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: C_₁₇H_₂₀N_₄S

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

Clinical Trials

Comparison of Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in Patients With Schizophrenia

Phase 3

Completed

Conditions: Schizophrenic Disorders

First Posted Date: 2004-07-28

Last Posted Date: 2007-06-22

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 1205

Registration Number: NCT00088491

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., Izmir, Turkey

Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia

Phase 3

Completed

Conditions: Schizophrenia

First Posted Date: 2004-07-28

Last Posted Date: 2007-06-12

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 402

Registration Number: NCT00088478

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 hrs, EST), or speak with your personal physician., St. Petersburg, Russian Federation

Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

Phase 3

Completed

Conditions: Schizophrenic Disorders
Schizoaffective Disorder

Interventions: Drug: Intramuscular olanzapine depot

First Posted Date: 2004-07-27

Last Posted Date: 2012-01-11

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 931

Registration Number: NCT00088465

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., Tao-Yuan, Taiwan

Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia

Phase 4

Completed

Conditions: Schizophrenia

First Posted Date: 2004-07-21

Last Posted Date: 2007-07-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 560

Registration Number: NCT00088049

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. test, Salt Lake City, Utah, United States

Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder

Phase 3

Completed

Conditions: Borderline Personality Disorder

First Posted Date: 2004-07-21

Last Posted Date: 2006-07-24

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 450

Registration Number: NCT00088036

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, New Haven, Connecticut, United States
🇹🇷
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, Istanbul, Capa, Turkey

Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia

Phase 2

Completed

Conditions: Schizophrenia

First Posted Date: 2003-11-18

Last Posted Date: 2006-08-04

Lead Sponsor: Abbott

Target Recruit Count: 400

Registration Number: NCT00073164

Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness

Phase 4

Terminated

Conditions: Bipolar Disorder

First Posted Date: 2003-10-20

Last Posted Date: 2006-08-04

Lead Sponsor: Abbott

Target Recruit Count: 180

Registration Number: NCT00071253

Locations: 🇺🇸
Rush Presbyterian - St. Luke's, Chicago, Illinois, United States
🇺🇸
UTMB Dept. of Psychiatry, Galveston, Texas, United States
🇺🇸
University of Mississippi Medical Center, Jackson, Mississippi, United States

and more 12 locations

Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay

Phase 3

Completed

Conditions: Mental Retardation
Developmental Delay Disorder

First Posted Date: 2003-07-22

Last Posted Date: 2005-06-24

Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Target Recruit Count: 50

Registration Number: NCT00065273

Locations: 🇺🇸
University of Kansas, Lawrence, Kansas, United States

A Controlled Study of Olanzapine in Children With Autism

Phase 2

Completed

Conditions: Autistic Disorder

Interventions: Drug: olanzapine (Zyprexa)
Drug: Placebo

First Posted Date: 2003-04-02

Last Posted Date: 2015-03-25

Lead Sponsor: FDA Office of Orphan Products Development

Target Recruit Count: 78

Registration Number: NCT00057408

Locations: 🇺🇸
Drexel University College of Medicine c/o Friends Hospital, Philadelphia, Pennsylvania, United States

Study of Pharmacotherapy of Psychotic Depression

Phase 3

Completed

Conditions: Major Depressive Disorder With Psychotic Features

Interventions: Drug: Olanzapine
Other: placebo
Drug: Sertraline

First Posted Date: 2003-03-17

Last Posted Date: 2013-08-02

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 259

Registration Number: NCT00056472

Locations: 🇺🇸
University of Massachusetts Medical School, Worcester, Massachusetts, United States
🇨🇦
University of Toronto, Toronto, Ontario, Canada
🇺🇸
Cornell University, New York, New York, United States

and more 1 locations

Drug Development Updates

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