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Otsuka Pharmaceuticals Submits NDA for Centanafadine to Treat ADHD in Children
Otsuka Pharmaceuticals seeks FDA approval for centanafadine, a novel ADHD treatment, showing significant efficacy in pivotal clinical trials.
Otsuka Pharmaceuticals announced on November 25, 2025, that the company submitted a New Drug Application (NDA) to the US Food & Drug Administration (FDA) for centanafadine, a novel, first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults aged 4 – 55 years.
Results from 4 pivotal phase 3 clinical trials assessing the efficacy and safety of centanafadine, a once daily extended-release capsule, support this NDA submission.
“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," said John Kraus, MD, PhD, executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc., in a statement. "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. We are grateful to the patients and caregivers for their participation in these trials."
The phase 3 trials showed centanafadine provided significant and clinically meaningful improvements in ADHD symptoms compared with placebo, as measured by the ADHD Rating Scale-5 (ADHD-RS-5) in adolescents and children, and the ADHD Investigator Symptom Rating Scale (AISRS) in adults. Centanafadine was generally well tolerated, with common adverse events including decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence in children and adolescents; decreased appetite and headache were common adverse events in adults.
The 4 trials included in the submission included:
- Phase 3 trial in children aged 4 – 12 years with ADHD. Over 6 weeks, the high-dose centanafadine group demonstrated significant improvement versus placebo, while the low—dose group did not reach statistical significance.
- Phase 3 trial in adolescents aged 13 – 17 years with ADHD. The high-dose arm achieved statistically significant reductions in ADHD symptoms compared with placebo.
- Phase 3 trial in adults aged 18 – 55 years with ADHD.
- Phase 3 trial in adults aged 18 – 55 years with ADHD.
In the adult trials, participants received either centanafadine 200 mg/day, 400 mg/day, or placebo over a 6-week treatment period. Both centanafadine groups provided statistically significant and clinically meaningful improvements over placebo.
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