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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.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Zyprexa, Zyprexa relprevv, Zyprexa zydis (generic drugs available since 2011-10-24)
Combinations
Lybalvi, 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
SYMBYAXEli LillyN-021520 RX2003-12-24
5 products, RLD
Olanzapine
Tradename
Company
Number
Date
Products
ZYPREXAEli LillyN-020592 RX1996-09-30
6 products, RLD
ZYPREXA ZYDISEli LillyN-021086 RX2000-04-06
4 products, RLD
ZYPREXAEli LillyN-021253 RX2004-03-29
1 products, RLD, RS
Olanzapine
+
Samidorphan l-malate
Tradename
Company
Number
Date
Products
LYBALVIAlkermesN-213378 RX2021-05-28
4 products, RLD
Olanzapine pamoate
Tradename
Company
Number
Date
Products
ZYPREXA RELPREVVEli LillyN-022173 RX2009-12-11
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
lybalviNew Drug Application2021-05-28
olanzapineANDA2023-06-12
symbyaxNew Drug Application2021-09-20
zyprexaNew Drug Application2022-12-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bipolar disorderEFO_0000289D001714F30.9
psychotic disordersD011618F20.81
schizophreniaEFO_0000692D012559F20
schizophrenia spectrum and other psychotic disordersD019967
Agency Specific
FDA
EMA
Expiration
Code
OLANZAPINE / SAMIDORPHAN L-MALATE, LYBALVI, ALKERMES INC
2026-05-28NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Olanzapine / Samidorphan L-Malate, Lybalvi, Alkermes Inc
87789602032-02-13U-3136, U-3137
91198482031-08-30DP
91269772031-08-23DPU-3136, U-3137
95172352031-08-23U-3138, U-3139
103000542031-08-23DPU-3140, U-3141
107167852031-08-23U-3136, U-3137
111855412031-08-23U-3140
112414252031-08-23U-3137
113511662031-08-23U-3140, U-3141
72622982025-11-23DP
ATC Codes
N: Nervous system drugs
N05: Psycholeptics
N05A: Antipsychotics
N05AH: Diazepines, oxazepines, thiazepines and oxepines antipsychotic drugs
N05AH03: Olanzapine
HCPCS
Code
Description
J2358
Injection, olanzapine, long-acting, 1 mg
S0166
Injection, olanzapine, 2.5 mg
Clinical
Clinical Trials
375 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F201428446529175
Psychotic disordersD011618F20.813311241253
Bipolar disorderD001714EFO_0000289F30.911527750
VomitingD014839HP_0002013R11.1892221
Healthy volunteers/patients7112111
DementiaD003704F031315
Anorexia nervosaD000856EFO_0004215F50.01135
DepressionD003863F33.91214
Metabolic syndromeD024821EFO_0000195E88.81224
Major depressive disorderD003865EFO_0003761F2211114
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80136312
NauseaD009325HP_0002018R11.063110
Postoperative nausea and vomitingD020250EFO_00048881414
Breast neoplasmsD001943EFO_0003869C5033
Treatment-resistant depressive disorderD06121833
AlcoholismD000437EFO_0003829F10.1213
Borderline personality disorderD001883HP_0012076F60.3213
RecurrenceD012008112
Intellectual disabilityD008607F73112
Autistic disorderD001321EFO_0003758F84.0212
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DeliriumD003693R41.0134
Germ cell and embryonal neoplasmsD00937311
Stomach neoplasmsD013274EFO_0003897C1611
Opioid-related disordersD009293EFO_0005611F1111
Squamous cell carcinoma of head and neckD00007719511
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Insulin resistanceD007333EFO_0002614134
FastingD005215EFO_000275622
ImmunoassayD00711811
Hiv infectionsD015658EFO_0000764B2011
Drug-induced dyskinesiaD004409EFO_100090411
Weight lossD015431HP_000182411
PharmacokineticsD01059911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 2 diabetes mellitusD003924EFO_0001360E1144
Psychomotor agitationD01159533
ObesityD009765EFO_0001073E66.922
Paranoid schizophreniaD012563F20.011
Dissociative disordersD004213F44.111
HyperlipidemiasD006949EFO_0003774E78.511
DyslipidemiasD050171HP_000311911
Movement disordersD009069EFO_0004280G2511
Lactic acidosisD000140EFO_1000036E87.2011
Migraine disordersD008881EFO_0003821G4311
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOLANZAPINE
INNolanzapine
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 classtricyclic compounds
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Identifiers
PDB
CAS-ID132539-06-1
RxCUI61381
ChEMBL IDCHEMBL715
ChEBI ID7735
PubChem CID135398745
DrugBankDB00334
UNII IDN7U69T4SZR (ChemIDplus, GSRS)
Target
Agency Approved
DRD2
DRD2
HTR2C
HTR2C
HTR2A
HTR2A
Organism
Homo sapiens
Gene name
DRD2
Gene synonyms
NCBI Gene ID
Protein name
D(2) dopamine receptor
Protein synonyms
Dopamine D2 receptor, seven transmembrane helix receptor
Uniprot ID
Mouse ortholog
Drd2 (13489)
D(2) dopamine receptor (Q0VGH9)
Alternate
HRH1
HRH1
HTR1D
HTR1D
HTR1E
HTR1E
HTR1B
HTR1B
HTR1A
HTR1A
HTR6
HTR6
HTR7
HTR7
HTR1F
HTR1F
ADRA1A
ADRA1A
ADRA1D
ADRA1D
Organism
Homo sapiens
Gene name
HRH1
Gene synonyms
NCBI Gene ID
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Variants
Clinical Variant
No data
Financial
Lybalvi - Alkermes
$
£
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Zyprexa - Eli Lilly
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 22,959 documents
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Safety
Black-box Warning
Black-box warning for: Lybalvi, Olanzapine, Symbyax, Zyprexa
Adverse Events
Top Adverse Reactions
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55,484 adverse events reported
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