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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
Drug Type
Small Molecule
Chemical Formula
C17H20N4S
CAS Number
132539-06-1
Unique Ingredient Identifier
N7U69T4SZR
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

3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)

Phase 3
Completed
Conditions
Bipolar Disorder
Interventions
First Posted Date
2005-09-12
Last Posted Date
2024-08-15
Lead Sponsor
Organon and Co
Target Recruit Count
489
Registration Number
NCT00159796

Efficacy and Safety of Asenapine With Placebo and Olanzapine (41021)(P05933)

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2005-09-12
Last Posted Date
2024-08-15
Lead Sponsor
Organon and Co
Target Recruit Count
417
Registration Number
NCT00156117

Efficacy and Safety of Asenapine With Placebo and Olanzapine (41022)(P05947)

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2005-09-09
Last Posted Date
2024-08-15
Lead Sponsor
Organon and Co
Target Recruit Count
277
Registration Number
NCT00151424

Study of LY2140023 in Schizophrenia Comparing LY2140023, Olanzapine, and Placebo

Phase 2
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2005-09-08
Last Posted Date
2021-08-20
Lead Sponsor
Denovo Biopharma LLC
Target Recruit Count
195
Registration Number
NCT00149292
Locations
🇷🇺

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Village Nikolskoe, Russian Federation

Energy Homeostasis Under Treatment With Atypical Antipsychotics

Phase 4
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2005-09-08
Last Posted Date
2008-09-29
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
40
Registration Number
NCT00148564
Locations
🇩🇪

Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy, Berlin, Germany

A First In Human Study Of PF-00184562 In Healthy Volunteers

Phase 1
Completed
Conditions
Schizophrenia
First Posted Date
2005-09-08
Last Posted Date
2006-07-25
Lead Sponsor
Pfizer
Target Recruit Count
18
Registration Number
NCT00150215
Locations
🇺🇸

Pfizer Investigational Site, Austin, Texas, United States

Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2005-09-05
Last Posted Date
2022-02-08
Lead Sponsor
Organon and Co
Target Recruit Count
468
Registration Number
NCT00145496

Kahn Study; Investigation Of The Efficacy Of Ziprasidone Versus Olanzapine In The Management Of Recent-Onset Psychosis; A Flexible-Dose, Parallel Group, Double-Blind Study

Phase 3
Completed
Conditions
Schizophrenia
Psychotic Disorders
First Posted Date
2005-09-05
Last Posted Date
2021-02-21
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
100
Registration Number
NCT00145444
Locations
🇳🇱

Pfizer Investigational Site, Utrecht, Netherlands

9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)

Phase 3
Completed
Conditions
Bipolar Disorder
Interventions
First Posted Date
2005-09-02
Last Posted Date
2024-08-15
Lead Sponsor
Organon and Co
Target Recruit Count
504
Registration Number
NCT00143182

Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder

Phase 3
Completed
Conditions
Bipolar Disorder
Interventions
First Posted Date
2005-08-11
Last Posted Date
2010-12-28
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
224
Registration Number
NCT00129220
Locations
🇯🇵

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tokyo, Japan

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