Otsuka Submits NDA to FDA for Centanafadine for Treatment of ADHD Across the Lifespan

Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Pharmaceutical Co., Ltd. have submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for centanafadine, an investigational once-daily extended-release norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) proposed for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults, according to a company announcement dated November 24, 2025.

The NDA is supported by 4 pivotal phase 3 trials that evaluated centanafadine’s efficacy and safety across pediatric and adult populations. These studies demonstrated statistically significant improvements in core ADHD symptoms, including inattention and hyperactivity-impulsivity, compared with placebo. Otsuka noted that clinical and preclinical data indicate a favorable safety and tolerability profile and a low potential for abuse and dependence.

“As an innovator in mental health, we are pleased to take this important step forward in the hope of providing a novel treatment option to patients living with ADHD,” John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka Pharmaceutical Development & Commercialization, Inc., said in a press release. “Centanafadine represents a first in class mechanism of action among available ADHD therapies, and if approved, may expand the range of options available to those managing this complex condition.”

Across all 4 studies, centanafadine demonstrated improvements on validated ADHD symptom scales:

• Children (ages 4–12; NCT05428033):
  In a 6-week, randomized, double-blind, fixed-dose trial, the high-dose group achieved statistically significant improvement on the ADHD Rating Scale–5 (ADHD-RS-5) compared with placebo. Low-dose centanafadine did not meet statistical significance. The most common adverse events were decreased appetite, rash, and vomiting.
• Adolescents (ages 13–17; NCT05257265):
  In a similar 6-week trial design, the high-dose arm showed statistically significant and clinically meaningful reductions in ADHD-RS-5 total scores versus placebo. Frequently reported adverse events included decreased appetite, nausea, headache, and rash.
• Adults (ages 18–55; NCT03605680, NCT03605836):
  Two placebo-controlled studies of sustained-release tablets (200 mg/day or 400 mg/day for 6 weeks) demonstrated statistically significant improvements on the Adult ADHD Investigator Symptom Rating Scale (AISRS) for both dose groups. Decreased appetite and headache were the most common adverse events.

Across studies, centanafadine was generally well tolerated, and data suggest low risk for abuse or dependence.

ADHD Epidemiology and Unmet Need

ADHD is a chronic neurodevelopmental disorder marked by impairments in attention, hyperactivity, and impulsivity. Although often diagnosed in childhood, symptoms may persist into adulthood, and many individuals are not diagnosed until later in life. An estimated 15.5 million adults in the United States carry an ADHD diagnosis, according to the company.

Otsuka stated that centanafadine’s novel NDSRI mechanism may offer a differentiated treatment approach if approved.

Reference: Otsuka Pharmaceutical Submits New Drug Application to U.S. FDA for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults. News release. Otsuka Pharmaceuticals. November 24, 2025. Accessed November 25, 2025. https://www.otsuka-us.com/news/otsuka-pharmaceutical-submits-new-drug-application-us-fda-centanafadine-treatment-adhd