ZYPREXA ZYDIS (olanzapine)
ZYPREXA ZYDIS is indicated for the treatment of Schizophrenia; Bipolar I Disorder.
How ZYPREXA ZYDIS Works
The exact mechanism of action of olanzapine is unclear. Its efficacy in the treatment of schizophrenia is thought to be mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism.
Details
- Status
- Prescription
- First Approved
- 2000-04-06
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING
ZYPREXA ZYDIS Approval History
What ZYPREXA ZYDIS Treats
2 indicationsZYPREXA ZYDIS is approved for 2 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
- Bipolar I Disorder
ZYPREXA ZYDIS Boxed Warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled tri...
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. ZYPREXA (olanzapine) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.5 ), and Patient Counseling Information ( 17 )] . When using olanzapine and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 , 8.5 , 17 ) When using olanzapine and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax.
ZYPREXA ZYDIS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ZYPREXA ZYDIS
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
106 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07581405 | 2026-0216 | Ph 2 | not yet recruiting | GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer |
| NCT05303064 | ALKS 3831-A312 | Ph 3 | recruiting | Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder |
| NCT06554613 | IIT-2024-6804 | Ph 2 | recruiting | Olanzapine Impact on First-line Immunotherapy for Advanced EGFR-negative NSCLC |
| NCT07565428 | MIN-101C19 | Ph 3 | recruiting | Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications |
| NCT07482891 | 2026-012 | Ph 4 | recruiting | An Exploratory Study on Efficacy and Safety of Fosaprepitant and Palonosetron Hydrochloride for Injection in Preventing CINV From Multi-Agent HEC |
| NCT07208305 | AHQU-2025003 | Ph 3 | recruiting | Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting |
| NCT04939090 | A222004 NCI-2021-03303, UG1CA189823 | Ph 3 | active not recruiting | Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients |
| NCT04478838 | 154-2018 | Ph 4 | recruiting | "Extended" (Alternate Day) Antipsychotic Dosing |
| NCT06331520 | Desineo | Ph 3 | completed | NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens |
| NCT06995508 | I 3757323 NCI-2025-03335, I 3757323 | Ph 2 | recruiting | Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial |
| NCT07413809 | 2025-097 | Ph 3 | recruiting | Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen |
| NCT06200181 | 2023-0492 NCI-2023-11092 | Ph 3 | recruiting | Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial |
| NCT05669742 | EMPA2022 | Ph 3 | recruiting | Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients |
| NCT05814640 STAR-AD | 1stChongqingMU--ZXY | Ph 1, Ph 2 | recruiting | Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) |
| NCT05705492 | STUDY00024724 P30CA069533, NCI-2022-10209 | Ph 2 | recruiting | Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer |
| NCT05676294 | 2000033786 No NIH funding | Ph 2 | completed | The Impact of Preoperative Olanzapine on Quality of Recovery After Discharge From Ambulatory Surgery |
| NCT03118986 | 1000053716 | Ph 2 | recruiting | RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy |
| NCT03367572 results posted | URCC16070 NCI-2017-00902, URCC16070 | Ph 3 | completed | Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer |
| NCT06175273 POINT | 89377 UL1TR001998 | Ph 2, Ph 3 | completed | Pediatric Oncology Nutrition Intervention Trial |
| NCT04503668 results posted | UMCC 2019.173 HUM00175458 | Ph 3 | terminated | Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients |
| NCT03781115 | 1612051594 | Ph 1 | recruiting | Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia |
| NCT02431702 DREaM results posted | CR106193 R092670SCH3013 | Ph 3 | completed | A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform |
| NCT03578081 results posted | A221602 NCI-2017-02410, UG1CA189823 | Ph 3 | completed | Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy |
| NCT06850454 | 811/2567(IRB3) | Ph 3 | recruiting | Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy |
| NCT02116530 results posted | A221301 NCI-2014-00446, U10CA031946 | Ph 3 | completed | Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy |
| NCT05895838 DANOHCA | H-21077461 2021-005876-21 | Ph 3 | recruiting | The Danish Out-of-Hospital Cardiac Arrest Study |
| NCT02088060 | CBD-FEP 2012-004335-23 | Ph 2 | terminated | A Four-week Clinical Trial Investigating Efficacy and Safety of Cannabidiol As a Treatment for Acutely Ill Schizophrenic Patients |
| NCT06588413 FONDO-LOW | 2216424 | Ph 3 | recruiting | Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan |
| NCT03557931 results posted | 4345-CL-0015 | Ph 2 | completed | A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication |
| NCT06649214 | QLG1130-301 | Ph 3 | not yet recruiting | A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia |
| NCT06600477 | OLA-1122-126 | Ph 1 | completed | A Study of Olanzapine After Intranasal and Intramuscular Administration |
| NCT05170919 | E-21-862 | Ph 2 | enrolling by invitation | Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer |
| NCT01617187 results posted | P05688 2010-018407-28 | Ph 3 | completed | A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688) |
| NCT06133114 | STUDY-22-01296 | Ph 4 | recruiting | Psychopharmacological Treatment of Emotional Distress |
| NCT05403580 | MC211002 NCI-2022-02478, MC211002 | Ph 3 | withdrawn | Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Patients With Advanced Cancer |
| NCT06357104 | SCI-CT-0001 | Ph 4 | completed | Detoxification From the Lipid Tract |
| NCT00876772 | OLN-ALS01 | Ph 2, Ph 3 | completed | Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS) |
| NCT04518319 | 20200815SMHC-sk-YChen | Ph 2 | suspended | Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome |
| NCT05179772 | 850369 | Ph 2 | withdrawn | Olanzapine in OUD Patients |
| NCT03187769 results posted | ALKS 3831-A307 | Ph 3 | completed | Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder |
| NCT00845026 results posted | 12648 H8Y-MC-HBBR | Ph 2 | completed | A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients |
| NCT02380118 | PR/CT 0309/2014 (SC) HKU 789813M | Ph 4 | terminated | IM Olanzapine Versus Haloperidol or Midazolam |
| NCT02536846 results posted | 2015P001140 041512 | Ph 4 | completed | The Effects of Antipsychotic Drugs on Brain Metabolism in Healthy Individuals |
| NCT04669132 OLNEPA | 38285020.8.0000.0072 | Ph 2 | completed | Efficacy of Olanzapine, Netupitant and Palonosetron in Controlling Nausea and Vomiting Associated With Highly Emetogenic Chemotherapy in Patients With Breast Cancer |
| NCT03631004 | 1287/18 | Ph 2, Ph 3 | completed | Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients |
| NCT01903837 results posted | ALK3831-302 | Ph 2 | completed | A Study of ALKS 3831 in Adults With Schizophrenia |
| NCT03137121 results posted | F170104006 (XUAB 16100) 000515449 | Ph 2, Ph 3 | completed | Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients |
| NCT02435654 | 81460218 | Ph 4 | completed | 5-HTR2A, DRD2,and COMT Genes Polymorphisms and Olanzapine Plasma Concentration in Treatment of Early-onset Schizophrenia |
| NCT00977301 FORZA | UMCN-AKF 08.04 | Ph 1 | completed | Interaction Between Fosamprenavir/Ritonavir and a Single-dose Olanzapine (FORZA) |
| NCT00895921 results posted | R21MH082805 R21MH082805, DATR A5-ETSE | Ph 4 | completed | Examining the Effects of Antipsychotic Medications on Insulin Sensitivity |
Showing 50 of 106 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZYPREXA ZYDIS FDA Label Details
Indications & Usage
FDA Label (PDF)ZYPREXA ZYDIS is indicated for the treatment of Schizophrenia; Bipolar I Disorder.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taki...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.