Otsuka has stated that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for centanafadine, an investigational once-daily extended-release treatment for attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults.

• Application Acceptance: The NDA for centanafadine has received a priority review designation, with a Prescription Drug User Fee Act (PDUFA) target action date of 24 July 2026.
• Compound Profile: Centanafadine is a novel norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) being developed to address core ADHD symptoms.
• Clinical Support: The application is backed by Phase 3 trial data showing statistically significant improvements in ADHD ratings versus placebo across age groups.

This summary is based on a press release issued by Otsuka.