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
-

Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders

First Posted Date
2017-09-26
Last Posted Date
2018-06-12
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
24
Registration Number
NCT03292848
Locations
🇺🇸

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

🇺🇸

Alliance for Wellness dba Alliance for Research, Long Beach, California, United States

🇺🇸

Cutting Edge Research Group, Oklahoma City, Oklahoma, United States

and more 6 locations

A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.

Phase 3
Completed
Conditions
Interventions
First Posted Date
2017-09-19
Last Posted Date
2020-08-17
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
381
Registration Number
NCT03287869
Locations
🇺🇸

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

🇧🇬

"Mental Health Centre-Ruse" EOOD, Male department for persons with severe mental disorders, Female department for persons with severe mental disorders, Ruse, Bulgaria

🇵🇱

Indywidualna Specjalistyczna Praktyka Lekarska Wieslaw Jerzy Cubala, Gdańsk, Poland

and more 68 locations

A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder

First Posted Date
2017-08-23
Last Posted Date
2020-02-10
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
322
Registration Number
NCT03259555
Locations
🇺🇸

Galiz Research, Hialeah, Florida, United States

🇺🇸

Ci Trials, Riverside, California, United States

🇺🇸

Richard H Weisler, MD, PA, and Associates, Raleigh, North Carolina, United States

and more 44 locations

A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder

First Posted Date
2017-08-22
Last Posted Date
2020-02-11
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
333
Registration Number
NCT03257865
Locations
🇺🇸

CiTrials, Santa Ana, California, United States

🇺🇸

Research Centers of America LLC, Hollywood, Florida, United States

🇺🇸

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

and more 34 locations

Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2017-08-03
Last Posted Date
2024-10-17
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
296
Registration Number
NCT03238326
Locations
🇺🇸

For additional information regarding sites, contact 844-687-8522, Kinston, North Carolina, United States

A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD)

Phase 4
Completed
Conditions
Interventions
First Posted Date
2017-05-11
Last Posted Date
2020-07-24
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
51
Registration Number
NCT03149991
Locations
🇺🇸

Massachusetts General Hospital, Depression Clinical and Research Program, Boston, Massachusetts, United States

🇺🇸

Nathan Kline Institute for Psychiatric Research, Orangeburg, New York, United States

🇺🇸

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

and more 3 locations

A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)

First Posted Date
2017-01-26
Last Posted Date
2021-12-08
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
336
Registration Number
NCT03033069
Locations
🇺🇸

Investigational Site, Everett, Washington, United States

A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2016-10-17
Last Posted Date
2019-03-05
Lead Sponsor
Duke University
Target Recruit Count
15
Registration Number
NCT02934932
Locations
🇺🇸

Pamela Smith, Durham, North Carolina, United States

Comparison of the Effectiveness of Brexpiprazole With That of Risperidone

Phase 3
Withdrawn
Conditions
Interventions
First Posted Date
2016-05-02
Last Posted Date
2016-08-01
Lead Sponsor
H. Lundbeck A/S
Registration Number
NCT02758067

Brexpiprazole (OPC 34712) Trial in the Treatment of Adults With Major Depressive Disorder and Irritability

First Posted Date
2014-08-08
Last Posted Date
2016-07-07
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Registration Number
NCT02212613
Locations
🇺🇸

Emory University, Atlanta, Georgia, United States

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