Brexpiprazole

Generic Name: Brexpiprazole

Brand Names: Rxulti, Rexulti

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₂₇N_₃O_₂S

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 serotonin receptors. Compared to aripiprazole, brexpiprazole has less potential for partial agonist-mediated adverse effects such as extrapyramidal symptoms, which is attributed to lower intrinsic activity at the D2 receptor. It also displays stronger antagonism at the 5-HT1A and 5-HT2A receptors.

Brexpiprazole was first approved by the FDA on July 10, 2015. Currently approved for the treatment of depression, schizophrenia, and agitation associated with dementia due to Alzheimer’s disease, brexpiprazole has also been investigated in other psychiatric disorders, such as post-traumatic stress disorder.

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.

Brexpiprazole is also indicated for the treatment of agitation associated with dementia due to Alzheimer’s disease; however, it is not indicated as an as-needed (“prn”) treatment for this condition.

Associated Conditions: Agitation, Schizophrenia, Major Depressive Disorder (MDD)

Associated Therapies: -

Clinical Trials

Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

Phase 3

Completed

Conditions: Post Traumatic Stress Disorder

Interventions: Drug: Brexpiprazole
Drug: Sertraline
Other: Placebo

First Posted Date: 2019-11-22

Last Posted Date: 2024-07-30

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 591

Registration Number: NCT04174170

Locations: 🇺🇸
For additional information regarding sites, contact 844-687-8522, New York, New York, United States

Canadian Biomarker Integration Network for Depression (CAN-BIND) - Validation Study

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Brexpiprazole
Drug: Escitalopram

First Posted Date: 2019-11-14

Last Posted Date: 2023-03-02

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 1

Registration Number: NCT04162522

Locations: 🇨🇦
University of Calgary, Calgary, Alberta, Canada
🇨🇦
University of British Columbia, Vancouver, British Columbia, Canada
🇨🇦
Queen's University, Kingston, Ontario, Canada

and more 3 locations

Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

Phase 3

Completed

Conditions: Post Traumatic Stress Disorder

Interventions: Drug: Brexpiprazole
Other: Placebo
Drug: Sertraline

First Posted Date: 2019-10-11

Last Posted Date: 2024-07-25

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 450

Registration Number: NCT04124614

Locations: 🇺🇸
For additional information regarding sites, contact 844-687-8522, San Diego, California, United States

A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder

Phase 2

Completed

Conditions: Borderline Personality Disorder

Interventions: Other: Placebo
Drug: Brexpiprazole

First Posted Date: 2019-09-24

Last Posted Date: 2024-07-18

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 332

Registration Number: NCT04100096

Locations: 🇺🇸
Institute of Living Hartford Hospital, Hartford, Connecticut, United States
🇺🇸
Mindful Behavioral Health, Boca Raton, Florida, United States
🇺🇸
University of Connecticut, Farmington, Connecticut, United States

and more 72 locations