Apnimed posts Phase 3 SynAIRgy results for AD109 in obstructive sleep apnea
Apnimed reported completed Phase 3 results for its investigational OSA drug AD109 versus placebo, with results first posted September 11, 2026.
Apnimed's main news this week is the release of results from its completed Phase 3 trial of AD109 in obstructive sleep apnea.
- The "SynAIRgy Study" (NCT05813275), a Phase 3 randomized, double-blind, placebo-controlled trial testing a fixed dose combination of aroxybutynin/atomoxetine (AD109) against placebo in obstructive sleep apnea over six months1, is listed as completed, with a actual enrollment of 646 participants1. Results posted September 11, 2026 show that on the primary endpoint of change from baseline in Apnea-Hypopnea Index at 6 months, AD109 reduced AHI by 3.28 and 6.11 events per hour in two reported measures, compared with increases of 0.71 and 0.44 in the placebo arm, with p-values of 0.001 and less than 0.0001 by mixed model repeated measures analysis1. Serious adverse events were reported in 5 of 325 AD109 patients and 8 of 319 placebo patients1.
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