Otsuka Pharmaceutical Development & Commercialization and Otsuka Pharmaceutical announced they have submitted a New Drug Application (NDA) to the US FDA for centanafadine, a once-daily extended-release capsule designed to treat attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults.

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), offering a novel mechanism of action among ADHD therapies. The NDA is backed by four pivotal Phase 3 trials demonstrating the drug’s efficacy and safety across multiple age groups.

“Centanafadine represents a potential new option for patients living with ADHD,” said John Kraus, executive vice president and chief medical officer of Otsuka Pharmaceutical Development & Commercialization. “We are grateful to the patients and caregivers who participated in these studies and look forward to providing an innovative treatment for this complex condition.”

In clinical trials, centanafadine showed statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo. The trials revealed a generally favorable safety profile, with the most common side effects in children and adolescents being decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence; adults most frequently reported decreased appetite and headache.

The Phase 3 program included: children (ages 4–12): High-dose centanafadine significantly improved ADHD symptoms over placebo in a 6-week trial; the drug demonstrated low abuse potential and was well tolerated.

For adolescents (ages 13–17): High-dose treatment produced clinically meaningful symptom reductions; side effects were mostly mild, including decreased appetite, nausea, headache, and rash.

And in case of adults (ages 18–55): Two 6-week studies confirmed statistically significant improvements with centanafadine at both 200 mg and 400 mg daily doses, with low potential for abuse and favorable tolerability.

If approved, centanafadine could expand treatment options for millions of ADHD patients across age groups, marking a significant step forward in mental health therapeutics.