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escitalopram

Trade name: lexapro

Small moleculeapproved

Approved

Aug 14, 2002

Escitalopram is one of a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). Escitalopram, also known by the brand names Lexapro and Cipralex among others, is an antidepressant. The mechanism of antidepressant action of escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT). In vitro and in vivo studies in animals suggest that escitalopram is a highly selective serotonin reuptake inhibitor (SSRI) with minimal effects on norepinephrine and dopamine neuronal reuptake. Escitalopram is at least 100-fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake and inhibition of 5-HT neuronal firing rate. LEXAPRO (escitalopram) is indicated for the treatment of major depressive disorder and generalized anxiety disorder . — NCATS

Clinical trial activity

431 trials · 330 clinical orgs · 36 marketing orgs

Phase 1
39
Phase 2
126
Phase 3
91
Phase 4
165

Earliest trial started Feb 1, 2002 (NCT00177216)

Timeline

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 3 Sponsor(trial)

  3. Aug 14, 2002

    Earliest FDA Approval

  4. Aug 14, 2002

    Allergan — NDA Secondary Org

  5. Aug 14, 2002

    Allergan — Marketing Organization

  6. Aug 14, 2002

    AbbVie — Marketing Organization

  7. Aug 14, 2002

    AbbVie — NDA Secondary Org

  8. Aug 29, 2002

    Forest Laboratories — First NDA Organization

  9. Aug 29, 2002

    Forest Laboratories — NDA Organization

  10. Jan 1, 2004

    Mylan — Earliest Phase 1 Sponsor(trial)

  11. May 31, 2006

    Alphapharm — Marketing Organization

  12. Jul 26, 2006

    Teva — Marketing Organization

  13. Jul 16, 2007

    Dr. Reddy's Laboratories — Marketing Organization

  14. Jul 31, 2007

    Mylan — Marketing Organization

  15. Oct 18, 2007

    Sandoz — Marketing Organization

  16. Oct 18, 2007

    Novartis — Marketing Organization

  17. Nov 29, 2007

    Caraco Pharmaceutical Laboratories — Marketing Organization

  18. Nov 29, 2007

    Sun Pharmaceuticals — Marketing Organization

  19. Mar 3, 2008

    Watson Pharmaceuticals — Marketing Organization

2010s

  1. Mar 14, 2012

    Amneal Pharmaceuticals — Marketing Organization

  2. Apr 2, 2012

    Aurobindo Pharma — Marketing Organization

  3. May 3, 2012

    Taro Pharmaceuticals — Marketing Organization

  4. Jun 12, 2012

    Hetero Labs Ltd — Marketing Organization

  5. Sep 11, 2012

    Accord Research — Marketing Organization

  6. Sep 11, 2012

    Apotex — Marketing Organization

  7. Sep 11, 2012

    Hikma — Marketing Organization

  8. Sep 11, 2012

    Invagen Pharms — Marketing Organization

  9. Sep 11, 2012

    Lupin — Marketing Organization

  10. Sep 11, 2012

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  11. Sep 11, 2012

    Torrent Pharmaceuticals Limited — Marketing Organization

  12. Sep 11, 2012

    Zydus Discovery DMCC — Marketing Organization

  13. Sep 11, 2012

    Cadila Healthcare — Marketing Organization

  14. Sep 11, 2012

    Graviti Pharmaceuticals — Marketing Organization

  15. Sep 11, 2012

    Rising Pharmaceuticals — Marketing Organization

  16. Sep 12, 2012

    Jubilant Innovation Ltd. — Marketing Organization

  17. Sep 12, 2012

    Pharmaceutical Associates — Marketing Organization

  18. Jun 12, 2013

    Lannett Company, Inc. — Marketing Organization

  19. Jun 12, 2013

    Chartwell Pharmaceuticals — Marketing Organization

  20. May 14, 2015

    Dash Pharms — Marketing Organization

  21. May 26, 2015

    Antrim Pharmaceuticals — Marketing Organization

  22. May 26, 2015

    Allied Pharmaceutical Services — Marketing Organization

  23. Aug 28, 2015

    Prinston Inc — Marketing Organization

  24. Mar 31, 2016

    Neogen — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAug 14, 2002

Chemistry & pharmacology

Loading structure…

SMILES

CN(C)CCC[C@@]1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Mol. weight
324.4 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

  • cipralex
  • cipralex
  • (+)-citalopram
  • (+)-citalopram
  • (+)-citalopram
  • escitalopram
  • escitalopram
  • escitalopram
  • escitalopram
  • escitalopram
  • escitalopram
  • escitalopram
  • escitalopram
  • escitalopram
  • escitalopram oxalate
  • escitalopram oxalate
  • escitalopram oxalate
  • escitalopram oxalate
  • escitalopramum
  • escitalopramum
  • escitaloprim
  • lexapro
  • lexapro
  • lexapro
  • lu-260540
  • lu-260540
  • (+)-(s)-citalopram
  • (s)-citalopram
  • (s)-citalopram
  • (s)-citalopram
  • s-citalopram
  • s-citalopram
  • s-(+)-citalopram
  • s-(+)-citalopram
  • s-(+)-citalopram
  • s(+)-citalopram
  • s(+)-citalopram
  • (s)-citalopram-d6 oxalate
  • seroplex
  • seroplex
  • seroplex

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07139834Phase 1Jan 31, 2026Columbia University
NCT06937476N/AMay 8, 2025Central South University, National Natural Science Foundation of China
NCT06957223N/AMay 6, 2025CMH Nowshera, Pakistan Army
NCT06957210N/AMay 6, 2025CMH Nowshera, Pakistan Army
NCT07025590N/AApr 22, 2025Shantou University
NCT06965569Phase 1Apr 21, 2025Alar Pharmaceuticals Inc.
NCT06216535Phase 2Apr 1, 2025National Heart, Lung, and Blood Institute (NHLBI), The University of Texas, Dallas
NCT06826326Phase 2Mar 1, 2025University of Kansas
NCT06828887Phase 2Mar 1, 2025Government of China, Jiao Tong University
NCT06696482Phase 1/Phase 2 (Phase 2)Jan 31, 2025University of Oxford, Wellcome Trust
NCT06705478Phase 2Jan 17, 2025Cipla, National Institute of Allergy and Infectious Diseases (NIAID)
NCT06692361N/ADec 31, 2024Capital Medical University, Hebei University, Sichuan University, Tianjin Medical University, Wuhu Fourth People's Hospital, Zhejiang University
NCT06433635Phase 4Sep 1, 2024Harvard University, Patient-Centered Outcomes Research Institute
NCT06680531Phase 1Aug 31, 2024Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
NCT06476509Phase 1May 30, 2024Government of China, Jiao Tong University
NCT05737511Phase 4Dec 30, 2023Sultan Qaboos University
NCT05818735N/ADec 1, 2023Jiao Tong University, Shanghai University of Traditional Chinese Medicine, Shanghai Xuhui District Central Hospital
NCT05973786Phase 4Nov 1, 2023University of Munster, Utrecht University
NCT05901571N/ASep 30, 2023Shanghai 7th People's Hospital, Shanghai University of Traditional Chinese Medicine
NCT05603104Phase 4Aug 1, 2023University of Munster, Utrecht University
Showing 20 of 431 trials
Page 1 / 22

Organizations

Research & Development (330)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Mental Health (NIMH)Government41352002
Forest LaboratoriesFor profit37742002
LundbeckFor profit37852004
Harvard UniversityAcademic/Hospital181842002
Columbia UniversityAcademic/Hospital171652004
OtsukaFor profit121032004
Johnson and JohnsonFor profit111132007
The University of Texas, DallasAcademic/Hospital11632007
Cornell UniversityAcademic/Hospital10832002
Duke UniversityAcademic/Hospital10942002
Tel Aviv UniversityAcademic/Hospital10942004
University of PittsburghAcademic/Hospital10932002
Jiao Tong UniversityAcademic/Hospital9652009
Seoul National UniversityAcademic/Hospital9852008
University of CopenhagenAcademic/Hospital9932004
Emory UniversityAcademic/Hospital8822002
University of PennsylvaniaAcademic/Hospital8732002
University of TorontoAcademic/Hospital8742005
Bristol-Myers SquibbFor profit7632004
Zhejiang UniversityAcademic/Hospital7622019
330 organizations
Page 1 / 17

Marketing (41)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGAug 14, 2002
AbbVieFor profitNDA2Aug 14, 2002
Accord ResearchFor profitMKTGSep 11, 2012
AllerganFor profitNDA2Aug 14, 2002
AllerganFor profitMKTGAug 14, 2002
Allied Pharmaceutical ServicesFor profitMKTGMay 26, 2015
AlphapharmFor profitMKTGMay 31, 2006
Amneal PharmaceuticalsFor profitMKTGMar 14, 2012
Antrim PharmaceuticalsFor profitMKTGMay 26, 2015
ApotexFor profitMKTGSep 11, 2012
Aurobindo PharmaFor profitMKTGApr 2, 2012
Cadila HealthcareFor profitMKTGSep 11, 2012
Caraco Pharmaceutical LaboratoriesFor profitMKTGNov 29, 2007
Chartwell PharmaceuticalsFor profitMKTGJun 12, 2013
Dash PharmsFor profitMKTGMay 14, 2015
Dr. Reddy's LaboratoriesFor profitMKTGJul 16, 2007
Forest LaboratoriesFor profitNDAAug 29, 2002
Graviti PharmaceuticalsFor profitMKTGSep 11, 2012
Hetero Labs LtdFor profitMKTGJun 12, 2012
HikmaFor profitMKTGSep 11, 2012
Invagen PharmsFor profitMKTGSep 11, 2012
Jubilant Innovation Ltd.For profitMKTGSep 12, 2012
Jubilant Innovation Ltd.For profitSYNSep 12, 2012
Lannett Company, Inc.For profitMKTGJun 12, 2013
LupinFor profitMKTGSep 11, 2012
Macleods Pharmaceuticals, LtdFor profitMKTGSep 11, 2012
MylanFor profitMKTGJul 31, 2007
MylanFor profitSYNMay 14, 2015
NeogenFor profitMKTGMar 31, 2016
NovartisFor profitMKTGOct 18, 2007
Pharmaceutical AssociatesFor profitMKTGSep 12, 2012
Prinston IncFor profitMKTGAug 28, 2015
Rising PharmaceuticalsFor profitMKTGSep 11, 2012
SandozFor profitMKTGOct 18, 2007
Sun PharmaceuticalsFor profitMKTGNov 29, 2007
Taro PharmaceuticalsFor profitMKTGMay 3, 2012
TevaFor profitMKTGJul 26, 2006
TevaFor profitSYNMar 14, 2012
Torrent Pharmaceuticals LimitedFor profitMKTGSep 11, 2012
Watson PharmaceuticalsFor profitMKTGMar 3, 2008
Zydus Discovery DMCCFor profitMKTGSep 11, 2012