Cariprazine

Generic Name: Cariprazine

Brand Names: Vraylar, Reagila

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₃₂Cl_₂N_₄O

CAS Number: 839712-12-8

Unique Ingredient Identifier: F6RJL8B278

Background: Cariprazine is an atypical antipsychotic agent and a piperazine derivative that was first developed in Hungary. It works as a partial agonist at central dopamine D2, dopamine D3, and serotonin 5-HT receptors and as an antagonist at serotonin 5-HT receptors. Cariprazine has been investigated in a variety of psychiatric disorders, including schizophrenia, bipolar disorders, and major depressive disorder. Cariprazine gained its first global approval in the US in September 2015 and was later approved by Health Canada in April 2022. It is currently used to treat schizophrenia, and manic or mixed episodes and depressive episodes associated with bipolar I disorder.

Indication: Cariprazine is indicated for the treatment of schizophrenia in adults to manage both positive and negative symptoms. It is also indicated to monotherapy for acute management of manic or mixed episodes associated with bipolar I disorder (bipolar mania) in adults, and acute management of depressive episodes associated with bipolar I disorder (bipolar depression) in adults.

Associated Conditions: Bipolar Disorder With Manic or Mixed Episodes, Depressive Episodes, Schizophrenia

Clinical Trials

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Phase 4

Recruiting

Conditions: Depression
Bipolar I Disorder

Interventions: Drug: Aripiprazole/Escitalopram combination
Drug: Lurasidone
Drug: Quetiapine
Drug: Cariprazine

First Posted Date: 2024-05-30

Last Posted Date: 2025-05-15

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 2726

Registration Number: NCT06433635

Locations: 🇺🇸
University of Alabama Birmingham, Birmingham, Alabama, United States
🇺🇸
Steve Strakowski, Bloomington, Indiana, United States
🇺🇸
John Hopkins, Baltimore, Maryland, United States

and more 14 locations

Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder

Phase 4

Not yet recruiting

Conditions: Depressive Disorder, Major

Interventions: Combination Product: Treatment as usual
Drug: Cariprazine

First Posted Date: 2023-07-06

Last Posted Date: 2023-07-07

Lead Sponsor: Sultan Qaboos University

Target Recruit Count: 110

Registration Number: NCT05933538

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

Phase 4

Recruiting

Conditions: Depression, Bipolar

Interventions: Drug: Lithium
Drug: Cariprazine

First Posted Date: 2023-06-22

Last Posted Date: 2023-06-22

Lead Sponsor: Aalborg University Hospital

Target Recruit Count: 122

Registration Number: NCT05913947

Locations: 🇩🇰
Aalborg University Hospital, Aalborg, Denmark

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

Phase 3

Completed

Conditions: Autism Spectrum Disorder

Interventions: Drug: Placebo
Drug: Cariprazine

First Posted Date: 2022-06-30

Last Posted Date: 2025-04-04

Lead Sponsor: AbbVie

Target Recruit Count: 161

Registration Number: NCT05439616

Locations: 🇺🇸
Cincinnati Children's Hospital /ID# 243968, Cincinnati, Ohio, United States
🇺🇸
Core Clinical Research /ID# 243084, Everett, Washington, United States
🇺🇸
Family Psychiatry of The Woodlands /ID# 242867, The Woodlands, Texas, United States

and more 33 locations

Cariprazine Versus Placebo for Social Anxiety Disorder

Phase 4

Completed

Conditions: Social Anxiety Disorder

Interventions: Drug: Cariprazine
Drug: Placebo

First Posted Date: 2022-05-20

Last Posted Date: 2024-08-21

Lead Sponsor: The Medical Research Network

Target Recruit Count: 40

Registration Number: NCT05384483

Locations: 🇺🇸
The Medical Research Network, LLC, New York, New York, United States

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

Phase 3

Active, not recruiting

Conditions: Schizophrenia

Interventions: Drug: Cariprazine
Drug: Placebo

First Posted Date: 2022-05-10

Last Posted Date: 2024-06-20

Lead Sponsor: AbbVie

Target Recruit Count: 34

Registration Number: NCT05368558

Locations: 🇯🇵
Hayakawa Clinic /ID# 242432, Kure City, Hiroshima, Japan
🇯🇵
National Hospital Organization Kure Medical Center /ID# 243405, Kure-shi, Hiroshima, Japan
🇯🇵
Hokkaido University Hospital /ID# 243245, Sapporo-shi, Hokkaido, Japan

and more 49 locations

Cariprazine for Comorbid Cocaine and Opioid Use Disorder

Phase 2

Recruiting

Conditions: Opioid-use Disorder
Cocaine Use Disorder

Interventions: Drug: Placebo
Drug: Cariprazine 1.5 MG

First Posted Date: 2021-10-01

Last Posted Date: 2025-05-20

Lead Sponsor: Kyle Kampman

Target Recruit Count: 48

Registration Number: NCT05063201

Locations: 🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

Dopamine D3 Receptor Occupancy in Bipolar Depression

Phase 4

Not yet recruiting

Conditions: Bipolar Depression

Interventions: Drug: Cariprazine

First Posted Date: 2021-09-29

Last Posted Date: 2025-04-24

Lead Sponsor: New York State Psychiatric Institute

Target Recruit Count: 8

Registration Number: NCT05060549

Locations: 🇺🇸
Columbia University Medical Center, New York, New York, United States

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

Phase 2

Withdrawn

Conditions: Generalized Anxiety Disorder

Interventions: Drug: Cariprazine 1.5 mg/day
Drug: Cariprazine 0.75 mg/day
Drug: Cariprazine 3.0 mg/day
Other: Placebo

First Posted Date: 2021-07-16

Last Posted Date: 2022-04-12

Lead Sponsor: AbbVie

Registration Number: NCT04965272

Locations: 🇺🇸
ATP Clinical Research, Inc /ID# 230445, Costa Mesa, California, United States
🇺🇸
FutureSearch Trials of Dallas, LP /ID# 230535, Dallas, Texas, United States
🇺🇸
Anderson Clinical Research /ID# 230440, Redlands, California, United States

and more 33 locations

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

Phase 4

Conditions: Attention Deficit Hyperactivity Disorder

Interventions: Drug: Cariprazine

First Posted Date: 2021-04-13

Last Posted Date: 2021-12-14

Lead Sponsor: Dr. Martin A. Katzman

Target Recruit Count: 15

Registration Number: NCT04843423

Locations: 🇨🇦
START Clinic for Mood and Anxiety Disorders, Toronto, Ontario, Canada

Drug Development Updates

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