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Last Updated: November 11, 2025

CLINICAL TRIALS PROFILE FOR SEP-363856

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Clinical Trials for SEP-363856

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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.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Summary

Clinical Trial Conditions for SEP-363856

Condition Name

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Condition Name
Intervention	Trials
Schizophrenia	23
Generalized Anxiety Disorder	1
Major Depressive Disorder	1
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Condition MeSH

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Condition MeSH
Intervention	Trials
Schizophrenia	23
Disease	2
Depression	1
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Clinical Trial Locations for SEP-363856

Trials by Country

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Trials by Country
Location	Trials
United States	82
Japan	51
Russian Federation	7
Ukraine	6
Romania	3
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Trials by US State

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Trials by US State
Location	Trials
California	12
Texas	8
Georgia	8
Arkansas	7
Florida	7
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Clinical Trial Progress for SEP-363856

Clinical Trial Phase

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Clinical Trial Phase
Clinical Trial Phase	Trials
PHASE3	1
Phase 3	7
Phase 2/Phase 3	3
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Clinical Trial Status

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Clinical Trial Status
Clinical Trial Phase	Trials
Completed	10
Not yet recruiting	9
Recruiting	8
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Clinical Trial Sponsors for SEP-363856

Sponsor Name

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

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Sponsor Type
Sponsor	Trials
Industry	29
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