Zyprexa(olanzapine)
Lybalvi, Olanzapine, Olazax, Symbyax, Zalasta, Zypadhera, Zyprexa (olanzapine) is a small molecule pharmaceutical. Olanzapine was first approved as Zyprexa on 1996-09-27. It is used to treat bipolar disorder, psychotic disorders, schizophrenia, and schizophrenia spectrum and other psychotic disorders in the USA. It has been approved in Europe to treat bipolar disorder and schizophrenia. The pharmaceutical is active against 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 2C, and D(2) dopamine receptor. In addition, it is known to target alpha-1A adrenergic receptor, 5-hydroxytryptamine receptor 1B, 5-hydroxytryptamine receptor 1F, 5-hydroxytryptamine receptor 7, 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 1D, alpha-1D adrenergic receptor, histamine H1 receptor, 5-hydroxytryptamine receptor 1E, and 5-hydroxytryptamine receptor 1A.
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2Y
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| mental disorders | D001523 |
Trade Name
FDA
EMA
Zyprexa, Zyprexa relprevv, Zyprexa zydis (generic drugs available since 2011-10-24)
CombinationsLybalvi, Symbyax (generic drugs available since 2011-10-24)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluoxetine hydrochloride
+
Olanzapine
Olanzapine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZYPREXA | CHEPLAPHARM Arzneimittel | N-020592 RX | 1996-09-30 | 6 products, RLD |
| ZYPREXA ZYDIS | CHEPLAPHARM Arzneimittel | N-021086 RX | 2000-04-06 | 4 products, RLD |
| ZYPREXA | CHEPLAPHARM Arzneimittel | N-021253 RX | 2004-03-29 | 1 products, RLD, RS |
Olanzapine
+
Samidorphan l-malate
Olanzapine pamoate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZYPREXA RELPREVV | CHEPLAPHARM Arzneimittel | N-022173 RX | 2009-12-11 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| olanzapine and fluoxetine | ANDA | 2024-01-29 |
| symbyax | New Drug Application | 2023-08-18 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
OLANZAPINE / SAMIDORPHAN L-MALATE, LYBALVI, ALKERMES INC | |||
| 2026-05-28 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Olanzapine / Samidorphan L-Malate, Lybalvi, Alkermes Inc | |||
| 11707466 | 2041-11-12 | DP | |
| 8778960 | 2032-02-13 | U-3136, U-3137 | |
| 9119848 | 2031-08-30 | DP | |
| 9126977 | 2031-08-23 | DP | U-3136, U-3137 |
| 9517235 | 2031-08-23 | U-3138, U-3139 | |
| 10300054 | 2031-08-23 | DP | U-3140, U-3141 |
| 10716785 | 2031-08-23 | U-3136, U-3137 | |
| 11185541 | 2031-08-23 | U-3140 | |
| 11241425 | 2031-08-23 | U-3137 | |
| 11351166 | 2031-08-23 | U-3140, U-3141 | |
| 11793805 | 2031-08-23 | U-3734 | |
| 7262298 | 2025-11-23 | DP | |
Clinical
Clinical Trials
519 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 | 21 | 36 | 60 | 83 | 60 | 253 |
| Psychotic disorders | D011618 | — | F20.81 | 5 | 3 | 15 | 31 | 22 | 76 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 4 | — | 18 | 33 | 14 | 69 |
| Vomiting | D014839 | HP_0002013 | R11.1 | — | 8 | 9 | 2 | 2 | 21 |
| Healthy volunteers/patients | — | — | — | 9 | 1 | 1 | 2 | 1 | 13 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | 4 | 7 | 11 |
| Weight gain | D015430 | HP_0004324 | — | 1 | 1 | 1 | 4 | 1 | 8 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | 1 | — | — | 1 | 6 | 8 |
| Depression | D003863 | — | F33.9 | 1 | 1 | 1 | 3 | 2 | 7 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 1 | 3 | 2 | 6 |
Show 36 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 3 | 6 | — | 3 | 12 |
| Nausea | D009325 | HP_0002018 | R11.0 | — | 6 | 3 | — | 1 | 10 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | 1 | 4 | 1 | — | — | 4 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 2 | 1 | — | 1 | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 3 | — | — | 3 |
| Treatment-resistant depressive disorder | D061218 | — | — | — | — | 3 | — | — | 3 |
| Borderline personality disorder | D001883 | HP_0012076 | F60.3 | — | — | 2 | — | 1 | 3 |
| Recurrence | D012008 | — | — | — | — | 1 | — | 1 | 2 |
| Intellectual disability | D008607 | EFO_0003847 | F73 | — | 1 | 1 | — | — | 2 |
| Autistic disorder | D001321 | HP_0000717 | F84.0 | — | 2 | 1 | — | — | 2 |
Show 14 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 2 | — | — | 2 | 5 |
| Delirium | D003693 | — | R41.0 | — | 1 | — | — | 3 | 4 |
| Accelerated idioventricular rhythm | D016170 | — | — | — | 2 | — | — | — | 2 |
| Germ cell and embryonal neoplasms | D009373 | — | — | — | 1 | — | — | — | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 1 | — | — | — | 1 |
| Hypochondriasis | D006998 | — | F45.2 | 1 | 1 | — | — | — | 1 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 1 | — | — | — | 1 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fasting | D005215 | EFO_0002756 | — | 2 | — | — | — | — | 2 |
| Immunoassay | D007118 | — | — | 1 | — | — | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | — | 1 |
| Drug-induced dyskinesia | D004409 | EFO_1000904 | — | 1 | — | — | — | — | 1 |
| Weight loss | D015431 | HP_0001824 | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Glucose metabolism disorders | D044882 | — | — | — | — | — | — | 1 | 1 |
| Paranoid schizophrenia | D012563 | — | F20.0 | — | — | — | — | 1 | 1 |
| Dissociative disorders | D004213 | — | F44.1 | — | — | — | — | 1 | 1 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | — | — | — | — | 1 | 1 |
| Dyslipidemias | D050171 | HP_0003119 | — | — | — | — | — | 1 | 1 |
| Micrognathism | D008844 | HP_0000347 | M26.04 | — | — | — | — | 1 | 1 |
| Behavior | D001519 | GO_0007610 | STY/T053 | — | — | — | — | 1 | 1 |
| Movement disorders | D009069 | HP_0100022 | — | — | — | — | — | 1 | 1 |
| Lactic acidosis | D000140 | HP_0003128 | E87.20 | — | — | — | — | 1 | 1 |
Show 12 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Olanzapine |
| INN | olanzapine |
| Description | Olanzapine, sold under the brand name Zyprexa among others, is an atypical antipsychotic primarily used to treat schizophrenia and bipolar disorder. For schizophrenia, it can be used for both new-onset disease and long-term maintenance. It is taken by mouth or by injection into a muscle.
|
| Classification | Small molecule |
| Drug class | tricyclic compounds |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 132539-06-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL715 |
| ChEBI ID | 7735 |
| PubChem CID | 4585 |
| DrugBank | DB00334 |
| UNII ID | N7U69T4SZR (ChemIDplus, GSRS) |
Target
Agency Approved
HTR2A
HTR2A
HTR2C
HTR2C
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
ADRA1A
ADRA1A
HTR1B
HTR1B
HTR1F
HTR1F
HTR7
HTR7
HTR6
HTR6
HTR1D
HTR1D
ADRA1D
ADRA1D
HRH1
HRH1
HTR1E
HTR1E
HTR1A
HTR1A
Organism
Homo sapiens
Gene name
ADRA1A
Gene synonyms
ADRA1C
NCBI Gene ID
Protein name
alpha-1A adrenergic receptor
Protein synonyms
Alpha-1A adrenoceptor, Alpha-1A adrenoreceptor, Alpha-1C adrenergic receptor, Alpha-adrenergic receptor 1c, G protein coupled receptor
Uniprot ID
Mouse ortholog
Adra1a (11549)
alpha-1A adrenergic receptor (Q8BV77)
Variants
No data
Financial
Estimated US medical usage
Olanzapine
+
Fluoxetine
Total medical expenditures per year (USD, in millions)
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Olanzapine
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 25,660 documents
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Safety
Black-box Warning
Black-box warning for: Olanzapine and fluoxetine, Symbyax
Adverse Events
Top Adverse Reactions
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61,769 adverse events reported
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