8 completed, 1 not yet recruiting, 1 terminated. 10 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 8, Not yet recruiting 1, Terminated 1 |
Follow brexpiprazole: new trials by email Literature Review of brexpiprazole trials Research Report on brexpiprazole
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Longitudinal PET Imaging of Antipsychotic Binding to the Dopamine-3 Receptor in Schizophrenia Brexpiprazole, Cariprazine, [11C] PHNO - Schizoaffective Disorder, Schizophreniform Disorder | Phase 1 | Not yet recruiting | New York State Psychiatric Institute | 100 | 2026-12-01 | 2026-07-20 |
| Bioequivalence Study to Compare Brexpiprazole 4 mg Film Coated Tablets Versus RXULTI 4 mg Film Coated Tablet (Brexpiprazole) Brexpiprazole Film Coated Tablets, RXULTI film coated tablet - Schizophrenia | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | 36 | 2025-06-22 | 2025-12-05 |
| The Pharmacokinetics, and Safety of Brexpiprazole Tablets in Chinese Healthy Subjects Brexpiprazole - Healthy | Phase 1 | Completed | Otsuka Beijing Research Institute | 10 | 2019-04-24 | 2023-11-01 |
| The Pharmacokinetics, Tolerability and Safety of Brexpiprazole in Healthy Chinese Subjects Brexpiprazole - Health | Phase 1 | Completed | Otsuka Beijing Research Institute | 30 | 2019-04-07 | 2023-11-01 |
| Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders Brexpiprazole - ADHD, Autism | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 24 | 2017-10-10 | 2018-06-12 |
| Safety and Tolerability Study of Single-dose Administration of Brexpiprazole in Adult Subjects With Schizophrenia Brexpiprazole, OPDC-34712 - Schizophrenia | Phase 1 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 22 | 2017-01-01 | 2018-01-12 |
| Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects OPC-34712 - Healthy Adult Male | Phase 1 | Completed | Otsuka Pharmaceutical Co., Ltd. | 18 | 2016-09-27 | 2021-02-23 |
| Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia Brexpiprazole (OPC-34712) - Schizophrenia | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 43 | 2015-03-01 | 2026-04-28 |
| PET Trial to Assess the Receptor Occupancy of Brexpiprazole in Adult Subjects With Schizophrenia Brexpiprazole 1mg to 4mg - Schizophrenia | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 12 | 2013-09-01 | 2016-02-04 |
| Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive Disorder Brexpiprazole, Placebo - Major Depressive Disorder | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 18 | 2012-07-01 | 2016-02-04 |
Schizophrenia (5) · Attention Deficit Disorder with Hyperactivity (1) · Autistic Disorder (1) · Central Nervous System Diseases (1) · Conduct Disorder (1) · Depressive Disorder, Major (1) · Oppositional Defiant Disorder (1) · Psychotic Disorders (1)
Otsuka Pharmaceutical Development & Commercialization, Inc. (5) · Otsuka Beijing Research Institute (2) · Humanis Saglık Anonim Sirketi (1) · New York State Psychiatric Institute (1) · Otsuka Pharmaceutical Co., Ltd. (1)
United States (5) · China (2) · India (1) · Japan (1)
Tao Jiang, Master (2) · James M. Youakim, MD (1)
R01MH139651 (1)