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 disorders	D001523

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)

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

Tradename	Company	Number	Date	Products
ZYPREXA	Eli Lilly	N-020592 RX	1996-09-30	6 products, RLD
ZYPREXA ZYDIS	Eli Lilly	N-021086 RX	2000-04-06	4 products, RLD
ZYPREXA	Eli Lilly	N-021253 RX	2004-03-29	1 products, RLD, RS

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

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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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

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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

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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

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Epidemiology

Epidemiological information for investigational and approved indications

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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

Agency Approved

DRD2

HTR2C

HTR2A

Organism

Homo sapiens

Gene name

DRD2

Gene synonyms

NCBI Gene ID

1813

Protein name

D(2) dopamine receptor

Protein synonyms

Dopamine D2 receptor, seven transmembrane helix receptor

Uniprot ID

Q9UPA9

Mouse ortholog

Drd2 (13489)

D(2) dopamine receptor (Q0VGH9)

Alternate

HRH1

HTR1D

HTR1E

HTR1B

HTR1A

HTR6

HTR7

HTR1F

ADRA1A

ADRA1D

Organism

Homo sapiens

Gene name

HRH1

Gene synonyms

NCBI Gene ID

3269

Protein name

histamine H1 receptor

Protein synonyms

histamine receptor, subclass H1

Uniprot ID

Q6P9E5

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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Real-time Data on

Companies, Drugs, and Diseases

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MATERIALS

COMPANY