Trial Profile

Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (SynAIRgy Study)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 12 Aug 2025

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At a glance

23 Jul 2025 According to an Apnimed media release,Based on the Phase 3 data from LunAIRo and SynAIRgy, Apnimed plans to file a New Drug Application (NDA) with the U.S. FDA in early 2026.
05 Jun 2025 According to an Apnimed media release, data from this study will be presented at the Annual Meeting of the Associated Professional Sleep Societies (SLEEP 2025) which will take place June 8-11, 2025, in Seattle, WA.
19 May 2025 Positive Topline results presented in the Apnimed media release.

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