Overview
Olanzapine is a thienobenzodiazepine classified as an atypical or second-generation antipsychotic agent. The second-generation antipsychotics were introduced in the 90s and quickly gained traction due to their impressive efficacy, reduced risk for extrapyramidal side effects and reduced susceptibility to drug-drug interactions. Olanzapine very closely resembles clozapine and only differs by two additional methyl groups and the absence of a chloride moiety. It was discovered by scientists at Eli Lilly and approved to be marketed in the US in 1996.
Indication
Olanzapine was initially used orally and intramuscularly for the chronic treatment of schizophrenia in patients over 13 years old and other psychiatric disorders such as bipolar I disorder including mixed or manic episodes. Olanzapine is also indicated, in combination with lithium or valproate for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults. As well, olanzapine is indicated, in combination with fluoxetine for the treatment of episodes of depression associated with bipolar disorder type 1 and treatment-resistant depression in patients over 10 years old. Olanzapine is also approved for the management of psychomotor agitation associated with schizophrenia and bipolar I mania. Schizophrenia is a complex biochemical brain disorder that affects the person's ability to differentiate reality. It is usually observed as the presence of delusions, hallucinations, social withdrawal and disturbed thinking. Bipolar disorder is a mental health condition defined by periods of extreme mood disturbances. It is categorized in different types from which type 1 is known to involve episodes of severe mania and often depression while type 2 presents less severe forms of mania. Olanzapine is also indicated in combination with samidorphan for the treatment of bipolar I disorder, either as an adjunct to lithium or valproate or as monotherapy for the acute treatment of manic or mixed episodes or as maintenance therapy, and for the treatment of schizophrenia in adults.
Associated Conditions
- Acute Agitation
- Bipolar 1 Disorder
- Bipolar Disorder With Manic or Mixed Episodes
- Delirium
- Delusional Parasitosis
- Depressive Episodes
- Gilles de la Tourette's Syndrome
- Major depressive disorder, recurrent episode
- Mixed manic depressive episode
- Post Traumatic Stress Disorder (PTSD)
- Psychosis
- Schizophrenia
- Acute Manic episode
Research Report
Olanzapine (DB00334): A Comprehensive Pharmacological and Clinical Monograph
I. Introduction and Drug Identification
1.1. Overview and Classification
Olanzapine is a potent, second-generation (atypical) antipsychotic (SGA) agent that has become a cornerstone in the management of severe and persistent psychiatric disorders, most notably schizophrenia and bipolar I disorder.[1] Chemically, it is classified as a thienobenzodiazepine derivative, a structural class it shares with its predecessor, clozapine.[1] This structural heritage is fundamental to understanding its clinical profile, as it foreshadows both its broad, clozapine-like efficacy and some of its significant metabolic liabilities.[4]
Reflecting its complex pharmacology, olanzapine is also categorized as a Multi-Acting Receptor Targeted Antipsychotic (MARTA). This designation highlights its mechanism of action, which involves simultaneous antagonism at a wide array of neurotransmitter receptors, including dopamine, serotonin, histamine, adrenergic, and muscarinic receptors.[1] This broad receptor-binding profile is responsible for its therapeutic effects across different symptom domains as well as its extensive side-effect profile.
1.2. Historical Context and Development
Developed by scientists at Eli Lilly and Company under the internal code LY170053, olanzapine was patented in 1991 and received its initial approval from the U.S. Food and Drug Administration (FDA) in 1996.[4] Its development was a direct and strategic effort to engineer a novel antipsychotic with the superior efficacy of clozapine but without the associated risk of life-threatening agranulocytosis, a severe adverse effect that necessitates rigorous hematological monitoring and limits clozapine's use.[5]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/08/18 | Not Applicable | Withdrawn | |||
2008/08/14 | Phase 2 | Terminated | |||
2008/08/05 | Phase 2 | Completed | |||
2008/07/10 | Phase 3 | Completed | |||
2008/06/18 | Not Applicable | Completed | The New England Baptist Hospital | ||
2008/06/06 | Phase 2 | Completed | |||
2008/05/30 | Phase 2 | Completed | |||
2008/05/28 | Phase 4 | Completed | |||
2008/05/15 | Phase 2 | Completed | |||
2008/05/06 | Phase 4 | Withdrawn |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eli Lilly and Company | 0002-4456 | ORAL | 20 mg in 1 1 | 11/11/2022 | |
| Apotex Corp. | 60505-3111 | ORAL | 5 mg in 1 1 | 7/19/2023 | |
| Indoco Remedies Limited | 14445-109 | ORAL | 10 mg in 1 1 | 8/14/2020 | |
| Quality Care Products, LLC | 55700-743 | ORAL | 10 mg in 1 1 | 4/25/2019 | |
| NorthStar RxLLC | 72603-154 | ORAL | 2.5 mg in 1 1 | 8/17/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-308 | INTRAMUSCULAR | 10 mg in 2 mL | 4/3/2023 | |
| AvPAK | 50268-617 | ORAL | 15 mg in 1 1 | 11/7/2023 | |
| H2-Pharma LLC | 61269-630 | ORAL | 2.5 mg in 1 1 | 10/9/2023 | |
| Qilu Pharmaceutical Co., Ltd. | 67184-0563 | ORAL | 7.5 mg in 1 1 | 5/1/2018 | |
| Rebel Distributors Corp | 42254-222 | ORAL | 7.5 mg in 1 1 | 9/10/2009 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OLANZAPINE | novopharm limited | 02301059 | Tablet - Oral | 15 MG | N/A |
| OLANZAPINE ODT | meliapharm inc | 02348179 | Tablet (Orally Disintegrating) - Oral | 10 MG | 10/18/2011 |
| AG-OLANZAPINE FC | angita pharma inc. | 02487616 | Tablet - Oral | 5 MG | 1/21/2020 |
| ACT OLANZAPINE | actavis pharma company | 02325675 | Tablet - Oral | 7.5 MG | 10/15/2009 |
| VAN-OLANZAPINE | vanc pharmaceuticals inc | 02428024 | Tablet - Oral | 7.5 MG | 7/10/2015 |
| OLANZAPINE | sivem pharmaceuticals ulc | 02385872 | Tablet - Oral | 5 MG | 6/12/2012 |
| OLANZAPINE | PRO DOC LIMITEE | 02311984 | Tablet - Oral | 7.5 MG | 2/1/2010 |
| OLANZAPINE | Cobalt Pharmaceuticals Company | 02343886 | Tablet - Oral | 20 MG | N/A |
| OLANZAPINE | Cobalt Pharmaceuticals Company | 02343878 | Tablet - Oral | 15 MG | N/A |
| OLANZAPINE | 02419386 | Tablet - Oral | 2.5 MG | N/A |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| OLANZAPINA QUALIGEN 5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Neuraxpharm Spain S.L. | 68733 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| OLANZAPINA PENSA 7,5 mg COMPRIMIDOS EFG | Towa Pharmaceutical S.A. | 68901 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| OLANZAPINA VIR 15 MG COMPRIMIDOS BUCODISPERSABLES EFG | Industria Quimica Y Farmaceutica Vir S.A. | 76711 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| OLANZAPINA KERN PHARMA 10 mg COMPRIMIDOS EFG | 68680 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| OLANZAPINA APOTEX 5 mg COMPRIMIDOS BUCODISPERSABLES EFG | Apotex Europe B.V. | 10635008 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| OLANZAPINA TEVA-RATIO 10 mg COMPRIMIDOS BUCODISPERSABLES EFG | Teva Pharma S.L.U. | 73478 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| OLANZAPINA ALTER 10 mg COMPRIMIDOS BUCODISPERSABLES EFG | Laboratorios Alter S.A. | 73413 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| OLANZAPINA SUN 10 mg COMPRIMIDOS EFG | 72157 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| ZYPREXA 5 MG COMPRIMIDOS RECUBIERTOS | 96022004IP5 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| OLANZAPINA AUROVITAS 7,5 MG COMPRIMIDOS EFG | Aurovitas Spain, S.A.U. | 81003 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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