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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR BREXPIPRAZOLE

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Clinical Trials for Brexpiprazole

Trial ID Title Status Sponsor Phase 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 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 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 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 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 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 Sponsor Phase Summary

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Clinical Trial Conditions for Brexpiprazole

Condition Name

Condition Name for Brexpiprazole
Intervention Trials
Schizophrenia 12
Major Depressive Disorder 8
Depression 6
Mood Disorders 5
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Condition MeSH

Condition MeSH for Brexpiprazole
Intervention Trials
Disease 24
Depressive Disorder 20
Depression 20
Depressive Disorder, Major 18
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Clinical Trial Locations for Brexpiprazole

Trials by Country

Trials by Country for Brexpiprazole
Location Trials
United States 339
Germany 11
Poland 10
Canada 9
Russian Federation 7
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Trials by US State

Trials by US State for Brexpiprazole
Location Trials
California 28
Florida 24
Texas 22
New York 20
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 3
Phase 3 35
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Brexpiprazole
Clinical Trial Phase Trials
Completed 20
Not yet recruiting 12
Recruiting 12
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Clinical Trial Sponsors for Brexpiprazole

Sponsor Name

Sponsor Name for Brexpiprazole
Sponsor Trials
Otsuka Pharmaceutical Development & Commercialization, Inc. 29
H. Lundbeck A/S 25
Otsuka Pharmaceutical Co., Ltd. 19
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Sponsor Type

Sponsor Type for Brexpiprazole
Sponsor Trials
Industry 80
Other 7
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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
AstraZeneca
McKinsey
Mallinckrodt
QuintilesIMS
Express Scripts
Moodys
Medtronic
Chubb

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