A potential breakthrough in the treatment of obstructive sleep apnea (OSA) may soon be within reach. Apnimed Inc., a biopharmaceutical company, has announced encouraging results from its Phase 3 clinical trial for AD109, a once-daily oral medication aimed at treating OSA — a condition currently managed primarily through continuous positive airway pressure (CPAP) machines.
In its latest 12-month study, AD109 demonstrated clinically meaningful and statistically significant reductions in upper airway obstruction among patients with mild to severe OSA. After 26 weeks, participants who received AD109 showed nearly a 50% reduction in disease severity, compared to just 6.8% in the placebo group. At the 51-week mark, 23% of participants achieved complete disease control, a promising indicator of the drug’s long-term effectiveness.
AD109 is a neuromuscular modulator that increases the tone of upper airway muscles, helping to maintain open airways during sleep — similar in concept to how CPAP machines physically deliver airflow through a mask to prevent airway collapse.
The drug was also well-tolerated across the participant group, with only mild or moderate adverse events reported, aligning with earlier clinical findings. No serious adverse events were observed throughout the trial.
“These results bring us closer to delivering the first oral pharmacotherapy for over 80 million adults in the U.S. living with OSA,” said Dr. Larry Miller, CEO of Apnimed. “With two large Phase 3 trials showing consistent and significant efficacy, AD109 has the potential to transform the OSA treatment landscape and expand access to millions currently left untreated.”
OSA is a common sleep disorder characterized by repeated episodes of partial or complete blockage of the airway during sleep, often marked by loud snoring, gasping, or choking. These interruptions can severely impact daytime alertness, cardiovascular health, and mental well-being.
While CPAP remains the frontline therapy, many patients find the device uncomfortable or difficult to use consistently. Alternatives like lifestyle modifications, including weight loss and avoiding sedatives or alcohol, can help, but options remain limited.
The search for pharmacological treatments gained momentum recently with the FDA’s approval of Eli Lilly’s weight-loss drug Zepbound for use in OSA patients with obesity. However, AD109 stands out as a dedicated, daily oral therapy for OSA, regardless of body weight. According to trial data, the drug’s efficacy was consistent across different weight categories.
Apnimed plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in early 2026.
If approved, AD109 could become the first prescription pill available for treating OSA — offering a simpler, non-invasive alternative for millions struggling with the disorder.