Otsuka Files NDA for Centanafadine, a First-in-Class ADHD Treatment Targeting Three Neurotransmitters

Otsuka Files NDA for Centanafadine, a First-in-Class ADHD Treatment Targeting Three Neurotransmitters

By, Admin 27 November 2025

Otsuka has taken a major step in ADHD innovation. The company has filed a New Drug Application (NDA) with the U.S. FDA for centanafadine, a once-daily extended-release capsule designed for children, adolescents, and adults.

Centanafadine is a novel norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). If approved, it would introduce a new mechanism of action to the ADHD treatment landscape.

Why Centanafadine Matters?

Most ADHD therapies target one or two neurotransmitters. Centanafadine targets three, offering a differentiated and potentially broader therapeutic approach.

The NDA is backed by four pivotal phase 3 trials conducted across children, adolescents, and adults. All studies showed statistically significant improvements in core ADHD symptoms.

Otsuka says the drug may expand treatment options for patients who need something beyond current stimulants or existing non-stimulants.

What Otsuka Says About the NDA?

John Kraus, Otsuka’s Chief Medical Officer, highlighted the importance of this submission:

“Centanafadine represents a first-in-class mechanism among ADHD therapies and may expand options for patients managing this complex condition.”

He also acknowledged patients and caregivers for their participation in the clinical trials.

Phase 3 Results: Clear, Consistent Efficacy

Across four phase 3 studies, centanafadine demonstrated statistically significant and clinically meaningful reductions in:

  • Inattention
  • Hyperactivity
  • Impulsivity

Assessments were based on ADHD-RS-5 for children and adolescents, and AISRS for adults.

Centanafadine was generally well tolerated with a low potential for abuse and dependence.

Study Breakdown: Children, Adolescents, and Adults

1. Children (Ages 4–12)

  • Study: Randomized, double-blind, three-arm, fixed-dose
  • Duration: 6 weeks
  • Primary measure: ADHD-RS-5 score change at Week 6
  • Outcome:
    - High-dose group showed significant improvement
    - Low-dose group did not reach significance
  • Common side effects: Decreased appetite, rash, vomiting

2. Adolescents (Ages 13–17)

  • Study: Randomized, double-blind, fixed-dose
  • Duration: 6 weeks
  • Primary measure: ADHD-RS-5 score at Week 6
  • Outcome:
    - High-dose group achieved significant, meaningful symptom reduction
  • Common side effects: Decreased appetite, nausea, headache, rash

3. Adults (Ages 18–55)

  • Studies: Two randomized, double-blind, placebo-controlled trials
  • Doses: 200 mg/day or 400 mg/day
  • Duration: 6 weeks
  • Primary measure: AISRS score at Week 6
  • Outcome:
    - Both doses produced significant and meaningful improvement versus placebo
  • Common side effects: Decreased appetite and headache

Why This NDA Is Important?

If approved, centanafadine would introduce:

  • A new drug class for ADHD
  • A triple-target mechanism
  • A once-daily dosing option
  • A lower risk of abuse and dependence compared with stimulants
  • Evidence across all age groups, something few ADHD therapies offer

The phase 3 program provides one of the most comprehensive evaluations seen for an investigational ADHD therapy in years.

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