Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate atomoxetine across diverse indications, primarily attention-deficit/hyperactivity disorder (ADHD), alongside morbid obesity, mild cognitive impairment, fetal alcohol syndrome, and substance use disorders. Sponsored by pharmaceutical companies, academic institutions, and government agencies like the National Institute on Drug Abuse, these investigations encompass statuses ranging from recruiting and active to completed, withdrawn, and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07724132 RECRUITING
Alzheimer's Disease (AD); Mild Cognitive Impairment Due to Alzheimer's Disease; Alzheimer Disease Dementia
University College, London
2026-07-24 PHASE3
NCT04216186 RECRUITING
ADHD
Sherief Abd-Elsalam
2018-11-01 PHASE3
NCT07679282 NOT_YET_RECRUITING
Obstructive Sleep Apnea (OSA)
Sairam Parthasarathy
2026-09-01 PHASE4
NCT00262470 ACTIVE_NOT_RECRUITING
Tachycardia; Chronic Orthostatic Intolerance
Satish R. Raj
1997-04 PHASE1; PHASE2
NCT06573970 RECRUITING
Posttraumatic Stress Disorder With Attention Defic
VA Office of Research and Development
2026-04-01 PHASE4
NCT06899178 RECRUITING
Melanocortin Obesity Syndrome; MCOS
Icahn School of Medicine at Mount Sinai
2026-09-01 PHASE2
NCT07577661 NOT_YET_RECRUITING
Obstructive Sleep Apnea; Sleep-disordered Breathing
Brigham and Women's Hospital
2026-06-01 PHASE1; PHASE2
NCT07239791 RECRUITING
Role of the Noradrenergic System in the Regulation of Learning Dynamics; No Disease or Condition is Being Studied
Centre Hospitalier St Anne
2025-11-18
NCT07771595 NOT_YET_RECRUITING
Apathy
University of Oxford
2026-08 PHASE4
NCT07316296 RECRUITING
Parkinson's Disease (PD); Freezing of Gait; Freezing of Gait Symptoms in Parkinson Disease
Radboud University Medical Center
2026-01-01 PHASE3
NCT04782830 RECRUITING
Orthostatic; Hypotension, Neurogenic; Autonomic Failure; Pure Autonomic Failure; Multiple System Atrophy; Orthostatic; Hypotension, Parkinsonism
Vanderbilt University Medical Center
2021-02-05
NCT05350215 RECRUITING
Obstructive Sleep Apnea
Brigham and Women's Hospital
2022-06-01 PHASE1; PHASE2
NCT07251348 ACTIVE_NOT_RECRUITING
Hematological Cancer
Necmettin Erbakan University
2026-02-01
NCT05293600 RECRUITING
Obstructive Sleep Apnea
Brigham and Women's Hospital
2023-07-01 PHASE1; PHASE2
NCT05159687 RECRUITING
Vasovagal Syncope
University of Calgary
2022-06-01 PHASE3
NCT06566820 ENROLLING_BY_INVITATION
OSA
Apnimed
2024-07-03 PHASE3
NCT05933603 ACTIVE_NOT_RECRUITING
Obstructive Sleep Apnea; Down Syndrome
University of Arizona
2023-09-29 PHASE2
NCT02879136 COMPLETED
Parkinson's Disease, Idiopathic
Hubert Fernandez
2017-01-03 EARLY_PHASE1
NCT06295562 COMPLETED
Obstructive Sleep Apnea of Adult
China Medical University Hospital
2024-11-05 PHASE4
NCT06542887 UNKNOWN
ADHD
Ain Shams University
2024-10-01 PHASE2
NCT03781765 UNKNOWN
ADHD; Attention Deficit Hyperactivity Disorder
Icahn School of Medicine at Mount Sinai
2019-06-04 PHASE4
NCT04085172 COMPLETED
Attention Deficit Hyperactivity Disorder
Shire
2019-09-18 PHASE4
NCT06841666 NOT_YET_RECRUITING
ADHD; Primary Nocturnal Enuresis
Tanta University
2025-02-28 EARLY_PHASE1
NCT05944965 COMPLETED
OSA
Brigham and Women's Hospital
2023-12-01 PHASE1; PHASE2
NCT05811247 COMPLETED
OSA
Apnimed
2023-08-28 PHASE3
NCT05813275 COMPLETED
OSA
Apnimed
2023-09-16 PHASE3
NCT06400615 COMPLETED
OSA
Apnimed
2024-05-20 PHASE2
NCT05550246 UNKNOWN
Obstructive Sleep Apnea
Brigham and Women's Hospital
2022-05-05 PHASE1; PHASE2
NCT05278104 COMPLETED
Attention Deficit Hyperactivity Disorder
Boehringer Ingelheim
2023-09-14
NCT05351944 COMPLETED
Impulsive Aggression; ADHD; Executive Dysfunction
Alexandria University
2023-05-07
NCT04354103 TERMINATED
Tourette Syndrome
Poitiers University Hospital
2022-05-31 PHASE2
NCT03919955 COMPLETED
Sleep Apnea
Brigham and Women's Hospital
2019-09-03 PHASE2
NCT04565288 COMPLETED
Alcohol Use Disorder
Brown University
2021-05-06 PHASE2
NCT04905979 COMPLETED
Obstructive Sleep Apnea; Hypertension
Apnimed
2021-07-31 PHASE2
NCT04115878 COMPLETED
Obstructive Sleep Apnea; Down Syndrome
University of Arizona
2020-10-21 PHASE2
NCT05071612 COMPLETED
OSA - Obstructive Sleep Apnea
Apnimed
2021-11-29 PHASE2
NCT05101122 COMPLETED
Obstructive Sleep Apnea
Apnimed
2021-10-19 PHASE1; PHASE2
NCT03808740 TERMINATED
Orthostatic Intolerance
Vanderbilt University Medical Center
2018-07-01 PHASE1
NCT04580394 COMPLETED
Obstructive Sleep Apnea
Apnimed
2020-10-27 PHASE2
NCT02784535 COMPLETED
Neurogenic Orthostatic Hypotension
Vanderbilt University Medical Center
2016-08-29 PHASE2
NCT03936491 COMPLETED
Attention Deficit Hyperactivity Disorder
National Taiwan University Hospital
2019-08-01
NCT04445688 COMPLETED
Obstructive Sleep Apnea
Apnimed
2020-07-15 PHASE2
NCT03350659 COMPLETED
Neurogenic Orthostatic Hypotension
Seoul National University Hospital
2018-01-01 PHASE4
NCT03324581 COMPLETED
Adult Attention Deficit Hyperactivity Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.
2017-11-09 PHASE2
NCT00780650 COMPLETED
Type 1 Diabetes
University of Maryland, Baltimore
2009-05 EARLY_PHASE1
NCT03091400 COMPLETED
Memory Disorders; Multiple Sclerosis
Icahn School of Medicine at Mount Sinai
2017-03-16 PHASE2
NCT01678209 COMPLETED
Attention Deficit Hyperactivity Disorder; ADHD
Icahn School of Medicine at Mount Sinai
2012-10 PHASE4
NCT02500732 COMPLETED
Vasovagal Syncope
University of Calgary
2015-07 PHASE2
NCT03661788 COMPLETED
ADHD
RWTH Aachen University
2016-05 PHASE4
NCT03154359 Completed
ADHD
Children''s Mercy Hospital Kansas City|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
2017-12-12 --
NCT02908529 COMPLETED
Obstructive Sleep Apnea (OSA)
Brigham and Women's Hospital
2016-09 PHASE1; PHASE2
NCT01522404 COMPLETED
Mild Cognitive Impairment
Emory University
2012-03 PHASE2
NCT02287038 COMPLETED
Post Traumatic Stress Disorder; Attention Deficit Hyperactivity Disorder
VA Office of Research and Development
2014-10-15 PHASE4
NCT02046551 WITHDRAWN
Nicotine Dependence
Yale University
2014-04 PHASE1; PHASE2
NCT00223691 COMPLETED
Autonomic Failure; Orthostatic Hypotension
Vanderbilt University
2002-03 PHASE1
NCT03460210 Recruiting
Obesity Morbid
Norwegian University of Science and Technology|St. Olavs Hospital|Volvat Medisinsk Senter Stokkan|Namsos Hospital|Alesund Hospital
2016-11-02 --
NCT02623114 UNKNOWN
Attention-deficit/Hyperactivity Disorder
Seoul National University Childrens Hospital
2012-05 PHASE4
NCT00716274 COMPLETED
Attention Deficit Hyperactivity Disorder; Dyslexia
Eli Lilly and Company
2008-09 PHASE4
NCT01330693 UNKNOWN
Attention Deficit Disorder With Hyperactivity
University of Cincinnati
2009-09 PHASE3
NCT00498173 COMPLETED
Autism
Massachusetts General Hospital
2007-07 PHASE3
NCT02482649 UNKNOWN
Attention Deficit Hyperactivity Disorder
Samsung Medical Center
2013-01
NCT01557569 COMPLETED
Methamphetamine Dependence
University of Arkansas
2012-04 PHASE1; PHASE2
NCT01133847 COMPLETED
Attention Deficit Hyperactivity Disorder; Reading Disabilities
The University of Texas Health Science Center, Houston
2010-11 PHASE4
NCT00418262 COMPLETED
Fetal Alcohol Syndrome; Attention Deficit Hyperactivity Disorder (ADHD)
University of Oklahoma
2005-08 PHASE3
NCT00417794 COMPLETED
Fetal Alcohol Syndrome; Attention Deficit Disorder With Hyperactivity (ADHD); Attention Deficit Disorder (ADD)
University of Oklahoma
2005-08 PHASE1
NCT02352051 COMPLETED
Executive Dysfunction
TC Erciyes University
2014-02 PHASE4
NCT01738191 COMPLETED
Parkinson's Disease; Cognitive Impairment
Medical University of South Carolina
2012-11 PHASE2
NCT01863251 COMPLETED
Opiate Dependence; Stimulant Dependence
Yale University
2013-05 PHASE2
NCT00844753 COMPLETED
Autism; Pervasive Development Disorder; Asperger's Disorder; Attention Deficit Hyperactivity Disorder
University of Rochester
2008-10 PHASE4
NCT01802515 TERMINATED
Cocaine Dependence; Opiate Dependence
Yale University
2012-12
NCT03651856 COMPLETED
Parkinson's Disease; Freezing of Gait
Medical University of South Carolina
2013-01 PHASE3
NCT01498549 COMPLETED
Addiction
Yale University
2011-12
NCT01244490 COMPLETED
Attention Deficit Hyperactivity Disorder
Shire
2011-01-17 PHASE3
NCT02788357 COMPLETED
Atomoxetine Hydrochloride; Placebos
Lumy Sawaki
2006-11 PHASE2
NCT01794975 COMPLETED
Changes in Striatal [11C]ORM-13070 Binding.
University of Turku
2012-08 PHASE1
NCT01741376 WITHDRAWN
Cocaine Dependence; Nicotine Dependence
University of Minnesota
2012-11
NCT02014064 COMPLETED
Continuous Methamphetamine Dependence; Methamphetamine Dependence in Remission
University of California, Los Angeles
2009-08 PHASE1
NCT01106430 COMPLETED
Attention-Deficit/Hyperactivity Disorder
Shire
2010-06-28 PHASE3
NCT01522404 Completed
Mild Cognitive Impairment
Emory University|National Institute on Aging (NIA)
2012-03 Phase 2
NCT00702364 COMPLETED
Traumatic Brain INjury
Craig Hospital
2008-01
NCT01343628 TERMINATED
Alcohol-induced Cue-craving; Alcohol Sensitivity
University of Virginia
2008-01 PHASE1
NCT01435213 COMPLETED
Healthy
University of Turku
2011-09 PHASE1
NCT00969618 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2009-11 PHASE3
NCT00697138 COMPLETED
Cocaine Dependence
University of Kentucky
2006-06 PHASE1
NCT01339286 UNKNOWN
Attention Deficit Hyperactivity Disorder
Peking University
2011-03 PHASE4
NCT00548327 TERMINATED
Schizophrenia; Memory Disorders; Cognition Disorders
National Institute of Mental Health (NIMH)
2007-10 PHASE2
NCT00700427 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2008-06 PHASE3
NCT00617201 COMPLETED
Substance Abuse
Sharon Walsh
2007-07 PHASE2
NCT00183391 COMPLETED
Attention Deficit Disorder With Hyperactivity
Icahn School of Medicine at Mount Sinai
2005-07 PHASE4
NCT01127646 TERMINATED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2010-06 PHASE4
NCT01709695 Completed
ADHD|Attention Deficit Hyperactivity Disorder
Icahn School of Medicine at Mount Sinai
2011-03 Phase 4
NCT00628394 COMPLETED
Cognition in Schizophrenia
University of Texas Southwestern Medical Center
2003-09 PHASE4
NCT00962104 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2009-08 PHASE3
NCT01065259 COMPLETED
Attention Deficit Hyperactivity Disorder
Peking University
2008-04 PHASE4
NCT01019707 TERMINATED
Methamphetamine Abuse; Methamphetamine Dependence
University of California, Los Angeles
2009-10 PHASE1
NCT00607919 COMPLETED
Attention Deficit Hyperactivity Disorder; Dyslexia
Eli Lilly and Company
2008-03 PHASE4
NCT01177943 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2010-08 PHASE1
NCT00760747 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2008-09 PHASE4
NCT00880217 COMPLETED
Attention Deficit Hyperactivity Disorder
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2009-05 PHASE2
NCT00938743 COMPLETED
Attention Deficit Hyperactivity Disorder
Central Institute of Mental Health, Mannheim
2008-01 PHASE4
NCT00856063 COMPLETED
Attention Deficit Hyperactivity Disorder
University of Arizona
2009-03 PHASE4
NCT00190684 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2000-08 PHASE3
NCT00191386 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2005-05 PHASE3
NCT00190775 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2004-09 PHASE4
NCT00687609 TERMINATED
Attention Deficit Hyperactivity Disorder; Cannabis Abuse
Eli Lilly and Company
2008-09 PHASE4
NCT00546910 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2007-10 PHASE4
NCT00447278 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2007-03 PHASE3
NCT00510276 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2007-08 PHASE4
NCT00406354 COMPLETED
Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder
Eli Lilly and Company
2006-11 PHASE4
NCT00566371 COMPLETED
Attention Deficit Hyperactivity Disorder; Insomnia
Rhode Island Hospital
2005-06 PHASE4
NCT00304161 COMPLETED
Depressive Disorder; Parkinson Disease
University of Pennsylvania
2004-07 PHASE4
NCT00471354 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2007-04 PHASE4
NCT00568685 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2007-11 PHASE3
NCT00320528 COMPLETED
Attention Deficit Disorder With Hyperactivity
Eli Lilly and Company
2006-04 PHASE3
NCT00636818 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2008-03 PHASE2
NCT00254462 COMPLETED
Attention Deficit Disorder With Hyperactivity
University of Nebraska
2005-10-01 PHASE4
NCT00181766 COMPLETED
ADHD NOS
Massachusetts General Hospital
2003-12 PHASE4
NCT00260533 COMPLETED
Generalized Social Phobia
University of California, San Diego
2005-11 PHASE2; PHASE3
NCT00286949 COMPLETED
Parkinson's Disease
Johns Hopkins University
2005-01-06
NCT00360269 COMPLETED
Marijuana Abuse; Attention Deficit Disorder With Hyperactivity
Medical University of South Carolina
2005-11 PHASE2
NCT00380692 COMPLETED
Autistic Disorder; Attention Deficit Disorder With Hyperactivity
Eli Lilly and Company
2006-10 PHASE4
NCT00918567 COMPLETED
Attention Deficit Hyperactivity Disorder
State University of New York at Buffalo
2007-01 PHASE4
NCT00530335 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2007-09 PHASE2
NCT00611533 COMPLETED
Menopause; Cognitive Disturbances
University of Pennsylvania
2004-05
NCT00953862 COMPLETED
Attention Deficit Hyperactivity Disorder
NYU Langone Health
2005-07
NCT00528697 COMPLETED
Attention-Deficit/Hyperactivity Disorder
AbbVie (prior sponsor, Abbott)
2007-09 PHASE2
NCT00517647 COMPLETED
Attention Deficit Hyperactivity Disorder
University of Arizona
2004-04 PHASE4
NCT00176436 COMPLETED
Schizophrenia
University of Maryland, Baltimore
2004-02 PHASE4
NCT00191945 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2005-05 PHASE3
NCT00368849 COMPLETED
Huntington Disease; Chorea
University of Iowa
2005-11 PHASE2
NCT00399763 COMPLETED
Attention Deficit Hyperactivity Disorder; Substance Abuse
Denver Health and Hospital Authority
2005-09
NCT00585910 COMPLETED
ADHD; Attention Deficit Hyperactivity Disorder
Massachusetts General Hospital
2004-01 PHASE4
NCT00191906 COMPLETED
Attention Deficit Hyperactivity Disorder; Reading Disorder
Eli Lilly and Company
2005-04 PHASE4
NCT01408589 TERMINATED
Alcohol Craving; Mood Changes
University of Colorado, Boulder
2005-06 PHASE1
NCT00299234 TERMINATED
Attention Deficit Hyperactivity Disorder
Monarch Medical Research
2006-06 PHASE4
NCT00181948 COMPLETED
ADHD
Massachusetts General Hospital
2004-09 PHASE4
NCT00429091 COMPLETED
Attention-Deficit/Hyperactivity Disorder; ADHD
Abbott
2007-01 PHASE2
NCT00607568 COMPLETED
Physiological Stress
Yale University
2006-06 PHASE1; PHASE2
NCT00611936 COMPLETED
Stress
Yale University
2006-06 PHASE1; PHASE2
NCT00488163 COMPLETED
Schizophrenia
Research Foundation for Mental Hygiene, Inc.
2005-01 PHASE4
NCT00327834 COMPLETED
Binge-eating Disorder
Lindner Center of HOPE
2006-05 PHASE4
NCT00218543 COMPLETED
Attention Deficit Disorder With Hyperactivity; Cocaine-Related Disorders
New York State Psychiatric Institute
2004-06 PHASE2
NCT00142961 COMPLETED
Attention Deficit Disorder With Hyperactivity; Marijuana Abuse
New York State Psychiatric Institute
2005-10 PHASE2
NCT00161031 COMPLETED
Schizophrenia
University of Maryland, Baltimore
2004-04
NCT00216281 TERMINATED
Schizophrenia
Indiana University
2005-09 PHASE3
NCT00265265 COMPLETED
Cocaine-Related Disorders
National Institute on Drug Abuse (NIDA)
2005-08 PHASE1
NCT00192023 COMPLETED
Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder
Eli Lilly and Company
2004-10 PHASE3
NCT00218322 COMPLETED
Attention Deficit Disorder With Hyperactivity; Substance-Related Disorders
Massachusetts General Hospital
2004-09 PHASE4
NCT00167297 COMPLETED
Cannabis Dependence
National Institute on Drug Abuse (NIDA)
2004-11 PHASE2
NCT00191698 COMPLETED
Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder
Eli Lilly and Company
2003-12 PHASE3
NCT00557960 COMPLETED
Attention Deficit Disorder With Hyperactivity
Shire
2004-02-25 PHASE3
NCT00506727 COMPLETED
ADHD
Shire
2003-08-05 PHASE4
NCT00191295 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2005-02 PHASE2; PHASE3
NCT00216918 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2005-09 PHASE4
NCT00191737 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2004-10 PHASE3
NCT01207622 WITHDRAWN
Attention Deficit Hyperactivity Disorder; Substance Use Disorder
Massachusetts General Hospital
PHASE4
NCT00191880 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2004-05 PHASE3
NCT00386581 COMPLETED
Attention Deficit Disorder With Hyperactivity
Eli Lilly and Company
2004-07 PHASE3
NCT00485849 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2004-02 PHASE4
NCT00255138 WITHDRAWN
Cancer; Cognitive Late Effects
Temple University
2005-11 PHASE3
NCT00485875 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2004-06 PHASE4
NCT00190957 COMPLETED
ADHD; Comorbid Alcohol Abuse
Eli Lilly and Company
2004-08 PHASE4
NCT00190736 COMPLETED
ADHD
Eli Lilly and Company
2004-09 PHASE4
NCT00420498 COMPLETED
Schizophrenia; Cognition; Smoking
Yale University
2005-08 PHASE2
NCT00191633 COMPLETED
Attention-Deficit/Hyperactivity Disorder
Eli Lilly and Company
2005-04 PHASE4
NCT00181740 COMPLETED
ADHD NOS
Massachusetts General Hospital
2003-12 PHASE4
NCT00485862 COMPLETED
Depressive Symptoms
Eli Lilly and Company
2003-06 PHASE4
NCT00485628 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2003-04 PHASE2
NCT00190879 COMPLETED
Attention Deficit Hyperactivity Disorder; Comorbid Social Anxiety Disorder
Eli Lilly and Company
2005-06 PHASE4
NCT00485459 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2004-02 PHASE3
NCT00191009 COMPLETED
Alzheimer Disease
Eli Lilly and Company
2003-10 PHASE2; PHASE3
NCT00866996 COMPLETED
Attention Deficit Hyperactivity Disorder
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
PHASE4
NCT00486083 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2003-12 PHASE3
NCT00485407 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2003-07 PHASE3
NCT00222794 COMPLETED
Schizophrenia; Schizoaffective Disorder
University of Pittsburgh
2003-11 PHASE4
NCT00089869 COMPLETED
Schizophrenia
Eli Lilly and Company
PHASE1; PHASE2
NCT00252278 UNKNOWN
Attention-Deficit/Hyperactivity Disorder (ADHD); Insomnia
Rhode Island Hospital
2005-11 PHASE4
NCT00191048 COMPLETED
Attention-Deficit/Hyperactivity Disorder; Comorbid Dyslexia
Eli Lilly and Company
2003-10 PHASE4
NCT00486122 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2003-09 PHASE4
NCT00191542 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2005-03 PHASE3
NCT00190931 COMPLETED
Attention Deficit Disorder With Hyperactivity
Eli Lilly and Company
2003-11 PHASE4
NCT00191659 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2004-06 PHASE3
NCT00191516 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2004-10 PHASE3
NCT00485550 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
2004-01 PHASE3
NCT00191035 COMPLETED
Attention-Deficit/Hyperactivity Disorder
Eli Lilly and Company
2004-03 PHASE4
NCT00562055 WITHDRAWN
Attention Deficit Hyperactivity Disorder
Pfizer
2007-11 PHASE2
NCT00029614 COMPLETED
Substance Use Disorders; Attention Deficit Hyperactivity Disorder
University of Pittsburgh
2006-05 PHASE2
NCT00174226 COMPLETED
Attention Deficit Disorder With Hyperactivity
Pfizer
2004-11 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-23)

Check the Atomoxetine HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Atomoxetine acts as a potent and selective inhibitor of the presynaptic norepinephrine transporter with a Ki of 5 nM, thereby blocking the reuptake of extracellular norepinephrine into presynaptic neurons and increasing synaptic neurotransmitter availability. This enhancement of central noradrenergic signaling improves executive function and attentional control, providing the mechanistic rationale for its clinical application in attention-deficit/hyperactivity disorder and mild cognitive impairment.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.