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Last update 11 Jul 2026

Atomoxetine Hydrochloride

Last update 11 Jul 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryAtomoxetine, a diminutive molecule drug concocted by Eli Lilly, procured its inaugural medical approval in 2002. The drug functions as an inhibitor of norepinephrine reuptake in the brain, inducing augmented levels of norepinephrine in the synaptic cleft. The drug's primary indication is for Attention Deficit Disorder with Hyperactivity (ADHD), a disorder typified by inattentiveness, impulsivity, and hyperactivity. Atomoxetine is postulated to operate by enhancing focus and concentration in individuals grappling with ADHD. Taking everything into account, atomoxetine's intricate mechanism of action and clinical indications proffer it as a valuable therapeutic option for those affected by ADHD.

Drug Type

Small molecule drug

Synonyms

(-)-Tomoxetine, Atomoxetine, Atomoxetine hydrochloride (JAN/USP)

+ [13]

Target

NET

Action

inhibitors

Mechanism

NET inhibitors(Norepinephrine transporter inhibitors)

Therapeutic Areas

Other Diseases

Active Indication

Attention Deficit Disorder With Hyperactivity

Inactive Indication

Alzheimer DiseaseAttention Deficit and Disruptive Behavior DisordersAttention Deficit Disorder+ [10]

Originator Organization

Eli Lilly & Co.

Active Organization

Hyloris Pharmaceuticals SA

Eli Lilly & Co.MAP77 LLC

+ [3]

Inactive Organization-

License Organization

KYE Pharmaceuticals, Inc.

Rosemont Pharmaceuticals Ltd.

Hyloris Pharmaceuticals SA

Drug Highest PhaseApproved

First Approval Date

United States (26 Nov 2002),

Attention Deficit Disorder With Hyperactivity

RegulationOrphan Drug (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC17H22ClNO

InChIKeyLUCXVPAZUDVVBT-UNTBIKODSA-N

CAS Registry82248-59-7

236

Clinical Trials associated with Atomoxetine Hydrochloride

NCT07679282

/ Not yet recruitingPhase 4IIT

Comparative Effectiveness of Positive Airway Pressure Therapy, Dental Device, and Atomoxetine-Oxybutynin for Sleep Apnea: the ADAPT-OSA Study

Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible participants will be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions. Over the course of one year, participants will attend two in-person visits and take part in four phone check-ins to complete surveys, report any side effects, and discuss how well they are following their assigned treatment.

Start Date01 Sep 2026

Sponsor / Collaborator

University of Arizona

[+5]

NCT07577661

/ Not yet recruitingPhase 1/2IIT

Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea: A Randomized-Controlled Trial.

Obstructive sleep apnea (OSA) is a common condition in which the airway repeatedly collapses during sleep, leading to poor sleep quality and reduced oxygen levels. Hypoglossal nerve stimulation (HGNS) is an approved treatment that uses a small implanted device to stimulate the genioglossus muscle and keep the airway open. However, some patients continue to have OSA despite using HGNS. Atomoxetine and oxybutynin, "AtoOxy", is a promising pharmacologcal therapy under investigation that has been shown to activate pharyngeal muscles-in particular non-genioglossus muscles--but appears more efficacious in some patients than others.
This study will test whether the combination of AtoOxy and HGNS can further improve breathing during sleep compared to either monotherapy alone. Participants with OSA and an HGNS device will be randomized to receive, in random order: HGNS+AtoOxy, HGNS alone (plus placebo), AtoOxy alone (HGNS device off), and placebo (HGNS device off), in a cross-over trial.
The main goal is to determine whether the combined treatment reduces the number of breathing events during sleep; the primary outcome test will compare HGNS+AtoOxy versus HGNS alone. The effect of each intervention versus placebo will also be presented.
The study will also examine how individual patient characteristics influence response to treatment.

Start Date01 Jun 2026

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

NCT06573970

/ RecruitingPhase 4IIT

Atomoxetine Effect on Attention, Executive Function, and Quality of Life in Veterans With Posttraumatic Stress Disorder

Attention deficits (AD) frequently co-occur with posttraumatic stress disorder (PTSD). The presence of AD is associated with greater PTSD clinical severity and poorer clinical outcomes. Knowledge regarding the mechanism underlying this association is limited, though the emerging evidence has indicated that executive function deficit (EFD) is strongly correlated with AD and PTSD symptoms. While treatments developed for PTSD have existed for years, a substantial portion of individuals do not fully respond to conventional treatment. Accumulating evidence suggest that attention deficit (AD) and EFD may be a driving force for PTSD treatment resistance. However, treatment of executive impairment in PTSD is very limited. As a result, untreated co-occurring AD and EFD in PTSD poses severe negative impacts on patients' functional recovery, treatment outcomes, and quality of life (QoL). Given that up to 50% of patients do not respond well to the first-line pharmacological PTSD treatments, it is imperative to seek novel treatment strategies to improve EF that may improve both standard treatment response and QoL, social function. The proposed study directly addresses this knowledge gap by testing the efficacy of atomoxetine (ATX) in improving EF and attention among Veterans with PTSD, which will further improve Veterans' QoL and social function. ATX represents a promising novel candidate pharmacotherapy for individuals with PTSD. ATX is a non-stimulant selective norepinephrine reuptake inhibitor (SNRI), approved by the FDA for the treatment of ADHD. Studies suggest that ATX, unlike stimulants, lacks addictive properties and shows efficacy in the treatment of comorbid depression and anxiety, which is ideal in the treatment of PTSD. Data from the investigators' preliminary study provides encouraging support for the therapeutic potential of ATX in improving EF in Veterans with comorbid PTSD/ADHD. The investigators' recent research uncovered a higher rate of ADHD among Veterans with PTSD, and the comorbid AD symptoms were correlated with PTSD severity and poorer treatment outcomes. Treatment with ATX showed significant symptoms reduction in ADHD and improvement in inhibitory function in Veterans with ADHD/PTSD. In the proposed study, the investigators will focus on ATX in improvement of EF and attention, and further psycho-social life function and QoL. The investigators will (1) employ a randomized, double-blind design that will consist of 12 weeks of treatment with ATX or placebo medication; (2) use standardized, repeated dependent measures to rigorously assess AD and EFD symptomatology; (3) measure impairment in associated mental and behavioral health problems (e.g., attention deficit, depression, anxiety, suicidality, QoL, family/social functioning); and (4) use response inhibition task GoNogo, working memory and attention tests Digit Span and Trail Making to investigate the underlying pathophysiology of PTSD and prognostic indicators of treatment outcome. To achieve these goals, the investigators have assembled a multidisciplinary team with expertise in PTSD, ADHD clinical trials, and human laboratory paradigms who have successfully collaborated in the past and are uniquely qualified to implement this type of investigation. The proposed project is directly responsive to the mission of the VA-RRD "to maximize Veterans' functional independence, quality of life and participation in their lives and community." Successful completion of this study will provide a platform for a large multi-center trial to further confirm the important role of EF in PTSD treatment outcomes. The findings from this study will provide critically needed evidence to help inform clinical practice guidelines on the treatment of PTSD. The outcome of the proposed research will be significant, because it provides a knowledge base to allow for development of new PTSD intervention strategies. More importantly, this clinical trial may immediately benefit Veterans by enhancing their cognitive function, reducing AD related disability, and further improving quality of life for Veterans who suffer from PTSD.

Start Date01 Apr 2026

Sponsor / Collaborator

VA Office of Research and Development

[+1]

100 Clinical Results associated with Atomoxetine Hydrochloride

100 Translational Medicine associated with Atomoxetine Hydrochloride

100 Patents (Medical) associated with Atomoxetine Hydrochloride

2,489

Literatures (Medical) associated with Atomoxetine Hydrochloride

01 Oct 2026·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

UPLC–MS/MS method for quantifying non-stimulant ADHD medications in human breast milk and plasma: Application in a lactating patient receiving atomoxetine

Article

Author: Furugen, Ayako ; Okamoto, Keisuke ; Kobayashi, Masaki ; Ueda, Hinata ; Ishikawa, Shuhei ; Aoyagi, Ryoichi ; Umazume, Takeshi ; Nishimura, Ayako ; Narumi, Katsuya

Non-stimulant medications, such as atomoxetine (ATX) and guanfacine (GFC), are increasingly prescribed for attention-deficit/hyperactivity disorder (ADHD), including among women of childbearing age. However, experimental data on the transfer of these drugs into human breast milk remain extremely limited. In this study, we developed and validated a highly sensitive and precise ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for the simultaneous quantification of ATX, its major metabolites (4-hydroxy ATX: 4-OH ATX and N-desmethyl ATX: N-DAT), and GFC in human plasma and breast milk. Stable isotope-labeled compounds were used as internal standards (IS). Plasma samples were prepared using liquid-liquid extraction with ethyl acetate, and breast milk samples were treated by protein precipitation with acetonitrile containing 0.5% formic acid. The method required only 100 µL of sample volume and showed good linearity, accuracy, and precision over the tested ranges (plasma: 0.5-50 ng/mL; breast milk: 0.8-50 ng/mL). Matrix effects were evaluated using six individual lots of plasma and breast milk, and acceptable variability was achieved. The validated method was applied to plasma and breast milk samples from an ATX-treated lactating woman, yielding milk-to-plasma ratios (M/P) of 0.089 for ATX and 1.17 for 4-OH ATX. The relative infant dose (RID) was estimated at 0.086% for ATX and 0.059% for 4-OH ATX, and the combined RID was estimated to be 0.145%. This study provides a robust and reliable tool for assessing the transfer of non-stimulant ADHD medications into human breast milk and strengthens the evidence base for safe pharmacotherapy during lactation.

01 Aug 2026·REPRODUCTIVE TOXICOLOGY

Atomoxetine hydrochloride impairs human sperm quality and function via disruption of calcium homeostasis and PKC signaling: A combined network pharmacology and in vitro study

Article

Author: Weng, Shiyao ; Luo, Tao ; Liu, Xuchang ; Gan, Fan ; Zhong, Xia ; Chen, Houyang ; Yuan, Yufeng

Atomoxetine Hydrochloride (ATX) is a widely prescribed first-line pharmacotherapy for adult attention deficit hyperactivity disorder (ADHD). Despite its chronic use among men of reproductive age, the potential impact of ATX on male fertility remains largely unknown. This study aimed to elucidate the toxicological effects of ATX on human sperm and to determine the underlying molecular mechanisms. In vitro exposure of human sperm to ATX (1-500 μM) revealed a significant concentration- and time-dependent inhibition of sperm motility. A critical mechanistic dissociation was observed: severe cytotoxicity, mitochondrial depolarization, and massive ROS accumulation (>6-fold increase) occurred exclusively at ≥ 100 μM. Conversely, 50 μM ATX potently reduced progressive motility (27.8% vs. 53.0% in controls at 120 min) without significantly compromising cell viability (68.9% vs. 74.4%) or mitochondrial function, indicating a specific signaling disruption. Network pharmacological analysis was employed to identify calcium signaling and Protein Kinase C (PKC) as key candidate pathways. Validation experiments using fluorescent assays confirmed that ATX disrupted physiological calcium homeostasis, specifically abolishing progesterone-induced calcium influx. Co-treatment with the PKC agonist PMA (100 nM) significantly reversed this calcium suppression (∼58%), alongside rescuing defects in motility, capacitation, and the acrosome reaction. These findings demonstrate that ATX compromises human sperm function primarily by disrupting PKC-dependent calcium channel regulation. These results highlight the potential reproductive risks, warranting further clinical assessment of patients undergoing chronic ATX therapy.

10 Jun 2026·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova

Pharmacological treatment of obstructive sleep apnea syndrome

Review

Author: Filin, A A ; Boldin, A V ; Tardov, M V ; Tardova, V M ; Bokova, I A ; Kotidis, I ; Bokova, O A

Obstructive sleep apnea syndrome (OSAS) is a potentially life-threatening condition that is increasingly prevalent in developed countries. OSAS treatment involves multiple components, including general lifestyle modifications and specific interventions such as intraoral fixation devices and continuous positive airway pressure (CPAP). Surgical treatments, including correction of nasopharyngeal and oropharyngeal structures, orthognathic operations, and bariatric surgery, are used under strict indications. Until recently, pharmacological management was limited to nasal decongestants for rhinitis exacerbation and modafinil for daytime sleepiness. However, low compliance with non-surgical therapies and limited efficacy of some surgical procedures highlight the need for effective drug treatments for OSAS. Despite decades of research, a highly effective pharmacological therapy was not available until the past 6—7 years, when new agents and their combinations were evaluated. Randomization by OSAS endotype is now recognized as crucial in clinical studies. This review summarizes recent advances in OSAS drug therapy, primarily based on randomized clinical trials, with a focus on agents such as semaglutide, tirzepatide, atomoxetine-oxybutynin, solriamfetol, sultiame, and acetazolamide, as well as established drugs. Further research with long-term follow-up and consideration of OSAS endotypes and drug side effects is needed. The importance of combining different therapeutic approaches for OSAS is emphasized.

News (Medical) associated with Atomoxetine Hydrochloride

01 Jul 2026

·www.prnewswire.com

Apnimed Strengthens Leadership Team with Appointments of Industry Veterans Michael Kelly as Chief Financial Officer and Steven Spector as Chief Legal Officer and Head of Corporate Affairs

New Chief Financial Officer and Chief Legal Officer and Head of Corporate Affairs follow recent appointment of Kevin Lind as Chief Executive Officer, in a planned succession strategy preparing Apnimed for its next stage of growth Michael Kelly brings more than 25 years of healthcare finance leadership experience, including execution of more than $30 billion in capital markets and M&A transactions Steven Spector is a distinguished legal, compliance and business development leader, most recently serving at Longboard Pharmaceuticals prior to its sale in 2024 CAMBRIDGE, Mass., July 1, 2026 /PRNewswire/ -- Apnimed, Inc., a late-stage clinical pharmaceutical company dedicated to the discovery, development, and commercialization of novel oral therapies that address the neurobiology of sleep-related breathing diseases, today announced the appointment of Michael Kelly as Chief Financial Officer ("CFO") and Steven Spector as Chief Legal Officer and Head of Corporate Affairs as part of a planned leadership transition. Mr. Kelly most recently served as Global Co-Head of Healthcare Investment Banking at Cantor Fitzgerald, where he helped build and lead a global biopharmaceutical franchise and executed more than $30 billion in capital markets and M&A transactions. As CFO, he will lead Apnimed's capital strategy and financial operations as Apnimed advances toward potential commercialization of AD109, if approved. Mr. Kelly succeeds Ramzi Benamar, who played an important role in strengthening Apnimed's financial foundation, supporting key strategic transactions, and advancing Apnimed's expected transition into a commercial-stage organization. Mr. Spector brings to Apnimed more than 25 years of legal, compliance and business development experience in the biotechnology industry, further strengthening Apnimed's legal and compliance capabilities as the company prepares for the potential commercial launch of AD109 for adults with obstructive sleep apnea ("OSA"). Mr. Spector most recently served as Executive Vice President, Head of Business Development, General Counsel, Chief Compliance Officer and Corporate Secretary at Longboard Pharmaceuticals, Inc. until its sale to H. Lundbeck A/S for approximately $2.6 billion in December 2024. Mr. Kelly and Mr. Spector will join Apnimed's leadership team and report to Chief Executive Officer ("CEO") Kevin Lind. "Michael and Steven are joining Apnimed at a critical point in our evolution, and their extensive experience in capital formation, commercial finance, legal, compliance and business development will be instrumental as we prepare for our next stage of growth," said Kevin Lind, CEO of Apnimed. "I am privileged to join Apnimed at such a pivotal moment as the company continues to build toward its next phase," said Mr. Kelly. "I look forward to partnering with the team to support its growth strategy and ensure strong financial discipline as we work toward the goal of expanding treatment options to people with OSA." "I'm excited to join Apnimed alongside such a strong leadership team and contribute to the company's continued growth, including commercial readiness efforts for AD109, as we work toward bringing this potential first-in-class treatment to the millions of people living with OSA," said Mr. Spector. About AD109 AD109 is investigational and is designed to be the first potential pharmacological treatment to improve oxygenation during sleep and target the neuromuscular root cause of upper airway collapse in people with OSA. It is a potentially first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor (NRI). AD109 is a once-daily oral pill taken at bedtime that is designed to lower the complexity of intervention and may help more people benefit from effective, restorative sleep. In a disease characterized by complex and invasive treatment options, AD109, if approved, may offer a convenient oral solution to help improve oxygenation and health for people living with OSA. About Obstructive Sleep Apnea OSA is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. OSA affects individuals across all walks of life, impacting both males and females of all age groups, ethnicities, and weight classes, including those with or without obesity. An estimated 80 million people in the United States and one billion people worldwide suffer from OSA. An individual with OSA can experience hundreds of sleep apnea events in a single night, each one reducing the blood oxygen levels and negatively impacting cellular functions vital to normal health and function. Failure to effectively treat OSA increases the risk of serious long-term health consequences, including cardiovascular, neurocognitive and cardiometabolic damage and heightened mortality. Yet, many patients diagnosed with OSA remain untreated. About Apnimed Apnimed is a privately held late stage clinical pharmaceutical company dedicated to the discovery, development and commercialization of novel oral therapies that address the neurobiology of sleep-related breathing diseases. We believe the introduction of once-nightly oral drugs has the potential to expand diagnosis and the reach of treatment for people with OSA. We believe that people with OSA would benefit from having multiple drugs with differing mechanisms to more fully address the heterogeneity of OSA's disease pathophysiology. Apnimed envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and help more people get the oxygen and restorative sleep needed to thrive. Based in Cambridge, Massachusetts, Apnimed is advancing its product candidate, AD109, designed to improve oxygenation in individuals living with OSA. We believe that AD109 could become the catalyst for a new oral treatment paradigm for OSA that has been historically limited to cumbersome devices or invasive surgeries. AD109 has completed two Phase 3 clinical trials for the treatment of mild, moderate and severe OSA, including the SynAIRgy study, with results published in a peer-reviewed journal. Apnimed has submitted its New Drug Application (NDA) for AD109 to the FDA. Based on FDA feedback, Apnimed expects a potential PDUFA target action date in the first quarter of 2027, subject to FDA acceptance of the NDA for review. Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact: [email protected] Investor Contact: [email protected] SOURCE Apnimed, Inc. 21% more press release views with Request a Demo

Executive ChangePhase 3

12 Jun 2026

·www.prnewswire.com

University of Arizona Announces Landmark $14 Million PCORI-Funded Clinical Trial Comparing Three Leading Treatments for Obstructive Sleep Apnea

Five-Year, 2,400-Patient Multi-Center Study to Generate First Comprehensive Head-to-Head Evidence on CPAP, Oral Appliance Therapy, and Pharmacological Treatment; Daybreak to Support OAT Access for Study Participants LOS ANGELES, June 12, 2026 /PRNewswire/ -- The University of Arizona has announced a landmark clinical trial that will deliver the most comprehensive head-to-head comparison of the three leading obstructive sleep apnea (OSA) treatments to date. Funded by a five-year, nearly $14 million award from the Patient-Centered Outcomes Research Institute (PCORI), the study will enroll 2,400 patients across four major academic medical centers to help patients and physicians make better-informed OSA treatment decisions. Led by Dr. Sairam Parthasarathy, Director of the University of Arizona Center for Sleep, Circadian & Neuroscience Research, the trial will compare CPAP therapy, a mandibular advancement device (MAD), and a pharmacological combination of atomoxetine and oxybutynin. Participants will be followed for 12 months across measures including daytime sleepiness, blood pressure, quality of life, and treatment adherence. Study sites include the University of Arizona (primary), Stanford Medicine, the University of Maryland School of Medicine, and the University of Miami Miller School of Medicine. "Access remains one of the biggest challenges in sleep medicine today. Daybreak's ability to streamline the path from diagnosis to treatment while preserving appropriate clinical oversight made them a compelling partner for this research." - Dr. Sairam Parthasarathy Daybreak's direct-to-patient delivery model and clinical support infrastructure were identified as a practical solution to many of the barriers that commonly impact OAT treatment access, adherence, and continuity of care in large-scale, nationwide clinical research. As part of the collaboration, Daybreak will provide its FDA-cleared MAD therapy and patient support services to OAT study subjects across all four trial participating sites. Daybreak's nationwide care model is uniquely positioned to deliver a highly standardized treatment experience across geographically diverse patient populations. Study subjects across all sites receive uniform onboarding process, treatment protocol, follow-up cadence, and clinical support infrastructure that supports retention. This model helps reduce operational variability while maintaining a consistent, high standard of care throughout the study. "This study has the potential to reshape how patients and physicians approach sleep apnea treatment for years to come. We are honored that Daybreak can contribute to that work by ensuring participants in the oral appliance therapy arm have reliable, consistent access to treatment throughout the study. We are grateful to Dr. Parthasarathy and the research teams at all four institutions for the trust they have placed in us." - Van Morgan, CFO & Co-founder, Daybreak Study findings are expected to inform clinical practice guidelines and treatment protocols for OSA on a national scale. Editor's Note: The University of Arizona originally announced this study on May 13, 2026. The full announcement is available at: news.arizona.edu/news/new-study-help-inform-patient-physician-choices-sleep-apnea-treatment. Daybreak is issuing this release to recognize the study's significance and its role supporting the oral appliance therapy arm. About Daybreak Daybreak is a sleep apnea solutions company helping patients diagnose and treat obstructive sleep apnea through at-home sleep testing and FDA-cleared mandibular advancement device therapy. Daybreak's model combines clinical rigor with patient accessibility, offering a streamlined pathway from diagnosis to treatment that meets patients where they are. Founded in 2022 and headquartered in Los Angeles, CA, Daybreak operates exclusively in the United States and partners with sleep physicians, DME providers, and federal healthcare institutions nationwide to extend access to evidence-based OSA care. For additional information regarding Daybreak, please contact [email protected]. About the Study The PCORI-funded trial is led by Dr. Sairam Parthasarathy at the University of Arizona, with site principal investigators Dr. Clete Kushida (Stanford Medicine), Dr. Emerson Wickwire (University of Maryland School of Medicine), and Dr. Girardin Jean-Louis (University of Miami Miller School of Medicine). PCORI is an independent nonprofit that funds patient-centered comparative effectiveness research to help patients and clinicians make better-informed healthcare decisions. The original University of Arizona announcement is available at news.arizona.edu. For additional information regarding this study, please contact: Heidi Erickson, BSN, RN, CCRP Director of Clinical Research & Regulatory Compliance Division of Pulmonary, Critical Care & Sleep Medicine University of Arizona Email: [email protected] Phone: 520-626-5287 SOURCE Daybreak 21% more press release views with Request a Demo

Clinical Study

10 Jun 2026

·www.prnewswire.com

Apnimed Announces Upcoming Oral Presentation at SLEEP 2026 to Highlight Pooled Phase 3 Data for AD109 in Obstructive Sleep Apnea

CAMBRIDGE, Mass., June 10, 2026 /PRNewswire/ -- Apnimed, Inc., a late stage clinical pharmaceutical company dedicated to the discovery, development, and commercialization of novel oral therapies that address the neurobiology of sleep-related breathing diseases, today announced that six abstracts have been selected for presentation, including an oral presentation, at the upcoming SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies (APSS), being held from June 14th to 17th at the Baltimore Convention Center. Certain abstracts being presented will feature a pooled analysis of the SynAIRgy and LunAIRo Phase 3 trials of AD109, Apnimed's lead product candidate, reflecting one of the largest clinical development programs conducted for an obstructive sleep apnea pharmacotherapy. Other research underscores substantial unmet needs in OSA, marked by persistent diagnostic delays and high proportion of diagnosed patients who remain untreated, highlighting an urgent need to improve awareness and education. SLEEP 2026 Annual Meeting Presentation Details: Oral Presentation Title: Concomitant Aroxybutynin and Atomoxetine (AD109) with GLP-1 Agonists: An Analysis of the SynAIRgy and LunAIRo Trials in Obstructive Sleep Apnea Session: O-23 – Frontiers in Sleep Medicine: Biomarkers, Wearables, and Next-Generation Therapeutics Session Date, Time: Wednesday, June 17, 2026, 5:15-5:30pm EDT Location: Room 314 on Level 3 Abstract ID: 589 Poster Presentations Title: Obstructive Sleep Apnea Management in Practice: Real-World Treatment Patterns Highlight Persistent Gaps in Care Poster Number: 277 Poster Presentation Session: P-12 Session Date, Time: Monday, June 15, 2026, 10:00-10:45am EDT Location: EXHIBIT HALL G Abstract ID: 539 Title: Obstructive Sleep Apnea Patient Journey from First Symptom to Confirmed Diagnosis: A Real-World Analysis of Patients in the United States Poster Number: 266 Poster Presentation Session: P-12 Session Date, Time: Monday, June 15, 2026, 11:00-11:45am EDT Location: EXHIBIT HALL G Abstract ID: 527 Title: Concomitant Aroxybutynin and Atomoxetine (AD109) with GLP-1 Agonists: An Analysis of the SynAIRgy and LunAIRo Trials in Obstructive Sleep Apnea Poster Number: 143 Poster Presentation Session: P-48 Session Date, Time: Wednesday, June 17, 2026, 10:00-10:45am EDT Location: EXHIBIT HALL G Abstract ID: 589 Title: Pharmacokinetics, Efficacy, and Safety of AD109 (Aroxybutynin and Atomoxetine) in Participants with Obstructive Sleep Apnea and Obesity Taking a GLP-1 Poster Number: 134 Poster Presentation Session: P-48 Session Date, Time: Wednesday, June 17, 2026, 11:00-11:45am EDT Location: EXHIBIT HALL G Abstract ID: 672 Title: Content Validity and Meaningful Change on Patient-Reported Outcome Measures for Use in Obstructive Sleep Apnea Poster Number: 126 Poster Presentation Session: P-48 Session Date, Time: Wednesday, June 17, 2026, 11:00-11:45am EDT Location: EXHIBIT HALL G Abstract ID: 663 Title: Psychometric Validation of the PROMIS Fatigue 8a, PROMIS Sleep Impairment 8a and ESS in Adults with Mild to Severe Obstructive Sleep Apnea Poster Number: 120 Poster Presentation Session: P-48 Session Date, Time: Wednesday, June 17, 2026, 11:00-11:45am EDT Location: EXHIBIT HALL G Abstract ID: 656 Product Theater Title: Dawn of a New Era: Emerging Clinical Overview of an Investigational Oral Tablet for OSA Session Date, Time: Tuesday, June 16, 2026, 11:45am-12:45pm EDT Location: Hilton Baltimore; Key Ballroom 7-8 Apnimed In-booth Presentations Title: Rethinking OSA Treatment Response: Beyond the AHI Session Date, Time: Monday, June 15, 2026, 2:00-2:10pm EDT Location: Apnimed Booth 913 Title: Rethinking OSA Treatment Response: Beyond the AHI Session Date, Time: Tuesday, June 16, 2026, 10:20-10:30am EDT Location: Apnimed Booth 913 About AD109 AD109 is investigational and is designed to be the first potential pharmacological treatment to improve oxygenation during sleep and target the neuromuscular root cause of upper airway collapse in people with OSA. It is a potentially first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor (NRI). AD109 is a once-daily oral pill taken at bedtime that is designed to lower the complexity of intervention and may help more people benefit from effective, restorative sleep. In a disease characterized by complex and invasive treatment options, AD109, if approved, may offer a convenient oral solution to help improve oxygenation and health for people living with OSA. About Obstructive Sleep Apnea OSA is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. OSA affects individuals across all walks of life, impacting both males and females of all age groups, ethnicities, and weight classes, including those with or without obesity. An estimated 80 million people in the United States and one billion people worldwide suffer from OSA. An individual with OSA can experience hundreds of sleep apnea events in a single night, each one reducing the blood oxygen levels and negatively impacting cellular functions vital to normal health and function. Failure to effectively treat OSA increases the risk of serious long-term health consequences, including cardiovascular, neurocognitive and cardiometabolic damage and heightened mortality. Yet, many patients diagnosed with OSA remain untreated. About Apnimed Apnimed is a privately held late stage clinical pharmaceutical company dedicated to the discovery, development and commercialization of novel oral therapies that address the neurobiology of sleep-related breathing diseases. We believe the introduction of once-nightly oral drugs has the potential to expand diagnosis and the reach of treatment for people with OSA. We believe that people with OSA would benefit from having multiple drugs with differing mechanisms to more fully address the heterogeneity of OSA's disease pathophysiology. Apnimed envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and help more people get the oxygen and restorative sleep needed to thrive. Based in Cambridge, Massachusetts, Apnimed is advancing its product candidate, AD109, designed to improve oxygenation in individuals living with OSA. We believe that AD109 could become the catalyst for a new oral treatment paradigm for OSA that has been historically limited to cumbersome devices or invasive surgeries. AD109 has completed two Phase 3 clinical trials for the treatment of mild, moderate and severe OSA, including the SynAIRgy study, with results published in a peer-reviewed journal. Apnimed has submitted its New Drug Application (NDA) for AD109 to the FDA. Based on FDA feedback, Apnimed expects a potential PDUFA target action date in the first quarter of 2027, subject to FDA acceptance of the NDA for review. Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact: [email protected] Investor Contact: [email protected] SOURCE Apnimed, Inc. 21% more press release views with Request a Demo

Phase 3NDA

100 Deals associated with Atomoxetine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02574	Atomoxetine Hydrochloride	N06BA09	DB00289

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	United States	Eli Lilly & Co.	26 Nov 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cognitive Dysfunction	Phase 3	United States	Eli Lilly & Co.	01 Nov 2005
Generalized anxiety disorder	Phase 3	-	Eli Lilly & Co.	01 Nov 2005
Neoplasms	Phase 3	United States	Eli Lilly & Co.	01 Nov 2005
Phobia, Social	Phase 3	-	Eli Lilly & Co.	01 Nov 2005
Attention Deficit and Disruptive Behavior Disorders	Phase 3	Australia	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	Belgium	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	Denmark	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	Finland	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	Germany	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	Netherlands	Eli Lilly & Co.	01 Dec 2003

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04565288 (CTgov)	Phase 2	Alcohol Use Disorder	42	Atomoxetine (Atomoxetine)	vowyqptqow = fhptxvitng gcngnkulyo (jvdmtsrhvm, wpwjrvgdpc - cmoxhqelik) View more	-	09 May 2025
				Placebo (Placebo)	vowyqptqow = uevaiifzta gcngnkulyo (jvdmtsrhvm, booxnxdgds - bejtehqzzl) View more
NCT04905979 (Pubmed \| Sleep Breath)	Phase 2	Sleep Apnea, Obstructive \| Hypertension	-	Atomoxetine 80 mg	hpywabgtho(fpfeemvvot) = pfbtipvoae xnsafzjwln (ixlasgbyrv, 18.8 - 28.5) View more	Positive	01 Dec 2024
				Atomoxetine 80 mg + Spironolactone 80/50 mg	hpywabgtho(fpfeemvvot) = agyrgedgyp xnsafzjwln (ixlasgbyrv, 5.7 - 14.1)
NCT04445688 (Pubmed \| Sleep Breath)	Phase 2	Sleep Apnea, Obstructive	62	AD036 (atomoxetine 80 mg and oxybutynin 5 mg)	svkzmeohno(zjbkjcorix) = bolkemxtcn qlsuktvths (uxnyjfoknm, 2.8 - 13.6)	Positive	13 May 2022
				Atomoxetine 80 mg alone	svkzmeohno(zjbkjcorix) = esqusbynjh qlsuktvths (uxnyjfoknm, 1.4 - 11.6)
WSC2022	Phase 2	Sleep Apnea, Obstructive	30	Atomoxetine 75 mg + Aroxybutynin 2.5 mg	mbvqsvlldu(nutmegyguj) = yfqqtdgsia lqlquzgegu (fwxbhkizkb ) View more	Positive	11 Mar 2022
				Atomoxetine 37.5 mg + Aroxybutynin 2.5 mg	mbvqsvlldu(nutmegyguj) = oxzqhrgytx lqlquzgegu (fwxbhkizkb ) View more
NCT00628394 (CTgov)	Phase 4	Schizophrenia	119	Atomoxetine (Atomox/CR)	ewjgsfvrpc(wktarngefn) = mafkgcarjc lccljokiut (nzadizldqj, 1.71) View more	-	25 Sep 2020
				Atomoxetine (Atomox/Control)	ewjgsfvrpc(wktarngefn) = zkvlpcwgpn lccljokiut (nzadizldqj, 1.77) View more
NCT01340885 (CTgov)	Phase 4	Cognitive Dysfunction \| Parkinson Disease	9	Strattera (Atomoxetine)	hhfdmnmywz(sudgcafnka) = cufkhcrgxt jccgqzptll (xfbycejxzn, qcyrsrbihk - ahfyxwrash) View more	-	07 Jul 2020
				Exelon (Rivastigimine)	hhfdmnmywz(sudgcafnka) = tjizstbhgv jccgqzptll (xfbycejxzn, gtugfoxxkt - pcerukywwh) View more
NCT02500732 (POST6, CTgov)	Phase 2	Syncope, Vasovagal	57	Placebo (Placebo)	wycwukiqrp = afdpoykhza dwjldqwdux (lbdscjzekz, afthuqdvdo - adiornnsic) View more	-	21 Apr 2020
				Atomoxetine (Atomoxetine)	wycwukiqrp = ejtyzqooge dwjldqwdux (lbdscjzekz, cuzitsctnc - yekanyhbly) View more
NCT00918567 (CTgov)	Phase 4	Attention Deficit Disorder With Hyperactivity	56	Behavior Modification Therapy+atomoxetine (Combined Therapy)	mccqcposbt(qmbsxictxh) = gbkqfpimyc yvsxxgdtnd (gtlfcgqvys, 1.37) View more	-	07 Apr 2020
				atomoxetine (Drug Therapy)	mccqcposbt(qmbsxictxh) = jgxyjquqnf yvsxxgdtnd (gtlfcgqvys, 1.36) View more
NCT03091400 (CTgov)	Phase 2	Memory Disorders \| Amnesia \| Multiple Sclerosis	11	Atomoxetine (Atomoxetine)	fikgbjmoqs(qideuqifzn) = ktaeqeapqt gkoorhqdtl (ejswycjemj, 0.60) View more	-	13 Mar 2020
				Placebo (Placebo)	fikgbjmoqs(qideuqifzn) = jxmqxtjjfn gkoorhqdtl (ejswycjemj, 0.46) View more
NCT01522404 (ATX-001, CTgov)	Phase 2	Mild cognitive disorder	39	Placebo+Atomoxetine (Atomoxetine / Inactive Compound)	velmnxoqwt(yzuwclcbah) = nwtxabfccp fyawqzdxjg (qioyaqfbwn, 8.6) View more	-	05 Dec 2018
				Placebo+Atomoxetine (Inactive Compound / Atomoxetine)	velmnxoqwt(yzuwclcbah) = wsaeqfxjrw fyawqzdxjg (qioyaqfbwn, 7.5) View more

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