Atomoxetine
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | STRATTERA | — | 2005-05-26 – 2008-07-23 | fda.gov ↗ |
| Approved | US (FDA) | STRATTERA | — | 2002-11-26 | fda.gov ↗ |
Trials 132 · started per year
Also used as a comparator or background therapy in 59 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02879136 Comparator | Jan 2017 → Dec 2025 | Parkinson disease | Hubert Fernandez | Completed | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT01794975 Comparator | Aug → Dec 2012 | — | University of Turku | Completed | No outcome recorded |
| Phase 1 | NCT01019707 Comparator | Oct 2009 → Dec 2010 | methamphetamine dependence, substance abuse | University of California, Los Angeles | Terminated | No outcome recorded |
| Phase 1 | NCT01343628 Comparator | Jan 2008 → Feb 2012 | alcohol sensitivity, acute, alcohol-induced mental disorder | University of Virginia | Terminated | No outcome recorded |
| Phase 1 | NCT00417794 Comparator | Aug 2005 → Apr 2015 | attention deficit-hyperactivity disorder, fetal alcohol syndrome | University of Oklahoma | Completed | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT05944965 Comparator | Dec 2023 → Jun 2025 | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT05293600 Comparator | Jul 2023 → Oct 2026 expected | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05350215 Comparator | Jun 2022 → Dec 2026 expected | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05101122 Comparator | Oct 2021 → Apr 2022 | obstructive sleep apnea syndrome | Apnimed | Completed | No outcome recorded |
| Phase 1/2 | NCT03720353 Comparator | Dec 2018 → Dec 2019 | — | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT02908529 Comparator | Sep 2016 → Dec 2017 | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT01557569 Comparator | Apr 2012 → Jun 2015 | methamphetamine dependence | University of Arkansas | Completed | No outcome recorded |
| Phase 216 trials | ||||||
| Phase 2 | NCT06899178 Comparator | Apr 2025 → Jul 2028 expected | obesity due to melanocortin 4 receptor deficiency | Icahn School of Medicine at Mount Sinai | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06542887 Background | Oct 2024 → Oct 2025 overdue | attention deficit-hyperactivity disorder | Ain Shams University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05071612 Comparator | Nov 2021 → Jul 2022 | obstructive sleep apnea syndrome | Apnimed | Completed | No outcome recorded |
| Phase 2 | NCT04580394 Comparator | Oct 2020 → May 2021 | obstructive sleep apnea syndrome | Apnimed | Completed | No outcome recorded |
| Phase 2 | NCT04115878 Comparator | Oct 2020 → Dec 2022 | Down syndrome, obstructive sleep apnea syndrome | University of Arizona | Completed | No outcome recorded |
| Phase 2 | NCT04445688 Comparator | Jul → Dec 2020 | obstructive sleep apnea syndrome | Apnimed | Completed | No outcome recorded |
| Phase 2 | NCT03324581 Comparator | Nov 2017 → Oct 2018 | attention deficit-hyperactivity disorder | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02784535 Comparator | Aug 2016 → May 2021 | orthostatic hypotension | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02500732 Comparator | Jul 2015 → Jan 2018 | syncope, familial vasovagal | University of Calgary | Completed | No outcome recorded |
| Phase 2 | NCT01738191 Comparator | Nov 2012 → Aug 2014 | Parkinson disease, cognitive disorder | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 2 | NCT01399827 Comparator | Feb 2012 → Nov 2017 | attention deficit-hyperactivity disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00880217 Comparator | May 2009 → Jan 2010 | attention deficit-hyperactivity disorder | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 2 | NCT00562055 Comparator | Nov 2007 → ? | attention deficit-hyperactivity disorder | Pfizer | Withdrawn | No outcome recorded |
| Phase 2 | NCT00548327 Comparator | Oct 2007 → Nov 2011 | amnestic disorder, schizophrenia | National Institute of Mental Health (NIMH) | Terminated | No outcome recorded |
| Phase 2 | NCT00528697 Comparator | Sep 2007 → Apr 2008 | attention deficit-hyperactivity disorder | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT00429091 Comparator | Jan → Aug 2007 | attention deficit-hyperactivity disorder | Abbott | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT05159687 Comparator | Jun 2022 → Sep 2026 expected | — | University of Calgary | Recruiting | No outcome recorded |
| Phase 3 | NCT04216186 Comparator | Nov 2018 → Dec 2030 expected | attention deficit-hyperactivity disorder | Tanta University | Recruiting | No outcome recorded |
| Phase 3 | NCT01106430 Comparator | Jun 2010 → Jul 2012 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01330693 Comparator | Sep 2009 → Nov 2015 | attention deficit-hyperactivity disorder | University of Cincinnati | Unknown | No outcome recorded |
| Phase 3 | NCT00568685 Comparator | Nov 2007 → Nov 2008 | attention deficit-hyperactivity disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00216281 Comparator | Sep 2005 → Oct 2006 | schizophrenia | Indiana University | Terminated | No outcome recorded |
| Phase 414 trials | ||||||
| Phase 4 | NCT07679282 Comparator | Sep 2026 → Mar 2030 expected | obstructive sleep apnea syndrome | Sairam Parthasarathy | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04085172 Comparator | Sep 2019 → Sep 2025 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 4 | NCT03781765 Comparator | Jun 2019 → Sep 2025 overdue | attention deficit-hyperactivity disorder | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 4 | NCT02287038 Comparator | Oct 2014 → Mar 2017 | attention deficit-hyperactivity disorder, post-traumatic stress disorder | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 4 | NCT02352051 Comparator | Feb → Oct 2014 | attention deficit-hyperactivity disorder | TC Erciyes University | Completed | No outcome recorded |
| Phase 4 | NCT01340885 Comparator | Jan 2011 → Jan 2013 | Parkinson disease | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 4 | NCT00844753 Comparator | Oct 2008 → Apr 2014 | attention deficit-hyperactivity disorder, autism | University of Rochester | Completed | No outcome recorded |
| Phase 4 | NCT01065259 Comparator | Apr 2008 → Dec 2010 | attention deficit-hyperactivity disorder | Peking University | Completed | No outcome recorded |
| Phase 4 | NCT00938743 Comparator | Jan 2008 → Dec 2009 | attention deficit-hyperactivity disorder | Central Institute of Mental Health, Mannheim | Completed | No outcome recorded |
| Phase 4 | NCT00183391 Comparator | Jul 2005 → Jun 2011 | attention deficit-hyperactivity disorder | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT00488163 Comparator | Jan 2005 → Apr 2007 | schizophrenia | Research Foundation for Mental Hygiene, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00304161 Comparator | Jul 2004 → Dec 2008 | Parkinson disease, depressive disorder | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT00506727 Comparator | Aug 2003 → Jul 2004 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 4 | NCT01207622 Comparator | — | attention deficit-hyperactivity disorder, substance-related disorder | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase not applicable11 trials | ||||||
| — | NCT05351944 Comparator | May 2023 → Jan 2024 | attention deficit-hyperactivity disorder, impulse control disorder | Alexandria University | Completed | No outcome recorded |
| — | NCT05635318 Comparator | Jan → Jun 2023 | attention deficit-hyperactivity disorder | Assiut University | Unknown | No outcome recorded |
| — | NCT04782830 Comparator | Feb 2021 → Jun 2027 expected | orthostatic hypotension, pure autonomic failure | Vanderbilt University Medical Center | Recruiting | No outcome recorded |
| — | NCT03936491 Comparator | Aug 2019 → Jan 2021 | attention deficit-hyperactivity disorder | National Taiwan University Hospital | Completed | No outcome recorded |
| — | NCT02788851 Comparator | Apr 2016 → Dec 2018 | attention deficit-hyperactivity disorder | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | No outcome recorded |
| — | NCT02482649 Comparator | Jan 2013 → Aug 2015 | attention deficit-hyperactivity disorder | Samsung Medical Center | Unknown | No outcome recorded |
| — | NCT01802515 Comparator | Dec 2012 → Mar 2014 | cocaine dependence, opiate dependence | Yale University | Terminated | No outcome recorded |
| — | NCT02142140 Comparator | Dec 2012 → Feb 2019 | attention deficit-hyperactivity disorder | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | No outcome recorded |
| — | NCT02172183 Background | Apr 2012 → Mar 2014 | attention deficit-hyperactivity disorder | Hospital Universitari Vall d'Hebron Research Institute | Completed | No outcome recorded |
| — | NCT01498549 Comparator | Dec 2011 → Jul 2013 | substance dependence | Yale University | Completed | No outcome recorded |
| — | NCT00611533 Comparator | May 2004 → Apr 2008 | cognitive disorder, premature menopause | University of Pennsylvania | Completed | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 202 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Atomoxetine | “adults with loud habitual snoring took atomoxetine plus oxybutynin for 10 days before bedtime at full adult doses (80 and 5 mg, respectively; half-dose run-in on days 1-3) and...” PMID 40471069 ↗ Sep 2025184“This study examined the effects of atomoxetine (ATX) and OROS methylphenidate (MPH) on laboratory measures of inhibitory control and attention in youth with...” PMID 24942409 ↗ Jun 2014 “CONCLUSIONS: This study provides additional support that a pharmacological intervention for obstructive sleep apnea, namely the combination of atomoxetine and aroxybutynin,...” PMID 35975547 ↗ Dec 2022 “Participants were only visited to monitor their adherence and continuation on medications for ADHD (methylphenidate or atomoxetine) as prescribed by their psychiatrist.” NCT02172183 ↗ “RESEARCH QUESTION: Is 2 weeks of 500 mg acetazolamide plus 100 mg atomoxetine daily effective for OHS severity (reduction in mean nocturnal CO2 as the primary outcome)?” PMID 41015199 ↗ Sep 2025 “Recently, a non-stimulant pharmacological agent, atomoxetine (ATMX), has been reported to be effective and safe in school-age children with ADHD.” NCT00517647 ↗ “Medications (methylphenidate, amphetamine, atomoxetine) will be provided by the pharmacy according to routines in standard clinical treatment.” NCT03250013 ↗ “a drug called atomoxetine in the treatment of freezing of gait for Parkinson's Disease patients.” NCT03651856 ↗ “Ritalin (methylphenidate HCl); Ritalin LA, Ritalin SR Strattera (atomoxetine HCl)” NCT05635318 ↗ “Aroxybutynin and atomoxetine (AD109) for obstructive sleep apnea: a randomized” PMID 42148495 ↗ Jul 2026 “single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg)” NCT05278104 ↗ “0.5 mg/kg (max 40 mg) of atomoxetine and 5mg oxybutynin taken nightly.” NCT07280468 ↗ “A single dose of Atomoxetine (ATX) (40 mg) will be administered.” NCT05708274 ↗ “Atomoxetine” NCT05944965 ↗ “Atomoxetine” NCT01399827 ↗ “Atomoxetine” NCT00573859 ↗ |
| Known as | Amphetamine mixed salts | “Amphetamine mixed salts” NCT00573859 ↗ |
| Known as | ATM | “Atomoxetine (ATM) is an approved drug currently on the market for the treatment of attention deficit.” NCT03651856 ↗1“Atomoxetine (ATM), a highly selective norepinephrine reuptake inhibitor,” PMID 19910721 ↗ Dec 2009 |
| Known as | ATMX | “The primary objective of the study is to investigate the efficacy of Atomoxetine (ATMX) in the treatments of adolescent and young adult Attention Deficit Hyperactivity Disorder...” NCT01207622 ↗2“Recently, a non-stimulant pharmacological agent, atomoxetine (ATMX), has been reported to be effective and safe in school-age children with ADHD.” NCT00517647 ↗ “Atomoxetine (ATMX) blocks the NE transporter (NET), and increases extracellular levels of NE throughout the brain.” NCT00856063 ↗ |
| Known as | ato | “Norepinephrine reuptake inhibitors such as atomoxetine (ato) can improve OSA by increasing pharyngeal muscle activity.” PMID 39305436 ↗ Sep 2024 |
| Known as | Atomoxetine HCl | “Patients will take one oral capsules each day in the morning upon awakening, either JNJ-31001074 (1, 3, or 10 mg), matching atomoxetine HCL (40 or 80 mg), matching OROS...” NCT00880217 ↗1“Ritalin (methylphenidate HCl); Ritalin LA, Ritalin SR Strattera (atomoxetine HCl)” NCT05635318 ↗ |
| Known as | atomoxetine hydrochloride | “To evaluate the effect of atomoxetine hydrochloride versus placebo on attention-deficit/hyperactivity disorder (ADHD) and substance use disorder (SUD) in adolescents receiving...” PMID 20494267 ↗ Jun 20108“Participants were randomly assigned equally to one of six treatment groups: placebo, bavisant 1 mg/day, 3 mg/day or 10 mg/day, atomoxetine hydrochloride 80 mg/day or...” PMID 22519922 ↗ May 2012 “Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder” NCT00386581 ↗ “A Double-Blind Study of Atomoxetine Hydrochloride Versus Placebo for the Treatment of ADHD in Young Adults With an Assessment of Associated Functional Outcomes” NCT00510276 ↗ “Drug: Atomoxetine Hydrochloride” NCT00191906 ↗ “Drug: Atomoxetine hydrochloride” NCT00191386 ↗ “Drug: Atomoxetine Hydrochloride” NCT00190775 ↗ |
| Known as | Atomoxetine only | “Atomoxetine only” NCT03350659 ↗ |
| Known as | ATX | “This study examined the effects of atomoxetine (ATX) and OROS methylphenidate (MPH) on laboratory measures of inhibitory control and attention in youth with...” PMID 24942409 ↗ Jun 20149“The purpose of this study is to examine the efficacy of atomoxetine (ATX) treatment for the mild to moderate cognitive disturbances frequently experienced by women during the...” NCT00611533 ↗ “OBJECTIVE: To examine status of children with autism spectrum disorder (ASD) 10 months after a 34-week clinical trial of atomoxetine (ATX) and parent training (PT).” PMID 29694241 ↗ Apr 2018 “Atomoxetine (ATX) once daily was compared with placebo (PBO) in adults with attention-deficit/hyperactivity disorder (ADHD) at 12 and 24 weeks.” PMID 21406998 ↗ Mar 2011 “In this 7 week placebo-controlled study, Atomoxetine (ATX) at mean dose of 1.3 mg/kg, significantly reduced teacher rated ADHD symptoms” NCT00918567 ↗ “the prodrug psychostimulant lisdexamfetamine dimesylate (LDX) and the non-stimulant noradrenergic compound atomoxetine (ATX)” PMID 23959815 ↗ Dec 2013 “An atomoxetine (ATX) arm was included to provide reference data against placebo.” PMID 25453486 ↗ Oct 2014 “using atomoxetine (ATX) as an add-on medication to other therapies” NCT02287038 ↗ “A single dose of Atomoxetine (ATX) (40 mg) will be administered.” NCT05708274 ↗ “atomoxetine (ATX)” PMID 26779845 ↗ Jan 2016 |
| Known as | LY139603 | “Atomoxetine (LY139603)” NCT00636818 ↗ |
| Known as | O-Methylphenidate | “O-Methylphenidate” NCT00573859 ↗ |
| Known as | Straterra | “atomoxetine (brand name: Straterra)” NCT04565288 ↗ |
| Known as | Strattera | “The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent Management Training (PMT) in children with Autism, Asperger's Disorder, or...” NCT00844753 ↗21“The purpose of this study is to determine if atomoxetine (a common brand name is Strattera), a medicine that is used for treating older children with Attention Deficit and...” NCT00517647 ↗ “The Formal Observation of Concerta versUs Strattera (FOCUS) study was conducted to assess, in children with ADHD, treatment outcomes with Concerta [OROS methylphenidate (MPH)],...” PMID 16350601 ↗ Oct 2005 “Strattera (atomoxetine) is a non-stimulant specific norepinephrine reuptake inhibitor recently approved by the Food and Drug Administration for the treatment of child,...” NCT00181766 ↗ “Strattera (atomoxetine) is a non-stimulant presynaptic norepinephrine reuptake inhibitor recently approved by the Food and Drug Administration for use in child, adolescent and...” NCT00181948 ↗ “Atomoxetine (Strattera®) is a non-stimulant drug used to treat ADHD symptoms in both children and adults, and there is evidence that it may also have a positive effect on sleep...” NCT00252278 ↗ “Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there is only one published study specifically designed to evaluate its efficacy in school...” NCT00918567 ↗ “The purpose of this study is to assess potential interactions between intravenous (i.v.) cocaine and atomoxetine (Strattera) administered orally in four escalating doses.” NCT00265265 ↗ “The second specific aim is to determine the efficacy of atomoxetine (Strattera®) as a putative agonist replacement pharmacotherapy for cocaine dependence.” NCT00697138 ↗ “Atomoxetine (Strattera) 25mg peroral (PO) each day for seven days, then up to 40mb bid 40mg PO each day for three days, then 80mg PO bid.” NCT00167297 ↗ “Ritalin (methylphenidate HCl); Ritalin LA, Ritalin SR Strattera (atomoxetine HCl)” NCT05635318 ↗ “Atomoxetine (Strattera), a selective norepinephrine reuptake inhibitor” NCT00222794 ↗ “Atomoxetine Oral Capsule [Strattera]” NCT05350215 ↗ “Atomoxetine (Strattera™)” NCT00420498 ↗ “atomoxetine (Strattera)” NCT00181740 ↗ “Atomoxetine, Strattera” NCT01408589 ↗ “Strattera” NCT01399827 ↗ “Strattera” NCT02142140 ↗ |
| Action | Inhibit | “Atomoxetine is a nonstimulant, selective norepinephrine reuptake inhibitor approved for the treatment of attention-deficit/hyperactivity disorder.” PMID 19358788 ↗ Apr 2009 |
| Modality | Other / unclassified | “the non-stimulant noradrenergic compound atomoxetine (ATX)” PMID 23959815 ↗ Dec 2013 |
| Route | Oral | “subjects will take one 25mg capsule of Atomoxetine orally” NCT00167297 ↗ |