The FDA is expected to decide by July 24, 2026, whether to approve a new class of ADHD medication, one that works differently from every other drug currently approved for the condition and would offer a genuine alternative for patients who cannot use or do not respond to stimulants.
The drug is centanafadine, developed by Otsuka Pharmaceutical. It is a once-daily extended-release capsule being reviewed for treatment of attention-deficit hyperactivity disorder in children, adolescents, and adults. The FDA accepted the New Drug Application in January 2026 and granted it Priority Review status — a designation the agency uses for therapies that may offer meaningful advantages over existing treatments.
