AD109 Effective as Oral Agent for Obstructive Sleep Apnea, With Patrick John Strollo, MD

A once-nightly oral pill called AD109 demonstrated statistically significant and clinically meaningful obstructive sleep apnea (OSA) improvements in the largest pharmacotherapy clinical development program ever conducted for the condition.1,2

These data, drawn from a pooled analysis of two phase 3 trials, SynAIRgy and LunAIRo, were presented at the 2026 American Thoracic Society (ATS) International Conference.1 Patrick John Strollo, MD, study author and a sleep medicine physician at the University of Pittsburgh Medical Center, spoke about AD109 and its efficacy.

“AD109, which is an investigational drug and which we studied in the SynAIRgy trial, offers another tool in the toolbox, and it's a first in class drug that is a neuromuscular modulator to address the problem with sleep apnea, which is airway obstruction,” Strollo explained.

AD109, he noted, combines 2 medications: aroxybutynin and atomoxetine. They are designed in this agent to work together to address the neuromuscular root causes of OSA, specifically the collapse of throat muscles during sleep that repeatedly obstructs the airway.

Strollo and his team’s 2 randomized, double-blind, placebo-controlled phase 3 trials assessed adults with mild-to-severe OSA who had failed or refused CPAP. They spanned a broad range of severity levels and body types. AD109 produced a model-estimated 39.3% reduction in the apnea-hypopnea index (AHI) from baseline in the pooled analysis, compared to 12.6% with placebo.

Additionally, Strollo et al found 28% of those given AD109 attained a 50% or greater AHI reduction. A significantly higher proportion reached complete disease control. AD109 also diminished patients’ hypoxic burden by 41.6% versus 9.9% with placebo, and those showing excessive daytime sleepiness reported meaningful improvements in fatigue and sleep impairment scores. Benefits were also shown by Strollo and coauthors to be consistent across severity levels and body types.

Apnimed has already submitted a New Drug Application to the US Food and Drug Administration (FDA), which has granted AD109 Fast Track designation. A potential PDUFA target action date is slated for the first quarter of 2027.

References

1. Patel S, Farkas R, Pho H, et al. (Poster Board # P194) Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea: A Pooled Analysis of the SynAIRgy and LunAIRo Phase 3 Trials. Poster presented at ATS 2026 on May 17.

2. Once-nightly pill treats causes of airway collapse to control OSA. American Thoracic Society. May 18, 2026. Accessed May 19, 2026. https://www.eurekalert.org/news-releases/1127768.