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atomoxetine

Trade name: strattera

Small moleculeapproved

Approved

Nov 26, 2002

Atomoxetine is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder. The precise mechanism by which atomoxetine produces its therapeutic effects in Attention-Deficit/Hyperactivity Disorder (ADHD) is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter. Most common adverse reactions are: nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence, constipation, dry mouth, dizziness, erectile dysfunction, and urinary hesitation. Atomoxetine is a substrate for CYP2D6 and hence concurrent treatment with CYP2D6 inhibitors such as bupropion (Wellbutrin) or fluoxetine (Prozac) is not recommended, as this can lead to significant elevations of plasma atomoxetine levels. — NCATS

Clinical trial activity

187 trials · 98 clinical orgs · 13 marketing orgs

Phase 1
30
Phase 2
89
Phase 3
37
Phase 4
63

Earliest trial started Apr 1, 1997 (NCT00262470)

Timeline

1990s

  1. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Eli Lilly — Earliest Phase 3 Sponsor(trial)

  2. Nov 26, 2002

    Eli Lilly — Earliest FDA Approval

  3. Nov 26, 2002

    Eli Lilly — NDA Organization

  4. Jan 1, 2003

    Eli Lilly — Earliest Phase 2 Sponsor(trial)

2010s

  1. Sep 16, 2010

    Zydus Discovery DMCC — Marketing Organization

  2. May 11, 2012

    Actavis — Marketing Organization

  3. May 11, 2012

    Mylan — Marketing Organization

  4. May 11, 2012

    Sun Pharmaceuticals — Marketing Organization

  5. May 11, 2012

    Novartis — Marketing Organization

  6. Aug 31, 2015

    Hetero Labs Ltd — Marketing Organization

  7. May 30, 2017

    Apotex — Marketing Organization

  8. May 30, 2017

    Aurobindo Pharma — Marketing Organization

  9. May 30, 2017

    Glenmark Pharmaceuticals — Marketing Organization

  10. May 30, 2017

    Teva — Marketing Organization

  11. Feb 23, 2018

    Dr. Reddy's Laboratories — Marketing Organization

2020s

  1. Feb 18, 2021

    Strides Pharma Science — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedNov 26, 2002

Chemistry & pharmacology

Loading structure…

SMILES

CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Mol. weight
255.36 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • atomexetine
  • atomoxetine
  • atomoxetine
  • atomoxetine
  • atomoxetine
  • atomoxetine
  • atomoxetine
  • atomoxetine
  • atomoxetine
  • atomoxetine hcl
  • atomoxetine hcl
  • atomoxetine hcl
  • atomoxetine hydrochloride
  • atomoxetine hydrochloride
  • atomoxetine hydrochloride
  • atomoxetine hydrochloride
  • atomoxetine hydrochloride
  • ly139603
  • ly139603
  • ly139603
  • ly139603
  • ly139603
  • ly139603
  • ly-139603
  • ly-139603
  • strattera
  • strattera
  • strattera
  • strattera
  • strattera
  • stratterra
  • tomoxetina
  • tomoxetina
  • tomoxetine
  • tomoxetine
  • tomoxetine
  • tomoxetine
  • (-)-tomoxetine
  • (-)-tomoxetine
  • (-)-tomoxetine
  • tomoxetine hcl
  • tomoxetine hcl
  • tomoxetine hcl
  • tomoxetine hydrochloride
  • tomoxetinum
  • tomoxetinum

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07280468Phase 4Feb 1, 2026Patient-Centered Outcomes Research Institute, University of Arizona
NCT07239791N/ANov 18, 2025Centre Hospitalier St Anne
NCT06899178Phase 2Apr 30, 2025Icahn School of Medicine at Mount Sinai, Vanderbilt University
NCT06841666Early Phase 1 (Phase 1)Feb 28, 2025Tanta University
NCT06827431Phase 3Feb 14, 2025Shijiazhuang Pharma Group (CSPC)
NCT06573970Phase 4Dec 16, 2024Department of Veteran Affairs, Medical University of South Carolina
NCT06295562Phase 4Oct 14, 2024China Medical University
NCT06542887Phase 2Oct 1, 2024Ain Shams University
NCT05550246Phase 1/Phase 2 (Phase 2)Oct 31, 2023Harvard University
NCT05944965Phase 1/Phase 2 (Phase 2)Oct 22, 2023Harvard University
NCT05933603Phase 2Aug 1, 2023National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), University of Arizona
NCT05762458Phase 2Feb 28, 2023Shijiazhuang Pharma Group (CSPC)
NCT05293600Phase 1/Phase 2 (Phase 2)Sep 1, 2022Harvard University
NCT05159687Phase 4Dec 31, 2021University of Calgary
NCT05071612Phase 2Dec 15, 2021Apnimed, Inc.
NCT05101122Phase 1/Phase 2 (Phase 2)Oct 6, 2021Apnimed, Inc.
NCT05018013Phase 2Aug 21, 2021Jiao Tong University, Shijiazhuang Pharma Group (CSPC)
NCT04905979Phase 2Jul 31, 2021Apnimed, Inc.
NCT04782830N/AFeb 5, 2021Vanderbilt University
NCT04565288Phase 2Nov 30, 2020Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Showing 20 of 187 trials
Page 1 / 10

Organizations

Research & Development (98)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Eli LillyFor profit675252000
Harvard UniversityAcademic/Hospital151532003
National Institute on Drug Abuse (NIDA)Government13232004
National Institute of Mental Health (NIMH)Government8232003
Vanderbilt UniversityAcademic/Hospital8541997
Yale UniversityAcademic/Hospital8722004
Apnimed, Inc.For profit7612019
Icahn School of Medicine at Mount SinaiAcademic/Hospital5432005
Shijiazhuang Pharma Group (CSPC)For profit5532017
ShireFor profit5522003
University of ArizonaAcademic/Hospital5522004
Department of Veteran AffairsGovernment4222006
Medical University of South CarolinaAcademic/Hospital4132005
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Government4022005
National Institutes of Health (NIH)Government4021997
University of CalgaryAcademic/Hospital4421997
National Heart, Lung, and Blood Institute (NHLBI)Government3022009
New York UniversityAcademic/Hospital3222005
University of CincinnatiAcademic/Hospital3222006
University of KentuckyAcademic/Hospital3322006
98 organizations
Page 1 / 5

Marketing (18)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGMay 11, 2012
ApotexFor profitSYNMay 30, 2017
ApotexFor profitMKTGMay 30, 2017
Aurobindo PharmaFor profitMKTGMay 30, 2017
Aurobindo PharmaFor profitSYNMay 30, 2017
Dr. Reddy's LaboratoriesFor profitSYNFeb 23, 2018
Dr. Reddy's LaboratoriesFor profitMKTGFeb 23, 2018
Eli LillyFor profitNDANov 26, 2002
Glenmark PharmaceuticalsFor profitMKTGMay 30, 2017
Hetero Labs LtdFor profitMKTGAug 31, 2015
Hetero Labs LtdFor profitSYNAug 31, 2015
MylanFor profitMKTGMay 11, 2012
MylanFor profitSYNFeb 18, 2021
NovartisFor profitMKTGMay 11, 2012
Strides Pharma ScienceFor profitMKTGFeb 18, 2021
Sun PharmaceuticalsFor profitMKTGMay 11, 2012
TevaFor profitMKTGMay 30, 2017
Zydus Discovery DMCCFor profitMKTGSep 16, 2010