Zyprexa(olanzapine)
Lybalvi, Symbyax, 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 D(2) dopamine receptor, 5-hydroxytryptamine receptor 2C, and 5-hydroxytryptamine receptor 2A. In addition, it is known to target histamine H1 receptor, 5-hydroxytryptamine receptor 1D, 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 1B, 5-hydroxytryptamine receptor 1A, 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 7, 5-hydroxytryptamine receptor 1F, alpha-1A adrenergic receptor, and alpha-1D adrenergic receptor.
Download report
Favorite
FDA Novel Drug Approvals 2021
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
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
SYMBYAX | Eli Lilly | N-021520 RX | 2003-12-24 | 5 products, RLD |
Olanzapine
Olanzapine
+
Samidorphan l-malate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
LYBALVI | Alkermes | N-213378 RX | 2021-05-28 | 4 products, RLD |
Olanzapine pamoate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ZYPREXA RELPREVV | Eli Lilly | N-022173 RX | 2009-12-11 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
lybalvi | New Drug Application | 2021-05-28 |
olanzapine | ANDA | 2023-06-12 |
symbyax | New Drug Application | 2021-09-20 |
zyprexa | New Drug Application | 2022-12-27 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
bipolar disorder | EFO_0000289 | D001714 | F30.9 |
psychotic disorders | — | D011618 | F20.81 |
schizophrenia | EFO_0000692 | D012559 | F20 |
schizophrenia spectrum and other psychotic disorders | — | D019967 | — |
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 | |||
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 | |
7262298 | 2025-11-23 | DP |
Clinical
Clinical Trials
375 clinical trials
View more details
![](https://www.pharmakb.com/hubfs/raw_assets/public/ccd-theme/images/generated-html-images/trials-plot.png)
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Schizophrenia | D012559 | EFO_0000692 | F20 | 14 | 28 | 44 | 65 | 29 | 175 |
Psychotic disorders | D011618 | F20.81 | 3 | 3 | 11 | 24 | 12 | 53 | |
Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | — | 15 | 27 | 7 | 50 |
Vomiting | D014839 | HP_0002013 | R11.1 | — | 8 | 9 | 2 | 2 | 21 |
Healthy volunteers/patients | — | 7 | 1 | 1 | 2 | 1 | 11 | ||
Dementia | D003704 | F03 | — | — | 1 | 3 | 1 | 5 | |
Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | 1 | — | 1 | 3 | 5 |
Depression | D003863 | F33.9 | — | — | 1 | 2 | 1 | 4 | |
Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | 2 | 2 | 4 |
Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | 1 | 1 | 1 | 4 |
Show 24 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 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 3 | — | — | 3 |
Treatment-resistant depressive disorder | D061218 | — | — | 3 | — | — | 3 | ||
Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 2 | 1 | — | — | 3 |
Borderline personality disorder | D001883 | HP_0012076 | F60.3 | — | — | 2 | — | 1 | 3 |
Recurrence | D012008 | — | — | 1 | — | 1 | 2 | ||
Intellectual disability | D008607 | F73 | — | 1 | 1 | — | — | 2 | |
Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | 2 | 1 | — | — | 2 |
Show 11 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Delirium | D003693 | R41.0 | — | 1 | — | — | 3 | 4 | |
Germ cell and embryonal neoplasms | D009373 | — | 1 | — | — | — | 1 | ||
Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 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 |
---|---|---|---|---|---|---|---|---|---|
Insulin resistance | D007333 | EFO_0002614 | 1 | — | — | — | 3 | 4 | |
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 |
---|---|---|---|---|---|---|---|---|---|
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 4 | 4 |
Psychomotor agitation | D011595 | — | — | — | — | 3 | 3 | ||
Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 2 | 2 |
Paranoid schizophrenia | D012563 | F20.0 | — | — | — | — | 1 | 1 | |
Dissociative disorders | D004213 | F44.1 | — | — | — | — | 1 | 1 | |
Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | — | — | — | 1 | 1 |
Dyslipidemias | D050171 | HP_0003119 | — | — | — | — | 1 | 1 | |
Movement disorders | D009069 | EFO_0004280 | G25 | — | — | — | — | 1 | 1 |
Lactic acidosis | D000140 | EFO_1000036 | E87.20 | — | — | — | — | 1 | 1 |
Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 1 | 1 |
Show 5 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common name | OLANZAPINE |
INN | olanzapine |
Description | Olanzapine is a benzodiazepine that is 10H-thieno[2,3-b][1,5]benzodiazepine substituted by a methyl group at position 2 and a 4-methylpiperazin-1-yl group at position 4. It has a role as a histamine antagonist, a muscarinic antagonist, a serotonergic antagonist, a dopaminergic antagonist, an antiemetic, a second generation antipsychotic and a serotonin uptake inhibitor. It is a benzodiazepine, a N-methylpiperazine and a N-arylpiperazine. |
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 | 61381 |
ChEMBL ID | CHEMBL715 |
ChEBI ID | 7735 |
PubChem CID | 135398745 |
DrugBank | DB00334 |
UNII ID | N7U69T4SZR (ChemIDplus, GSRS) |
Target
Alternate
HRH1
HRH1
HTR1D
HTR1D
HTR1E
HTR1E
HTR1B
HTR1B
HTR1A
HTR1A
HTR6
HTR6
HTR7
HTR7
HTR1F
HTR1F
ADRA1A
ADRA1A
ADRA1D
ADRA1D
Variants
Clinical Variant
No data
Financial
Lybalvi - Alkermes
$
€
£
₣
![](https://www.pharmakb.com/hubfs/raw_assets/public/ccd-theme/images/generated-html-images/sales-plot.png)
Mock data
Subscribe for the real data
Subscribe for the real data
![](https://www.pharmakb.com/hubfs/raw_assets/public/ccd-theme/images/generated-html-images/sales-plot.png)
Mock data
Subscribe for the real data
Subscribe for the real data
Zyprexa - Eli Lilly
$
€
£
₣
![](https://www.pharmakb.com/hubfs/raw_assets/public/ccd-theme/images/generated-html-images/sales-plot.png)
Mock data
Subscribe for the real data
Subscribe for the real data
![](https://www.pharmakb.com/hubfs/raw_assets/public/ccd-theme/images/generated-html-images/sales-plot.png)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
![](https://www.pharmakb.com/hubfs/raw_assets/public/ccd-theme/images/generated-html-images/top-terms-plot.png)
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 22,959 documents
View more details
Safety
Black-box Warning
Black-box warning for: Lybalvi, Olanzapine, Symbyax, Zyprexa
Adverse Events
Top Adverse Reactions
![](https://www.pharmakb.com/hubfs/raw_assets/public/ccd-theme/images/generated-html-images/top-adverse-reactions-plot.png)
Mock data
Subscribe for the real data
Subscribe for the real data
55,484 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more