SEP-363856

Generic Name
SEP-363856
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C9H13NOS
CAS Number
1310426-33-5
Unique Ingredient Identifier
3K6270MG59
Background

SEP-363856 is a novel psychotropic drug being investigated for the treatment of schizophrenia. Unlike other drugs used for this condition, SEP-363856 does not bind to the dopamine D2 receptors, but exerts actions on the trace amine–associated receptor 1 (TAAR1) and 5-hydroxytryptamine type 1A (5-HT1A).
...

Associated Conditions
-
Associated Therapies
-

A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia

Phase 1
Completed
Conditions
Interventions
First Posted Date
2023-05-08
Last Posted Date
2024-06-26
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
60
Registration Number
NCT05848700
Locations
🇺🇸

Woodland International Research Group, LLC, Little Rock, Arkansas, United States

🇺🇸

Neuro-Behavioral Clinical Research, Inc, North Canton, Ohio, United States

🇺🇸

Pillar Clinical Research, LLC, Richardson, Texas, United States

and more 4 locations

An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication

Phase 3
Conditions
Interventions
First Posted Date
2023-02-23
Last Posted Date
2024-02-20
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
67
Registration Number
NCT05741528
Locations
🇺🇸

Advanced Research Center Inc., Anaheim, California, United States

🇺🇸

Collaborative Neuroscience Research, LLC, Torrance, California, United States

🇺🇸

Clinical Innovations, Inc., Riverside, California, United States

and more 17 locations

A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2023-02-15
Last Posted Date
2024-06-26
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
434
Registration Number
NCT05729373
Locations
🇪🇸

Hospital de Antequera Site#400, Málaga, Spain

🇺🇸

University of Alabama at Birmingham Site #116, Huntsville, Alabama, United States

🇺🇸

Excell Research, Inc. Site #106, Oceanside, California, United States

and more 59 locations

A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication

Phase 3
Completed
Conditions
Interventions
First Posted Date
2022-11-28
Last Posted Date
2024-06-26
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
101
Registration Number
NCT05628103
Locations
🇺🇸

Clinical Innovations, Inc, Riverside, California, United States

🇺🇸

California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC), San Diego, California, United States

🇺🇸

Cenexel CNS Research, Torrance, California, United States

and more 22 locations

A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2022-10-25
Last Posted Date
2024-05-29
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
900
Registration Number
NCT05593029
Locations
🇺🇸

For additional information regarding sites, contact 844-687-8522, New York, New York, United States

A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia

First Posted Date
2022-09-15
Last Posted Date
2024-06-26
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
19
Registration Number
NCT05542264
Locations
🇺🇸

Shari DeSilva, Rogers, Arkansas, United States

🇺🇸

Woodland International Research Group, Little Rock, Arkansas, United States

🇺🇸

Endeavor Clinical Trials, San Antonio, Texas, United States

and more 1 locations

A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia

Phase 1
Completed
Conditions
Interventions
First Posted Date
2022-07-19
Last Posted Date
2024-06-26
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
15
Registration Number
NCT05463770
Locations
🇺🇸

CNRI - San Diego LLC, San Diego, California, United States

🇺🇸

Catalina Research Institute LLC, Montclair, California, United States

🇺🇸

Pillar Clinical Research, LLC, Richardson, Texas, United States

and more 5 locations

A Clinical Study That Will Assess How Food Moves Through the Stomach and Effects Blood Glucose Levels in Subjects With Schizophrenia Taking SEP-363856 or and Prior Antipsychotic (PA) Standard

First Posted Date
2022-06-02
Last Posted Date
2024-06-26
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
31
Registration Number
NCT05402111
Locations
🇺🇸

Woodland Research Northwest, LLC, Rogers, Arkansas, United States

🇺🇸

Woodland International Research Group, Little Rock, Arkansas, United States

🇺🇸

Collaborative Neuroscience Research, LLC, Long Beach, California, United States

and more 4 locations

A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2022-05-03
Last Posted Date
2024-04-12
Lead Sponsor
Sumitomo Pharma Co., Ltd.
Target Recruit Count
68
Registration Number
NCT05359081
Locations
🇯🇵

Sangubashi Kokorono Clinic, Shibuya-ku, Tokyo, Japan

🇯🇵

Ryokuwakai Stresscare Hibiya Clinic, Chiyoda-ku, Tokyo, Japan

🇯🇵

Kuramitsu Hospital, Fukuoka-shi, Fukuoka, Japan

and more 48 locations

A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia.

Phase 1
Completed
Conditions
Interventions
First Posted Date
2021-04-29
Last Posted Date
2024-06-26
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
21
Registration Number
NCT04865835
Locations
🇺🇸

Hassman Research Institute, Marlton, New Jersey, United States

🇺🇸

At Fort Lauderdale Behavioral Health Center, Oakland Park, Florida, United States

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