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Drug

Atomoxetine

Approved · FDA
Emerging researchLate-stage developmentCooling momentum
Also known as Atoncy, Strattera, Tomoxetina, Tomoxetinum+4 more

Atoncy, Strattera, Tomoxetina, Tomoxetinum, (-)-Tomoxetine, Tomoxetine, Atomoxetina, Atomoxetine Hydrochloride.

RxNorm38400ChEMBLCHEMBL641UNIIASW034S0B8
9
Research papers
11
Active clinical trials
4
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Effect of Atomoxetine and DAW2022 on OSA Severity

Clinical trial2026-07-10Results expected Q4 2026 · ClinicalTrials.gov

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

Clinical trial2026-07-07Results expected Q2 2029 · ClinicalTrials.gov

A Novel Pharmacological Therapy for Obstructive Sleep Apnea

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

Approval: ATOMOXETINE (ANDA218875)

Regulatory2026-06-16FDA

A Phase 4, Multicenter, 2-part Study Composed of a Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation Followed by a 1-Year Open-label Evaluation to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged-release (SPD503) in Children and Adolescents Aged 6 to 17 Years With Attention-deficit/Hyperactivity Disorder

Clinical trial2026-04-13Results posted · ClinicalTrials.gov

Recall (Class II): ATOMOXETINE

Regulatory2025-01-29FDA

Efficacy of atomoxetine plus oxybutynin in the treatment of obstructive sleep apnea with moderate pharyngeal collapsibility.

Research2022-05-13Sleep & breathing = Schlaf & Atmung

Drug Safety Update: Atomoxetine (Strattera▼): increases in blood pressure and heart rate

Regulatory2014-12-11MHRA

Drug Safety Update: Atomoxetine: risk of psychotic or manic symptoms in children and adolescents

Regulatory2014-12-11MHRA

Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: a randomized, controlled, phase III trial.

Research2014-10-23European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology

Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study.

Research2013-12-01CNS drugs

A double-blind, placebo-controlled study of atomoxetine in young children with ADHD.

Research2011-03-21Pediatrics

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Atomoxetine
Aliases & brands
AtoncyStratteraTomoxetinaTomoxetinum(-)-TomoxetineTomoxetineAtomoxetinaAtomoxetine Hydrochloride
RxNorm CUI
38400
ChEMBL ID
CHEMBL641
UNII
ASW034S0B8
Regulatory jurisdictions
fdamhra

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2026-06-16
Latest approval
2026-06-16
Authorities
FDA · MHRA
Total events
4
fdaU.S. Food and Drug Administration· 2 events
2026-06-16Approval
Approval: ATOMOXETINE (ANDA218875)
Evidence ↗
2025-01-29RecallSafety
Recall (Class II): ATOMOXETINE
Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2014-12-11Safety communicationSafety
Drug Safety Update: Atomoxetine (Strattera▼): increases in blood pressure and heart rate
Evidence ↗
2014-12-11Safety communicationSafety
Drug Safety Update: Atomoxetine: risk of psychotic or manic symptoms in children and adolescents
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

155 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
155
registered trials across all phases
LATEST COMPLETION 2025
11
Active studies
10
Recruiting
102
Late-stage (III+)
127
Completed
17
Discontinued
PHASE DISTRIBUTIONn = 155
Early Phase 13Phase 18Phase 1 / 29Phase 233Phase 2 / 33Phase 330Phase 457Phase N / A12

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

RecruitingPH IVVA Office of Research and Developmentn=1602029

Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk

RecruitingPH IVIcahn School of Medicine at Mount Sinain=442025

A Phase 4, Multicenter, 2-part Study Composed of a Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation Followed by a 1-Year Open-label Evaluation to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged-release (SPD503) in Children and Adolescents Aged 6 to 17 Years With Attention-deficit/Hyperactivity Disorder

CompletedPH IVShiren=3962025

Efficacy and Safety of Midodrine and Atomoxetine Treatment in Patients With Neurogenic Orthostatic Hypotension : A Prospective Randomized Study

CompletedPH IVSeoul National University Hospitaln=502019

Network Connectivity and Inhibitory Control Under Atomoxetin Challenge- A Pharmacological 'Resting State' and 'Inhibiton Task' Study in Patients With ADHD

CompletedPH IVRWTH Aachen Universityn=382018

Recent completions

Trials that read out recently, adding to the completed evidence base.

TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease: A Single Center, Randomized Pilot Study

CompletedPH IHubert Fernandezn=232025

A Phase 4, Multicenter, 2-part Study Composed of a Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation Followed by a 1-Year Open-label Evaluation to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged-release (SPD503) in Children and Adolescents Aged 6 to 17 Years With Attention-deficit/Hyperactivity Disorder

CompletedPH IVShiren=3962025

Pharyngeal Muscle Control Mechanisms of Atomoxetine-plus-oxybutynin in Obstructive Sleep Apnea

CompletedPH I/IIBrigham and Women's Hospitaln=272025

A Novel Pharmacological Therapy for Obstructive Sleep Apnea

CompletedPH IIBrigham and Women's Hospitaln=1172023

Phase 2 Norepinephrine Transporter Blockade, Autonomic Failure IND117394 12/28/12

CompletedPH IIVanderbilt University Medical Centern=482023

Randomized Double-Blind 2-Period Multiple Dose Crossover Study to Evaluate the Efficacy and Safety of AD113 vs Atomoxetine in OSA Patients With Hypertension

CompletedPH IIApnimedn=212023

Research activity

9 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20092023
Most influential

Atomoxetine for depression and other neuropsychiatric symptoms in Parkinson disease.

Neurology · 2010 · 179 cites

Atomoxetine for the treatment of executive dysfunction in Parkinson's disease: a pilot open-label study.

Movement disorders : official journal of the Movement Disorder Society · 2009 · 102 cites

Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study.

CNS drugs · 2013 · 58 cites

Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: a randomized, controlled, phase III trial.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2014 · 50 cites

Once-daily treatment with atomoxetine in adults with attention-deficit/hyperactivity disorder: a 24-week, randomized, double-blind, placebo-controlled trial.

Clinical neuropharmacology · 2011 · 48 cites

A double-blind, placebo-controlled study of atomoxetine in young children with ADHD.

Pediatrics · 2011 · 46 cites
Recent papers

Efficacy of atomoxetine plus oxybutynin in the treatment of obstructive sleep apnea with moderate pharyngeal collapsibility.

Sleep & breathing = Schlaf & Atmung · 2023 · 30 cites

Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: a randomized, controlled, phase III trial.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2014 · 50 cites

Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study.

CNS drugs · 2013 · 58 cites

Once-daily treatment with atomoxetine in adults with attention-deficit/hyperactivity disorder: a 24-week, randomized, double-blind, placebo-controlled trial.

Clinical neuropharmacology · 2011 · 48 cites

A double-blind, placebo-controlled study of atomoxetine in young children with ADHD.

Pediatrics · 2011 · 46 cites

An open-label, dose-titration tolerability study of atomoxetine hydrochloride in Japanese adults with attention-deficit/hyperactivity disorder.

Psychiatry and clinical neurosciences · 2011 · 17 cites
Major research themes1
Sleep Apnea, Obstructive1
Journals, researchers & institutions
Top journals
  • Clinical neuropharmacology1
  • CNS drugs1
  • European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology1
  • Journal of clinical psychopharmacology1
  • Movement disorders : official journal of the Movement Disorder Society1
  • Neurology1
Leading researchers
  • Bloomfield R2
  • Lyne A2
  • Anderson CS1
  • Biglan K1
  • Caballero B1
  • Cardo E1
  • Chrisman AK1
  • Civil R1
Leading institutions
free-text, unnormalised
  • Arkansas Center of Sleep Medicine1
  • Brigham and Women's Hospital and Harvard Medical School1
  • Center for Pediatric Excellence1
  • Central Institute of Mental Health1
  • CTI Clinical Trial and Consulting1
  • Johannes Gutenberg-University Mainz1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.