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Home › Medications › brexpiprazole

brexpiprazole

2 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials of brexpiprazole

37 trials tracked of brexpiprazole: 33 in phase 3 or 4 and 20 with published results. The most-cited published study has 91 citations.

37Trials tracked
33Phase 3 & 4
0Recruiting
20With published results
Phase distribution
Phase 4 4 Phase 3 29 Phase 2 3 Phase 1 1
  1. Phase 3 Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia Completed · 91 cited
  2. Phase 3 Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment Completed · 22 cited
  3. Phase 3 Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms Completed · 22 cited
  4. Phase 3 A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial Completed · 20 cited
  5. Phase 3 Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Schizophrenia With Impulsivity Completed · 16 cited
  6. Phase 3 A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type Completed · 13 cited
Show 31 more trials
  1. Phase 3 Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD Completed · 12 cited
  2. Phase 3 Brexpiprazole in Patients With Schizophrenia Completed · 10 cited
  3. Phase 3 Brexpiprazole in Patients With Acute Schizophrenia Completed · 10 cited
  4. Phase 3 Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia Completed · 10 cited
  5. Phase 4 Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder Completed · 6 cited
  6. Phase 3 A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder Completed · 3 cited
  7. Phase 3 Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type Completed · 3 cited
  8. Phase 4 Brexpiprazole for Bipolar Depression Completed · 2 cited
  9. Phase 3 A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder Completed · 2 cited
  10. Phase 3 Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD) Completed · 2 cited
  11. Phase 3 A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type Completed · 1 cited
  12. Phase 3 Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type Completed · 1 cited
  13. Phase 4 Controlled Trial of Brexpiprazole For The Treatment of Co-occurring Schizophrenia and Substance Use Disorder Completed
  14. Phase 3 Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder Completed
  15. Phase 4 A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD) Completed
  16. Phase 3 Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia Completed
  17. Phase 3 Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment Completed
  18. Phase 3 A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder Completed
  19. Phase 3 A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder Completed
  20. Phase 3 A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder. Completed
  21. Phase 3 Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148 Completed
  22. Phase 3 A Study of Brexpiprazole in Patients With Major Depressive Disorder Completed
  23. Phase 3 Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder Completed
  24. Phase 3 Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy Completed
  25. Phase 3 Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder Completed
  26. Phase 3 Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy Completed
  27. Phase 3 Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia Completed
  28. Phase 2 A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD) Completed
  29. Phase 2 A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder Completed
  30. Phase 2 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 Completed
  31. Phase 1 Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive Disorder Completed

Showing the 37 most-cited and recently-updated of 37 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Brexpiprazole improves PANSS scores by 0.19 Cohen's d in early-episode schizophrenia versus placebo
Psychiatry RCT
Brexpiprazole improves PANSS scores by 0.19 Cohen's d in early-episode schizophrenia versus placebo Brexpiprazole helps early schizophrenia symptoms more than placebo in adults and teens
This post hoc analysis of Phase 3 trials evaluated brexpiprazole versus placebo in 476 adults and adolescents aged 13-35 years with early-ep…
A look at trial data shows brexpiprazole improved symptoms and daily functioning better than placebo for people with early schizophrenia.
Jun 1, 2026
FDA Approves Rexulti (brexpiprazole) for Agitation in Alzheimer's Dementia
Psychiatry FDA Approval
FDA Approves Rexulti (brexpiprazole) for Agitation in Alzheimer's Dementia FDA approves Rexulti to treat agitation in Alzheimer's patients
FDA approved Rexulti (brexpiprazole) for treatment of agitation associated with dementia due to Alzheimer's disease. It is not indicated for…
The FDA approved Rexulti (brexpiprazole) to treat agitation in people with Alzheimer's disease. This is a new option for managing this chall…
FDA May 5, 2026