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.
Background
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
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2014/05/14 | Phase 4 | Completed | |||
2014/05/02 | Phase 2 | Completed | |||
2014/04/17 | Phase 3 | Completed | |||
2014/03/27 | Phase 2 | Completed | |||
2014/03/14 | Phase 2 | Terminated | Central Institute of Mental Health, Mannheim | ||
2014/01/31 | Phase 1 | Completed | Central Institute of Mental Health, Mannheim | ||
2013/11/27 | Phase 1 | Completed | |||
2013/11/27 | Phase 1 | Completed | |||
2013/11/21 | Not Applicable | Completed | University of Turin, Italy | ||
2013/11/06 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Dr. Reddy's Laboratories Ltd. | 55111-168 | ORAL | 20 mg in 1 1 | 11/27/2019 | |
Aurobindo Pharma Limited | 65862-657 | ORAL | 10 mg in 1 1 | 5/3/2020 | |
REMEDYREPACK INC. | 70518-2299 | ORAL | 10 mg in 1 1 | 2/28/2024 | |
Eli Lilly and Company | 0002-3230 | ORAL | 3 mg in 1 1 | 12/23/2021 | |
REMEDYREPACK INC. | 70518-2698 | ORAL | 5 mg in 1 1 | 3/5/2024 | |
American Health Packaging | 68084-525 | ORAL | 2.5 mg in 1 1 | 10/4/2022 | |
Golden State Medical Supply, Inc. | 60429-622 | ORAL | 7.5 mg in 1 1 | 8/8/2023 | |
Major Pharmaceuticals | 0904-6376 | ORAL | 10 mg in 1 1 | 11/21/2019 | |
Golden State Medical Supply, Inc. | 60429-624 | ORAL | 15 mg in 1 1 | 8/8/2023 | |
Apotex Corp. | 60505-3277 | ORAL | 15 mg in 1 1 | 12/4/2023 |
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 |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
TOLAZINE ODT 10 olanzapine 10 mg orodispersible tablet blister pack | 177803 | Medicine | A | 1/18/2012 | |
ZYPINE olanzapine 10 mg tablet blister pack | 154617 | Medicine | A | 11/7/2011 | |
OLANZAPINE SANDOZ ODT 5 olanzapine 5mg orally disintegrating tablet blister pack | 179092 | Medicine | A | 8/12/2011 | |
ZYPINE olanzapine 2.5 mg tablet blister pack | 154620 | Medicine | A | 11/7/2011 | |
Pharm-Olanzapine olanzapine 5mg film-coated tablet blister pack | 207860 | Medicine | A | 12/12/2014 | |
OLANZACOR olanzapine 7.5mg film-coated tablet blister pack | 207851 | Medicine | A | 12/12/2014 | |
ZYLAPINE ODT olanzapine 20 mg orally disintegrating tablet blister pack | 287483 | Medicine | A | 11/3/2017 | |
AURO-OLANZAPINE ODT 20 olanzapine 20 mg orally disintegrating tablet blister pack | 212894 | Medicine | A | 8/26/2014 | |
APO-OLANZAPINE olanzapine 2.5 mg tablet blister pack | 303714 | Medicine | A | 8/29/2018 | |
OLANZAPINE TIH olanzapine 20 mg film-coated tablet bottle | 158961 | Medicine | A | 11/26/2009 |