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Last Updated: December 14, 2024

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) Completed 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.
NCT01670279 ↗ Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive Disorder Completed H. Lundbeck A/S Phase 1 2012-07-01 The purpose of this study is to assess the safety and tolerability of ascending multiple oral doses of brexpiprazole as adjunctive therapy in the treatment of elderly subjects with MDD.
NCT01670279 ↗ Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive Disorder Completed Otsuka Pharmaceutical Development & Commercialization, Inc. Phase 1 2012-07-01 The purpose of this study is to assess the safety and tolerability of ascending multiple oral doses of brexpiprazole as adjunctive therapy in the treatment of elderly subjects with MDD.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Brexpiprazole

Condition Name

Condition Name for Brexpiprazole
Intervention Trials
Schizophrenia 17
Major Depressive Disorder 13
Depression 6
Depressive Disorder, Major 5
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Condition MeSH

Condition MeSH for Brexpiprazole
Intervention Trials
Disease 32
Depressive Disorder 27
Depression 27
Depressive Disorder, Major 24
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Clinical Trial Locations for Brexpiprazole

Trials by Country

Trials by Country for Brexpiprazole
Location Trials
United States 406
Canada 20
Poland 12
Japan 11
Germany 11
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Trials by US State

Trials by US State for Brexpiprazole
Location Trials
California 32
New York 28
Florida 27
Texas 27
Georgia 20
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Clinical Trial Progress for Brexpiprazole

Clinical Trial Phase

Clinical Trial Phase for Brexpiprazole
Clinical Trial Phase Trials
Phase 4 6
Phase 3 45
Phase 2/Phase 3 3
[disabled in preview] 19
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Clinical Trial Status

Clinical Trial Status for Brexpiprazole
Clinical Trial Phase Trials
Completed 39
Recruiting 21
Terminated 6
[disabled in preview] 7
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Clinical Trial Sponsors for Brexpiprazole

Sponsor Name

Sponsor Name for Brexpiprazole
Sponsor Trials
Otsuka Pharmaceutical Development & Commercialization, Inc. 39
H. Lundbeck A/S 28
Otsuka Pharmaceutical Co., Ltd. 26
[disabled in preview] 12
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Sponsor Type

Sponsor Type for Brexpiprazole
Sponsor Trials
Industry 105
Other 38
NIH 1
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