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Featured news
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
NephrologyOtsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) today announce the U.S. Food and Drug Administration (FDA) has granted accelerated approval of VOYXACT (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. VOYXACT is a self-administered, subcutaneous injection dosed every four weeks. VOYXACT was granted accelerated approval based on the VISIONARY Phase 3 interim analysis, where it achieved a significant placebo-adjusted treatment effect of 51% (P<0.0001) reduction in proteinuria at nine months (n=320) of treatment (-50% VOYXACT vs 2% placebo). VOYXACT is the first and only therapy to block A-PRoliferation-Inducing-Ligand (APRIL).
Otsuka Pharmaceutical Submits New Drug Application to U.S. FDA for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for centanafadine, once daily extended release capsules, a novel norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. The NDA submission is supported by results from four pivotal Phase 3 clinical trials evaluating the efficacy and safety of centanafadine across patient populations.
Otsuka Announces First Participants Enrolled in Phase 3 Clinical Trial Evaluating Investigational Compound Quabodepistat for Drug-resistant Pulmonary Tuberculosis
Otsuka Pharmaceutical Development & Commercialization, Inc. and our parent company Otsuka Pharmaceutical Co. Ltd., announces the first patients have been successfully enrolled and dosed in its Phase 3 clinical trial evaluating quabodepistat, an investigational compound for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB). TB, and particularly its resistant forms, remains a major global health challenge.