How many clinical trials are studying Brexpiprazole?

3 recruiting trials in our tracked data involve Brexpiprazole.

What conditions is Brexpiprazole being studied for?

In our tracked recruiting trials, Brexpiprazole is being studied in trials for Depression, Bipolar Depression, Bipolar disorder.

Brexpiprazole: clinical trials recruiting now

Q: Is Brexpiprazole FDA-approved?

Yes. According to the FDA drug label available through openFDA, Brexpiprazole 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. Brexpiprazole appears in the FDA drug-label database. Marketed as Rexulti.
Drug class: Atypical Antipsychotic (FDA established pharmacologic class)
Boxed warning: The FDA label for Brexpiprazole carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

REXULTI is indicated for: Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults Treatment of schizophrenia in adults and pediatric patients ages 13 years and older Treatment of agitation associated with dementia due to Alzheimer's disease Limitations of Use: REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease [see Clinical Studies (14.3) ] . REXULTI is an atypical antipsychotic indicated for: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 , 14.1 ) Treatment of schizophrenia in adults and pediatric patients ages 13 years and older ( 1 , 14.2 ) Treatment of agitation associated with dementia due to Alzheimer's disease ( 1 , 14.3 ) Limitations of Use : REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease ( 1 )

FDA label via openFDA

Phase breakdown

Phase 3 1 Phase 4 1 Not applicable 1

Conditions being studied

Condition	Trials
Depression · Brexpiprazole for Depression	3
Bipolar Depression	1
Bipolar disorder	1
Major Depressive Disorder	1
Psychosis	1
Schizophrenia	1

Recruiting trials involving Brexpiprazole

Brexpiprazole Treatment for Bipolar I Depression
NCT04569448 · Phase: Phase 3 · Ages: 18 Years to 75 Years · Sex: All (male and female) · 3 locations
Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)
NCT05017311 · Phase: Phase 4 · Ages: 18 Years to 65 Years · Sex: All (male and female) · 10 locations
Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders
NCT05962216 · Phase: Not specified · Ages: 18 Years to 65 Years · Sex: All (male and female) · 1 location

Common questions

Is Brexpiprazole FDA-approved?

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

How many recruiting trials involve Brexpiprazole?

3 recruiting trials across 6 conditions.

Is this list of trials complete?

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