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Drug ReportsClozapine
Clozapine
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 5-hydroxytryptamine receptor 2A and D(2) dopamine receptor. In addition, it is known to target 5-hydroxytryptamine receptor 2B, alpha-1B adrenergic receptor, muscarinic acetylcholine receptor M1, D(1A) dopamine receptor, D(1B) dopamine receptor, 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 5A, 5-hydroxytryptamine receptor 6, D(3) dopamine receptor, 5-hydroxytryptamine receptor 1D, G protein-activated inward rectifier potassium channel 2, histamine H3 receptor, D(4) dopamine receptor, 5-hydroxytryptamine receptor 1F, 5-hydroxytryptamine receptor 1B, 5-hydroxytryptamine receptor 1A, histamine H4 receptor, 5-hydroxytryptamine receptor 2C, 5-hydroxytryptamine receptor 7, histamine H1 receptor, alpha-1A adrenergic receptor, and alpha-1D adrenergic receptor.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Clozapine, Clozaril, Versacloz (discontinued: Clozapine, Clozaril, 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
VERSACLOZDouglas PharmaceuticalsN-203479 RX2013-02-06
1 products, RLD, RS
CLOZARILHeritage Life Sciences BarbadosN-019758 RX1989-09-26
2 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
clozapineANDA2025-06-24
clozarilNew Drug Application2025-06-06
versaclozNew Drug Application2025-06-23
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
176 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F20108126148136
Psychotic disordersD011618F20.81211251645
Treatment-resistant schizophreniaD0000906632449623
Bipolar disorderD001714EFO_0000289F30.91133816
Mental disordersD001523EFO_0000677F91.9117413
Metabolic syndromeD024821EFO_0000195E88.810235
DepressionD003863F33.91225
Weight gainD01543011125
ObesityD009765EFO_0001073E66.91214
Schizophrenia spectrum and other psychotic disordersD019967134
Show 28 more
Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PoisoningD011041EFO_0008546T65.9122
Chinese traditional medicineD00851611
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnxietyD001007EFO_0005230F41.1112
NeuralgiaD009437EFO_000943011
Intractable painD01014811
Post-traumatic stress disordersD013313EFO_0001358F43.111
Obsessive-compulsive disorderD009771EFO_0004242F4211
Personality disordersD010554F60.611
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug-related side effects and adverse reactionsD064420T88.733
NeutropeniaD009503D7033
InfectionsD007239EFO_000054422
Communicable diseasesD00314122
SeizuresD012640G40.422
StrokeD020521EFO_0000712I63.911
Drug interactionsD00434711
EmergenciesD00463011
HemorrhageD006470MP_0001914R5811
Heart failureD006333EFO_0003144I5011
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameClozapine
INNclozapine
Description
Clozapine is a psychiatric medication and is the first atypical antipsychotic (also called second-generation antipsychotic) to be discovered. It is primarily used to treat people with schizophrenia and schizoaffective disorder who have had an inadequate response to two other antipsychotics or who have been unable to tolerate other drugs due to extrapyramidal side effects. It is also used for the treatment of psychosis in Parkinson's disease.
Classification
Small molecule
Drug classtricyclic compounds
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN1CCN(C2=Nc3cc(Cl)ccc3Nc3ccccc32)CC1
Identifiers
PDB
CAS-ID5786-21-0
RxCUI
ChEMBL IDCHEMBL42
ChEBI ID3766
PubChem CID2818
DrugBankDB00363
UNII IDJ60AR2IKIC (ChemIDplus, GSRS)
Target
Agency Approved
HTR2A
HTR2A
DRD2
DRD2
Organism
Homo sapiens
Gene name
HTR2A
Gene synonyms
HTR2
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 2A
Protein synonyms
5-HT2 receptor, 5-hydroxytryptamine (serotonin) receptor 2A, G protein-coupled, serotonin 5-HT-2A receptor, Serotonin receptor 2A
Uniprot ID
Mouse ortholog
Htr2a (15558)
5-hydroxytryptamine receptor 2A (P35363)
Alternate
HTR2B
HTR2B
ADRA1B
ADRA1B
CHRM1
CHRM1
DRD1
DRD1
DRD5
DRD5
HTR1E
HTR1E
HTR5A
HTR5A
HTR6
HTR6
DRD3
DRD3
HTR1D
HTR1D
KCNJ6
KCNJ6
HRH3
HRH3
DRD4
DRD4
HTR1F
HTR1F
HTR1B
HTR1B
HTR1A
HTR1A
HRH4
HRH4
HTR2C
HTR2C
HTR7
HTR7
HRH1
HRH1
ADRA1A
ADRA1A
ADRA1D
ADRA1D
Organism
Homo sapiens
Gene name
HTR2B
Gene synonyms
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 2B
Protein synonyms
5-HT 2B receptor, 5-hydroxytryptamine (serotonin) receptor 2B, G protein-coupled, 5-hydroxytryptamine 2B receptor, Serotonin receptor 2B
Uniprot ID
Mouse ortholog
Htr2b (15559)
5-hydroxytryptamine receptor 2B (Q9QWS2)
Variants
No data
Financial
Revenue by drug
$
£
Fazaclo Jazz Pharmaceuticals
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Tabular view
Estimated US medical usage
Clozapine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 29,328 documents
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Safety
Black-box Warning
Black-box warning for: Clozapine, Clozaril, Versacloz
Adverse Events
Top Adverse Reactions
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134,600 adverse events reported
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