Drug intelligence / Profile preview

AD109

Development stage
Phase 3
Lead developer
Apnimed
Modality
Small Molecules
Administration
Oral
01

Overview

AD109 is an investigational, first-in-class oral combination therapy being developed for the treatment of obstructive sleep apnea (OSA). It combines two active pharmaceutical ingredients: aroxybutynin, a novel selective antimuscarinic agent, and atomoxetine, a selective norepinephrine reuptake inhibitor. The drug is designed to target the underlying neuromuscular dysfunction in OSA by activating upper airway dilator muscles during sleep via action on the hypoglossal motor nucleus. This mechanism aims to maintain an open airway and prevent collapse during sleep without the need for devices or surgery. AD109 is dosed once nightly at bedtime and has demonstrated significant reductions in apnea-hypopnea index (AHI) across mild, moderate, and severe OSA in clinical trials. It is currently being evaluated in Phase 3 clinical trials (LunAIRo and SynAIRgy) after positive results from multiple Phase 1/2 studies[1][2][3][5].

Brand names
AD109AD-109AD 109
Other names
aroxybutynin + atomoxetine
02

Targets

NET (Norepinephrine Transporter)CHRM3 (M3)

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