ELLICOTT CITY, Md. — A potential oral treatment for obstructive sleep apnea might be one step closer to reality for OSA patients after pharmaceutical company Apnimed announced positive results, on July 23, 2025, from its second Phase 3 clinical trial for AD109. The investigational drug must still undergo FDA approval before it is available to the public. Once approved, this drug has the potential to remove barriers to care. 

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“This second set of strong clinical data reinforces the hope building within the OSA community,” said Dr. Monica Mallampalli, President and CEO of the Alliance for Sleep Apnea Partners. “The need for accessible and well-tolerated treatment options for OSA is urgent as patients are looking for options. AD109’s consistent results across two pivotal studies signal a potential breakthrough for patients who have struggled with the limitations of existing therapies.”

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According to the statement released by Apnimed, the LunAIRo trial, AD109 demonstrated a 46.8% mean reduction in apnea-hypopnea index (AHI) at 26 weeks and sustained effectiveness through 12 months. This once-daily oral medication showed complete disease control in 22.9% of participants at 26 weeks and in 22.5% of participants at 51 weeks. It further showed meaningful improvement in oxygen desaturation and disease severity, but additional analysis is ongoing. Apnimed reported no serious adverse events related to AD109. 

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ASAP supports the development of innovative treatment options, whether used alone or in combination with existing therapies, to allow people living with OSA to manage their symptoms effectively and have better quality of life. As a patient advocacy organization, ASAP calls on healthcare providers, policymakers, and payers to proactively prepare for the potential addition of a new FDA-approved therapy that would expand the spectrum of treatments. 

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“With the promise shown by AD109, we urge a continued commitment to equitable access, better insurance coverage, and the inclusion of patient voices in the rollout of any new therapies. A once daily pill could have potential to remove barriers to care for some patients,” Mallampalli added.

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About Obstructive Sleep Apnea

Obstructive sleep apnea is a serious chronic health condition characterized by repeated collapse of the upper airway during sleep, leading to interrupted breathing and oxygen deprivation. OSA affects people of all ages, genders, ethnicities, and body types, though it often goes undiagnosed. Left untreated, OSA can increase the risk of heart disease, stroke, type 2 diabetes, and other serious health complications.

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About the Alliance for Sleep Apnea Partners

The Alliance for Sleep Apnea Partners (ASAP) is a U.S. based patient-oriented non-profit organization dedicated to improving the lives of people with sleep apnea through education, advocacy and support. Founded in 2018, ASAP is committed to promoting screening, diagnosis, treatment, and management of sleep apnea on behalf of the patient community to advance the lifelong well-being of sleep apnea patients.

 

Contact:
Monica P. Mallampalli, PhD

Alliance for Sleep Apnea Partners
info@apneapartners.org

855-545-1717