Otsuka Pharmaceutical Development & Commercialization, Inc., together with Otsuka Pharmaceutical Co., Ltd., has reached a key regulatory milestone after the U.S. Food and Drug Administration accepted for priority review its New Drug Application for centanafadine, an investigational treatment for attention-deficit hyperactivity disorder (ADHD). The FDA has set a Prescription Drug User Fee Act target action date of July 24, 2026.
Centanafadine is being developed as a once-daily, extended-release oral capsule and represents a potential first-in-class therapy. Unlike existing treatments, it is a norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), a novel mechanism designed to address ADHD symptoms across multiple neurotransmitter pathways. The application seeks approval for use in children, adolescents, and adults, reflecting the broad and lifelong nature of the condition.
The NDA is supported by data from four pivotal Phase 3 clinical trials that evaluated centanafadine’s safety and efficacy across pediatric, adolescent, and adult patient populations. In these studies, the drug demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo. Efficacy in children and adolescents was measured using the ADHD Rating Scale-5, while adult outcomes were assessed using the ADHD Investigator Symptom Rating Scale.
Across the trials, centanafadine was generally well tolerated. The most commonly reported adverse events in children and adolescents included decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence. In adult patients, decreased appetite and headache were the most frequently observed side effects. Otsuka said the overall safety profile was consistent across studies and age groups.
John Kraus, M.D., Ph.D., executive vice president and chief medical officer of Otsuka Pharmaceutical Development & Commercialization, said the FDA’s decision underscores the need for multiple therapeutic approaches in ADHD. He noted that the disorder can present differently across individuals and life stages, making treatment choice and flexibility especially important. According to Kraus, if approved, centanafadine could offer a new, first-in-class option designed to support broad symptom management for people living with ADHD.
ADHD has historically been viewed primarily as a childhood condition, but growing evidence shows that many individuals continue to experience symptoms into adolescence and adulthood. For some, these symptoms can cause significant impairment in academic performance, work productivity, and social functioning. Otsuka emphasized that expanding treatment options remains critical to addressing the diverse needs of patients across age groups.
With priority review status, the FDA will evaluate centanafadine on an accelerated timeline, reflecting its potential to offer meaningful benefits over existing therapies. If approved, centanafadine would mark an important addition to the ADHD treatment landscape and a notable advancement in Otsuka’s central nervous system portfolio.