8 completed, 1 not yet recruiting, 1 recruiting, 1 terminated. 11 Phase 2, 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 11 | Completed 8, Not yet recruiting 1, Recruiting 1, Terminated 1 |
| Phase 3 | 4 | Completed 3, Not yet recruiting 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 |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Brexpiprazole for Extended-Release Injection in Subjects With Schizophrenia Brexpiprazole for ER injection, 45 mg, Brexpiprazole for ER injection, 100 mg - Schizophrenia | Phase 2 / Phase 3 | Not yet recruiting | Bostal Drug Delivery Co., Ltd | 16 | 2026-08-01 | 2026-08-03 |
| Brexpiprazole in Alcohol Use Disorder Brexpiprazole, Placebo - Alcohol Use Disorder | Phase 2 | Recruiting | University of Colorado, Denver | 250 | 2020-10-30 | 2026-05-01 |
| Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD) Brexpiprazole - Borderline Personality Disorder | Phase 2 / Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 201 | 2020-01-13 | 2024-10-03 |
| A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder Brexpiprazole, Placebo - Borderline Personality Disorder | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 332 | 2019-10-17 | 2024-07-18 |
| Brexpiprazole in Borderline Personality Disorder Rexulti, Placebo - Borderline Personality Disorder | Phase 2 | Completed | University of Chicago | 80 | 2018-11-26 | 2022-03-18 |
| Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type Brexpiprazole, Placebo - Agitation Associated With Dementia of the Alzheimer's Type | Phase 2 / Phase 3 | Completed | Otsuka Pharmaceutical Co., Ltd. | 410 | 2018-08-20 | 2024-11-14 |
| A Study of Brexpiprazole in Patients With Major Depressive Disorder Brexpiprazole, Placebo - Major Depressive Disorder | Phase 2 / Phase 3 | Completed | Otsuka Pharmaceutical Co., Ltd. | 740 | 2018-07-30 | 2024-08-09 |
| A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication ASP4345, placebo, risperidone - Schizophrenia | Phase 2 | Completed | Astellas Pharma Global Development, Inc. | 233 | 2018-07-13 | 2024-11-12 |
| A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD Brexpiprazole - Post Traumatic Stress Disorder | Phase 2 | Terminated | Duke University | 15 | 2017-04-25 | 2019-03-05 |
| A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD) Brexpiprazole, Sertraline, Brexpiprazole Matching Placebo - Stress Disorders, Post-Traumatic | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 336 | 2017-01-26 | 2021-12-08 |
| Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder OPDC-34712, Placebo, Stimulant Therapy - Attention Deficit Hyperactivity Disorder | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 740 | 2010-03-16 | 2023-02-02 |
Borderline Personality Disorder (3) · Schizophrenia (2) · Stress Disorders, Post-Traumatic (2) · Alcoholism (1) · Attention Deficit Disorder with Hyperactivity (1) · Depressive Disorder, Major (1) · Impulsive Behavior (1) · Spasm (1)
Otsuka Pharmaceutical Development & Commercialization, Inc. (4) · Otsuka Pharmaceutical Co., Ltd. (2) · Astellas Pharma Global Development, Inc. (1) · Bostal Drug Delivery Co., Ltd (1) · Duke University (1) · University of Chicago (1) · University of Colorado, Denver (1)
United States (8) · Japan (2) · Spain (1) · Ukraine (1)
Jon E Grant, JD, MD, MPH (1) · Joseph P Schacht, PhD (1) · Steven T Szabo, MD, PhD (1)
PMID 36375174, PMID 39558901, PMID 32533536, PMID 40009045, PMID 40717666, PMID 42847294
2019 (1), R01AA027765 (1)