AD109 sleep apnea pill cuts breathing interruptions 44% in phase 3 trial

September 1, 2026 at 05:00 AM2 min

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The investigational oral drug AD109 reduced breathing interruptions by 44% in adults with obstructive sleep apnea in the phase 3 SynAIRgy trial. The six-month study enrolled 646 participants at 69 sites in the U.S. and Canada who had refused or could not tolerate CPAP. More than 40% of treated patients moved to a less severe OSA category, while 18% achieved complete disease control.

Key Facts

AD109 reduced the apnea-hypoxia index by about 44% compared with an 18% reduction in the placebo group.
The SynAIRgy trial enrolled 646 adults with mild to severe OSA at 69 sites in the U.S. and Canada.
More than 40% of AD109-treated participants improved to a less severe OSA category, and 18% achieved complete disease control.
AD109 combines aroxybutynin and atomoxetine to target neuromuscular causes of airway collapse during sleep.
The study was published in the American Journal of Respiratory and Critical Care Medicine and presented at the 2026 ATS International Conference.

Trial Results

The phase 3 SynAIRgy trial tested AD109 in 646 adults with mild to severe obstructive sleep apnea who had refused or could not tolerate CPAP. Participants taking AD109 experienced a 44% reduction in the apnea-hypoxia index, a measure of breathing interruptions per hour, compared with an 18% reduction in the placebo group. The drug also improved nighttime oxygen measures, including the oxygen desaturation index and hypoxic burden. Benefits were observed across patients with varying disease severity and body types.

Mechanism and Patient Impact

AD109 combines aroxybutynin and atomoxetine, two drugs intended to support throat muscles and reduce airway collapse during sleep. First author Patrick John Strollo, MD, of the University of Pittsburgh Medical Center, said the results provide encouraging evidence that targeting neuromuscular dysfunction can translate into meaningful clinical outcomes. More than 40% of treated patients moved to a less severe OSA category, and 18% achieved complete disease control. Dr. Strollo noted that an oral pill targeting underlying neuromuscular drivers could help address the gap for patients who remain untreated or undertreated.