FDA Approves Simtriyo, a First-in-Class ADHD Treatment for Children and Adults

The U.S. Food and Drug Administration (FDA) has approved Simtriyo (centanafadine), an extended-release capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older. This marks the first FDA-approved norepinephrine-dopamine-serotonin reuptake inhibitor (NDSRI) for ADHD, introducing a new mechanism distinct from existing stimulant and nonstimulant therapies. The approval was supported by four randomized, double-blind, placebo-controlled phase 3 trials demonstrating significant reductions in ADHD symptoms.