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).
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- Associated Conditions
- -
- Associated Therapies
- -
Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia
- First Posted Date
- 2020-03-30
- Last Posted Date
- 2022-04-12
- Lead Sponsor
- Sumitomo Pharma Co., Ltd.
- Target Recruit Count
- 13
- Registration Number
- NCT04325737
- Locations
- 🇯🇵
Mental Support SOYOKAZE Hospital, Ueda-shi, Nagano-Ken, Japan
🇯🇵Shiranui Hospital, Omuta-shi, Fukuoka-Ken, Japan
🇯🇵Nishiurakai Keihan Hospital, Osaka-Fu, Moriguchi-shi, Japan
A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
- First Posted Date
- 2019-10-01
- Last Posted Date
- 2024-12-16
- Target Recruit Count
- 463
- Registration Number
- NCT04109950
- Locations
- 🇺🇦
Research Site, Vinnytsia, Ukraine
A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging
- First Posted Date
- 2019-07-31
- Last Posted Date
- 2024-11-25
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Target Recruit Count
- 22
- Registration Number
- NCT04038957
- Locations
- 🇬🇧
King's College London, London, United Kingdom
Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia in 2 Parts (Part 1 and 2).
- First Posted Date
- 2017-12-12
- Last Posted Date
- 2022-04-12
- Lead Sponsor
- Sumitomo Pharma Co., Ltd.
- Target Recruit Count
- 24
- Registration Number
- NCT03370640
- Locations
- 🇯🇵
Mental Support SOYOKAZE Hospital, Ueda, Nagano, Japan
🇯🇵Showa University Karasuyama Hospital, Setagaya-Ku, Tokyo, Japan
🇯🇵Yuge Hospital, Kumamoto, Japan
An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia
- First Posted Date
- 2016-11-22
- Last Posted Date
- 2024-07-05
- Target Recruit Count
- 157
- Registration Number
- NCT02970929
- Locations
- 🇺🇸
CNRI-Los Angeles, LLC, Pico Rivera, California, United States
🇺🇸Atlanta Center for Medical Research, Atlanta, Georgia, United States
🇺🇸UCSD Medical Center UCSD Department of Psychiatry, San Diego, California, United States
A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia
- First Posted Date
- 2016-11-21
- Last Posted Date
- 2024-07-05
- Target Recruit Count
- 245
- Registration Number
- NCT02969382
- Locations
- 🇷🇴
Spitalul Clinic de Neuropsihiatrie Craiova, Craiova, Romania
🇺🇸Atlanta Center for Medical Research, Atlanta, Georgia, United States
🇺🇸California Neuropsychopharmacology Clinical Research Institute-LA, LLC(CNRI- LA, LLC), Pico Rivera, California, United States
A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis
- Conditions
- Interventions
- First Posted Date
- 2016-11-21
- Last Posted Date
- 2024-07-05
- Target Recruit Count
- 39
- Registration Number
- NCT02969369
- Locations
- 🇺🇸
Keck School of Medicine of USC/ University of Southern California, Los Angeles, California, United States
🇺🇸University of Miami, Dept. of Neurology, Miami, Florida, United States
🇺🇸The Emory Clinic, Atlanta, Georgia, United States
Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia
- Conditions
- Interventions
- First Posted Date
- 2013-11-25
- Last Posted Date
- 2024-06-26
- Target Recruit Count
- 48
- Registration Number
- NCT01994473
- Locations
- 🇺🇸
California Clinical Trials Medical Group, Glendale, California, United States
🇺🇸Collaborative Neuroscience Network, LLC, Long Beach, California, United States
Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics
- First Posted Date
- 2013-10-30
- Last Posted Date
- 2024-06-26
- Target Recruit Count
- 105
- Registration Number
- NCT01972711
- Locations
- 🇬🇧
University of Manchester, Neuroscience and Psychiatry Unit, Manchester, United Kingdom
🇬🇧Department of Psychiatry, University of Oxford, Warneford Hospital, Headington, Oxford, United Kingdom
A Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia
- First Posted Date
- 2013-09-12
- Last Posted Date
- 2024-06-26
- Target Recruit Count
- 48
- Registration Number
- NCT01940159
- Locations
- 🇺🇸
California Clinical Trials Medical Group, Glendale, California, United States
🇺🇸Collaborative Neuroscience Network, LLC, Long Beach, California, United States
Drug Development Updates
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