Drugs / Brexpiprazole
Brexpiprazole
also known as
OPC-34712 · Brexpiprazole fumarate · OPC-34712FUM · OPDC-34712 · Brexpiprazol · Rexulti · Rxulti
Small molecule targets DRD2, HTR1A, HTR2A via activation / inhibition
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | REXULTI | — | 2016-09-23 – 2025-05-09 | fda.gov ↗ |
| Approved | EU (EMA) | Rxulti | — | 2018-07-26 | europa.eu ↗ |
| Approved | US (FDA) | REXULTI | — | 2015-07-10 | fda.gov ↗ |
Trials 81 · started per year
today
US approved 2015
EU approved 2018
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Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT01423916 Comparator | Jul 2011 → Feb 2012 | schizoaffective disorder, schizophrenia | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01289080 Comparator | Jan → Dec 2011 | schizophrenia | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01299454 Comparator | Dec 2010 → Jun 2011 | schizophrenia | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04066192 Comparator | Oct 2020 → Aug 2026 overdue | alcohol-related disorders | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 2 | NCT03557931 Background | Jul 2018 → Oct 2019 | schizophrenia | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04162522 Comparator | Dec 2019 → Dec 2022 | major depressive disorder | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05017311 Comparator | Jan 2023 → Dec 2028 expected | major depressive disorder | Nova Scotia Health Authority | Recruiting | No outcome recorded |
| Phase 4 | NCT03149991 Comparator | Sep 2017 → Mar 2019 | depressive disorder | Massachusetts General Hospital | Completed | No outcome recorded |
Press releases naming this drug 78 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | REXULTI Listed in the "Essential Medicines List for the Ultra-Acute Phase of Disasters" by the Japanese Association for Disaster Medicine ® otsuka.co.jp ↗ |
| 2025-09-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Receive Complete Response Letter from U.S. FDA for sNDA of REXULTI (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)® otsuka.co.jp ↗ |
| 2025-09-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Receive Complete Response Letter from U.S. FDA for sNDA of REXULTI® (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka-us.com ↗ |
| 2025-07-19 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)® otsuka.co.jp ↗ |
| 2025-03-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Rxulti (brexpiprazole) approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older® otsuka.co.jp ↗ |
| 2025-01-10 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces FDA Plans to Host an Advisory Committee Meeting to Discuss the sNDA for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka.co.jp ↗ |
| 2025-01-10 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces FDA Plans to Host an Advisory Committee Meeting to Discuss the sNDA for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka-us.com ↗ |
| 2024-12-19 | Otsuka Pharmaceutical Development & Commercialization, Inc. | JAMA Psychiatry Publishes Results of Otsuka and Lundbeck's Phase 3 Trial of Brexpiprazole in Combination with Sertraline in Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka.co.jp ↗ |
| 2024-12-18 | Otsuka Pharmaceutical Development & Commercialization, Inc. | JAMA Psychiatry Publishes Results of Otsuka and Lundbeck's Phase 3 Trial of Brexpiprazole in Combination with Sertraline in Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka-us.com ↗ |
| 2024-08-02 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Present New REXULTI (brexpiprazole) Post Hoc Efficacy Data Analyses for Agitation Associated with Dementia Due to Alzheimer's Disease at Alzheimer's Association International Conference (AAIC) 2024® otsuka.co.jp ↗ |
| 2024-07-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Present New REXULTI® (brexpiprazole) Post Hoc Efficacy Data Analyses for Agitation Associated with Dementia Due to Alzheimer’s Disease at Alzheimer’s Association International Conference (AAIC) 2024 otsuka-us.com ↗ |
| 2024-06-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) otsuka.co.jp ↗ |
| 2024-06-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Announce FDA Acceptance of sNDA Filing for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka-us.com ↗ |
| 2024-05-29 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka.co.jp ↗ |
| 2024-05-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka-us.com ↗ |
| 2024-04-10 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD otsuka-us.com ↗ |
| 2024-04-09 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD otsuka.co.jp ↗ |
| 2024-03-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Presented New Data Analyses on the Efficacy of REXULTI (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer's Disease ® otsuka.co.jp ↗ |
| 2024-03-18 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Present New Data Analyses on the Efficacy of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease otsuka-us.com ↗ |
| 2023-12-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Obtains the Additional Indication of Adjunctive Treatment of Major Depressive Disorder for Rexulti in Japan ® otsuka.co.jp ↗ |
| 2023-11-06 | Otsuka Pharmaceutical Development & Commercialization, Inc. | JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease otsuka-us.com ↗ |
| 2023-10-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Applies in Japan for the Additional Indication for Agitation Associated with Dementia due to Alzheimer's Disease for Rexulti (brexpiprazole) ® otsuka.co.jp ↗ |
| 2023-09-07 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical and Lundbeck Announce Topline Results from Two Phase 3 Trials of Brexpiprazole as Combination Therapy with Sertraline for the Treatment of Post-Traumatic Stress Disorder in Adults otsuka.co.jp ↗ |
| 2023-09-07 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical and Lundbeck Announce Topline Results from Two Phase 3 Trials of Brexpiprazole as Combination Therapy with Sertraline for the Treatment of Post-Traumatic Stress Disorder in Adults otsuka-us.com ↗ |
| 2023-06-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical announces positive results of phase III trial in Japan showingreduced agitation in patients with Alzheimer's dementia treated with brexpiprazole otsuka.co.jp ↗ |
| 2023-05-11 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA) Approval of supplemental New Drug Application (sNDA) for REXULTI (brexpiprazole) for the Treatment of Agitation Associated with Dementia due to Alzheimer's Disease ® otsuka.co.jp ↗ |
| 2023-05-11 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA) Approval of Supplemental New Drug Application (sNDA) for REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease otsuka-us.com ↗ |
| 2023-04-17 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on brexpiprazole for the Treatment of Agitation Associated with Alzheimer's Dementia otsuka.co.jp ↗ |
| 2023-04-16 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Alzheimer’s Dementia otsuka-us.com ↗ |
| 2023-01-30 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Applies for the Additional Indication of Adjunctive Treatmentof Major Depressive Disorder for Rexulti (brexpiprazole) in Japan ® otsuka.co.jp ↗ |
| 2023-01-10 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer's dementia otsuka.co.jp ↗ |
| 2023-01-07 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia otsuka-us.com ↗ |
| 2022-12-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical and Lundbeck Present Positive Data From Multiple Phase 3 Studies Showing Brexpiprazole Significantly Improved Symptoms of Agitation in Patients with Alzheimer's Dementia at the 2022 Clinical Trials for Alzheimer’s Disease Congress otsuka-us.com ↗ |
| 2022-09-12 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical announces positive results of phase III trial in Japan for brexpiprazole in the treatment of major depressive disorder otsuka.co.jp ↗ |
| 2022-08-05 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical and Lundbeck present positive results showing reduced agitation in patients with Alzheimer's dementia treated with brexpiprazole at the 2022 Alzheimer's Association International Conference otsuka.co.jp ↗ |
| 2022-08-04 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical and Lundbeck present positive results showing reduced agitation in patients with Alzheimer’s dementia treated with brexpiprazole at the 2022 Alzheimer's Association International Conference otsuka-us.com ↗ |
| 2022-06-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical and Lundbeck announce positive results showing reduced agitation in patients with Alzheimer's dementia treated with brexpiprazole otsuka.co.jp ↗ |
| 2022-06-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical and Lundbeck announce positive results showing reduced agitation in patients with Alzheimer’s dementia treated with brexpiprazole otsuka-us.com ↗ |
| 2022-01-07 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Announce U.S. FDA Approval of Supplemental New Drug Application for REXULTI (brexpiprazole) to Treat Schizophrenia in Pediatric Patients® otsuka.co.jp ↗ |
| 2022-01-05 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Announce FDA Approval of Supplemental New Drug Application for REXULTI® (brexpiprazole) to Treat Schizophrenia in Pediatric Patients Ages 13-17 otsuka-us.com ↗ |
| 2021-08-18 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Obtains Approval in Japan for Orally-Disintegrating-Dose Form of REXULTI Tablets® otsuka.co.jp ↗ |
| 2021-08-18 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka reports topline outcomes on a phase II trial that evaluated brexpiprazole for the treatment of borderline personality disorder otsuka.co.jp ↗ |
| 2021-04-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck announce decision to continue phase III clinical trial evaluating brexpiprazole for treatment of agitation in patients with Alzheimer's-type dementia otsuka.co.jp ↗ |
| 2021-04-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Announce Decision to Continue Phase III Clinical Trial Evaluating Brexpiprazole for Treatment of Agitation in Patients with Alzheimer's-type Dementia otsuka-us.com ↗ |
| 2019-02-15 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck report phase III data evaluating brexpiprazole for the treatment of manic episodes associated with bipolar I disorder otsuka.co.jp ↗ |
| 2018-11-30 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck report positive phase II data for the combination treatment of brexpiprazole and sertraline for the treatment of Post-Traumatic Stress Disorder (PTSD) otsuka.co.jp ↗ |
| 2018-10-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Data Demonstrate Safety and Efficacy of Brexpiprazole in Patients with Schizophrenia Experiencing Severe Psychotic Symptoms otsuka-us.com ↗ |
| 2018-07-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck's Rxulti (brexpiprazole) approved by the European Commission® otsuka.co.jp ↗ |
| 2018-06-04 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck's Rxulti® (brexpiprazole) receives positive opinion in EUfrom CHMP for the treatment of schizophrenia in adults otsuka.co.jp ↗ |
| 2018-05-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck to Start Third Phase 3 Trial in June to Evaluate Brexpiprazole in the Treatment of Agitation in Patients with Alzheimer's Disease otsuka.co.jp ↗ |
| 2018-05-23 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck to Start Third Phase 3 Trial in June to Evaluate Brexpiprazole in the Treatment of Agitation in Patients with Alzheimer's Disease otsuka-us.com ↗ |
| 2018-04-18 | Otsuka Pharmaceutical Development & Commercialization, Inc. | REXULTI Tablets, a New Antipsychotic Drug, Launched in Japan® otsuka.co.jp ↗ |
| 2018-01-19 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Receives Approval in Japan for the Manufacture and Sale of New Antipsychotic Drug Rexulti Tablets for Schizophrenia ® otsuka.co.jp ↗ |
| 2017-11-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck will Initiate a Third Phase 3 Trial to Evaluate Brexpiprazole in the Treatment of Agitation in Patients with Dementia of the Alzheimer's Type otsuka.co.jp ↗ |
| 2017-10-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck will initiate a third Phase 3 trial to evaluate brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type otsuka-us.com ↗ |
| 2017-10-12 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Announce Initiation of Two Phase 3 Trials of Brexpiprazole in Patients with Bipolar I Disorder otsuka.co.jp ↗ |
| 2017-10-11 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Announce Initiation of Two Phase 3 Trials of Brexpiprazole in Patients with Bipolar I Disorder otsuka-us.com ↗ |
| 2017-05-02 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Announce Results of Brexpiprazole on Symptoms of Agitation Related to Alzheimer's-type Dementia otsuka.co.jp ↗ |
| 2017-05-02 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck announce results of brexpiprazole on symptoms of agitation related to Alzheimer’s-type dementia otsuka-us.com ↗ |
| 2017-03-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Lundbeck and Otsuka's Brexpiprazole for Adult Patients with Schizophrenia Accepted for Review by EMA otsuka.co.jp ↗ |
| 2017-02-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Health Canada Approves Otsuka and Lundbeck's REXULTI (brexpiprazole) as a Treatment for Schizophrenia in Adults otsuka.co.jp ↗ |
| 2017-01-06 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Submits New Drug Application in Japan for Brexpiprazole in the Treatment of Schizophrenia otsuka.co.jp ↗ |
| 2016-09-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | U.S. FDA Approves Labeling Update of REXULTI(brexpiprazole) for Maintenance Treatment of Schizophrenia in Patients in the U.S.® otsuka.co.jp ↗ |
| 2016-09-23 | Otsuka Pharmaceutical Development & Commercialization, Inc. | U.S. FDA Approves Labeling Update of REXULTI® (brexpiprazole) for Maintenance Treatment of Schizophrenia otsuka-us.com ↗ |
| 2016-02-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | U.S. FDA Accepts For Review Otsuka and Lundbeck’s sNDA Filing for Labeling Update of REXULTI® (brexpiprazole) for Maintenance Treatment of Schizophrenia otsuka-us.com ↗ |
| 2015-07-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | U.S. FDA Approves Otsuka and Lundbeck's REXULTI (brexpiprazole) as Adjunctive Treatment for Adults with Major Depressive Disorder and as a Treatment for Adults with Schizophrenia® otsuka.co.jp ↗ |
| 2015-07-10 | Otsuka Pharmaceutical Development & Commercialization, Inc. | U.S. FDA Approves Otsuka and Lundbeck’s REXULTI® (Brexpiprazole) as Adjunctive Treatment for Adults with Major Depressive Disorder and as a Treatment for Adults with Schizophrenia otsuka-us.com ↗ |
| 2015-05-12 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck to Present Data on Investigational Compound Brexpiprazole in Schizophrenia and Major Depressive Disorder at American Psychiatric Association Annual Meeting otsuka-us.com ↗ |
| 2015-04-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results of Phase III Study of Brexpiprazole in Adult Patients with Schizophrenia Published in American Journal of Psychiatry otsuka.co.jp ↗ |
| 2015-04-17 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results of Phase III Study of Brexpiprazole in Adult Patients With Schizophrenia Published in American Journal of Psychiatry otsuka-us.com ↗ |
| 2014-12-11 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka And Lundbeck's Brexpiprazole Demonstrates Statistically Significant Effects In New Phase III Studies In Adult Patients With Schizophrenia Presented At The American College Of Neuropsychopharmacology Annual Meeting otsuka.co.jp ↗ |
| 2014-12-10 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka And Lundbeck Present Phase III Data on Brexpiprazole As Adjunctive Therapy In Adult Patients With Major Depression At The American College Of Neuropsychopharmacology Annual Meeting otsuka.co.jp ↗ |
| 2014-09-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | U.S. FDA Accepts Otsuka and Lundbeck's Filing for Review of Brexpiprazole for the Treatment of Schizophrenia and as Adjunctive Therapy for the Treatment of Major Depression otsuka.co.jp ↗ |
| 2014-09-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | U.S. FDA accepts Otsuka and Lundbeck’s filing for review of brexpiprazole for the treatment of schizophrenia and as adjunctive therapy for the treatment of major depression. otsuka-us.com ↗ |
| 2014-07-14 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Submit New Drug Application in The US for Brexpiprazole for The Treatment of Schizophrenia and as Adjunctive Therapy for The Treatment of Major Depressive Disorder otsuka.co.jp ↗ |
| 2014-07-14 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck Submit New Drug Application in the US for Brexpiprazole for the Treatment of Schizophrenia and as Adjunctive Therapy for the Treatment of Major Depressive Disorder otsuka-us.com ↗ |
| 2014-01-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Lundbeck to present new data on brexpiprazole in major depressive disorder (MDD) at European Psychiatry Association 2014 Congress otsuka.co.jp ↗ |
| 2011-05-16 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Co., LTD. Announces Results from a Phase 2 Study of Investigational Product OPC-34712 as Adjunctive Therapy in Adults with Major Depressive Disorder otsuka.co.jp ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 91 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | brexpiprazole | “To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment...” NCT01360645 ↗73“A post hoc analysis was performed using data obtained over eight weeks from 200 Japanese patients with schizophrenia who were switched to brexpiprazole monotherapy in a...” PMID 32297486 ↗ Apr 2020 “In each cohort, subjects will receive a brexpiprazole 2 mg conventional tablet on Day 1of Period 1, the QW formulation on Day 1 of Period 2 and 3, as single and multiple dose...” NCT04118127 ↗ “oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)” NCT01360866 ↗ “CAU plan modified to include a trial of phenelzine (or, if contraindicated: brexpiprazole).” NCT06580041 ↗ “OPC-34712 (brexpiprazole)” NCT01360632 ↗ |
| Known as | Brexpiprazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105760 ↗ |
| Known as | Brexpiprazole fumarate | “OPC-34712FUM/ Brexpiprazole fumarate” NCT05325645 ↗2“OPC-34712FUM/ Brexpiprazole fumarate” NCT05326347 ↗ “OPC-34712FUM/ Brexpiprazole fumarate” NCT06036108 ↗ |
| Known as | OPC-34712 | “A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the...” NCT03620981 ↗26“Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress” NCT02196506 ↗ “To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment” NCT01360632 ↗ “Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia” NCT01668797 ↗ “Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms” NCT02013531 ↗ “Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia” NCT02013622 ↗ “OPC-34712 [Brexpiprazole] High Dose” NCT01396421 ↗ “Brexpiprazole (OPC-34712)” NCT03198078 ↗ “Brexpiprazole (OPC-34712)” NCT02411695 ↗ “Brexpiprazole, OPC-34712” NCT01862640 ↗ “Brexpiprazole, OPC-34712” NCT01922258 ↗ “Drug: OPC-34712” NCT01456897 ↗ |
| Known as | OPC-34712FUM | “OPC-34712FUM/ Brexpiprazole fumarate” NCT05325645 ↗2“OPC-34712FUM/ Brexpiprazole fumarate” NCT05326347 ↗ “OPC-34712FUM/ Brexpiprazole fumarate” NCT06036108 ↗ |
| Known as | OPDC-34712 | “Brexpiprazole, OPDC-34712” NCT02968121 ↗ |
| Known as | Rexulti | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03418675 ↗ |
| Known as | Rxulti | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105760 ↗ |
| Action | Activate | “Serotonin 1a (5-HT1a) receptor partial agonist” CHEMBL2105760 ↗1“Dopamine D2 receptor partial agonist” CHEMBL2105760 ↗ |
| Action | Inhibit | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL2105760 ↗ |
| Modality | Small molecule | — CHEMBL2105760 ↗ |
| Route | Oral | “Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks” NCT00797966 ↗ |
| Target | DRD2 | “Dopamine D2 receptor partial agonist” CHEMBL2105760 ↗ |
| Target | HTR1A | “Serotonin 1a (5-HT1a) receptor partial agonist” CHEMBL2105760 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL2105760 ↗ |