FDA approval establishes centanafadine as the first-in-class NDSRI for ADHD, expanding options across adult and pediatric populations aged ≥6 years and >20 kg.
Phase 3 pediatric and adolescent programs met week-6 efficacy endpoints on ADHD-RS-5 versus placebo in high-dose cohorts, supporting benefit across school-age developmental stages.
Adult phase 3 trials demonstrated significant, clinically meaningful symptom reductions at both 200 mg and 400 mg versus placebo by week 6 on an investigator-rated scale.
Post hoc analyses suggested improvements in executive function domains and emotional dysregulation, including time management, planning/prioritization, task initiation/completion, and working memory.
Safety profiles were characterized mainly by decreased appetite and headache in adults, and decreased appetite, nausea, headache, and rash in younger populations; dependence and abuse potential were reported as low.
“The norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) and central nervous system (CNS) stimulant, developed by Otsuka Pharmaceutical, is the first FDA-approved NDSRI for ADHD.”
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