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Featured news
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
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced new open-label extension study data for repinatrabit (JNT-517), demonstrating early and clinically meaningful reductions in blood phenylalanine (Phe) levels (-67% mean change from baseline) in adolescents with phenylketonuria (PKU). These new data, along with the study design for the pivotal global Phase 3 PheORD trial (NCT06971731) in adults, were presented at the 2026 American College of Medical Genetics and Genomics (ACMG) meeting.
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 Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for centanafadine, an investigational, once-daily extended release capsule and the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. The Prescription Drug User Fee Act (PDUFA) target action date is set for July 24, 2026.
Otsuka Initiates Global Phase 3 Clinical Trial Evaluating Repinatrabit for the Treatment of Phenylketonuria (PKU)
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announces today the initiation of the global Phase 3 clinical trial evaluating repinatrabit (JNT-517), an investigational, oral, small-molecule compound for the treatment of phenylketonuria (PKU). The goal of the PheORD Phase 3, randomized study is to assess the efficacy, safety and tolerability of oral repinatrabit, administered twice a day, in participants with PKU.1 Repinatrabit received orphan drug designation and rare pediatric disease designation for the treatment of PKU from the U.S. Food and Drug Administration (FDA).