News Releases

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 April

1 APR 2026

Corporate

Otsuka Pharmaceutical Recognized as a "Food and Nutrition Education Practice Excellent Corporation 2026" by the MAFFLeveraging Proprietary Expertise and Services to Promote Health through Nutrition

2026 March

News Releases

Otsuka Pharmaceutical Recognized as a "Food and Nutrition Education Practice Excellent Corporation 2026" by the MAFFLeveraging Proprietary Expertise and Services to Promote Health through Nutrition

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) -

Otsuka Submits Application in Japan for Iclusig® for First-Line Treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Otsuka Unveils New Repinatrabit Open-Label Extension Data in Phenylketonuria (PKU) Signaling Efficacy in Adolescents at the 2026 American College of Medical Genetics and Genomics (ACMG) Meeting

Launch of Joint Sales of the QuickNavi™-Campylobacter Antigen Diagnostic Kit in Japan

New and Improved Calorie Mate JELLYEnhanced Taste and Balanced Nutrition, Now Even More Accessible

Otsuka Pharmaceutical Appointments of Board Members and Statutory Auditors (PDF: 148.8 KB)

Otsuka Pharmaceutical Named Tokyo Sports Promotion Model Company (Sports Practice Category) Employee and Communities Health Initiatives Recognized

New Release: SOYJOY Azuki & HojichaA Deep Japanese Flavor with Gentle Sweetness and a Roasted Aroma

Paradise Ultrasound Renal Denervation System for the Treatment of Resistant Hypertension,Now Covered by Insurance and Commercially Available in Japan

New Product Release: /zeroz - a self-conditioning food that supports the body's natural abilities and contains plant-derived kaempferol to help make more effective use of oxygen

Otsuka to Sponsor TOKYO MARATHON 2026Supporting Runners from Around the World Under the Theme "Believe in People's Potential."

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

Opening Egypt's First ORONAMIN C DRINK FactoryMeeting Growing Demand and Contributing to Community Health

Otsuka Enters into Agreement with South Korea-based Sky Labs for Exclusive Commercialization Rights in Japan to the Automated Blood Pressure Monitor CART BP pro First-in-world ring‑type blood pressure monitor that has received regulatory approval and insurance reimbursement in South Korea

Tianjin Otsuka Beverage Opens New POCARI SWEAT Factory New facility to serve as a "health awareness hub"

Otsuka Announces FDA Acceptance and Priority Review of New Drug Application for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults

Otsuka Pharmaceutical Begins Rollout of PET Bottles Made from 100% Recycled PET ResinAiming to Realize a Decarbonized and Circular Society

Otsuka and Towa Conclude Basic Agreement on the Succession and Manufacturing Outsourcing of Long Listed Products, Establishing a Collaborative Framework for Stable Supply

DawnzeraTM (donidalorsen) granted European Union marketing authorisation for the prevention of hereditary angioedema

Otsuka Pharmaceutical and Dr. Keisuke Kataoka of the National Cancer Center Japan and Keio University Receive the Minister of Education, Culture, Sports, Science and Technology Award for Development of Gene Panel Test for Hematological Malignancies

Otsuka Pharmaceutical Expands On-Site Solar Power Facilities at Factory Premises Accelerating Carbon-Neutral Initiatives

Otsuka Holdings Submits Commitment Letter to Obtain Science-Based Targets Validation for the Entire Otsuka Group

Otsuka Pharmaceutical Supports Anti-Doping Initiative"CLEAN SPORT NIPPON SELECT"

Otsuka Initiates Global Phase 3 Clinical Trial Evaluating Repinatrabit for the Treatment of Phenylketonuria (PKU)

Otsuka Launches Frailty Prevention Support VR as Newest Content in FACEDUO VR Program Portfolio - Enables earlier detection of frailty to support health maintenance and prevent or defer the need for nursing care -

Otsuka Receives FDA Accelerated Approval for VOYXACT® (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression

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

Otsuka launches NEXLETOL® in Japan

Donidalorsen Receives Positive CHMP Opinion for the Prevention of Hereditary Angioedema Attacks

Sibeprenlimab Phase 3 Data Presented at American Society of Nephrology Kidney Week 2025 Showed Proteinuria Reduction through 12 Months for the Treatment of Immunoglobulin A Nephropathy (IgAN) Trial Interim Analysis Outcomes Published in New England Journal of Medicine

Otsuka Announces First Participants Enrolled in Phase 3 Clinical Trial Evaluating Investigational Compound Quabodepistat for Drug-resistant Pulmonary Tuberculosis

Otsuka Signs Joint Research Agreement in Japan with National Cerebral and Cardiovascular Center -Purpose Is to Evaluate Salt Reduction Behavior Change in Heart Disease Patients Using a Nutritional Monitoring App-

Otsuka Enters into Licensing Agreement for Ophthalmic Gene Therapy Drug Candidate 4D-150 (Anti-VEGF agent) ‐ Acquires Exclusive Development and Commercialization Rights for Asia-Oceania Region, Including Japan, from 4DMT ‐

Research on Work Productivity Among Japanese Workers Published in the Journal of Occupational Health — Visualizing the Impact of a Range of Diseases on Productivity Using Large-Scale Data —

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 Receives Approval in Japan for NEXLETOL®as a Treatment for Hypercholesterolemia

POCARI SWEAT × TOKUSHIMA VORTIS Football Dream Project Phase 5 Welcomes Junior Soccer Players from the Middle East to Tokushima for International Exchange

Joint Research on Athletes' Heat Acclimatization and Fluid/Nutrition Strategies at the World Athletics Championships Tokyo 25Provide New Insights for People Involved in Sports Around the World

Otsuka Pharmaceutical Supports World Athletics Championships Tokyo 25 with POCARI SWEAT "Believe In Your Potential." is the Key Message We are Spreading to People Around the World

Otsuka Pharmaceutical Diagnostic Division Opens a New Laboratory in Tokyoto Advance Development of Next-Generation Medical Devices

Research Findings on Skin Condition Fluctuations and Recommended Foods During the Menstrual Cycle

Free Outdoor Live Music Event "EXCITING SUMMER in WAJIKI 2025" Live Stage Will Run on Solar Power Promoting More Sustainable Event Experience

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 Acquires Worldwide Rights to Cantargia's CAN10 for Development and Commercialization as a Potential Treatment for Autoimmune Diseases

Otsuka Pharmaceutical Launches Sales of POCARI SWEAT in India Expanding the Nutraceutical Business Globally

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

Otsuka Pharmaceutical Launches Portal for Corporate Health Services Empowering Employee Health Through Several Service Options

POCARI SWEAT ICE SLURRY Adopted as a New Heat Illness Prevention at Expo 2025 Osaka, Kansai, Japan, Supporting the Safe and Secure Operation of the Expo

Otsuka Obtains Exclusive License from Harbour BioMed for HBM7020: A Novel BCMAxCD3 Bispecific T-Cell Engager

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

Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN)

Otsuka Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)

Pharmavite Established a New Facility in Ohio, US, Dedicated to The Manufacturing of Gummy SupplementsFacilitating the Research and Development of Gummy Products

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

Otsuka Pharmaceutical Opens First POCARI SWEAT Factory in VietnamSupporting Health and Meeting Growing Demand

Otsuka Pharmaceutical is Focusing on "Water, Nutrition, and Oxygen" to Tap into Human PotentialProvide "Wellness Energy" at Expo 2025 in Osaka, Kansai, Japan

Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

Otsuka Pharmaceutical is Expanding "Local Production and Local Recycling" of PET Bottle Initiatives in Cooperation with Local CommunitiesAgreement Signed with the Saga Eastern Environmental Facilities Association for Horizontal Recycling of PET Bottle

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

Otsuka Pharmaceutical Appointments of Board Members and Statutory Auditors (PDF: 62.5 KB)

New Release: SOYJOY Black Sesame A Bold Sesame Experience with a Delightful Popping Texture and Roasted Aroma

HemeSight®, the First-in-Japan Comprehensive Genomic Profiling Assay for Hematological Malignancies, Is Now on Sale - Insurance coverage begins on March 1, 2025

Otsuka Sponsor TOKYO MARATHON 2025 Supporting the Conditioning of Runners Worldwide with the Global Brand POCARI SWEAT

Otsuka Holdings Receives Award by the Commissioner of the Consumer Affairs Agency at FY2024 Award for Good Practices of Consumer

Otsuka Pharmaceutical to Offer "Wellness Energy" at the Expo 2025 Osaka, Kansai, JapanIntroducing a New Vision for "Shaping the Health of the Future"

Otsuka Pharmaceutical Finalizes an Agreement with Fukuroi City on the Horizontal Recycling of PET BottlesPartnering with Its Factory to Promote a "Local Production and Local Recycling" Initiative for PET Bottles

Otsuka Group Selected for CDP Climate Change A List for a Third Consecutive Year

Otsuka Pharmaceutical Launches the "Conditioning Supporter Training Program"Encouraging the Practice of Self-Conditioning

Otsuka Pharmaceutical Releases the Total Conditioning Handbook for Well-Being to Support Life Performance

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)

European Medicines Agency Commences Review of Donidalorsen in Hereditary Angioedema

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 Expanding Use of Environmentally Friendly, Reusable Temperature-Controlled Containers - Initiated use for shipment of some pharmaceutical products to Europe -

Otsuka Pharmaceutical Launches POCARI SWEAT Basketball Dream Project to Promote Sports and International Exchanges

Otsuka Submits New Drug Application in Japan for Bempedoic Acid in the Treatment of Hypercholesterolemia

Otsuka Submits Application in Japan for Iclusig^® for First-Line Treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

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

Dawnzera^TM (donidalorsen) granted European Union marketing authorisation for the prevention of hereditary angioedema

Otsuka Receives FDA Accelerated Approval for VOYXACT^® (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression

Otsuka launches NEXLETOL^® in Japan

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 Receives Approval in Japan for NEXLETOL^®as a Treatment for Hypercholesterolemia

Free Outdoor Live Music Event　"EXCITING SUMMER in WAJIKI 2025" Live Stage Will Run on Solar Power Promoting More Sustainable Event Experience

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 Pharmaceutical Launches Sales of POCARI SWEAT in India　Expanding the Nutraceutical Business Globally

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

HemeSight^®, the First-in-Japan Comprehensive Genomic Profiling Assay for Hematological Malignancies, Is Now on Sale - Insurance coverage begins on March 1, 2025

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

Otsuka launches Lupkynis^® in Japan

HemeSight^®, the First-in-Japan Comprehensive Genomic Profiling Assay for Hematological Malignancies, Receives Its First Regulatory Approval - HemeSight^® hematological malignancies gene panel test approved in Japan -

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

Otsuka Receives Approval in Japan for Lupkynis^® as a Treatment for Lupus Nephritis

Otsuka Pharmaceutical Joins Project to Promote Use of Sustainable Aviation Fuel in Air Cargo Transportation
ーOperated by Tokyo Metropolitan Government, Aiming for a Decarbonized Societyー

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 Pharmaceutical to Acquire Jnana Therapeutics Inc. - Transaction Includes JNT-517, a Potential First-In-Class Oral Treatment for Phenylketonuria (PKU) -
- Expands Specialty and Autoimmune Portfolios and Drug Discovery Technologies -

Novartis launches Entresto_® Granular Tablets for Pediatric Use, a formulation dedicated for pediatric patients

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

Novartis receives approval in Japan for Entresto_® Granular Tablets for Pediatric Use, a formulation dedicated for pediatric patients with chronic heart failure

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

Novartis Obtains Approval for Additional Indication of Pediatric Chronic Heart Failure for Angiotensin Receptor Neprilysin Inhibitor (ARNI) Entresto_® Tablet = Novartis and Otsuka to provide information to healthcare professionals on additional indication for Entresto =