Brexpiprazole

Generic Name
Brexpiprazole
Brand Names
Rxulti, Rexulti
Drug Type
Small Molecule
Chemical Formula
C25H27N3O2S
CAS Number
913611-97-9
Unique Ingredient Identifier
2J3YBM1K8C
Background

Brexpiprazole is an atypical antipsychotic and a novel D2 dopamine and serotonin 1A partial agonist called serotonin-dopamine activity modulator (SDAM). It has a high affinity for serotonin, dopamine and alpha (α)-adrenergic receptors. Although it is structurally similar to aripiprazole, brexpiprazole has different binding affinities for dopamine and seroton...

Indication

Brexpiprazole is indicated as adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults. It is also indicated for the treatment of schizophrenia in patients 13 years of age and older.
...

Associated Conditions
Agitation, Schizophrenia, Major Depressive Disorder (MDD)
Associated Therapies
-

A Study of Brexpiprazole in Patients With Major Depressive Disorder

Phase 2
Completed
Conditions
Interventions
First Posted Date
2018-10-05
Last Posted Date
2024-08-09
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
740
Registration Number
NCT03697603
Locations
🇯🇵

Nanko-kokorono clinic, Fukushima, Japan

Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

First Posted Date
2018-08-08
Last Posted Date
2024-11-14
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
410
Registration Number
NCT03620981
Locations
🇯🇵

Jisenkai Nanko Psychiatric Institute, Shirakawa, Japan

A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

Phase 3
Completed
Conditions
Interventions
First Posted Date
2018-07-20
Last Posted Date
2023-11-14
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
259
Registration Number
NCT03594123
Locations
🇺🇸

For additional information regarding sites, contact 844-687-8522, Miami, Florida, United States

A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

First Posted Date
2018-06-15
Last Posted Date
2024-11-11
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
233
Registration Number
NCT03557931
Locations
🇺🇸

CNS Research Science, Inc., Jamaica, New York, United States

🇺🇸

Synergy East, Lemon Grove, California, United States

🇺🇸

Pacific Research Partners, LLC, Oakland, California, United States

and more 22 locations

A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type

First Posted Date
2018-06-07
Last Posted Date
2023-09-18
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
345
Registration Number
NCT03548584
Locations
🇺🇸

For additional information regarding sites, contact 844-687-8522, Los Angeles, California, United States

A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder

First Posted Date
2018-05-29
Last Posted Date
2023-10-12
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
1149
Registration Number
NCT03538691
Locations
🇺🇸

For additional information regarding sites, contact 844-687-8522, Los Angeles, California, United States

Controlled Trial of Brexpiprazole For The Treatment of Co-occurring Schizophrenia and Substance Use Disorder

First Posted Date
2018-05-16
Last Posted Date
2024-03-20
Lead Sponsor
University of Massachusetts, Worcester
Target Recruit Count
52
Registration Number
NCT03526354
Locations
🇺🇸

UMass Medical School, Worcester, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Augusta University, Augusta, Georgia, United States

and more 1 locations

The Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in the Treatment of Major Depressive Disorder

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2018-04-03
Last Posted Date
2020-12-29
Lead Sponsor
Otsuka Beijing Research Institute
Target Recruit Count
65
Registration Number
NCT03487198
Locations
🇨🇳

Beijing Anding Hospital of Capital Medical University, Beijing, Beijing, China

Brexpiprazole for Bipolar Depression

Phase 4
Completed
Conditions
Interventions
First Posted Date
2018-02-09
Last Posted Date
2019-03-13
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
21
Registration Number
NCT03427892
Locations
🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

Brexpiprazole in Borderline Personality Disorder

Phase 2
Completed
Conditions
Interventions
First Posted Date
2018-02-01
Last Posted Date
2022-03-18
Lead Sponsor
University of Chicago
Target Recruit Count
80
Registration Number
NCT03418675
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

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