Olanzapine
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1996
- First approval year
- 1996
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Olanzapine
- Molecular weight
- 312.44
- Structure (SMILES)
- Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
- arkolamyl
- Arkolamyl
- olansek
- Olansek
- olanzapine
- Olanzapine
- olanzapine apotex
- Olanzapine apotex
- Olanzapine cipla (previously olanzapine neopharma)
- olanzapine cipla previously olanzapine neopharma
- olanzapine component of lybalvi
- Olanzapine component of lybalvi
- olanzapine component of symbyax
- Olanzapine component of symbyax
- olanzapine glenmark
- Olanzapine glenmark
- olanzapine glenmark europe
- Olanzapine glenmark europe
- olanzapine mylan
- Olanzapine mylan
- olanzapine teva
- Olanzapine teva
- olazax
- Olazax
- olazax disperzi
And 9 more, listed on the interactive page.
- ly 170053
- LY-170053
- ly170053
- LY170053
- lybalvi component olanzapine
- LYBALVI COMPONENT OLANZAPINE
- olansek
- Olansek
- olanzapina
- Olanzapina
- olanzapine
- Olanzapine
- OLANZAPINE [EMA EPAR]
- OLANZAPINE [EP MONOGRAPH]
- olanzapine [INN]
- OLANZAPINE [JAN]
- OLANZAPINE [MART.]
- OLANZAPINE [MI]
- OLANZAPINE [ORANGE BOOK]
- OLANZAPINE [USAN]
- OLANZAPINE [USP MONOGRAPH]
- OLANZAPINE [USP-RS]
- OLANZAPINE [VANDF]
- Olanzapine [WHO-DD]
- olanzapine apotex
And 33 more, listed on the interactive page.
- ATC classification codes
- N05AH03
Sources for recorded values
- CAS registry numbers
- 132539-06-1
- ChEMBL ID
- CHEMBL715
- InChIKey
- KVWDHTXUZHCGIO-UHFFFAOYSA-N
- PubChem compound IDs
- 135398745
- FDA ingredient codes (UNII)
- N7U69T4SZR
- 61381
- 1294588
- Applicant
- CHEPLAPHARM
- Approval date
- 30 Sept 1996
- Application number
- NDA020592
- Status
- Authorised
- Status date
- 27 Sept 1996
- Authorisation date
- 27 Sept 1996
- Approved indications
- Coated tablets Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder. Injection Adults Zyprexa powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with Zyprexa powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate.
- Product number
- EMEA/H/C/000115
- Authorisation holder
- CHEPLAPHARM Registration GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 7
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Bipolar Disorder
- Schizophrenia
European medicines record
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- olanzapine
- Type
- Synthetic organic
- Drug name stem
- -pine
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Parenteral
- Action
- Antagonist
- Action type
- Antagonist
- Target
- D2 receptor
- Gene symbol
- DRD2
- Protein identifier
- P14416
- Median affinity
- 8.68
- Affinity units
- pKi
- Primary target
- Yes
- Action
- Antagonist
- Action type
- Antagonist
- Target
- 5-HT2A receptor
- Gene symbol
- HTR2A
- Protein identifier
- P28223
- Affinity units
- pKi
- Primary target
- Yes
- Action
- Antagonist
- Action type
- Antagonist
- Target
- 5-HT7 receptor
- Gene symbol
- HTR7
- Protein identifier
- P34969
- Median affinity
- 6.5
- Affinity units
- pKi
- Action
- Antagonist
- Action type
- Antagonist
- Target
- H1 receptor
- Gene symbol
- HRH1
- Protein identifier
- P35367
- Affinity units
- pKi
- Mechanism
- D2-like dopamine receptor antagonist
- Action type
- Antagonist
- Target
- D2-like dopamine receptor
- Protein identifier
- P14416
- Mechanism
- D2-like dopamine receptor antagonist
- Action type
- Antagonist
- Target
- D2-like dopamine receptor
- Protein identifier
- P21917
- Mechanism
- D2-like dopamine receptor antagonist
- Action type
- Antagonist
- Target
- D2-like dopamine receptor
- Protein identifier
- P35462
- Mechanism
- Serotonin 2a (5-HT2a) receptor antagonist
- Action type
- Antagonist
- Target
- 5-hydroxytryptamine receptor 2A
- Protein identifier
- P28223
- Mechanism
- Serotonin 2c (5-HT2c) receptor antagonist
- Action type
- Antagonist
- Target
- 5-hydroxytryptamine receptor 2C
- Protein identifier
- P28335
- Action
- Full agonist
- Action type
- FULL_AGONIST
- Target
- 5-HT1A receptor
- Gene symbol
- HTR1A
- Protein identifier
- P08908
- Affinity units
- pKi
- Action
- Full agonist
- Action type
- FULL_AGONIST
- Target
- 5-HT1D receptor
- Gene symbol
- HTR1D
- Protein identifier
- P28221
- Median affinity
- 6.2
- Affinity units
- pKi
- Action
- Full agonist
- Action type
- FULL_AGONIST
- Target
- 5-HT1B receptor
- Gene symbol
- HTR1B
- Protein identifier
- P28222
- Median affinity
- 6.3
- Affinity units
- pKi
- Action
- Full agonist
- Action type
- FULL_AGONIST
- Target
- 5-ht1e receptor
- Gene symbol
- HTR1E
- Protein identifier
- P28566
- Median affinity
- 5.7
- Affinity units
- pKi
- Action
- Full agonist
- Action type
- FULL_AGONIST
- Target
- 5-HT1F receptor
- Gene symbol
- HTR1F
- Protein identifier
- P30939
- Median affinity
- 6.5
- Affinity units
- pKi
- Action
- Inverse agonist
- Action type
- INVERSE_AGONIST
- Target
- 5-HT2C receptor
- Gene symbol
- HTR2C
- Protein identifier
- P28335
- Affinity units
- pKi
- Primary target
- Yes
- Action
- Inverse agonist
- Action type
- INVERSE_AGONIST
- Target
- 5-HT6 receptor
- Gene symbol
- HTR6
- Protein identifier
- P50406
- Median affinity
- 8
- Affinity units
- pKi
- Mechanism
- D2-like dopamine receptor antagonist
- Action type
- Antagonist
- Target
- D2-like dopamine receptor
- Mechanism
- Serotonin 2a (5-HT2a) receptor antagonist
- Action type
- Antagonist
- Target
- 5-hydroxytryptamine receptor 2A
- Mechanism
- Serotonin 2c (5-HT2c) receptor antagonist
- Action type
- Antagonist
- Target
- 5-hydroxytryptamine receptor 2C
- Action type
- Agonist
- Gene symbol
- HTR1E
- Protein identifier
- P28566
- Organism
- Homo sapiens
- Target development level
- Chemical evidence
- Action type
- Antagonist
- Gene symbol
- DRD2
- Protein identifier
- P14416
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Antagonist
- Gene symbol
- DRD4
- Protein identifier
- P21917
- Organism
- Homo sapiens
- Target development level
- Chemical evidence
- Action type
- Antagonist
- Gene symbol
- HTR2A
- Protein identifier
- P28223
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Antagonist
- Gene symbol
- HTR2C
- Protein identifier
- P28335
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Antagonist
- Gene symbol
- DRD3
- Protein identifier
- P35462
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Mental Disorders
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000677
- Subject identifier
- D001523
- Condition
- Autistic Disorder
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003758
- Subject identifier
- D001321
- Condition
- Depressive Disorder, Major
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003761
- Subject identifier
- D003865
- Condition
- Developmental Disabilities
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003852
- Subject identifier
- D002658
- Condition
- Mood Disorders
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004247
- Subject identifier
- D019964
- Condition
- Weight Gain
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004566
- Subject identifier
- D015430
- Condition
- Gambling
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004699
- Subject identifier
- D005715
- Condition
- Postoperative Nausea and Vomiting
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004888
- Subject identifier
- D020250
- Condition
- Testicular Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005088
- Subject identifier
- D013736
- Condition
- Feeding and Eating Disorders
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005203
- Subject identifier
- D001068
- Condition
- Anxiety
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005230
- Subject identifier
- D001007
- Condition
- Psychotic Disorders
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005407
- Subject identifier
- D011618
- Condition
- Psychotic Disorders
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005411
- Subject identifier
- D011618
- Condition
- Nausea
- Highest recorded phase
- 3
- Condition identifier
- EFO:0006911
- Subject identifier
- D009325
- Condition
- Delirium
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009267
- Subject identifier
- D003693
- Condition
- Depressive Disorder, Treatment-Resistant
- Highest recorded phase
- 3
- Condition identifier
- EFO:0009854
- Subject identifier
- D061218
- Condition
- Bipolar Disorder
- Highest recorded phase
- 4
- Condition identifier
- EFO:0009963
- Subject identifier
- D001714
- Condition
- Opioid-Related Disorders
- Highest recorded phase
- 2
- Condition identifier
- EFO:0010702
- Subject identifier
- D009293
- Condition
- Dyskinesia, Drug-Induced
- Highest recorded phase
- 1
- Condition identifier
- EFO:1000904
- Subject identifier
- D004409
- Condition
- Genital Neoplasms, Female
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001331
- Subject identifier
- D005833
- Condition
- Mental Disorders
- Highest recorded phase
- 4
- Condition identifier
- HP:0000713
- Subject identifier
- D001523
- Condition
- Psychomotor Agitation
- Highest recorded phase
- 4
- Condition identifier
- HP:0000713
- Subject identifier
- D011595
- Condition
- Dementia
- Highest recorded phase
- 3
- Condition identifier
- HP:0000726
- Subject identifier
- D003704
- Condition
- Intellectual Disability
- Highest recorded phase
- 3
- Condition identifier
- HP:0001249
- Subject identifier
- D008607
And 15 more, listed on the interactive page.
- Condition identifier
- EFO_0000195
- Condition identifier
- EFO_0000616
- Highest recorded phase
- 3
- Condition identifier
- EFO_0002756
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003015
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003758
- Condition identifier
- EFO_0004566
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004609
- Condition identifier
- EFO_0004699
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004888
- Condition identifier
- EFO_0005088
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005203
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005407
- Condition identifier
- EFO_0005411
- Highest recorded phase
- 3
- Condition identifier
- EFO_0006911
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008572
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009267
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009854
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009963
- Condition identifier
- EFO_0009963
- Highest recorded phase
- 4
- Condition identifier
- EFO_0010702
- Highest recorded phase
- 2
- Condition identifier
- EFO_0801084
- Condition identifier
- EFO_1000904
- Highest recorded phase
- 1
- Condition identifier
- EFO_1001331
- Highest recorded phase
- 3
- Condition identifier
- GO_0006006
- Highest recorded phase
- 1
- Condition identifier
- HP_0000360
- Highest recorded phase
- 1
And 46 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
Open Targets warnings
- Warning
- Black Box Warning
- Country
- United States
- Event
- aggression
- Reports
- 500
- Reporting signal score
- 559.674
- Event
- agitation
- Reports
- 884
- Reporting signal score
- 1,070.59
- Event
- akathisia
- Reports
- 521
- Reporting signal score
- 1,193.51
- Event
- anosognosia
- Reports
- 207
- Reporting signal score
- 815.553
- Event
- arthralgia
- Reports
- 53
- Reporting signal score
- 289.298
- Event
- blood creatine phosphokinase increased
- Reports
- 535
- Reporting signal score
- 614.225
- Event
- blood glucose increased
- Reports
- 481
- Reporting signal score
- 349.307
- Event
- blood prolactin abnormal
- Reports
- 242
- Reporting signal score
- 956.928
- Event
- blood triglycerides increased
- Reports
- 309
- Reporting signal score
- 466.864
- Event
- catatonia
- Reports
- 345
- Reporting signal score
- 869.492
- Event
- coma
- Reports
- 615
- Reporting signal score
- 779.668
- Event
- confusional state
- Reports
- 873
- Reporting signal score
- 574.566
- Event
- delirium
- Reports
- 419
- Reporting signal score
- 438.773
- Event
- delusion
- Reports
- 367
- Reporting signal score
- 679.597
- Event
- depressed level of consciousness
- Reports
- 541
- Reporting signal score
- 629.091
- Event
- diabetes mellitus
- Reports
- 722
- Reporting signal score
- 983.918
- Event
- disturbance in social behaviour
- Reports
- 210
- Reporting signal score
- 681.093
- Event
- drug abuse
- Reports
- 747
- Reporting signal score
- 909.231
- Event
- drug interaction
- Reports
- 841
- Reporting signal score
- 321.868
- Event
- dysarthria
- Reports
- 351
- Reporting signal score
- 306.816
- Event
- dyskinesia
- Reports
- 430
- Reporting signal score
- 553.833
- Event
- dyslipidaemia
- Reports
- 169
- Reporting signal score
- 330.05
- Event
- dystonia
- Reports
- 505
- Reporting signal score
- 1,010.89
- Event
- electrocardiogram qt prolonged
- Reports
- 783
- Reporting signal score
- 1,144.17
- Event
- extrapyramidal disorder
- Reports
- 596
- Reporting signal score
- 1,249.48
And 32 more, listed on the interactive page.
- NCT00000374
- NCT00001656
- NCT00007774
- NCT00014001
- NCT00018668
- NCT00034801
- NCT00034892
- NCT00036088
- NCT00044655
- NCT00048828
- NCT00051298
- NCT00053703
- NCT00073164
- NCT00088049
- NCT00088465
- NCT00088478
- NCT00088491
- NCT00089869
- NCT00090012
- NCT00094640
- NCT00100776
- NCT00103571
- NCT00108368
- NCT00113594
- NCT00145444
And 225 more, listed on the interactive page.
- Dose
- 10mg, 7.5mg, 5mg, or 2.5mg
- Route
- Intramuscular
- How often
- Every 2 to 4 hours as needed, up to 3 doses
- Assess for orthostatic hypotension prior to subsequent doses
- Maximum of 3 doses within 2 to 4 hours
- Hydrogen bond acceptors
- 5
- Hydrogen bond donors
- 1
- Polar surface area
- 30.87
- Calculated partition coefficient (ALogP)
- 3.44
- Calculated partition coefficient (XLogP)
- 2.9
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 0
- Heavy atoms
- 22
- Molecular formula
- C17H20N4S
- Monoisotopic mass
- 312.14086783
- Natural product
- Yes
- 0093-5245
- 0093-5246
- 0093-5247
- 0093-5248
- 0093-5503
- 0093-5504
- 0093-5505
- 0093-5506
- 0093-5507
- 0121-1072
- 0143-9199
- 0517-0955
- 0527-3161
- 0527-3162
- 0527-3163
- 0527-3164
- 0615-8243
- 0615-8244
- 0615-8245
- 0615-8246
- 0615-8566
- 0781-3159
- 0781-9105
- 0904-6286
- 0904-6287
And 212 more, listed on the interactive page.
- Recorded assays
- 3,502
- Active assays
- 477
- Confirmatory
- Other
- Screening
- Summary
- Antiemetics
- Antipsychotic Agents
- Selective Serotonin Reuptake Inhibitors
These details could not be displayed.
Related records
Trials (398)
- "Extended" (Alternate Day) Antipsychotic Dosing
- "Olanzapine for Prevention of Chemotherapy Induced Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy (HEC)"
- 15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
- 3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008)
- 3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)
- 40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)
- 5-HTR2A, DRD2,and COMT Genes Polymorphisms and Olanzapine Plasma Concentration in Treatment of Early-onset Schizophrenia
- 6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)
- 6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)
- 9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)
- A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia
- A Clinical Study That Will Assess How Food Moves Through the Stomach and Effects Blood Glucose Levels in Subjects With Schizophrenia Taking SEP-363856 or and Prior Antipsychotic (PA) Standard
- A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia
- A Cohort Study on the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy for Lung Cancer Using Rolapitant and Palonosetron
- A Combination of Two Currently Approved Drugs to Enhance the Treatment of Schizophrenia
- A Comparative Study of New Medications for Psychosis in Adolescents
- A Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug
- A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients
- A Comparison of Two Standard Therapies in the Management of Dementia With Agitation
- A Controlled Study of Olanzapine in Children With Autism
Approved for (7)
- Bipolar depression
- Bipolar disorder
- Major depressive disorder
- Mental disorder
- Psychotic disorder
- Schizoaffective disorder
- Schizophrenia
In development for (22)
- Alcohol dependence Phase 3
- Amyotrophic lateral sclerosis Phase 2
- Anorexia nervosa Phase 2
- Anxiety Phase 3
- Autism Phase 2
- Borderline personality disorder Phase 3
- Delirium Phase 2
- Dementia Phase 3
- Depressive disorder Phase 3
- Developmental disability Phase 3
- Drug-induced dyskinesia Phase 1
- Eating disorder Phase 3
- Female reproductive organ cancer Phase 3
- Fish eye disease Phase 1
- Gastric cancer Phase 2
- Huntington disease Phase 3
- Intellectual disability Phase 3
- Mood disorder Phase 1
- Neoplasm Phase 3
- Opioid abuse Phase 2
Other linked conditions (2)
- Migraine disorder
- Treatment-refractory schizophrenia