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

The U.S. Food and Drug Administration (FDA) has approved centanafadine (Sintriyo), an extended-release capsule, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older. This marks the first approval of a norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) for ADHD, offering a new mechanism of action distinct from existing stimulant and nonstimulant therapies. The drug is expected to be available later in 2026.