Otsuka: FDA Acceptance, Priority Review of NDA for Nonstimulant Centanafadine for ADHD

 

• Centanafadine is an investigational compound for the treatment of ADHD in children, adolescents, and adults. It is a novel norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI).
• The Prescription Drug User Fee Act (PDUFA) target action date is July 24, 2026.
• If approved, centanafadine would offer a first-in-class NDSRI treatment option for patients managing ADHD.
• ADHD is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity. It is often not diagnosed until adulthood, with an estimated 15.5 million adults in the U.S. currently diagnosed.

https://www.otsuka-us.com/news/otsuka-announces-fda-acceptance-and-priority-review-new-drug-application-centanafadine