News Releases

News releases related to the central nervous system

Information in this news release was current as of the original release date.

Otsuka Pharmaceutical's news releases are intended to provide information to the media. It may contain information about ethical drugs or products under development, however information contained in the news releases are not intended to constitute promotion, advertisement, or medical advice.

2026

News releases related to the central nervous system

Otsuka Pharmaceutical to Acquire Transcend Therapeutics - Expands Otsuka portfolio in psychiatric and neurological fields and aims to accelerate development of Transcend’s portfolio, including the TSND-201 program for post-traumatic stress disorder (PTSD) -

REXULTI ® Listed in the "Essential Medicines List for the Ultra-Acute Phase of Disasters" by the Japanese Association for Disaster Medicine

Otsuka Pharmaceutical Submits New Drug Application to U.S. FDA for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults

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 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)

eMind, Tohoku University, and Otsuka Pharmaceutical Launch Epilepsy Smart Medical Joint Research Project (Phase II) Aiming to Start and Expand Epilepsy Treatment Support System

Otsuka Launches Comprehensive Support Program for Families of People with Severe Social Withdrawal (Hikikomori) in Collaboration with Hokkaido University

New smartphone app, Rejoyn®, launched in Great Britain as a treatment for those living with depressive disorder

Otsuka Signs Joint Research Agreement with Keio UniversityIndustry-academia collaboration for infrastructure development toward the social implementation of psychedelics in Japan

Rxulti® (brexpiprazole) approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older

MIREVO®, the first neuropsychological testing program in Japan to support dementia treatment, now available

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)

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 and Jolly Good initiate the sale of FACEDUO Dementia Care Support VR

Otsuka Obtains Exclusive Global Licensing Rights from Ionis to Ulefnersen, a Potential Treatment for Amyotrophic Lateral Sclerosis Caused by Mutations in the Fused in Sarcoma Gene (FUS-ALS)

Otsuka Obtains Additional Indication for Rexulti®in Japan as an Adjunctive Treatment for Agitation Associated with Dementia due to Alzheimer's Disease

Otsuka to Participate in the Orange Innovation Project, Promoted by Japan's Ministry of Economy, Trade and Industry

Otsuka and Jolly Good Launch FACEDUO Dementia Care Support VR

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 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 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 to Terminate Development of AVP-786

Otsuka and Lundbeck submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD

FACEDUO Emotion Recognition Training VR now available - Support for those with developmental conditions such as autism spectrum disorder (ASD), which makes it difficult to read emotions -

U.S. Food and Drug Administration (FDA) Clearance of Rejoyn® First Prescription Digital Therapeutic Authorized in the U.S. for the Adjunctive Treatment of Major Depressive Disorder (MDD) symptoms

Abilify Maintena® 960mg (aripiprazole) approved in the EU as the first once-every-two-months long-acting injectable for the maintenance treatment of schizophrenia

Otsuka and Lundbeck Presented New Data Analyses on the Efficacy of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer's Disease

Otsuka and Sumitomo Revise License Agreement - Otsuka holds exclusive rights to develop, manufacture, and commercialize ulotaront and SEP-380135 worldwide -

Otsuka Announces Phase 3 Topline Results of AVP-786 in the Treatment of Agitation Associated with Dementia due to Alzheimer's Disease

Otsuka and Jolly Good to Start Delivery of FACEDUO Content for Family Support of People with Severe Social Withdrawal (Hikikomori) FACEDUO is a virtual reality program for social skills training support

Otsuka Obtains the Additional Indication of Adjunctive Treatment of Major Depressive Disorder for Rexulti® in Japan

MIREVO®, a New Cognitive Function Testing Application for Dementia Care Support, Obtains Regulatory Approval, a First in Japan

Otsuka Applies in Japan for the Additional Indication for Agitation Associated with Dementia due to Alzheimer's Disease for Rexulti® (brexpiprazole)

Otsuka Pharmaceutical Announces Positive Topline Results from Two Pivotal Phase 3 Trials of Centanafadine as a Treatment for Adolescents and Children with Attention-Deficit/Hyperactivity Disorder (ADHD)

Otsuka Pharmaceutical Enters into Cooperative Agreement with Japan Association of Public Mental Health & Welfare Workers

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 Pharmaceutical to Acquire Mindset Pharma - Strengthens pipeline in the area of psychiatric and neurological disorders -

Sumitomo Pharma and Otsuka Announce Topline Results from Phase 3 DIAMOND 1 and DIAMOND 2 Clinical Studies Evaluating Ulotaront in Schizophrenia

Otsuka Pharmaceutical announces positive results of phase III trial in Japan showingreduced agitation in patients with Alzheimer's dementia treated with brexpiprazole

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

FDA Approves Otsuka and Lundbeck's ABILIFY ASIMTUFII®(aripiprazole), the First, Two-month, Long-acting Injectable (LAI) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults

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 Applies for the Additional Indication of Adjunctive Treatmentof Major Depressive Disorder for Rexulti® (brexpiprazole) in Japan

Otsuka and Schrödinger Announce Single-Target, Drug Discovery Collaboration in Neurology

Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer's dementia

Otsuka Announces the Launch in Japan of Auto-Injector Dosage Form for AJOVY® Subcutaneous Injection 225mg for Preventive Treatment of Migraine

Avanir Pharmaceuticals, Inc. Business Will Be IntegratedInto Otsuka America Pharmaceuticals, Inc. as of January 1, 2023

Otsuka and Jolly Good to Launch FACEDUO, a Virtual Reality Support Program forPatients with Schizophrenia and Their Supporters

Otsuka and Lundbeck Announce U.S. FDA Acceptance of New Drug Application forAripiprazole 2-month, Ready-to-Use, Long-acting Injectable to Treat Schizophrenia andBipolar I Disorder in Adults

Otsuka Pharmaceutical announces positive results of phase III trial in Japan for brexpiprazole in the treatment of major depressive disorder

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 Pharmaceutical and Lundbeck announce positive results showing reduced agitation in patients with Alzheimer's dementia treated with brexpiprazole

European Medicines Agency Commences Review of Aripiprazole2-Month Long-Acting Injectable for the Maintenance Treatment of Schizophrenia in Adult Patients Stabilised with Aripiprazole

Otsuka Obtains Approval in Japan for Auto-Injector Dosage Form for AJOVY® Subcutaneous Injection 225 mg for Preventive Treatment of Migraine

Otsuka and Ai-BrainScience Announce Sales Collaboration Agreement for New Cognitive Function Testing Application That Uses Eye Tracking Technology

Otsuka Enters Agreement with Jolly Good for Co-Development and Sales Rights in Japanfor a Social Skills Training Platform Using Virtual Reality in the Psychiatric Field

Otsuka and Lundbeck Announce U.S. FDA Approval of Supplemental New Drug Application for REXULTI® (brexpiprazole) to Treat Schizophrenia in Pediatric Patients

Sumitomo Dainippon Pharma and Otsuka Announce a Worldwide Collaborationand License Agreement for Four Psychiatry and Neurology Compounds

Otsuka to Launch AJOVY® Subcutaneous Injection 225 mg Syringe in Japan

Otsuka Obtains Approval in Japan for Orally-Disintegrating-Dose Form of REXULTI® Tablets

Otsuka reports topline outcomes on a phase II trial that evaluated brexpiprazole for the treatment of borderline personality disorder

Otsuka Files Application in Japan for Approval of Auto-Injector Dosage Form for AJOVY® Subcutaneous Injection 225 mg for Preventive Treatment of Migraine

AJOVY® Subcutaneous Injection 225 mg Syringe, as a Preventive Treatment of Migraine, Granted Approval in Japan

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 and Perception Neuroscience Announce Collaboration on Development of PCN-101 (R-ketamine) in Japan for Treatment of Depressive Disorders

Otsuka's ABILIFY MAINTENA approved for the additional indication of bipolar I disorder in Japan

Otsuka Filed Application in Japan for Approval of Fremanezumab as a Prophylactic Treatment for Migraine

Otsuka Pharmaceutical and Axcelead Drug Discovery Partners announce joint research in CNS indications

Otsuka Announces Positive Top-line Results from Two Phase 3 Studies of Centanafadine for the Treatment of Attention-deficit Hyperactivity Disorder (ADHD) in Adult Patients

Otsuka announces positive top-line results from clinical trials in Japan offremanezumab as a prophylactic treatment for migraine

Otsuka Pharmaceutical and Avanir Pharmaceuticals to Continue Clinical Development ofInvestigational AVP-786 for the Treatment of Agitation in Patients with Alzheimer's Dementia

Otsuka's Subsidiary Avanir Pharmaceuticals Reports Top-line Data from Second Phase 3 Trial Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer's Dementia

Otsuka Applies for the Additional Indication in Japan of Bipolar Disorder for ABILIFY MAINTENA for Suspended Release Injectable Suspension

Otsuka's Subsidiary Avanir Pharmaceuticals Reports Phase 3 Data Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer's Dementia

Notice regarding the conclusion of co-development/co-promotion activities in Japan for the anti-epileptic drug "E Keppra"

Selincro Tablets 10mg Launched in Japan

Otsuka and Lundbeck report phase III data evaluating brexpiprazole for the treatment of manic episodes associated with bipolar I disorder

Avanir Pharmaceuticals, Inc. Reaches Agreement in Principle with U.S. Department of Justice Regarding NUEDEXTA (dextromethorphan HBr and quinidine sulfate) 20 mg/10 mg capsule

Selincro (nalmefene) Tablets 10mg Receives Regulatory Approval in Japan

REXULTI^® Listed in the "Essential Medicines List for the Ultra-Acute Phase of Disasters" by the Japanese Association for Disaster Medicine

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 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)

New smartphone app, Rejoyn^®, launched in Great Britain as a treatment for those living with depressive disorder

Rxulti^® (brexpiprazole) approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older

MIREVO_®, the first neuropsychological testing program in Japan to support dementia treatment, now available

Otsuka Obtains Additional Indication for Rexulti^®in Japan as an Adjunctive Treatment for Agitation Associated with Dementia due to Alzheimer's Disease

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

U.S. Food and Drug Administration (FDA) Clearance of Rejoyn^® First Prescription Digital Therapeutic Authorized in the U.S. for the Adjunctive Treatment of Major Depressive Disorder (MDD) symptoms

Abilify Maintena^® 960mg (aripiprazole) approved in the EU as the first once-every-two-months long-acting injectable for the maintenance treatment of schizophrenia

Otsuka and Lundbeck Presented New Data Analyses on the Efficacy of REXULTI^® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer's Disease

Otsuka Obtains the Additional Indication of Adjunctive Treatment of Major Depressive Disorder for Rexulti^® in Japan

MIREVO_®, a New Cognitive Function Testing Application for Dementia Care Support, Obtains Regulatory Approval, a First in Japan

Otsuka Applies in Japan for the Additional Indication for Agitation Associated with Dementia due to Alzheimer's Disease for Rexulti^® (brexpiprazole)

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

FDA Approves Otsuka and Lundbeck's ABILIFY ASIMTUFII^®(aripiprazole), the First, Two-month, Long-acting Injectable (LAI) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults

Otsuka Applies for the Additional Indication of Adjunctive Treatmentof Major Depressive Disorder for Rexulti^® (brexpiprazole) in Japan

Otsuka Announces the Launch in Japan of Auto-Injector Dosage Form for AJOVY^® Subcutaneous Injection 225mg for Preventive Treatment of Migraine

Otsuka Obtains Approval in Japan for Auto-Injector Dosage Form for AJOVY^® Subcutaneous Injection 225 mg for Preventive Treatment of Migraine

Otsuka and Lundbeck Announce U.S. FDA Approval of Supplemental New Drug Application for REXULTI^® (brexpiprazole) to Treat Schizophrenia in Pediatric Patients

Otsuka to Launch AJOVY^® Subcutaneous Injection 225 mg Syringe in Japan

Otsuka Obtains Approval in Japan for Orally-Disintegrating-Dose Form of REXULTI^® Tablets

Otsuka Files Application in Japan for Approval of Auto-Injector Dosage Form for AJOVY^® Subcutaneous Injection 225 mg for Preventive Treatment of Migraine

AJOVY^® Subcutaneous Injection 225 mg Syringe, as a Preventive Treatment of Migraine, Granted Approval in Japan

Otsuka and Lundbeck's Rxulti^® (brexpiprazole) approved by the European Commission

REXULTI^® Tablets, a New Antipsychotic Drug, Launched in Japan

Otsuka Receives Approval in Japan for the Manufacture and Sale of New Antipsychotic Drug Rexulti^® Tablets for Schizophrenia

U.S. FDA Approves Labeling Update of REXULTI^®(brexpiprazole) for Maintenance Treatment of Schizophrenia in Patients in the U.S.

"Neupro^® Patch", a Dopaminergic, Anti-Parkinsonian Drug,Will Become Available in Japan in an Additional New Dosage, "Neupro Patch 18 mg"

Anti-epileptic Drug E Keppra^® (generic name: levetiracetam) Obtains Additional Indication of Adjunctive Therapy for Generalized Tonic-Clonic Seizures in Japan

Otsuka's Subsidiary Avanir Pharmaceuticals Announces U.S. FDA Approval of ONZETRA^™Xsail^™ for the Acute Treatment of Migraine in Adults

E Keppra^® Injectable, to be Launched in Japan on December 1; Will Contribute to Uninterrupted Treatment of Epilepsy Patients Aged 4 and Over with Partial-onset Seizures

Otsuka Pharmaceutical's Subsidiary Avanir Pharmaceuticals Prevails in NUEDEXTA^® Patent Appeal Maintaining Exclusivity Through 2026 in the U.S.

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

Novel Anti-epileptic Drug E Keppra^® Filed in Japan for Additional Indication of Adjunctive Therapy for Generalized Tonic-clonic Seizures

Novel Anti-epileptic Drug E Keppra^® Approved in Japan for Additional Indication as Monotherapy for Partial-onset Seizures, in Addition to Existing Indication as Adjunctive Therapy for These Seizures

E Keppra^® 500 mg Injectable For Monotherapy Treatment of Epilepsy Submitted For Regulatory Review in Japan

E Keppra^® Injectable Receives Marketing Authorization in Japan Will Contribute to Uninterrupted Treatment of Epilepsy Patients Aged Four and Over

Otsuka Pharmaceutical's Samsca^® Approved in Japan as the World's First Drug Therapy for ADPKD, a Rare Kidney Disease

Anti-Epileptic Drug E Keppra^® Filed in Japan for Additional Indication of Monotherapy for Partial-Onset Seizures

Otsuka And Lundbeck Receive Postive Chmp Opinion In Europe For Abilify Maintena^™, A Once-Monthly Injectable For Schizophrenia

Phase II clinical data show statistically significant improvement for Lu AE58054 as add-on to donepezil, versus donepezil alone, on cognitive symptoms of Alzheimer's disease^*1 Lundbeck and Otsuka present data at Alzheimer’s Association International Conference 2013

Two New Formulations of E Keppra^® Developed Dry Syrup Obtains Approval; Application Filed for Injectable Formulation Address various needs of patients with epilepsy from 4 years of age and contribute to improvement of compliance with medication

Antiepileptic Drug E Keppra^® Tablet Approved in Japan for Pediatric Epilepsy (Partial-Onset Seizures)