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FEB 28 2027
UPCOMING · 152 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 breathing to stop and start. AD109 is a once-daily oral pill combining aroxybutynin, which relaxes throat muscles, and atomoxetine, which helps keep the airway open. This dual-action approach may reduce breathing interruptions and improve sleep quality without requiring a bulky machine.

Pivotal trial

MARIPOSA Phase 2 completed NCT05071612

This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.

Source: ClinicalTrials.gov

Also in development