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clomipramine

Trade name: anafranil

Small moleculeapproved

Approved

Dec 29, 1989

Clomipramine is an antidepressant drug which was approved by FDA for the treatment of Obsessive-Compulsive Disorder. The exact mechanism of its action is unknown, however it is supposed that it may exert its effect by inhibiting serotonin reuptake. — NCATS

Clinical trial activity

14 trials · 22 clinical orgs · 23 marketing orgs

Phase 1
2
Phase 2
7
Phase 3
4
Phase 4
1

Earliest trial started Nov 1, 1992 (NCT00913783)

Timeline

1980s

  1. Dec 29, 1989

    Ciba-Geigy — Earliest FDA Approval

  2. Dec 29, 1989

    Ciba-Geigy — NDA Organization

  3. Dec 29, 1989

    Specgx Llc — NDA Secondary Org

1990s

  1. Jan 1, 1992

    Sandoz — Earliest Phase 1 Sponsor(trial)

  2. Mar 29, 1996

    Sandoz — Marketing Organization

  3. Mar 29, 1996

    Novartis — Marketing Organization

  4. Nov 27, 1996

    Watson Pharmaceuticals — Marketing Organization

  5. Dec 31, 1996

    Taro Pharmaceuticals — Marketing Organization

  6. Apr 4, 1997

    Teva — Marketing Organization

  7. Apr 30, 1998

    Mylan — Marketing Organization

  8. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Dec 27, 2017

    Zydus Discovery DMCC — Marketing Organization

  2. Oct 31, 2018

    Amneal Pharmaceuticals — Marketing Organization

  3. Nov 21, 2018

    Lupin — Marketing Organization

  4. Apr 8, 2019

    MannKind Corp — Marketing Organization

  5. Apr 8, 2019

    Mankind Pharma — Marketing Organization

  6. Oct 21, 2019

    Jubilant Innovation Ltd. — Marketing Organization

2020s

  1. Feb 7, 2020

    Leading Pharma Llc — Marketing Organization

  2. Apr 3, 2020

    Tulex Pharmaceuticals — Marketing Organization

  3. Jun 22, 2020

    Micro Labs Ltd India — Marketing Organization

  4. Jun 22, 2020

    Vgyaan — Marketing Organization

  5. Jun 22, 2020

    Apicore — Marketing Organization

  6. Aug 7, 2020

    Unique Pharmaceuticals Ltd, India — Marketing Organization

  7. Oct 2, 2020

    Ajanta Pharma Ltd — Marketing Organization

  8. Aug 4, 2021

    Alembic — Marketing Organization

  9. Mar 20, 2023

    Aurobindo Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewDec 29, 1989

Chemistry & pharmacology

Loading structure…

SMILES

CN(C)CCCN1c2ccccc2CCc2ccc(Cl)cc21
Mol. weight
314.86 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 3-(3-chloro-10,11-dihydro-5h-dibenzo[b,f]azepin-5-yl)-n,n-dimethyl-1-propanamine
  • 3-(3-chloro-10,11-dihydro-5h-dibenzo[b,f]azepin-5-yl)-n,n-dimethyl-1-propanamine
  • 3-(3-chloro-5h-dibenzo[b,f]azepin-5-yl)-n,n-dimethylpropan-1-amine
  • 3-(3-chloro-5h-dibenzo[b,f]azepin-5-yl)-n,n-dimethylpropan-1-amine
  • 3-chloroimipramine
  • 3-chloroimipramine
  • anafranil
  • anafranil
  • anafranil
  • anafranil
  • anafranil clomipramine hydrochloride
  • anafranil sr
  • chlorimipramine
  • chlorimipramine
  • chlorimipramine
  • chlorimipramine
  • clomipramina
  • clomipramina
  • clomipramine
  • clomipramine
  • clomipramine
  • clomipramine
  • clomipramine
  • clomipramine
  • clomipramine
  • clomipramine
  • clomipramine
  • clomipramine
  • clomipramine hcl
  • clomipramine hcl
  • clomipramine hcl
  • clomipramine hydrochloride
  • clomipramine hydrochloride
  • clomipramine hydrochloride
  • clomipramine hydrochloride
  • clomipramine hydrochloride
  • clomipraminum
  • clomipraminum
  • g-34586
  • g-34586
  • monochlorimipramine
  • monochlorimipramine
  • tranquax

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02571101Phase 2Nov 1, 2015Catholic University of Korea, CTC Bio, Inc., Symyoo
NCT02374567Phase 3Jan 1, 2015Gottfried Wilhelm Leibniz Universität Hannover
NCT01896349N/AApr 1, 2013Federal University of Rio Grande do Sul
NCT01439984Phase 3Sep 1, 2011Catholic University of Korea, Symyoo
NCT01203202Phase 2Sep 1, 2010Catholic University of Korea, Symyoo
NCT00944996N/AJun 1, 2009Ariel University, Technion University, The Nazareth Hospital, Israel, University of Michigan
NCT01404871N/AApr 1, 2009Obsessive Compulsive Foundation, University of Toronto
NCT00564564Phase 4Jan 1, 2006Conselho Nacional de Desenvolvimento Científico e Tecnológico, University of Sao Paulo
NCT00074815Phase 3Sep 1, 2003Duke University, National Institute of Mental Health (NIMH)
NCT00254735Phase 3Apr 1, 2002AstraZeneca
NCT00004310Phase 2Oct 1, 1999National Center for Research Resources (NCRR), Stanford University
NCT01575158N/AOct 1, 1997Aarhus University, Danish University
NCT00913952Phase 1Apr 1, 1994Phoenix International Life Science Inc., Sandoz
NCT00913783Phase 1Nov 1, 1992Phoenix International Life Science Inc., Sandoz
Showing 14 of 14 trials
Page 1 / 1

Organizations

Research & Development (22)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Catholic University of KoreaAcademic/Hospital3022010
SymyooFor profit3222010
Phoenix International Life Science Inc.For profit2011992
SandozFor profit2211992
Aarhus UniversityAcademic/Hospital1111997
Ariel UniversityAcademic/Hospital1012009
AstraZenecaFor profit1112002
Conselho Nacional de Desenvolvimento Científico e TecnológicoGovernment1012006
CTC Bio, Inc.For profit1112015
Danish UniversityAcademic/Hospital1011997
Duke UniversityAcademic/Hospital1112003
Federal University of Rio Grande do SulAcademic/Hospital1112013
Gottfried Wilhelm Leibniz Universität HannoverAcademic/Hospital1112015
National Center for Research Resources (NCRR)Government1111999
National Institute of Mental Health (NIMH)Government1012003
Obsessive Compulsive FoundationAcademic/Hospital1012009
Stanford UniversityAcademic/Hospital1011999
Technion UniversityAcademic/Hospital1112009
The Nazareth Hospital, IsraelAcademic/Hospital1012009
University of MichiganAcademic/Hospital1012009
22 organizations
Page 1 / 2

Marketing (26)

OrganizationOrg typeRelationshipDate
Ajanta Pharma LtdFor profitMKTGOct 2, 2020
AlembicFor profitMKTGAug 4, 2021
AlembicFor profitSYNAug 4, 2021
Amneal PharmaceuticalsFor profitMKTGOct 31, 2018
ApicoreFor profitMKTGJun 22, 2020
Aurobindo PharmaFor profitMKTGMar 20, 2023
Ciba-GeigyFor profitNDADec 29, 1989
Jubilant Innovation Ltd.For profitMKTGOct 21, 2019
Leading Pharma LlcFor profitMKTGFeb 7, 2020
Leading Pharma LlcFor profitSYNFeb 7, 2020
LupinFor profitMKTGNov 21, 2018
Mankind PharmaFor profitMKTGApr 8, 2019
MannKind CorpFor profitMKTGApr 8, 2019
Micro Labs Ltd IndiaFor profitMKTGJun 22, 2020
MylanFor profitMKTGApr 30, 1998
NovartisFor profitMKTGMar 29, 1996
SandozFor profitMKTGMar 29, 1996
Specgx LlcFor profitNDA2Dec 29, 1989
Taro PharmaceuticalsFor profitMKTGDec 31, 1996
TevaFor profitMKTGApr 4, 1997
Tulex PharmaceuticalsFor profitMKTGApr 3, 2020
Unique Pharmaceuticals Ltd, IndiaFor profitMKTGAug 7, 2020
Unique Pharmaceuticals Ltd, IndiaFor profitSYNAug 7, 2020
VgyaanFor profitMKTGJun 22, 2020
Watson PharmaceuticalsFor profitMKTGNov 27, 1996
Zydus Discovery DMCCFor profitMKTGDec 27, 2017