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FEB 28 2027
UPCOMING · 212 DAYS TO PDUFA

Apnimed aroxybutynin + atomoxetine

for obstructive sleep apnea (OSA) in adults

NDA

Accepted JUL 14 2026.

About

Obstructive sleep apnea is a common disorder where the throat muscles relax during sleep, repeatedly blocking the airway and causing loud snoring and dangerous drops in oxygen. AD109 is a once-daily oral pill combining aroxybutynin, which relaxes throat muscles, and atomoxetine, which helps keep the airway open during sleep. This dual-action approach may reduce breathing pauses without needing a bulky machine, potentially offering a more convenient treatment for the condition.

Pivotal trial

NCT05811247 Phase 3 completed NCT05811247

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.

Source: ClinicalTrials.gov

Also in development