Vraylar

(Cariprazine)

ApprovedSmall molecule

Vraylar is a small molecule that works as a Dopamine D2 Receptor Modulator; Dopamine D3 Receptor Modulator.[2] It is being used across 14 indications, with its most advanced program in Approved.[1]

Vraylar is one of 379 small molecule programs targeting Bipolar I Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

378

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Bipolar I DisorderActive, not recruiting

Depressive DisorderApproved

CognitionActive, not recruiting

PsychosisActive, not recruiting

Cocaine Use DisorderActive, not recruiting

Social Anxiety DisorderActive, not recruiting

Autism Spectrum DisorderActive, not recruiting

Major Depressive DisorderApproved

SchizophreniaActive, not recruiting

Bipolar DisorderActive, not recruiting

Bipolar I DisorderPhase 3

Active, not recruiting

Depressive DisorderApproved

Approved

CognitionPhase 3

Active, not recruiting

PsychosisApproved

Active, not recruiting

Cocaine Use DisorderPhase 2

Active, not recruiting

Social Anxiety DisorderApproved

Active, not recruiting

Autism Spectrum DisorderPhase 3

Active, not recruiting

Major Depressive DisorderApproved

Approved

SchizophreniaPhase 3

Active, not recruiting

Bipolar DisorderApproved

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

583 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Vraylar

AbbVie

Approved

11 2

Celexa

AbbVie

Preclinical

4 3

Ozempic

Novo Nordisk

Preclinical

1 4

Resotran

Takeda

Preclinical

1 5

Inapsine

Alnylam Pharmaceuticals

Preclinical

1 6

Zocor

OOrganon and Co

Preclinical

6 7

Depakote

Ibrance

Lunesta

3 10

Persantine

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Schizophrenia

NCT03817502

Q1 2027

Phase 3Recruiting

Depression

NCT04777357

Q2 2027

Post-ApprovalNot yet recruiting

Bipolar Depression

NCT05060549

Phase 1/2Recruiting

Long-Acting Injection

NCT07185815

Q3 2027

ApprovedNot yet recruiting

Depression

NCT07676669

Clinical

Trials by Indication[1]

Schizophrenia11 trials

Safety and Efficacy of Cariprazine in Schizophrenia

Completed·FForest Laboratories·Phase 3·NCT01104779·446 enrolled

Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia

Terminated· AbbVie logo

AbbVie·Phase 3·NCT03593213·587 enrolled

Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

Completed·FForest Laboratories·Phase 2·NCT00694707·732 enrolled

Show 8 more trials

Long-term Study of Cariprazine in Patients With Schizophrenia

Completed·FForest Laboratories·Phase 3·NCT01104792·752 enrolled

A Study of Cariprazine in Patients With Chronic Stable Schizophrenia

Completed·FForest Laboratories·Phase 2·NCT00839852·97 enrolled

Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 2·NCT00862992·34 enrolled

Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

Completed·FForest Laboratories·Phase 1·NCT01376076·129 enrolled

Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia

Recruiting·GGedeon Richter Plc.·Phase 3·NCT03817502·330 enrolled

Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia

Terminated· AbbVie logo

AbbVie·Phase 3·NCT05368558·34 enrolled

A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia

Completed·FForest Laboratories·Phase 3·NCT01412060·765 enrolled

Safety and Efficacy of Cariprazine in Patients With Schizophrenia

Completed·FForest Laboratories·Phase 3·NCT01104766·617 enrolled

Major Depressive Disorder6 trials

Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

Completed·FForest Laboratories·Phase 2·NCT01469377·819 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT03739203·752 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT03738215·759 enrolled

Show 3 more trials

Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

Completed·FForest Laboratories·Phase 3·NCT01715805·1,022 enrolled

Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder

Completed·FForest Laboratories·Phase 3·NCT01838876·442 enrolled

Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder

Not yet recruiting·SSultan Qaboos University·Phase 4·NCT05933538·110 enrolled

Bipolar Depression4 trials

Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

Completed·FForest Laboratories·Phase 2·NCT01396447·584 enrolled

Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)

Recruiting·—·Phase 4·NCT05913947·122 enrolled

Dopamine D3 Receptor Occupancy in Bipolar Depression

Not yet recruiting·NNew York State Psychiatric Institute·Phase 4·NCT05060549·8 enrolled

Show 1 more trial

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Active, not recruiting·MMassachusetts General Hospital·Phase 4·NCT06433635·2,726 enrolled

Depression4 trials

Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression

Completed·FForest Laboratories·Phase 3·NCT02670551·488 enrolled

Comparison Of Efficacy And Safety Of Lumateperone And Cariprazine as Adjunctive Treatment in Bipolar I Depression

Not yet recruiting·WWatim Medical & Dental College·Approved·NCT07676669·140 enrolled

A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in Pediatric Subjects (10 to 17 Years of Age) in the Treatment of Depressive Episodes Associated With Bipolar I Disorder

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT04777357·380 enrolled

Show 1 more trial

RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)

Recruiting·MMayo Clinic·Approved·NCT07266545·120 enrolled

Bipolar I Disorder4 trials

Safety and Efficacy of Cariprazine for Bipolar I Disorder

Completed·FForest Laboratories·Phase 3·NCT01058668·497 enrolled

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

Completed·FForest Laboratories·Phase 3·NCT02670538·493 enrolled

Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

Completed·FForest Laboratories·Phase 3·NCT01059539·403 enrolled

Show 1 more trial

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT03573297·901 enrolled

13 more indications

Autism Spectrum Disorder2 trials

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT05439616·161 enrolled

Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder

Completed· AbbVie logo

AbbVie·Phase 3·NCT04578756·310 enrolled

Safety and Efficacy2 trials

Safety and Efficacy of Cariprazine for Mania

Completed·FForest Laboratories·Phase 3·NCT01058096·323 enrolled

Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression

Completed·FForest Laboratories·Phase 2·NCT00852202·234 enrolled

Cocaine Use Disorder1 trial

Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder

Terminated·—·Phase 2·NCT03430544·14 enrolled

Attention Deficit Hyperactivity Disorder1 trial

Adjunct Treatment With Cariprazine for Adults With Attention-deficit/Hyperactivity Disorder

Unknown status·—·Phase 4·NCT04843423·15 enrolled

Long-Acting Injection1 trial

Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine

Recruiting·MMapi Pharma Ltd.·Phase 1/2·NCT07185815·24 enrolled

Generalized Anxiety Disorder1 trial

A Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone

Withdrawn· AbbVie logo

AbbVie·Phase 2·NCT04965272

Opioid Use Disorder1 trial

Cariprazine for Comorbid Cocaine and Opioid Use Disorder

Completed·KKyle Kampman·Phase 2·NCT05063201·26 enrolled

Cognition1 trial

Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients

Terminated·LLakshmi N Yatham·Phase 3·NCT04771299·1 enrolled

Treatment1 trial

Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania

Completed·FForest Laboratories·Phase 2·NCT00488618·238 enrolled

CAR1 trial

Cariprazine: Comparison of Slow- and Immediate-release Forms

Completed·GGedeon Richter Plc.·Phase 1·NCT02165098·160 enrolled

Pediatric1 trial

Cariprazine Pediatric ASD PK Study

Completed· AbbVie logo

AbbVie·Phase 1·NCT04382885·24 enrolled

Social Anxiety Disorder1 trial

Cariprazine Versus Placebo for Social Anxiety Disorder

Completed·TThe Medical Research Network·Phase 4·NCT05384483·40 enrolled

Bipolar 1 Disorder1 trial

Risperidone vs Cariprazine in Acute Mania a Head to Head Comparison of Efficacy vs Tolerability

Not yet recruiting·PPakistan Institute of Medical Sciences·Approved·NCT07665073·50 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 18, 2025

VRAYLAR

NDA NDA204370

Sources

References

[1]
ClinicalTrials.gov — 44 trial records for Cariprazine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cariprazine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cariprazine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA204370). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Vraylar. U.S. Food & Drug Administration.
[6]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dopamine D2 Receptor Modulator; Dopamine D3 Receptor Modulator[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AbbVie

Patent Landscape[5]

Patent Cliff

Dec 20, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7943621Dec 20, 2028

7943621*PEDJun 16, 2029

RE47350Jul 16, 2029

RE49110Jul 16, 2029

RE49302Jul 16, 2029

5 more patents

7737142Sep 17, 2029

RE49302*PEDJan 16, 2030

RE47350*PEDJan 16, 2030

RE49110*PEDJan 16, 2030

7737142*PEDMar 17, 2030

Vraylar

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Schizophrenia11 trials

Major Depressive Disorder6 trials

Bipolar Depression4 trials

Depression4 trials

Bipolar I Disorder4 trials

Autism Spectrum Disorder2 trials

Safety and Efficacy2 trials

Cocaine Use Disorder1 trial

Attention Deficit Hyperactivity Disorder1 trial

Long-Acting Injection1 trial

Generalized Anxiety Disorder1 trial

Opioid Use Disorder1 trial

Cognition1 trial

Treatment1 trial

CAR1 trial

Pediatric1 trial

Social Anxiety Disorder1 trial

Bipolar 1 Disorder1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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