Drugs / Aroxybutynin
Aroxybutynin
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT04631107 | Dec 2020 → May 2021 | obstructive sleep apnea syndrome | Apnimed | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06566820 | Jul 2024 → Jun 2026 overdue | obstructive sleep apnea syndrome | Apnimed | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT05813275 | Sep 2023 → Mar 2025 | obstructive sleep apnea syndrome | Apnimed | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT04580394 Comparator | Oct 2020 → May 2021 | obstructive sleep apnea syndrome | Apnimed | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-05-18 | Apnimed | Results Apnimed Announces Publication of its Phase 3 SynAIRgy Trial of AD109 for Obstructive Sleep Apnea in the American Journal of Respiratory and Critical Care Medicine apnimed.com ↗
The published Phase 3 data support AD109’s potential, if approved, to expand access to treatment for people with OSA who cannot tolerate or refuse PAP devices |
| 2025-07-23 | Apnimed | Results Apnimed Reports Positive Topline Results from Second Phase 3 Trial of AD109, Reinforcing Potential of First Oral Pill for Obstructive Sleep Apnea apnimed.com ↗
today announced positive topline results from its second pivotal Phase 3 clinical trial of Apnimed’s lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg). |
| 2025-05-19 | Apnimed | Results Apnimed Announces Positive Topline Results in the First Landmark Phase 3 Clinical Trial of AD109, an Investigational Once-Daily Oral Pill for Obstructive Sleep Apnea apnimed.com ↗
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). |
All press releases naming this drug 3 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Aroxybutynin | “The current study is with aroxybutynin (AD109), a new enantiomerically pure form of oxybutynin with better safety profile compared to racemic oxybutynin.” PMID 35975547 ↗ Dec 20222“Aroxybutynin 2.5 mg/atomoxetine 75 mg tablet, administered orally once daily at bedtime (Weeks 2-26).” NCT05813275 ↗ |
| Known as | Aroxybutynin component of ad-109 | ChEMBL registry synonym — accepted as the source's own label CHEMBL185434 ↗ |
| Known as | Aroxybutynina | ChEMBL registry synonym — accepted as the source's own label CHEMBL185434 ↗ |
| Known as | Aroxybutynine | ChEMBL registry synonym — accepted as the source's own label CHEMBL185434 ↗ |
| Known as | R-oxybutynin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04580394 ↗ |
| Modality | Small molecule | — CHEMBL185434 ↗ |
| Route | Oral | “Oral administration before bed” NCT04580394 ↗ |