FDA Accepts Otsuka’s Centanafadine NDA for Priority Review in ADHD

The U.S. Food and Drug Administration (FDA) has accepted and granted priority review to a New Drug Application (NDA) from Otsuka Pharmaceutical for centanafadine, an investigational once-daily extended-release treatment for attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. The application is supported by positive data from four pivotal Phase 3 clinical trials demonstrating statistically significant improvements in core ADHD symptoms versus placebo. The Prescription Drug User Fee Act (PDUFA) target action date is set for 24 July 2026.

New Mechanism Could Expand ADHD Treatment Options

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), a novel mechanism that differentiates it from currently available ADHD therapies. Across its Phase 3 program, the compound showed meaningful symptom reduction on standard rating scales in both pediatric and adult populations and was generally well tolerated, with common adverse events including decreased appetite, nausea, headache, and somnolence in younger patients.

Regulatory and Market Implications

Priority review status underscores the FDA’s recognition of centanafadine’s potential to address unmet needs in ADHD management, particularly given the chronic nature of the disorder and limitations of existing treatments. If approved, centanafadine could provide clinicians and patients with a novel non-stimulant option spanning age groups. The upcoming PDUFA date will be an important regulatory milestone to watch in the ADHD therapeutic landscape.