Olanzapine - PharmaKB

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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FDA Novel Drug Approvals 2021

Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
mental disorders	D001523

Trade Name

FDA

EMA

Olanzapine, Zyprexa, Zyprexa relprevv, Zyprexa zydis (discontinued: Olanzapine)

Combinations

Lybalvi, Olanzapine fluoxetine, Symbyax

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	CHEPLAPHARM Arzneimittel	N-021253 RX	2004-03-29	1 products, RLD, RS
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

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	CHEPLAPHARM Arzneimittel	N-022173 RX	2009-12-11	3 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
lybalvi	New Drug Application	2024-01-31
olanzapine	ANDA	2024-10-30
olanzapine and fluoxetine	ANDA	2024-04-19
symbyax	New Drug Application	2023-08-18
zyprexa	New Drug Application	2024-07-29
zyprexa zyprexa	New Drug Application	2023-12-13
zyprexa zyprexa	New Drug Application	2009-08-31

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
schizophrenia	EFO_0000692	D012559	F20
psychotic disorders	—	D011618	F20.81
bipolar disorder	EFO_0000289	D001714	F30.9
schizophrenia spectrum and other psychotic disorders	—	D019967	—
bulimia	—	D002032	F50.2
panic disorder	EFO_0004262	D016584	F41.0
major depressive disorder	EFO_0003761	D003865	F22
obsessive-compulsive disorder	EFO_0004242	D009771	F42

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

ATC Codes

N: Nervous system drugs

— N05: Psycholeptics

— N05A: Antipsychotics

— N05AH: Diazepines, oxazepines, thiazepines and oxepines antipsychotic drugs

— N05AH03: Olanzapine

— N05AH53: Olanzapine and samidorphan

HCPCS

Code	Description
J2358	Injection, olanzapine, long-acting, 1 mg
S0166	Injection, olanzapine, 2.5 mg

Clinical

Clinical Trials

529 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	24	39	66	87	67	276
Psychotic disorders	D011618	—	F20.81	6	3	18	35	24	86
Bipolar disorder	D001714	EFO_0000289	F30.9	4	1	19	35	14	73
Vomiting	D014839	HP_0002013	R11.1	1	15	25	2	2	42
Nausea	D009325	HP_0002018	R11.0	1	14	18	2	2	34
Depression	D003863	—	F33.9	4	2	7	11	3	25
Depressive disorder	D003866	EFO_1002014	F32.A	5	2	6	10	3	24
Weight gain	D015430	HP_0004324	—	3	6	3	8	3	23
Mental disorders	D001523	EFO_0000677	F91.9	2	1	5	8	7	23
Healthy volunteers/patients	—	—	—	11	1	1	2	1	15

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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	4	11	—	3	17
Delirium	D003693	—	R41.0	—	1	1	—	4	6
Hematologic neoplasms	D019337	—	—	—	—	4	—	1	5
Postoperative nausea and vomiting	D020250	EFO_0004888	—	1	4	1	—	—	4
Malnutrition	D044342	EFO_0008572	E40-E46	3	1	1	—	—	4
Breast neoplasms	D001943	EFO_0003869	C50	—	—	3	—	—	3
Borderline personality disorder	D001883	HP_0012076	F60.3	—	—	2	—	1	3
Personality disorders	D010554	HP_0012075	F60.6	—	—	2	—	1	3
Disease progression	D018450	—	—	—	—	2	—	—	2
Intellectual disability	D008607	EFO_0003847	F73	—	1	1	—	—	2

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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
Dyslipidemias	D050171	HP_0003119	—	—	1	—	—	2	3
Cognitive dysfunction	D060825	HP_0001268	G31.84	—	2	—	—	—	2
Accelerated idioventricular rhythm	D016170	—	—	—	2	—	—	—	2
Carcinoma	D002277	—	C80.0	—	2	—	—	—	2
Germ cell and embryonal neoplasms	D009373	—	—	—	1	—	—	—	1
Anhedonia	D059445	—	R45.84	—	1	—	—	—	1
Stomach neoplasms	D013274	EFO_0003897	C16	—	1	—	—	—	1
Oncogenes	D009857	—	—	—	1	—	—	—	1
Alcohol drinking	D000428	EFO_0004329	—	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Movement disorders	D009069	HP_0100022	—	1	—	—	—	1	2
Fasting	D005215	EFO_0002756	—	2	—	—	—	—	2
Immunoassay	D007118	—	—	1	—	—	—	—	1
Hiv infections	D015658	EFO_0000764	B20	1	—	—	—	—	1
Glioblastoma	D005909	EFO_0000515	—	1	—	—	—	—	1
Gliosarcoma	D018316	—	—	1	—	—	—	—	1
Drug-induced dyskinesia	D004409	EFO_1000904	—	1	—	—	—	—	1
Psychotic affective disorders	D000341	—	F39	1	—	—	—	—	1
Pharmacokinetics	D010599	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hyperprolactinemia	D006966	HP_0000870	E22.1	—	—	—	—	3	3
Stroke	D020521	EFO_0000712	I63.9	—	—	—	—	1	1
Glucose metabolism disorders	D044882	—	—	—	—	—	—	1	1
Congenital abnormalities	D000013	EFO_0003915	Q89.9	—	—	—	—	1	1
Delusions	D003702	HP_0000746	—	—	—	—	—	1	1
Paranoid schizophrenia	D012563	—	F20.0	—	—	—	—	1	1
Conversion disorder	D003291	—	F44	—	—	—	—	1	1
Dissociative disorders	D004213	—	F44.1	—	—	—	—	1	1
Gastroparesis	D018589	EFO_1000948	K31.84	—	—	—	—	1	1
Hyperlipidemias	D006949	HP_0003077	E78.5	—	—	—	—	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, 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

HTR2C

DRD2

Organism

Homo sapiens

Gene name

HTR2A

Gene synonyms

HTR2

NCBI Gene ID

3356

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

Q5T8C0

Mouse ortholog

Htr2a (15558)

5-hydroxytryptamine receptor 2A (P35363)

Alternate

ADRA1A

HTR1B

HTR1F

HTR7

HTR6

HTR1D

ADRA1D

HRH1

HTR1E

HTR1A

Organism

Homo sapiens

Gene name

ADRA1A

Gene synonyms

ADRA1C

NCBI Gene ID

148

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

Q9UD67

Mouse ortholog

Adra1a (11549)

alpha-1A adrenergic receptor (Q8BV77)

Variants

No data

Financial

Revenue by drug

€

₣

Lybalvi – Alkermes

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Zyprexa – Eli Lilly

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Estimated US medical usage

Olanzapine

Fluoxetine

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Refill frequency

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Price per prescription (USD)

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Olanzapine

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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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 26,553 documents

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Safety

Black-box Warning

Black-box warning for: Lybalvi, Olanzapine, Olanzapine and fluoxetine, Symbyax, Zyprexa, Zyprexa zyprexa, Zyprexa zyprexa

Adverse Events

Top Adverse Reactions

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76,424 adverse events reported

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