Drugs / AD109
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | obstructive sleep apnea syndrome | 2026-05-18 | “Apnimed has submitted its New Drug Application (NDA) for AD109 to the FDA.” apnimed.com ↗ “Apnimed has submitted its NDA for AD109 to the FDA.” apnimed.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT05071612 | Nov 2021 → Jul 2022 | obstructive sleep apnea syndrome | Apnimed | Completed | Met primary |
| Phase 2 | NCT04580394 | Oct 2020 → May 2021 | obstructive sleep apnea syndrome | Apnimed | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05811247 | Aug 2023 → May 2025 | obstructive sleep apnea syndrome | Apnimed | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT06400615 Comparator | May → Dec 2024 | obstructive sleep apnea syndrome | Apnimed | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-07-14 | Apnimed | Regulatory Apnimed Announces FDA Acceptance of New Drug Application for AD109, An Investigational Oral Pill to Treat Adults with Obstructive Sleep Apnea apnimed.com ↗ |
| 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 |
| 2026-05-11 | Apnimed | Results Apnimed Announces Three Oral Presentations and a Late-breaking Poster at the American Thoracic Society (ATS) 2026 International Conference apnimed.com ↗
AD109 Significantly Reduces Snoring in Patients with Obstructive Sleep Apnea |
| 2025-10-17 | Apnimed | Results Apnimed To Present Additional Phase 3 Data for AD109, an Investigational Oral Pill for Obstructive Sleep Apnea, at CHEST 2025 Annual Meeting apnimed.com ↗
Results provide additional support for how AD109, a once-nightly investigational oral pill, addresses the neuromuscular root cause of OSA and the associated oxygenation deficits |
| 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). |
| 2023-10-10 | Apnimed | Results American Journal of Respiratory and Critical Care Medicine Publishes Full, Positive Results of Apnimed’s MARIPOSA Study on AD109, an Investigational Oral Drug for Obstructive Sleep Apnea apnimed.com ↗
The published data reinforce findings from the placebo-controlled trial of 211 randomized patients that showed: AD109 demonstrated a clinically and statistically significant improvement in OSA over the four-week period in adults with mild to severe sleep apnea. |
| 2023-05-21 | Apnimed | Results Apnimed Presented Positive Phase 2b Results on AD109, an Investigational Oral Drug for Obstructive Sleep Apnea, for the First Time at ATS 2023 apnimed.com ↗
Dosing with AD109 led to clinically important reductions in AHI in most patients with mild, moderate and severe OSA. |
| 2023-05-15 | Apnimed | Results Apnimed to Present Positive Phase 2b Results on AD109, an Investigational Oral Treatment for Obstructive Sleep Apnea, at ATS 2023 apnimed.com ↗
The Oral Agent AD109 Improves Objective and Subjective Outcomes in Obstructive Sleep Apnea Patients. |
All press releases naming this drug 20 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AD109 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06400615 ↗ |
| Known as | Aroxybutynin/Atomoxetine | “Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109)” NCT06400615 ↗ |
| Route | Oral | “Oral administration before bed” NCT04580394 ↗ |