Otsuka won U.S. FDA approval for Simtriyo (centanafadine), granting the once-daily extended-release capsule a label for attention deficit hyperactivity disorder (ADHD) in adults and children aged 6 years and older who weigh at least 20 kg. The approval positions Simtriyo as the first and only approved norepinephrine, dopamine, and serotonin reuptake inhibitor for the labeled population, with Otsuka preparing for availability this year after DEA scheduling. Simtriyo’s expanded indication reflects the continued momentum around next-generation ADHD therapeutics that aim for improved convenience and target engagement profiles compared with older monoamine strategies. For competitors and payers, the new label may intensify pharmacologic differentiation and channel adoption, particularly where once-daily regimens support adherence.