Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)

Phase 3 Completed 646 enrolled Apnimed

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.

Timeline

Start: 2023-09-16
Primary completion: 2025-03-10
Completion: 2025-03-14

Outcome

Met primary endpoint

paper At week 26, mean AHI treatment difference was -4.0 events/hour (95% CI, -6.4 to -1.6; P = .001) PMID 42148495 ↗

release “The SynAIRgy trial met its primary endpoint: mean change from baseline in the apnea-hypopnea index (AHI) at 26 weeks compared to placebo (p=0.001).” apnimed.com ↗

Publications

Strollo PJ Jr, Farkas R, Taranto-Montemurro L, Cronin J, Patel SR; SynAIRgy Investigators. Aroxybutynin and atomoxetine (AD109) for obstructive sleep apnea: a randomized phase 3 trial (SynAIRgy). Am J Respir Crit Care Med. 2026 Jul 1;212(7):1569-1584. doi: 10.1093/ajrccm/aamag215.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aroxybutynin	Small molecule	2.5 mg	Oral
Subject	Atomoxetine	Other / unclassified	75 mg	Oral