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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EMA approval date
Patent expiration date
Study first post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| mental disorders | D001523 |
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 |
|---|---|---|---|---|
| CLOZARIL | Heritage Life Sciences Barbados | N-019758 RX | 1989-09-26 | 4 products, RLD, RS |
| VERSACLOZ | Tasman Pharma | N-203479 RX | 2013-02-06 | 1 products, RLD, RS |
Show 1 discontinued
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Clozapine, Versacloz, Tasman Pharma | |||
| 8057811 | 2028-05-01 | DP | |
HCPCS
Code | Description |
|---|---|
| S0136 | Clozapine, 25 mg |
Clinical
Clinical Trials
160 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | 8 | 8 | 9 | 50 | 36 | 108 |
| Psychotic disorders | D011618 | — | F20.81 | 1 | 1 | 1 | 21 | 12 | 36 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 1 | 3 | 3 | 7 | 14 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | 2 | 3 | 5 |
| Weight gain | D015430 | HP_0004324 | — | 1 | 1 | — | 1 | 2 | 5 |
| Treatment-resistant schizophrenia | D000090663 | — | — | — | — | 1 | 2 | 2 | 5 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | 2 | 1 | 3 |
| Dual (psychiatry) diagnosis | D017831 | — | — | — | — | — | 3 | — | 3 |
| Schizophrenia spectrum and other psychotic disorders | D019967 | — | — | — | — | — | 1 | 2 | 3 |
| Marijuana abuse | D002189 | EFO_0007191 | F12 | — | — | — | 2 | 1 | 3 |
Show 8 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | — | — | 1 | — | 1 | 2 |
| Intellectual disability | D008607 | EFO_0003847 | F73 | — | 1 | 1 | — | — | 2 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 1 | — | — | 1 |
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | — | 1 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 1 | — | — | 1 |
| Developmental disabilities | D002658 | EFO_0003852 | F89 | — | — | 1 | — | — | 1 |
| Hallucinations | D006212 | HP_0000738 | F06.0 | — | — | 1 | — | — | 1 |
| Tic disorders | D013981 | — | F95 | — | — | 1 | — | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sialorrhea | D012798 | HP_0002307 | K11.7 | 1 | 2 | — | — | 3 | 5 |
| Chinese traditional medicine | D008516 | — | — | — | 1 | — | — | — | 1 |
| Poisoning | D011041 | EFO_0008546 | T65.91 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | 1 | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 2 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 1 | 1 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | — | 1 | 1 |
Show 41 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Clozapine |
| INN | clozapine |
| 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 class | tricyclic compounds |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN1CCN(C2=Nc3cc(Cl)ccc3Nc3ccccc32)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 5786-21-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL42 |
| ChEBI ID | 3766 |
| PubChem CID | 2818 |
| DrugBank | DB00363 |
| UNII ID | J60AR2IKIC (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
$
€
£
â‚£
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 26,418 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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89,898 adverse events reported
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