathways associated with the intermittent hypoxia (IH) and hypercapnia that characterize OSA. In a prior clinical trial, IHL-42X was shown to reduce the Apnea-Hypopnea Index (AHI) in all dosage strengths, with the lowest dose reducing AHI by an average of 51 percent relative to baseline. Currently, the drug is in Phase II/III stage of its development for the treatment of Obstructive Sleep Apnea (OSA).

• Lorundrostat: Mineralys Therapeutics Inc.

Lorundrostat, an investigational drug, is a novel, oral, highly selective, once-daily aldosterone synthase inhibitor. Lorundrostat targets aldosterone-driven hypertension by inhibiting the enzyme that catalyzes the final steps of aldosterone synthesis. The goal is to decrease levels of aldosterone by selectively inhibiting aldosterone synthesis without affecting cortisol synthesis. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated approximately a 70% reduction in plasma aldosterone concentration in hypertensive subjects. Currently, the drug is in Phase II stage of its development for the treatment of Obstructive Sleep Apnea (OSA).

Obstructive Sleep Apnea (OSA): Therapeutic Assessment

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

• Major Players in Obstructive Sleep Apnea (OSA)
• There are approx. 8+ key companies which are developing the therapies for Obstructive Sleep Apnea (OSA). The companies which have their Obstructive Sleep Apnea (OSA) drug candidates in the most advanced stage, i.e. Phase III include, Apnimed.
• Phases

DelveInsight's report covers around 10+ 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

Obstructive Sleep Apnea (OSA) 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.

Obstructive Sleep Apnea (OSA): Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Obstructive Sleep Apnea (OSA) 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 Obstructive Sleep Apnea (OSA) drugs.

Obstructive Sleep Apnea (OSA) Report Insights

• Obstructive Sleep Apnea (OSA) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Apnimed
• Incannex Healthcare Ltd
• Mineralys Therapeutics Inc.
• Eli Lilly and Company
• Desitin Arzneimittel GmbH
• Shionogi Apnimed Sleep Science

Key Products

• AD109
• IHL-42X
• Lorundrostat
• Orforglipron
• Sulthiame
• SASS-001