VRAYLAR (cariprazine hydrochloride)
VRAYLAR is indicated for the treatment of Schizophrenia; Major Depressive Disorder.
How VRAYLAR Works
The exact mechanism of action of cariprazine is unknown, but its efficacy is thought to be mediated through a combination of activities at dopamine and serotonin receptors. The drug acts as a partial agonist at central dopamine D2 and serotonin 5-HT1A receptors and as an antagonist at serotonin 5-HT2A receptors. Cariprazine also forms two major metabolites, desmethylcariprazine and didesmethylcariprazine, which possess receptor binding profiles similar to the parent drug.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-09-17
- Patent Cliff
- 2030
- Revenue
- $905M (Q1-2026)
- Routes
- ORAL
- Dosage Forms
- CAPSULE
VRAYLAR Approval History
What VRAYLAR Treats
2 indicationsVRAYLAR is approved for 2 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
- Major Depressive Disorder
VRAYLAR Boxed Warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS 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. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicida...
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS 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. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for the emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.2 )] . WARNING : INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS 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. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 ) Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. ( 5.2 )
VRAYLAR 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 VRAYLAR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
32 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04777357 3112 Ped BPD | 3112-301-001 2020-004758-32 | Ph 3 | recruiting | A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. |
| NCT05060549 | 8079 | Ph 4 | withdrawn | Dopamine D3 Receptor Occupancy in Bipolar Depression |
| NCT05913947 DUAG9 | 2021-006706-69 | Ph 4 | recruiting | Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9) |
| NCT06433635 SMART-BD | 2024P000831 | Ph 4 | active not recruiting | Sequential Multiple Assignment Randomized Trial for Bipolar Depression |
| NCT05368558 509 JPN Schz results posted | M22-509 | Ph 3 | terminated | Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia |
| NCT03817502 | RGH-MD-20 2018-004006-26 | Ph 3 | recruiting | Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia |
| NCT05439616 | M21-465 | Ph 3 | completed | Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD |
| NCT04771299 CARPZ-01 | H20-01293 | Ph 3 | terminated | Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients |
| NCT05384483 | VRA-MRN-S40 | Ph 4 | completed | Cariprazine Versus Placebo for Social Anxiety Disorder |
| NCT03573297 results posted | RGH-MD-25 2017-000803-25 | Ph 3 | completed | A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features |
| NCT05933538 | 133 | Ph 4 | not yet recruiting | Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder |
| NCT03738215 results posted | 3111-301-001 2018-002782-19 | Ph 3 | completed | Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone |
| NCT03739203 results posted | 3111-302-001 2018-003164-31 | Ph 3 | completed | The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone |
| NCT04382885 | 2000-103-009 | Ph 1 | completed | Cariprazine Pediatric ASD PK Study |
| NCT03593213 results posted | RGH-MD-24 2017-000818-34 | Ph 3 | terminated | Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia |
| NCT01715805 results posted | RGH-MD-72 | Ph 3 | completed | Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) |
| NCT00839852 results posted | RGH-MD-17 | Ph 2 | completed | A Study of Cariprazine in Patients With Chronic Stable Schizophrenia |
| NCT01838876 results posted | RGH-MD-76 | Ph 3 | completed | Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder |
| NCT01104792 results posted | RGH-MD-11 | Ph 3 | completed | Long-term Study of Cariprazine in Patients With Schizophrenia |
| NCT01059539 results posted | RGH-MD-36 | Ph 3 | completed | Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder |
| NCT00694707 results posted | RGH-MD-16 | Ph 2 | completed | Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia |
| NCT02670538 results posted | RGH-MD-53 2016-000756-98 | Ph 3 | completed | Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder |
| NCT02670551 results posted | RGH-MD-54 2016-000757-13 | Ph 3 | completed | Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression |
| NCT01104779 results posted | RGH-MD-05 | Ph 3 | completed | Safety and Efficacy of Cariprazine in Schizophrenia |
| NCT01104766 results posted | RGH-MD-04 | Ph 3 | completed | Safety and Efficacy of Cariprazine in Patients With Schizophrenia |
| NCT00852202 results posted | RGH-MD-52 | Ph 2 | completed | Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression |
| NCT01412060 results posted | RGH-MD-06 2011-002048-29 | Ph 3 | completed | A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia |
| NCT01396447 results posted | RGH-MD-56 2011-002334-39 | Ph 2 | completed | Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression |
| NCT01469377 results posted | RGH-MD-75 | Ph 2 | completed | Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder |
| NCT01058096 results posted | RGH-MD-32 | Ph 3 | completed | Safety and Efficacy of Cariprazine for Mania |
| NCT01058668 results posted | RGH-MD-33 | Ph 3 | completed | Safety and Efficacy of Cariprazine for Bipolar I Disorder |
| NCT01376076 | RGH-MD-02 | Ph 1 | completed | Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia |
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.
VRAYLAR FDA Label Details
Indications & Usage
FDA Label (PDF)VRAYLAR is indicated for the treatment of Schizophrenia; Major Depressive Disorder.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS 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 d...
VRAYLAR Patents & Exclusivity
Patents (10 active)
Exclusivity
Pro Intelligence Preview
Deep insights for VRAYLAR
Revenue Insights
- • Q1-2026: $905M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 636 active patents
Trial Analysis
- • 33 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