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
-

Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Schizophrenia With Impulsivity

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-07-21
Last Posted Date
2018-11-08
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
38
Registration Number
NCT02194933
Locations
🇺🇸

University of California at Irvine Medical Center, Orange, California, United States

Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-02-04
Last Posted Date
2015-12-30
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
97
Registration Number
NCT02054702

Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-12-17
Last Posted Date
2016-03-29
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
37
Registration Number
NCT02013531

Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-12-17
Last Posted Date
2016-03-29
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
49
Registration Number
NCT02013622

Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy

First Posted Date
2013-12-16
Last Posted Date
2015-12-29
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
61
Registration Number
NCT02012218
Locations
🇺🇸

Goldpoint Clinical Research, Indianapolis, Indiana, United States

🇺🇸

St. Louis Clinical Trials, St. Louis, Missouri, United States

🇺🇸

Behavioral Medical Research of Staten Island, Staten Island, New York, United States

and more 20 locations

Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

First Posted Date
2013-11-20
Last Posted Date
2017-03-13
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
417
Registration Number
NCT01987960
Locations
🇵🇱

PL002, Lublin, Poland

🇫🇮

FI004, Turku, Finland

🇫🇮

FI002, Helsinki, Finland

and more 56 locations

Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2013-09-18
Last Posted Date
2018-10-17
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
26
Registration Number
NCT01944969
Locations
🇺🇸

US008, Orlando, Florida, United States

Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-09-16
Last Posted Date
2019-03-20
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
44
Registration Number
NCT01942733

Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-09-16
Last Posted Date
2016-03-15
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
55
Registration Number
NCT01942785
Locations
🇺🇸

US015, Tucson, Arizona, United States

🇺🇸

US019, Glendale, California, United States

🇺🇸

US011, Denver, Colorado, United States

and more 12 locations
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