Evidence map›Paper›PMID 41050845›Full record

ArticleContemporary clinical trials communications2025

Aroxybutynin and atomoxetine (AD109) for the treatment of obstructive sleep apnea: Rationale, design and baseline characteristics of the phase 3 clinical trials.

Luigi Taranto-Montemurro, Sanjay R Patel, Patrick J Strollo, John Cronin, John Yee, Huy Pho, Andrea Werner, Ron Farkas

2 registry-linked trialsAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05811247 phase3completednot on this map

Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (LunAIRo Study)

TypeinterventionalSponsorApnimedRan2023 to 2025Enrolled660ConditionsOSAArmsAD109, Placebo
NCT05813275 phase3completednot on this map

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)

TypeinterventionalSponsorApnimedRan2023 to 2025Enrolled646ConditionsOSAArmsAD109, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Luigi Taranto-MontemurroApnimed, Inc., Cambridge, MA, USA.
Sanjay R PatelDivision of Pulmonary, Allergy, Critical Care, and Sleep Medicine, University of Pittsburgh, PA, USA.
Patrick J StrolloDivision of Pulmonary, Allergy, Critical Care, and Sleep Medicine, University of Pittsburgh, PA, USA.
John CroninApnimed, Inc., Cambridge, MA, USA.
John YeeApnimed, Inc., Cambridge, MA, USA.
Huy PhoApnimed, Inc., Cambridge, MA, USA.
Andrea WernerApnimed, Inc., Cambridge, MA, USA.
Ron FarkasApnimed, Inc., Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Two key factors leading to obstructive sleep apnea (OSA) pathogenesis include relaxation of upper airway muscles at sleep onset and their insufficient reactivation during obstructive events. Medications that address this neuromuscular dysfunction by increasing upper airway tone during sleep represent a potential strategy for mitigating OSA. Methods: AD109 is an investigational, once-daily oral agent taken at bedtime that combines an antimuscarinic, aroxybutynin (2.5 mg), with a selective norepinephrine reuptake inhibitor, atomoxetine (75 mg). LunAIRo (NCT05811247) and SynAIRgy (NCT05813275) are two ongoing, placebo-controlled 51-week and 26-week phase 3 clinical trials, respectively, investigating the efficacy and safety of AD109 to treat mild to severe OSA. Participants include adults with an apnea-hypopnea index with 4% desaturation (AHI Discussion: LunAIRo and SynAIRgy are fully enrolled, large Phase 3 clinical trials designed to confirm and extend our understanding of the safety and efficacy of AD109, a combination oral drug targeting the underlying neuromuscular dysfunction contributing to upper airway muscle collapse during sleep in adults with OSA.

Identifiers

PMID41050845
PMCPMC12490522

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.