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Last Updated: September 22, 2021

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CLINICAL TRIALS PROFILE FOR BREXPIPRAZOLE

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All Clinical Trials for Brexpiprazole

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01360632 ↗ Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial) Completed Otsuka Pharmaceutical Development & Commercialization, Inc. Phase 3 2011-06-01 To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT
NCT01360645 ↗ Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial) Completed Otsuka Pharmaceutical Development & Commercialization, Inc. Phase 3 2011-07-01 To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT
NCT01360866 ↗ Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial) Active, not recruiting Otsuka Pharmaceutical Development & Commercialization, Inc. Phase 3 2011-10-01 To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)
NCT01668797 ↗ Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia Completed Quintiles, Inc. Phase 3 2012-10-01 The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.
NCT01668797 ↗ Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia Completed Otsuka Pharmaceutical Development & Commercialization, Inc. Phase 3 2012-10-01 The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Brexpiprazole

Condition Name

Condition Name for Brexpiprazole
Intervention Trials
Schizophrenia 14
Major Depressive Disorder 13
Depression 6
Mental Disorders 5
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Condition MeSH

Condition MeSH for Brexpiprazole
Intervention Trials
Disease 31
Depressive Disorder 26
Depression 26
Depressive Disorder, Major 23
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Clinical Trial Locations for Brexpiprazole

Trials by Country

Trials by Country for Brexpiprazole
Location Trials
United States 346
Canada 18
Germany 11
Poland 10
Russian Federation 7
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Trials by US State

Trials by US State for Brexpiprazole
Location Trials
California 29
Florida 24
Texas 23
New York 22
Georgia 18
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Clinical Trial Progress for Brexpiprazole

Clinical Trial Phase

Clinical Trial Phase for Brexpiprazole
Clinical Trial Phase Trials
Phase 4 5
Phase 3 43
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Brexpiprazole
Clinical Trial Phase Trials
Completed 20
Recruiting 20
Not yet recruiting 19
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Clinical Trial Sponsors for Brexpiprazole

Sponsor Name

Sponsor Name for Brexpiprazole
Sponsor Trials
Otsuka Pharmaceutical Development & Commercialization, Inc. 36
H. Lundbeck A/S 27
Otsuka Pharmaceutical Co., Ltd. 22
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Sponsor Type

Sponsor Type for Brexpiprazole
Sponsor Trials
Industry 96
Other 37
NIH 1
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