LYBALVI (olanzapine)
LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist. It is approved for the treatment of schizophrenia in adults and for various stages of bipolar I disorder in adults. In patients with bipolar I disorder, it is used for the acute treatment of manic or mixed episodes as monotherapy or as an adjunct to lithium or valproate, as well as for maintenance monotherapy.
How LYBALVI Works
The efficacy of LYBALVI is mediated through the distinct actions of its two components on the central nervous system. Olanzapine acts as an antagonist at both dopamine and serotonin type 2 receptors, which is believed to provide its antipsychotic and mood-stabilizing effects. Samidorphan functions as an opioid receptor antagonist. These combined mechanisms work to manage the symptoms associated with schizophrenia and bipolar I disorder.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-05-28
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- TABLET
LYBALVI Approval History
What LYBALVI Treats
3 indicationsLYBALVI is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
- Bipolar I Disorder
- Manic Episode
LYBALVI 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. LYBALVI is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psy...
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. LYBALVI is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )] . 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. LYBALVI is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 )
LYBALVI 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 LYBALVI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
107 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 |
| NCT05547100 | ALKS 3831-112 | Ph 1 | completed | Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan |
| 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) |
Showing 50 of 107 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.
LYBALVI FDA Label Details
Indications & Usage
FDA Label (PDF)LYBALVI is indicated for the treatment of Schizophrenia; Bipolar I Disorder; Manic Episode.
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. LYBALVI is not approved for the treatment of patients with dementia-related psychosis [see Warnings an...
LYBALVI Patents & Exclusivity
Patents (14 active)
Exclusivity
Pro Intelligence Preview
Deep insights for LYBALVI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 336 active patents
Trial Analysis
- • 107 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment