News & Media

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 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).