Obstructive Sleep Apnea Clinical Trial Pipeline Expands as 12+ Companies Driving Innovation in OSA Therapeutics | DelveInsight

The obstructive sleep apnea (OSA) market is being propelled by the rapid evolution of early detection and diagnostic tools. Technologies like home sleep apnea testing (HSAT), AI-powered applications, and smart wearables are transforming the diagnostic landscape by making it more accessible and user-friendly. These innovations not only reduce the dependency on traditional sleep labs but also facilitate earlier diagnosis and timely intervention. As a result, more patients are entering the treatment pathway, supporting both improved clinical outcomes and sustained market expansion.

New York, USA, July 16, 2025 (GLOBE NEWSWIRE) -- Obstructive Sleep Apnea Clinical Trial Pipeline Expands as 12+ Companies Driving Innovation in OSA Therapeutics | DelveInsight

The obstructive sleep apnea (OSA) market is being propelled by the rapid evolution of early detection and diagnostic tools. Technologies like home sleep apnea testing (HSAT), AI-powered applications, and smart wearables are transforming the diagnostic landscape by making it more accessible and user-friendly. These innovations not only reduce the dependency on traditional sleep labs but also facilitate earlier diagnosis and timely intervention. As a result, more patients are entering the treatment pathway, supporting both improved clinical outcomes and sustained market expansion.

DelveInsight’s 'Obstructive Sleep Apnea Pipeline Insight 2025' report provides comprehensive global coverage of pipeline obstructive sleep apnea therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the obstructive sleep apnea pipeline domain.

Key Takeaways from the Obstructive Sleep Apnea Pipeline Report

• DelveInsight’s obstructive sleep apnea pipeline report depicts a robust space with 12+ active players working to develop 14+ pipeline obstructive sleep apnea drugs. 
• Key obstructive sleep apnea companies such as Apnimed, Incannex Healthcare Ltd, Mineralys Therapeutics Inc., Eli Lilly and Company, KYORIN Pharmaceutical Co., Shionogi Apnimed Sleep Science, and others are evaluating new obstructive sleep apnea drugs to improve the treatment landscape.
• Promising pipeline obstructive sleep apnea therapies, such as Sulthiame, IHL-42X, Lorundrostat, Retatrutide, BAY2925976, SASS-001, and others, are in different phases of obstructive sleep apnea clinical trials.
• In June 2025, Innovent Biologics, Inc. announced that the first participant had been successfully dosed in a Phase III clinical trial (GLORY-OSA) of Mazdutide, a dual glucagon (GCG) and glucagon-like peptide-1 (GLP-1) receptor agonist, in Chinese participants with moderate-to-severe obstructive sleep apnea (OSA) and obesity (BMI ≥ 28 kg/m2).
• In April 2025, Apnimed announced that the first patient had been dosed in the Phase IIA RESTEADY trial evaluating the novel oral drug combination, SASS-001, in an underserved population of patients suffering from sleep apnea with a central component. Top-line results from the study are expected in the first half of 2026. SASS-001 represents the first clinical stage asset from Shionogi-Apnimed Sleep Science, LLC (SASS), Apnimed's joint venture with Shionogi & Co., Ltd. (Shionogi).
• In April 2025, Shionogi & Co., Ltd. announced that it had entered into an agreement with Apnimed, Inc. for the introduction of sulthiame* and a new drug development program. With the conclusion of this agreement, Shionogi acquired a joint ownership interest in the intellectual property rights related to the use of sulthiame in the field of sleep apnea and also in other intellectual property rights related to a different drug development program of Apnimed by paying a one-time fee to Apnimed.
• In April 2025, Apnimed announced that it had acquired the intellectual property and exclusive global rights to develop and commercialize sulthiame, a differentiated carbonic anhydrase inhibitor, in the broad field of sleep apnea and sleep-related breathing diseases, from Desitin Arzneimittel GmbH. Apnimed will develop sulthiame with Shionogi & Co. Ltd. through their joint venture, Shionogi-Apnimed Sleep Science (SASS).
• In April 2025, Incannex Healthcare Inc. announced that the Company has completed Phase II patient enrollment in the global Phase II/III RePOSA study of IHL-42X for the treatment of Obstructive Sleep Apnea (OSA). IHL-42X is an oral fixed dose combination medicine designed to reduce the incidence of interruptions to breathing during sleep and improve sleep quality.
• In January 2025, Mineralys Therapeutics, Inc. announced that the US Food and Drug Administration (FDA) had cleared the Company’s Investigational New Drug (IND) Application for a Phase II clinical trial to evaluate the effect of lorundrostat in the treatment of subjects with moderate-to-severe obstructive sleep apnea (OSA) and hypertension. 

Request a sample and discover the recent advances in obstructive sleep apnea drugs @ Obstructive Sleep Apnea Pipeline Report

The obstructive sleep apnea pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Obstructive Sleep Apnea drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the obstructive sleep apnea clinical trial landscape. 

Obstructive Sleep Apnea Overview

Obstructive sleep apnea (OSA) is a sleep disorder marked by repeated episodes of partial or complete blockage of the upper airway during sleep. These episodes cause drops in oxygen levels and frequent awakenings, resulting in fragmented, poor-quality sleep. Common signs include loud snoring, witnessed pauses in breathing, and excessive daytime sleepiness. OSA can have wide-ranging health effects, impairing cardiovascular health, behavior, quality of life, and even driving safety. While other types of sleep-disordered breathing, such as central sleep apnea, upper airway resistance syndrome, and obesity hypoventilation, share some features with OSA, they are distinct conditions and will be discussed separately.

The symptoms of OSA vary and can severely impact day-to-day functioning. These include persistent daytime drowsiness, loud snoring, gasping or choking during sleep, morning headaches, dry mouth or sore throat upon waking, difficulty concentrating, mood disturbances such as irritability or depression, high blood pressure, and reduced libido. These manifestations can greatly affect both physical well-being and overall life quality.

The underlying cause of OSA involves upper airway obstruction during sleep, mainly due to negative pressure that causes the airway to collapse during inhalation. A key area of concern is the narrowing of the airway in the retropalatal region during exhalation. Obesity is a significant risk factor, with a higher body mass index (BMI) linked to greater airway narrowing. Both structural factors (like airway size) and neuromuscular control contribute to this condition. Understanding how airflow interacts with pressure in collapsible airways is vital to grasping the mechanics of OSA. Additional anatomical and physiological factors also influence the severity of the disorder.

Managing OSA requires a personalized and multifaceted approach. For mild-to-moderate cases, lifestyle changes, such as losing weight, maintaining good sleep habits, and avoiding alcohol and sedatives, are important first steps. Continuous positive airway pressure (CPAP) therapy is the most effective treatment for moderate-to-severe OSA, though adherence can be difficult. Alternatives like oral appliances, especially mandibular advancement devices, may help in less severe cases. Surgical options, including uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), and hypoglossal nerve stimulation (HNS), may be considered for more severe or treatment-resistant cases. In rare, severe situations, a tracheostomy may be necessary, particularly for patients with significant comorbidities. Ultimately, the best outcomes are achieved through an individualized treatment plan that may combine several strategies to relieve symptoms, improve sleep quality, and enhance overall health.

Find out more about obstructive sleep apnea drugs @ Obstructive Sleep Apnea Treatment

A snapshot of the Pipeline Obstructive Sleep Apnea Drugs mentioned in the report:

Learn more about the emerging obstructive sleep apnea therapies @ Obstructive Sleep Apnea Clinical Trials

Obstructive Sleep Apnea Therapeutics Assessment

The obstructive sleep apnea pipeline report proffers an integral view of the emerging obstructive sleep apnea therapies segmented by stage, product type, molecule type, route of administration, and mechanism of action.

Scope of the Obstructive Sleep Apnea Pipeline Report 

• Coverage: Global 
• Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
• Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
• Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical
• Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy
• Therapeutics Assessment By Mechanism of Action: Adrenergic uptake inhibitors, Cholinergic receptor antagonists, Muscarinic receptor antagonists, Cannabinoid receptor CB2 agonists, Carbonic anhydrase inhibitors, Aldosterone synthase inhibitors, Glucagon-like peptide-1 receptor agonists, Purinergic P2X3 receptor antagonists
• Key Obstructive Sleep Apnea Companies: Apnimed, Incannex Healthcare Ltd, Mineralys Therapeutics Inc., Eli Lilly and Company, KYORIN Pharmaceutical Co., Shionogi Apnimed Sleep Science, and others.
• Key Obstructive Sleep Apnea Pipeline Therapies: Sulthiame, IHL-42X, Lorundrostat, Retatrutide, BAY2925976, SASS-001, and others.

Dive deep into rich insights for new obstructive sleep apnea treatments, visit @ Obstructive Sleep Apnea Drugs

Table of Contents

For further information on the obstructive sleep apnea pipeline therapeutics, reach out @ Obstructive Sleep Apnea Therapeutics

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