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Last Updated: May 10, 2024

CLINICAL TRIALS PROFILE FOR SEP-363856


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Clinical Trials for SEP-363856

Trial ID Title Status Sponsor Phase Summary
NCT01940159 ↗ A Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia Completed Sunovion Phase 1 This is a single-center, randomized, single-blind, placebo-controlled, ascending single oral dose study designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of SEP-363856 and its metabolite SEP-363854 in male and female subjects with schizophrenia.
NCT01972711 ↗ Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics Completed Sunovion Phase 1 This study is designed to evaluate the effects of a single dose of SEP-363856 in healthy male and female volunteers with high or low schizotype characteristics.
NCT01994473 ↗ Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia Completed Sunovion Phase 1 This is a study designed to evaluate the safety, tolerability, and PK of SEP-363856 and its metabolite SEP-363854 in male and female subjects with schizophrenia.
NCT02969369 ↗ A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis Completed Sunovion Phase 2 A study to evaluate the safety and tolerability of SEP363856 in subjects with Parkinson's Disease Psychosis. This study is accepting male and female participants 55 years of age and older who have been diagnosed with Parkinson's Disease. This study will be conducted in 24 study centers in the United States. The study will last approximately 21 weeks
NCT02969382 ↗ A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia Completed Sunovion Phase 2 A study to evaluate the efficacy and safety of an experimental drug (SEP-363856) in acutely psychotic adults with schizophrenia
NCT02970929 ↗ An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia Completed Sunovion Phase 2 An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for SEP-363856

Condition Name

Condition Name for
Intervention Trials
Schizophrenia 22
Generalized Anxiety Disorder 1
Major Depressive Disorder 1
Narcolepsy 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Schizophrenia 22
Disease 2
Mental Disorders 1
Depressive Disorder 1
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Clinical Trial Locations for SEP-363856

Trials by Country

Trials by Country for
Location Trials
United States 72
Japan 51
Russian Federation 7
Ukraine 6
Bulgaria 3
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Trials by US State

Trials by US State for
Location Trials
California 11
Texas 7
Georgia 7
Florida 6
Arkansas 6
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Clinical Trial Progress for SEP-363856

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 7
Phase 2/Phase 3 3
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 10
Not yet recruiting 9
Recruiting 7
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Clinical Trial Sponsors for SEP-363856

Sponsor Name

Sponsor Name for
Sponsor Trials
Sunovion 22
Sumitomo Dainippon Pharma Co., Ltd. 3
Sumitomo Pharma Co., Ltd. 2
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 28
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