How many clinical trials are studying Cariprazine?

3 recruiting trials in our tracked data involve Cariprazine.

What conditions is Cariprazine being studied for?

In our tracked recruiting trials, Cariprazine is being studied in trials for Bipolar disorder, Depression, Bipolar I Disorder.

Cariprazine: clinical trials recruiting now

Q: Is Cariprazine FDA-approved?

Yes. According to the FDA drug label available through openFDA, Cariprazine is an FDA-approved drug. Its FDA label carries a boxed warning.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Cariprazine appears in the FDA drug-label database. Marketed as Vraylar.
Drug class: Atypical Antipsychotic (FDA established pharmacologic class)
Boxed warning: The FDA label for Cariprazine carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

. INDICATIONS AND USAGE VRAYLAR ® is indicated for: • Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies ( 14.1 )] • Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies ( 14.2 )] • Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies ( 14.3 )] • Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies ( 14.4 )] VRAYLAR is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults and pediatric patients 13 years of age and older ( 1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and pediatric patients 10 years of age and older ( 1 ) Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults ( 1 ) Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 )

FDA label via openFDA

Phase breakdown

Phase 3 2 Phase 4 1

Conditions being studied

Condition	Trials
Bipolar disorder	2
Depression	2
Bipolar I Disorder	1
Depression, Bipolar	1
Schizophrenia	1

Recruiting trials involving Cariprazine

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.
NCT04777357 · Phase: Phase 3 · Ages: 10 Years to 17 Years · Sex: All (male and female) · 81 locations
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
NCT03817502 · Phase: Phase 3 · Ages: 13 Years to 17 Years · Sex: All (male and female) · 57 locations
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
NCT05913947 · Phase: Phase 4 · Ages: 18 Years to 65 Years · Sex: All (male and female) · 1 location

Common questions

Is Cariprazine FDA-approved?

Yes, marketed as Vraylar. Its FDA label carries a boxed warning.

How many recruiting trials involve Cariprazine?

3 recruiting trials across 5 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.