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Olanzapine

Generic Name
Olanzapine
Brand Names
Lybalvi, Olazax, Symbyax, Zalasta, Zypadhera, Zyprexa, Olanzapine Glenmark Europe, Olanzapine Apotex, Olanzapine Teva, Olazax Disperzi, Olanzapine Mylan, Zyprexa Velotab, Olanzapine Glenmark, Olanzapine Viatris (previously Olanzapine Mylan)
Drug Type
Small Molecule
Chemical Formula
C17H20N4S
CAS Number
132539-06-1
Unique Ingredient Identifier
N7U69T4SZR

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
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
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
Sandoz Inc
0781-3159
INTRAMUSCULAR
10 mg in 2 mL
7/30/2015
Strides Pharma Science Limited
64380-174
ORAL
15 mg in 1 1
2/27/2023

EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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