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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/25 | Phase 3 | Not yet recruiting | Shanghai Children's Medical Center | ||
2025/05/29 | Phase 2 | Not yet recruiting | |||
2025/02/27 | Phase 3 | Recruiting | |||
2024/10/18 | Phase 3 | Not yet recruiting | |||
2024/09/19 | Phase 1 | Completed | |||
2024/09/19 | Phase 3 | Recruiting | |||
2024/08/15 | Phase 2 | Not yet recruiting | Second Affiliated Hospital of Nanchang University | ||
2024/07/24 | Phase 3 | Recruiting | |||
2024/04/10 | Phase 4 | Completed | Pachankis, Yang I., M.D. | ||
2024/03/29 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Dispensing Solutions, Inc. | 68258-7096 | ORAL | 10 mg in 1 1 | 9/10/2009 | |
| Bryant Ranch Prepack | 71335-1936 | ORAL | 10 mg in 1 1 | 5/4/2020 | |
| Apotex Corp. | 60505-3276 | ORAL | 10 mg in 1 1 | 12/4/2023 | |
| Golden State Medical Supply, Inc. | 51407-263 | ORAL | 15 mg in 1 1 | 12/27/2023 | |
| Macleods Pharmaceuticals Limited | 33342-070 | ORAL | 10 mg in 1 1 | 9/29/2022 | |
| AvKARE | 42291-656 | ORAL | 12 mg in 1 1 | 1/10/2024 | |
| AvPAK | 50268-615 | ORAL | 5 mg in 1 1 | 11/7/2023 | |
| Aurobindo Pharma Limited | 65862-562 | ORAL | 5 mg in 1 1 | 11/8/2022 | |
| REMEDYREPACK INC. | 70518-0935 | ORAL | 5 mg in 1 1 | 2/14/2024 | |
| Dispensing Solutions, Inc. | 68258-7093 | ORAL | 15 mg in 1 1 | 10/4/2011 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/27/1996 | ||
Authorised | 2/3/2000 | ||
Authorised | 12/3/2009 | ||
Apotex Europe BV,Baarnsche Dijk 1,3741 LN Baarn,The Netherlands | Authorised | 6/10/2010 | |
Authorised | 12/3/2009 | ||
Authorised | 12/12/2007 | ||
Authorised | 9/27/2007 | ||
Authorised | 10/6/2008 | ||
Authorised | 12/10/2009 | ||
Authorised | 12/11/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ZYPREXA TABLET 10 mg | SIN09410P | TABLET, FILM COATED | 10 mg | 7/23/1997 | |
| Onzapin ODT Orodispersible Tablet 5 mg | SIN13957P | TABLET, ORALLY DISINTEGRATING | 5.0 mg | 5/5/2011 | |
| Onzapin Tablet 10 mg | SIN13956P | TABLET, FILM COATED | 10 mg | 5/5/2011 | |
| JUBREXA ORODISPERSIBLE TABLET 10MG | SIN15496P | TABLET, ORALLY DISINTEGRATING | 10mg | 5/28/2018 | |
| OLANKLINE TABLETS 5MG | SIN14124P | TABLET, FILM COATED | 5.0 MG | 3/20/2012 | |
| ZYPREXA ZYDIS ORODISPERSIBLE TABLET 5 mg | SIN12475P | TABLET | 5 mg | 12/9/2003 | |
| OLANCOR FC TABLETS 5MG | SIN14638P | TABLET, FILM COATED | 5.00 mg | 9/29/2014 | |
| Onzapin Tablet 5 mg | SIN13955P | TABLET, FILM COATED | 5 mg | 5/5/2011 | |
| Olanzapine Mevon Film-coated Tablets 10 mg | SIN14228P | TABLET, FILM COATED | 10.00 mg | 9/13/2012 | |
| Onzapin ODT Orodispersible Tablet 10 mg | SIN13958P | TABLET, ORALLY DISINTEGRATING | 10.0 mg | 5/5/2011 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| OLANZAPINE STADA TAB 5MG | N/A | N/A | N/A | 9/14/2010 | |
| ONZAPIN TAB 5MG | N/A | N/A | N/A | 10/20/2010 | |
| OLANZAPINE ADAMED ORODISPERSIBLE TABLETS 5MG | N/A | N/A | N/A | 4/28/2025 | |
| OLANZAPINE ADAMED ORODISPERSIBLE TABLETS 10MG | N/A | N/A | N/A | 4/28/2025 | |
| OLANZAPINE ORODISPERSIBLE TABLETS 15MG | N/A | N/A | N/A | 6/10/2014 | |
| OLANZAPINE ORODISPERSIBLE TABLETS 20MG | N/A | N/A | N/A | 6/10/2014 | |
| OLANZAPINE STADA TAB 10MG | N/A | N/A | N/A | 9/14/2010 | |
| OLANZAPINE ORODISPERSIBLE TABLETS 10MG | N/A | N/A | N/A | 6/10/2014 | |
| OLANZAPINE ORODISPERSIBLE TABLETS 5MG | N/A | N/A | N/A | 6/10/2014 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| OLANZAPINE CH olanzapine 5 mg tablets bottle | 179930 | Medicine | A | 11/15/2011 | |
| OLANZAPINE ARW olanzapine 15 mg film coated tablet blister pack | 178979 | Medicine | A | 8/11/2011 | |
| TOLAZINE ODT 5 olanzapine 5 mg orodispersible tablet blister pack | 177802 | Medicine | A | 1/18/2012 | |
| ZYPINE olanzapine 7.5 mg tablet blister pack | 154621 | Medicine | A | 11/7/2011 | |
| OLANZAPINE SANDOZ ODT 20 olanzapine 20mg orally disintegrating tablet blister pack | 179093 | Medicine | A | 8/12/2011 | |
| OLANCOR olanzapine 7.5mg film-coated tablet blister pack | 207840 | Medicine | A | 12/12/2014 | |
| OPREXA olanzapine 5 mg tablet blister pack | 335114 | Medicine | A | 7/1/2020 | |
| PRYZEX olanzapine 10 mg tablet blister pack | 335112 | Medicine | A | 7/1/2020 | |
| OLANZAPINE SANDOZ olanzapine 2.5mg film coated tablet, blister pack | 148450 | Medicine | A | 4/5/2011 | |
| ZYPINE olanzapine 5 mg tablet blister pack | 154624 | Medicine | A | 11/7/2011 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OLANZAPINE | 02419394 | Tablet - Oral | 5 MG | N/A | |
| MAR-OLANZAPINE ODT | marcan pharmaceuticals inc | 02389088 | Tablet (Orally Disintegrating) - Oral | 5 MG | 5/16/2013 |
| MAR-OLANZAPINE ODT | marcan pharmaceuticals inc | 02389096 | Tablet (Orally Disintegrating) - Oral | 10 MG | 5/16/2013 |
| APO-OLANZAPINE | 02281821 | Tablet - Oral | 10 MG | 10/9/2009 | |
| DOM-OLANZAPINE | dominion pharmacal | 02307359 | Tablet - Oral | 10 MG | N/A |
| ZYPREXA | 02238850 | Tablet - Oral | 15 MG | 6/24/2002 | |
| AG-OLANZAPINE FC | angita pharma inc. | 02487608 | Tablet - Oral | 2.5 MG | 1/21/2020 |
| ABBOTT-OLANZAPINE ODT | 02414554 | Tablet (Orally Disintegrating) - Oral | 15 MG | 12/3/2014 | |
| ACT OLANZAPINE ODT | teva canada limited | 02327570 | Tablet (Orally Disintegrating) - Oral | 10 MG | 10/16/2009 |
| DOM-OLANZAPINE | dominion pharmacal | 02307324 | Tablet - Oral | 2.5 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| OLANZAPINA TEVA-RATIO 5 mg COMPRIMIDOS BUCODISPERSABLES EFG | Teva Pharma S.L.U. | 73482 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ZYPREXA VELOTAB 10 mg COMPRIMIDOS BUCODISPERSABLES | 99125006 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| OLAZAX 7,5 MG COMPRIMIDOS EFG | 109597002 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| ZYPREXA VELOTAB 5 MG COMPRIMIDOS BUCODISPERSABLES | 99125001IP4 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| ZALASTA 10 MG COMPRIMIDOS BUCODISPERSABLES EFG | Krka D.D. Novo Mesto | 07415043 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| OLANZAPINA QUALIGEN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Neuraxpharm Spain S.L. | 68735 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| OLANZAPINA VIATRIS 20 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 08475030 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| OLANZAPINA AUROVITAS 10 MG COMPRIMIDOS BUCODISPERSABLES EFG | Aurovitas Spain, S.A.U. | 81009 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| OLANZAPINA TEVA 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 107427001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| OLANZAPINA BLUEFISH 5 MG COMPRIMIDOS BUCODISPERSABLES EFG | Bluefish Pharmaceuticals Ab (Publ) | 75739 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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