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
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/12/31 | Not Applicable | Completed | |||
2015/12/21 | Phase 3 | Completed | |||
2015/12/18 | Phase 3 | Completed | |||
2015/11/09 | N/A | Completed | |||
2015/11/01 | Phase 4 | Completed | University of Ghana Medical School | ||
2015/10/21 | N/A | Completed | Canadian Network for Observational Drug Effect Studies, CNODES | ||
2015/09/29 | Phase 4 | UNKNOWN | |||
2015/09/01 | Phase 4 | Completed | Dost Ongur | ||
2015/06/30 | Phase 3 | Completed | First Affiliated Hospital of Harbin Medical University | ||
2015/06/04 | Phase 2 | Terminated |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Virtus Pharmaceuticals, LLC | 69543-381 | ORAL | 5 mg in 1 1 | 6/15/2022 | |
| H2-Pharma LLC | 61269-635 | ORAL | 20 mg in 1 1 | 10/9/2023 | |
| Zydus Lifesciences Limited | 70771-1416 | ORAL | 2.5 mg in 1 1 | 9/27/2023 | |
| Torrent Pharmaceuticals Limited | 13668-088 | ORAL | 10 mg in 1 1 | 12/8/2022 | |
| Aurobindo Pharma Limited | 65862-658 | ORAL | 15 mg in 1 1 | 5/3/2020 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-265 | ORAL | 5 mg in 1 1 | 3/25/2024 | |
| Major Pharmaceuticals | 0904-6283 | ORAL | 2.5 mg in 1 1 | 12/11/2022 | |
| Cardinal Health 107, LLC | 55154-6889 | ORAL | 10 mg in 1 1 | 12/20/2022 | |
| Bryant Ranch Prepack | 63629-8719 | ORAL | 20 mg in 1 1 | 10/14/2021 | |
| Qilu Pharmaceutical Co., Ltd. | 67184-0561 | ORAL | 2.5 mg in 1 1 | 5/1/2018 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| OPREXA olanzapine 2.5 mg tablet blister pack | 335113 | Medicine | A | 7/1/2020 | |
| ZYLAPINE olanzapine 5 mg uncoated tablet blister pack | 287477 | Medicine | A | 11/3/2017 | |
| OLANCOR olanzapine 5mg film-coated tablet blister pack | 207855 | Medicine | A | 12/12/2014 | |
| APO-OLANZAPINE olanzapine 5 mg tablet blister pack | 303715 | Medicine | A | 8/29/2018 | |
| AURO-OLANZAPINE ODT 5 olanzapine 5 mg orally disintegrating tablet blister pack | 212895 | Medicine | A | 8/26/2014 | |
| ZYPREXA olanzapine 10mg tablet blister pack | 56606 | Pharmaco Australia Ltd | Medicine | A | 3/5/1997 |
| AURO-OLANZAPINE 2.5 olanzapine 2.5 mg tablets bottle | 179936 | Medicine | A | 11/15/2011 | |
| ZYPINE ODT olanzapine 20 mg orally disintegrating tablet blister pack | 189673 | Medicine | A | 6/20/2012 | |
| OLANZAPINE ARW olanzapine 2.5 mg film coated tablet blister pack | 178975 | Medicine | A | 8/11/2011 | |
| OLANCOR olanzapine 10mg film-coated tablet blister pack | 207843 | Medicine | A | 12/12/2014 |
Health Canada Drug Approvals
View More Health Canada Approvals
Sign in to access additional Health Canada approved drug information with detailed regulatory data.
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| MYLAN-OLANZAPINE ODT | Mylan Pharmaceuticals ULC | 02382733 | Tablet (Orally Disintegrating) - Oral | 20 MG | 3/30/2012 |
| APO-OLANZAPINE ODT | 02360624 | Tablet (Orally Disintegrating) - Oral | 10 MG | 8/8/2011 | |
| AVA-OLANZAPINE | avanstra inc | 02373467 | Tablet - Oral | 10.0 MG | 11/23/2011 |
| ACT OLANZAPINE ODT | teva canada limited | 02327562 | Tablet (Orally Disintegrating) - Oral | 5 MG | 10/16/2009 |
| AG-OLANZAPINE ODT | angita pharma inc. | 02487691 | Tablet (Orally Disintegrating) - Oral | 20 MG | N/A |
| PHL-OLANZAPINE ODT | pharmel inc | 02307472 | Tablet (Orally Disintegrating) - Oral | 10 MG | 2/18/2010 |
| RIVA-OLANZAPINE ODT | laboratoire riva inc. | 02339811 | Tablet (Orally Disintegrating) - Oral | 5 MG | 2/17/2010 |
| PMS-OLANZAPINE ODT | 02303191 | Tablet (Orally Disintegrating) - Oral | 5 MG | 10/15/2009 | |
| RAN-OLANZAPINE IR | ranbaxy pharmaceuticals canada inc. | 02429632 | Tablet - Oral | 15 MG | N/A |
| OLANZAPINE | sanis health inc | 02372835 | Tablet - Oral | 7.5 MG | 10/26/2011 |
CIMA AEMPS Drug Approvals
View More CIMA AEMPS Approvals
Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| OLANZAPINA FLAS TARBIS 5 mg COMPRIMIDOS BUCODISPERSABLES EFG | Tarbis Farma S.L. | 73692 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| OLANZAPINA FLAS QUALIGEN 5 mg COMPRIMIDOS BUCODISPERSABLES EFG | Neuraxpharm Spain S.L. | 73677 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| OLANZAPINA KRKA 10 MG COMPRIMIDOS EFG | Krka D.D. Novo Mesto | 70678 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ZYPREXA 5 mg comprimidos recubiertos | 96022004IP1 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| ZOLAFREN 5 mg COMPRIMIDOS EFG | Adamed Laboratorios S.L.U. | 70350 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ARENBIL 2,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Neuraxpharm Spain S.L. | 68990 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| OLANZAPINA TECNIGEN 10 mg COMPRIMIDOS BUCODISPERSABLES EFG | Tecnimede España Industria Farmaceutica S.A. | 75722 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ZYPREXA 10 mg POLVO PARA SOLUCION INYECTABLE | 96022016 | POLVO PARA SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| ZYPREXA 10 mg COMPRIMIDOS RECUBIERTOS | 96022009 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| OLANZAPINA FLAS CINFA 20 mg COMPRIMIDOS BUCODISPERSABLES EFG | Laboratorios Cinfa S.A. | 75237 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
View More Philippines FDA Approvals
Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
View More Saudi SFDA Approvals
Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
View More Malaysia NPRA Approvals
Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
View More UK EMC Drug Information
Sign in to access additional UK EMC drug information with detailed pharmaceutical data.
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.