Product
Brexpiprazole
Aliases
Brex, Brexpiprazole (OPC-34712), OPC-34712, Rexulti
Name
Brexpiprazole
INN Name
brexpiprazole
FDA Approved
Yes
23 clinical trials
5 organizations
18 indications
3 documents
Indication
SchizophreniaIndication
Major Depressive DisorderIndication
Agitation in Alzheimer's DiseaseIndication
Post-Traumatic Stress DisorderIndication
borderline personality disorderIndication
Alzheimer's diseaseIndication
HealthyIndication
Alzheimer's DiseaseIndication
Autism Spectrum DisorderIndication
healthIndication
Schizoaffective DisorderIndication
Substance Use DisordersIndication
AnxietyIndication
Alcohol Use DisorderIndication
Bipolar disorderIndication
PsychosisClinical trial
A Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 Years Old) With SchizophreniaStatus: Completed, Estimated PCD: 2023-04-03
Clinical trial
A Long-term, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents (13-17 Years Old) With SchizophreniaStatus: Active (not recruiting), Estimated PCD: 2025-05-01
Clinical trial
A Multi-center, Open-label Trial to Assess the Long-term Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive DisorderStatus: Completed, Estimated PCD: 2021-03-17
Clinical trial
A Phase 1/2 Open-Label, Dose-Escalation Study to Determine the Safety Tolerability & Efficacy of BMN 331 an AAV Vector-Mediated Gene Transfer of Human SERPING1 Gene in Subjects With HAE Due to Human C1-INH DeficiencyStatus: Recruiting, Estimated PCD: 2028-11-01
Clinical trial
A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Adult Subjects With Borderline Personality DisorderStatus: Completed, Estimated PCD: 2021-09-22
Clinical trial
A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's TypeStatus: Completed, Estimated PCD: 2023-04-21
Clinical trial
A Phase 3, Multicenter, Randomized, Double-blind Trial of Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress DisorderStatus: Completed, Estimated PCD: 2023-07-19
Clinical trial
A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's TypeStatus: Completed, Estimated PCD: 2022-05-23
Clinical trial
A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress DisorderStatus: Completed, Estimated PCD: 2023-07-25
Clinical trial
A Phase 4, Multicenter, Single-arm, Open-label, Interventional fMRI Trial to Assess the Effect of Brexpiprazole as Adjunctive Therapy on Functional Brain Network Organization in Adults With Major Depressive Disorder and Symptoms of AnxietyStatus: Withdrawn, Estimated PCD: 2023-03-22
Clinical trial
A 12-week, Multicenter, Active-treatment Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's TypeStatus: Completed, Estimated PCD: 2022-09-19
Clinical trial
A Phase 3, Multicenter, Open Label Trial to Evaluate the Long-term Safety and Tolerability of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum DisorderStatus: Active (not recruiting), Estimated PCD: 2023-04-30
Clinical trial
A Single-center, Open-label Study Evaluating the Pharmacokinetics, and Safety of Multiple Dose Oral Brexpiprazole Tablets (1 mg) in Chinese Healthy SubjectsStatus: Completed, Estimated PCD: 2020-06-10
Clinical trial
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole as Adjunctive Therapy in the Maintenance Treatment of Adults With Major Depressive DisorderStatus: Completed, Estimated PCD: 2022-07-08
Clinical trial
A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum DisorderStatus: Completed, Estimated PCD: 2022-08-08
Clinical trial
A Single-center, Open-label Study Evaluating the Pharmacokinetics, Tolerability and Safety of Single Dose Oral Brexpiprazole Tablets in Healthy Chinese SubjectsStatus: Completed, Estimated PCD: 2020-05-18
Clinical trial
A Multi-center, Randomized, Controlled Trial of Brexpiprazole for the Treatment of Co-occurring Schizophrenia and Substance Use DisorderStatus: Completed, Estimated PCD: 2024-02-29
Clinical trial
Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)Status: Recruiting, Estimated PCD: 2028-12-31
Clinical trial
Real-life Assessment of Aripiprazole Long-acting Injection (Abilify Maintena) Combined With Brexpiprazole (Rexulti) in Schizophrenia: a Naturalistic Non-interventional Prospective Follow-up StudyStatus: Recruiting, Estimated PCD: 2024-12-31
Clinical trial
A Pharmacogenetic Human Laboratory Investigation of Brexpiprazole in Alcohol Use DisorderStatus: Recruiting, Estimated PCD: 2025-08-31
Clinical trial
Low-Dose Adjunctive Brexpiprazole in the Treatment of Bipolar I Depression: An Open-Label StudyStatus: Recruiting, Estimated PCD: 2025-02-01
Clinical trial
Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders: a Naturalistic Non-interventional Prospective Follow-up StudyStatus: Recruiting, Estimated PCD: 2025-12-31
Clinical trial
Integrated Biological Markers for the Prediction of Treatment Response in Depression: Validation StudyStatus: Completed, Estimated PCD: 2022-12-31
Organization
Amneal Pharmaceuticals NY LLCDocument
DailyMed Label: BrexpiprazoleOrganization
Ajanta Pharma USA Inc.Organization
Otsuka America Pharmaceutical, Inc.Document
DailyMed Label: Brexpiprazole
Organization
Camber Pharmaceuticals, Inc.Document
DailyMed Label: RexultiOrganization
REMEDYREPACK INC.