Data updated: May 26, 2026
BREXPIPRAZOLE
CNS
Approved 2022-08-11
12
Indications
--
Phase 3 Trials
3
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2022-08-11
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
MSN PHARMS INC Novartis Aurobindo Pharma Teva Apotex ALKEM LABS LTD ALEMBIC ZYDUS PHARMS CHARTWELL RX Lupin AMNEAL PRINSTON PHARMA INC HETERO LABS LTD V AJANTA PHARMA LTD ZENARA ACCORD HLTHCARE INC
Active Ingredient: BREXPIPRAZOLE
Website: ↗
BREXPIPRAZOLE Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
107 FDA actions from 2022 to 2026
Apr 2026 SUPPL
Label · Labeling
Jan 2025 ORIGINAL
Update
Nov 2024 SUPPL
Label
Nov 2023 ORIGINAL
Update
Nov 2023 ORIGINAL
Update
What BREXPIPRAZOLE Treats
12 FDA approvalsOriginally approved for its first indication in 2022 . Covers 12 distinct patient populations.
- Other (12)
Other
(12 approvals)- • Approved indication (Aug 2022)Letter
- • Approved indication (Sep 2022)Letter
- • Approved indication (Jan 2023)Letter
- • Approved indication (Jan 2023)Letter
- • Approved indication (Feb 2023)Letter
- • Approved indication (Mar 2023)Letter
- • Approved indication (Oct 2023)Letter
- • Approved indication (Nov 2023)
- • Approved indication (Nov 2023)
- • Approved indication (Nov 2023)Letter
- • Approved indication (Jan 2025)
- • Approved indication (Feb 2025)Letter
📋
Clinical Trial Registry
52 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04066192 | 19-1658 1R01AA027765-01 | Ph 2 | recruiting | Brexpiprazole in Alcohol Use Disorder |
| NCT05017311 CAN-BIND-17 | 1027397 | Ph 4 | recruiting | Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D) |
| NCT03238326 results posted | 331-10-236 | Ph 3 | completed | Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia |
| NCT04174365 results posted | 331-201-00148 | Ph 3 | completed | Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder |
| NCT04124614 results posted | 331-201-00071 | Ph 3 | completed | Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD |
| NCT04174170 results posted | 331-201-00072 | Ph 3 | completed | Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder |
| NCT03526354 results posted | 14611 | Ph 4 | completed | Controlled Trial of Brexpiprazole For The Treatment of Co-occurring Schizophrenia and Substance Use Disorder |
| NCT03874494 | 331-403-00027 | Ph 3 | completed | Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia |
| NCT03620981 results posted | 331-102-00088 | Ph 2, Ph 3 | completed | Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type |
| NCT03557931 results posted | 4345-CL-0015 | Ph 2 | completed | 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 |
| NCT04186403 results posted | 331-201-00195 2019-002897-30 | Ph 2, Ph 3 | completed | Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD) |
| NCT03724942 results posted | 331-102-00184 JapicCTI-184179 | Ph 3 | completed | Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type |
| NCT03697603 results posted | 331-102-00058 | Ph 2, Ph 3 | completed | A Study of Brexpiprazole in Patients With Major Depressive Disorder |
| NCT04569448 | RSS 5182913 | Ph 3 | recruiting | Brexpiprazole Treatment for Bipolar I Depression |
| NCT04100096 results posted | 331-201-00242 | Ph 2 | completed | A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder |
| NCT04258839 results posted | 331-201-00191 2018-004899-35 | Ph 3 | completed | Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148 |
| NCT03737474 results posted | 331-102-00059 | Ph 3 | completed | A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder |
| NCT04830215 results posted | 331-201-00289 | Ph 4 | completed | Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder |
| NCT03594123 results posted | 331-201-00182 | Ph 3 | completed | 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 |
| NCT03734302 | 331-403-00025 | Ph 1 | completed | The Pharmacokinetics, and Safety of Brexpiprazole Tablets in Chinese Healthy Subjects |
| NCT03734354 | 331-403-00024 | Ph 1 | completed | The Pharmacokinetics, Tolerability and Safety of Brexpiprazole in Healthy Chinese Subjects |
| NCT03538691 results posted | 331-201-00079 2018-000601-22 | Ph 3 | completed | A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder |
| NCT03548584 results posted | 331-14-213 | Ph 3 | completed | A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type |
| NCT04162522 | 19-5371 | Ph 3 | completed | Canadian Biomarker Integration Network for Depression (CAN-BIND) - Validation Study |
| NCT05504486 | 331-201-00376 | Ph 4 | withdrawn | Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety |
| NCT03033069 results posted | 331-201-00061 | Ph 2 | completed | A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD) |
| NCT03487198 | 331-403-00023 | Ph 3 | terminated | The Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in the Treatment of Major Depressive Disorder |
| NCT03287869 results posted | 331-201-00083 2017-002225-38 | Ph 3 | completed | A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder. |
| NCT03149991 results posted | KETBREX001 | Ph 4 | completed | A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD) |
| NCT03257865 results posted | 331-201-00081 | Ph 3 | completed | A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder |
| NCT03259555 results posted | 331-201-00080 | Ph 3 | completed | A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder |
| NCT01942733 results posted | 15352A | Ph 3 | completed | Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder |
| NCT03427892 results posted | 102016-048 | Ph 4 | completed | Brexpiprazole for Bipolar Depression |
| NCT02934932 results posted | Pro00071923 | Ph 2 | terminated | A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD |
| NCT02194933 results posted | 331-13-009 | Ph 3 | completed | Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Schizophrenia With Impulsivity |
| NCT01944969 results posted | 14767B 2012-004169-42 | Ph 3 | terminated | Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder |
| NCT03292848 | 331-201-00103 | Ph 1 | completed | Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders |
| NCT01727726 results posted | 331-12-282 | Ph 3 | completed | A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial |
| NCT01838681 results posted | 14570A 2012-001380-76 | Ph 3 | completed | Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment |
| NCT01810783 results posted | 14644B 2012-002705-21 | Ph 3 | completed | Brexpiprazole in Patients With Schizophrenia |
| NCT01810380 results posted | 14644A 2012-002252-17 | Ph 3 | completed | Brexpiprazole in Patients With Acute Schizophrenia |
| NCT01987960 results posted | 14865A 2012-004982-41 | Ph 3 | terminated | Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD) |
| NCT01668797 EQUATOR results posted | 331-10-232 2011-005766-38 | Ph 3 | completed | Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia |
| NCT02758067 TAILWIND | 16758A 2015-001749-97 | Ph 3 | withdrawn | Comparison of the Effectiveness of Brexpiprazole With That of Risperidone |
| NCT02212613 | 331-13-004 | Ph 3 | withdrawn | Brexpiprazole (OPC 34712) Trial in the Treatment of Adults With Major Depressive Disorder and Irritability |
| NCT02013531 results posted | 331-13-002 | Ph 3 | completed | Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms |
| NCT02013622 results posted | 331-13-006 | Ph 3 | completed | Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia |
| NCT02013609 results posted | 331-13-003 | Ph 3 | completed | 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 |
| NCT01942785 results posted | 15353A | Ph 3 | completed | Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy |
| NCT01670279 results posted | 331-12-291 | Ph 1 | completed | Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive Disorder |
Showing 50 of 52 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BREXPIPRAZOLE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.