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Clozapine
Clozaril, Versacloz (clozapine) is a small molecule pharmaceutical. Clozapine was first approved as Clozaril on 1989-09-26. It is used to treat bipolar disorder, psychotic disorders, schizophrenia, and schizophrenia spectrum and other psychotic disorders in the USA. The pharmaceutical is active against D(2) dopamine receptor and 5-hydroxytryptamine receptor 2A. In addition, it is known to target D(1B) dopamine receptor, 5-hydroxytryptamine receptor 1F, 5-hydroxytryptamine receptor 6, alpha-1D adrenergic receptor, 5-hydroxytryptamine receptor 1A, alpha-1B adrenergic receptor, 5-hydroxytryptamine receptor 2B, 5-hydroxytryptamine receptor 5A, 5-hydroxytryptamine receptor 1D, alpha-1A adrenergic receptor, 5-hydroxytryptamine receptor 1B, D(1A) dopamine receptor, muscarinic acetylcholine receptor M1, 5-hydroxytryptamine receptor 2C, histamine H1 receptor, 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 7, D(4) dopamine receptor, histamine H4 receptor, D(3) dopamine receptor, G protein-activated inward rectifier potassium channel 2, and histamine H3 receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Clozaril, Versacloz (generic drugs available since 1997-11-26, discontinued: Fazaclo)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Clozapine
Tradename
Company
Number
Date
Products
CLOZARILHeritage Life Sciences BarbadosN-019758 RX1989-09-26
4 products, RLD, RS
VERSACLOZTasman PharmaN-203479 RX2013-02-06
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
clozarilNew Drug Application2021-02-11
versaclozNew Drug Application2020-08-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bipolar disorderEFO_0000289D001714F30.9
psychotic disorders—D011618F20.81
schizophreniaEFO_0000692D012559F20
schizophrenia spectrum and other psychotic disorders—D019967—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Clozapine, Versacloz, Tasman Pharma
80578112028-05-01DP
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05A: Antipsychotics
— N05AH: Diazepines, oxazepines, thiazepines and oxepines antipsychotic drugs
— N05AH02: Clozapine
HCPCS
Code
Description
S0136
Clozapine, 25 mg
Clinical
Clinical Trials
18 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.9—32319
AnxietyD001007EFO_0005230F41.1———1—1
Drug resistant epilepsyD000069279———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myoclonic epilepsiesD004831EFO_1001900G40.4——2——2
SeizuresD012640G40.4—11——2
Generalized epilepsyD004829—11——2
DementiaD003704F03——1——1
Psychophysiologic disordersD011602F45.9——1——1
SchizophreniaD012559EFO_0000692F20——1——1
DepressionD003863F33.9——1——1
Anxiety disordersD001008EFO_0006788F41.1——1——1
Low back painD017116HP_0003419M54.5——1——1
PainD010146EFO_0003843R52——1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuralgiaD009437EFO_000943011———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCLOZAPINE
INNclozapine
Description
Clozapine is a benzodiazepine that is 5H-dibenzo[b,e][1,4]diazepine substituted by a chloro group at position 8 and a 4-methylpiperazin-1-yl group at position 11. It is a second generation antipsychotic used in the treatment of psychiatric disorders like schizophrenia. It has a role as a serotonergic antagonist, a dopaminergic antagonist, an adrenergic antagonist, a histamine antagonist, a muscarinic antagonist, a second generation antipsychotic, a GABA antagonist, an EC 3.4.21.26 (prolyl oligopeptidase) inhibitor, a xenobiotic and an environmental contaminant. It is a benzodiazepine, a N-methylpiperazine, a N-arylpiperazine and an organochlorine compound.
Classification
Small molecule
Drug classtricyclic compounds
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN1CCN(C2=Nc3cc(Cl)ccc3Nc3ccccc32)CC1
Identifiers
PDB—
CAS-ID5786-21-0
RxCUI2626
ChEMBL IDCHEMBL42
ChEBI ID3766
PubChem CID135398737
DrugBankDB00363
UNII IDJ60AR2IKIC (ChemIDplus, GSRS)
Target
Agency Approved
DRD2
DRD2
HTR2A
HTR2A
Organism
Homo sapiens
Gene name
DRD2
Gene synonyms
NCBI Gene ID
1813
Protein name
D(2) dopamine receptor
Protein synonyms
Dopamine D2 receptor, seven transmembrane helix receptor
Uniprot ID
Q9UPA9
Mouse ortholog
Drd2 (13489)
D(2) dopamine receptor (Q0VGH9)
Alternate
DRD5
DRD5
HTR1F
HTR1F
HTR6
HTR6
ADRA1D
ADRA1D
HTR1A
HTR1A
ADRA1B
ADRA1B
HTR2B
HTR2B
HTR5A
HTR5A
HTR1D
HTR1D
ADRA1A
ADRA1A
HTR1B
HTR1B
DRD1
DRD1
CHRM1
CHRM1
HTR2C
HTR2C
HRH1
HRH1
HTR1E
HTR1E
HTR7
HTR7
DRD4
DRD4
HRH4
HRH4
DRD3
DRD3
KCNJ6
KCNJ6
HRH3
HRH3
Organism
Homo sapiens
Gene name
DRD5
Gene synonyms
DRD1B, DRD1L2
NCBI Gene ID
1816
Protein name
D(1B) dopamine receptor
Protein synonyms
D(5) dopamine receptor, D1beta dopamine receptor, Dopamine D5 receptor, dopamine receptor D1B
Uniprot ID
Q8NEQ8
Mouse ortholog
Drd5 (13492)
D(1B) dopamine receptor (Q8BLD9)
Variants
Clinical Variant
No data
Financial
Fazaclo - Jazz Pharmaceuticals
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 23,547 documents
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Safety
Black-box Warning
Black-box warning for: Clozaril, Versacloz
Adverse Events
Top Adverse Reactions
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8,609 adverse events reported
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