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A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder

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Trial Profile

A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Feb 2026

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At a glance

  • Drugs Centanafadine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

Most Recent Events

  • 27 Jan 2026 According to Otsuka Pharmaceutical media release, company announce that the U.S. Food and Drug Administration (FDA) has accepted for priority review the NDA for centanafadine, once-daily extended release capsule and the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. The Prescription Drug User Fee Act (PDUFA) target action date is set for July 24, 2026.
  • 24 Nov 2025 According to Otsuka Pharmaceutical media release, company announced the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for centanafadine, once daily extended release capsules for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults.
  • 02 Jun 2022 Results of two studies (NCT03605680 and NCT03605836) assessing efficacy and safety profiles of 200 mg/d and 400 mg/d centanafadine in adults with Attention-Deficit/Hyperactivity Disorder, published in the Journal of Clinical Psychopharmacology.

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