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clozapine

Trade name: clozaril

Small moleculeapproved

Approved

Sep 26, 1989

Clozapine was discovered in 1958 by an anesthetist and now it is used for the treatment of schizophrenia. Although the exact mechanism of its action is unknown, the effect of clozapine on schizophrenia is associated with inhibition of dopamine D2 and serotonin 2A receptors. — NCATS

Clinical trial activity

76 trials · 87 clinical orgs · 16 marketing orgs

Phase 1
15
Phase 2
17
Phase 3
11
Phase 4
32

Earliest trial started Oct 1, 1993 (NCT00004826)

Timeline

1980s

  1. Sep 26, 1989

    Heritage Pharma — Earliest FDA Approval

  2. Sep 26, 1989

    Heritage Pharma — NDA Organization

  3. Sep 26, 1989

    Heritage Pharma — NDA Secondary Org

1990s

  1. Aug 30, 1996

    Sandoz — Marketing Organization

  2. Aug 30, 1996

    Novartis — Marketing Organization

  3. Nov 26, 1997

    Teva — Marketing Organization

  4. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

  5. May 27, 1999

    Mylan — Marketing Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2001

    Novartis — Earliest Phase 2 Sponsor(trial)

  3. Nov 15, 2002

    Sun Pharmaceuticals — Marketing Organization

  4. Feb 10, 2004

    Jazz Pharmaceuticals — NDA Secondary Org

  5. Apr 26, 2005

    Par Pharmaceuticals — Marketing Organization

2010s

  1. Feb 6, 2013

    Tasman Pharma — NDA Secondary Org

  2. Feb 6, 2013

    Douglas Pharmaceuticals — Marketing Organization

  3. Sep 17, 2015

    Mayne Pharma — Marketing Organization

  4. Sep 17, 2015

    Dr. Reddy's Laboratories — Marketing Organization

  5. Nov 25, 2015

    Accord Research — Marketing Organization

  6. Nov 25, 2015

    Barr Laboratories — Marketing Organization

  7. Nov 29, 2016

    Aurobindo Pharma — Marketing Organization

  8. Dec 6, 2017

    Zydus Discovery DMCC — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewSep 26, 1989

Chemistry & pharmacology

Loading structure…

SMILES

CN1CCN(CC1)C2=NC3=CC(Cl)=CC=C3NC4=CC=CC=C24
Mol. weight
326.823 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

  • asaleptin
  • azaleptine
  • clozapin
  • clozapin
  • clozapin
  • clozapina
  • clozapina
  • clozapine
  • clozapine
  • clozapine
  • clozapine
  • clozapine
  • clozapine
  • clozapine
  • clozapine
  • clozapine
  • clozapine
  • clozapine
  • clozapine
  • clozapinum
  • clozapinum
  • clozaril
  • clozaril
  • clozaril
  • clozaril
  • clozaril
  • fazaclo
  • fazaclo
  • fazaclo
  • fazaclo odt
  • fazaclo odt
  • hf-1854
  • hf-1854
  • klozapol
  • leponex
  • lu af35700
  • zaponex
  • zaponex

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06969755Phase 4Jul 30, 2025National Institute of Mental Health (NIMH), Northwell Health
NCT06596681Early Phase 1 (Phase 1)Sep 12, 2024Capital Medical University
NCT05958875Phase 4Nov 1, 2023University of Munster, Utrecht University
NCT05741502Phase 4Aug 16, 2023Ohio State University
NCT05603104Phase 4Aug 1, 2023University of Munster, Utrecht University
NCT06906224Early Phase 1 (Phase 1)May 1, 2022Bengbu Medical College
NCT05208190Phase 4Mar 17, 2022Columbia University, National Institute of Mental Health (NIMH)
NCT05316883Phase 4Feb 28, 2021Mental health Service, Glostrup, Mental Health Services in the Capital Region, Denmark
NCT07262736Phase 1Feb 6, 2021Univerisiti Sains Malaysia
NCT04849026Phase 1Jan 15, 2021Naju National Hospital, Whanin Pharmaceutical Company
NCT04528095Phase 3Dec 31, 2020Jiao Tong University
NCT04580134Phase 4Dec 31, 2020Harvard University, National Institute of Mental Health (NIMH), The University of Texas, Dallas, University of Chicago, University of Connecticut, University of Georgia
NCT04529226Phase 2Sep 30, 2020Andalusian Health Service, Fundación Pública Andaluza
NCT04240496N/AOct 17, 2019University of Monastir
NCT03857581Phase 4Jul 31, 2019Augusta University
NCT03807882Phase 4Feb 1, 2019All India Institute of Medical Sciences
NCT03772951N/AJan 10, 2019Jiao Tong University
NCT03670082Phase 1Sep 5, 2018Lundbeck
NCT03652974N/AAug 1, 2018Jiao Tong University
NCT03394482Phase 1Jan 3, 2018Lundbeck
Showing 20 of 76 trials
Page 1 / 4

Organizations

Research & Development (87)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Mental Health (NIMH)Government14541994
LundbeckFor profit121232013
Dartmouth UniversityAcademic/Hospital7421994
Harvard UniversityAcademic/Hospital6421994
Jiao Tong UniversityAcademic/Hospital5432005
NovartisFor profit5231994
National Institutes of Health (NIH)Government3121997
Northwell HealthAcademic/Hospital3322000
University of TorontoAcademic/Hospital3321999
Utrecht UniversityAcademic/Hospital3212011
Ben Gurion UniversityAcademic/Hospital2122005
Capital Medical UniversityAcademic/Hospital2122005
Naju National HospitalAcademic/Hospital2012012
New York UniversityAcademic/Hospital2121999
Seoul National UniversityAcademic/Hospital2122011
Taipei Medical UniversityAcademic/Hospital2212008
Technion UniversityAcademic/Hospital2222011
University of MassachusettsAcademic/Hospital2112009
University of MunsterAcademic/Hospital2012023
University of South CarolinaAcademic/Hospital2012000
87 organizations
Page 1 / 5

Marketing (21)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGNov 25, 2015
Aurobindo PharmaFor profitSYNNov 29, 2016
Aurobindo PharmaFor profitMKTGNov 29, 2016
Barr LaboratoriesFor profitMKTGNov 25, 2015
Douglas PharmaceuticalsFor profitMKTGFeb 6, 2013
Dr. Reddy's LaboratoriesFor profitMKTGSep 17, 2015
Heritage PharmaFor profitNDASep 26, 1989
Heritage PharmaFor profitNDA2Sep 26, 1989
Jazz PharmaceuticalsFor profitNDA2Feb 10, 2004
Jazz PharmaceuticalsFor profitSYNFeb 10, 2004
Mayne PharmaFor profitMKTGSep 17, 2015
MylanFor profitMKTGMay 27, 1999
MylanFor profitSYNSep 15, 2015
NovartisFor profitMKTGAug 30, 1996
Par PharmaceuticalsFor profitMKTGApr 26, 2005
SandozFor profitMKTGAug 30, 1996
Sun PharmaceuticalsFor profitMKTGNov 15, 2002
Tasman PharmaFor profitNDA2Feb 6, 2013
TevaFor profitMKTGNov 26, 1997
TevaFor profitSYNNov 25, 2015
Zydus Discovery DMCCFor profitMKTGDec 6, 2017