53 completed, 6 terminated, 5 recruiting, 3 withdrawn. 43 Phase 3, 11 Phase 2, 10 Phase 1, 6 Phase 4, 1 Not applicable.
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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 |
| 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 |
| Single-case Intervention Study for Visual Screening Assessment for Proof of Concept and Prediction of Clinical Response to Brexiprazole as Adjunctive Treatment in Adults With Major Depressive Disorder. Eyetracking (Tobii Pro Fusion 250 hz) - Depression - Major Depressive Disorder | Not applicable | Active not recruiting | University of Sao Paulo | 1 | 2026-04-01 | 2026-07-23 |
| 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 |
| REXULTI General Use Results Survey in Patients With Hyperactivity, or Aggressive Behavior Associated With Alzheimer's Dementia Brexpiprazole (Rexulti) - Alzheimer Disease | Recruiting | Otsuka Pharmaceutical Co., Ltd. | 200 | 2025-04-17 | 2026-10-20 | |
| Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders Brexpiprazole - Psychosis, Depression | Recruiting | Dr. Albert Kar-Kin Chung | 40 | 2023-07-01 | 2025-07-08 | |
| Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D) Escitalopram, Brexpiprazole - Major Depressive Disorder | Phase 4 | Recruiting | Nova Scotia Health Authority | 400 | 2023-01-20 | 2026-06-11 |
| Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety Brexpiprazole - Major Depressive Disorder (MDD) | Phase 4 | Withdrawn | Otsuka Pharmaceutical Development & Commercialization, Inc. | 2022-08-29 | 2023-01-30 | |
| Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia ARIPiprazole Injection [Abilify], Brexpiprazole - Schizophrenia and Related Disorders, Anxiety Depression | Completed | The University of Hong Kong | 6 | 2022-02-01 | 2026-04-27 | |
| Brexpiprazole Treatment for Bipolar I Depression Brexpiprazole - Bipolar Depression | Phase 3 | Recruiting | Douglas Mental Health University Institute | 58 | 2021-05-10 | 2026-08-27 |
| Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder Brexpiprazole - Major Depressive Disorder | Phase 4 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 122 | 2021-04-01 | 2024-02-02 |
| Brexpiprazole in Alcohol Use Disorder Brexpiprazole, Placebo - Alcohol Use Disorder | Phase 2 | Recruiting | University of Colorado, Denver | 250 | 2020-10-30 | 2026-05-01 |
| Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148 Brexpiprazole - Irritability Associated With Autism Spectrum Disorder | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 95 | 2020-01-23 | 2024-05-30 |
| 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 |
| Canadian Biomarker Integration Network for Depression (CAN-BIND) - Validation Study Escitalopram, Brexpiprazole - Major Depressive Disorder | Phase 3 | Completed | University Health Network, Toronto | 1 | 2019-12-23 | 2023-03-02 |
| Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia Brexpiprazole, Aripiprazole - Schizophrenia | Phase 3 | Completed | Otsuka Beijing Research Institute | 371 | 2019-11-27 | 2025-04-18 |
| Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder Brexpiprazole, Sertraline, Placebo - Post Traumatic Stress Disorder | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 591 | 2019-10-30 | 2025-05-30 |
| Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder Brexpiprazole, Placebo - Irritability Associated With Autism Spectrum Disorder (ASD) | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 119 | 2019-10-30 | 2025-08-28 |
| 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 as Combination Therapy With Sertraline in Treatment of Adults With PTSD Brexpiprazole, Sertraline, Placebo - Post Traumatic Stress Disorder | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 450 | 2019-10-17 | 2025-06-13 |
Showing 20 of 71. Sign in to see all of them.
Schizophrenia (21) · Depressive Disorder, Major (19) · Mental Disorders (9) · Psychotic Disorders (8) · Depression (6) · Alzheimer Disease (5) · Stress Disorders, Post-Traumatic (5) · Psychomotor Agitation (4) · Autistic Disorder (3) · Borderline Personality Disorder (3) · Mania (3) · Alcoholism (2) · Anxiety Disorders (2) · Attention Deficit Disorder with Hyperactivity (2) · Autism Spectrum Disorder (2)
Otsuka Pharmaceutical Development & Commercialization, Inc. (35) · H. Lundbeck A/S (9) · Otsuka Pharmaceutical Co., Ltd. (6) · Otsuka Beijing Research Institute (4) · Astellas Pharma Global Development, Inc. (1) · Bostal Drug Delivery Co., Ltd (1) · Douglas Mental Health University Institute (1) · Dr. Albert Kar-Kin Chung (1) · Duke University (1) · Humanis Saglık Anonim Sirketi (1) · Massachusetts General Hospital (1) · New York State Psychiatric Institute (1) · Nova Scotia Health Authority (1) · Otsuka Pharmaceutical, Inc., Philippines (1) · The University of Hong Kong (1)
United States (46) · Ukraine (10) · Serbia (9) · Canada (8) · Poland (8) · Japan (7) · Russia (6) · Romania (5) · Bulgaria (4) · China (4) · France (4) · Croatia (3) · Estonia (3) · Finland (3) · Germany (3)
Junichi Hashimoto, PhD (6) · Aleksandar Skuban, M.D. (2) · Eva Kohegyi, MD (2) · Matthew Leoni, M.D. (2) · Tao Jiang, Master (2) · Albert KK Chung (1) · Caroline Ward, PhD. (1) · Eva Koheygi, MD (1) · Heather Guthrie, MD (1) · Hermano Tavares (1) · Hongyan Zhang, PhD (1) · James M. Youakim, MD (1)
PMID 34901863, PMID 35235720, PMID 40681915, PMID 41533472, PMID 41961243, PMID 34894307, PMID 39108660, PMID 41591746, PMID 42474330, PMID 31708380, PMID 36375174, PMID 39558901, PMID 39749727, PMID 40847656, PMID 40859756, PMID 41439450, PMID 41689409, PMID 41849920, PMID 42052145, PMID 42502037, PMID 25882325, PMID 27188270, PMID 27379823, PMID 27566723, PMID 27781135, PMID 27784751, PMID 27835722, PMID 29985680, PMID 30306884, PMID 30508090, PMID 31577867, PMID 31847007, PMID 32450497, PMID 32533536, PMID 32979560, PMID 37683234, PMID 37930669, PMID 38425284, PMID 39415650, PMID 39424742, PMID 39534972, PMID 39693081, PMID 40009045, PMID 40209740, PMID 40290781, PMID 40520975, PMID 40717666, PMID 40913583, PMID 40982703, PMID 41129678
2017 (2), 2018 (2), 2015 (1), 2019 (1), R01AA027765 (1), R01MH139651 (1)