FDA Accepts NDA for Priority Review: Centanafadine for Treatment of ADHD

The US Food and Drug Administration (FDA) has accepted for priority review Otsuka’s New Drug Application (NDA) for centanafadine, an investigational, 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.¹

The NDA, which was first submitted back in November 2025,² is supported by results from 4 pivotal phase 3 clinical trials evaluating the efficacy and safety of centanafadine across varied patient populations.^3-5 In these trials, centanafadine demonstrated statistically 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. The phase 3 program included 1 trial for children, 1 trial for adolescents, and 2 trials for adults. Centanafadine was generally well tolerated across studies, with the most common adverse events including decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence in children and adolescents, and decreased appetite and headache in adults. All trials showed low potential for abuse and dependence with this drug.^3-5

"ADHD manifests differently across patients, highlighting the importance of having multiple therapeutic approaches available," said John Kraus, MD, PhD, the executive vice president and chief medical officer of Otsuka Pharmaceutical Development & Commercialization. "The FDA's acceptance and priority review designation of our NDA for centanafadine marks an important milestone in our effort to bring forward a novel treatment option for people living with ADHD. If approved, centanafadine would offer a first-in-class NDSRI option designed to support broad symptom management. We extend our sincere gratitude to the patients, caregivers, and investigators whose participation made this milestone possible."

A recent poster presentation at the 2026 American Professional Society of ADHD and Related Diseases Annual Conference, in San Diego, California, further emphasized centanafadine’s effectiveness. Investigators used intracerebral microdialysis on rats to measure the effects of centanafadine on extracellular monoamines in the prefrontal cortex and ventral striatum. Data showed potential for benefit in symptoms associated with ADHD, such as emotional dysregulation, executive function deficits, and comorbid anxiety symptoms. Centanafadine increased extracellular concentrations of norepinephrine, dopamine, and serotonin in cortical and subcortical regions, dependent on dose. Increases in concentration plateaued around 60 minutes, with effects maintained through 4 hours. These results confirm centanafadine’s potential benefit to treat symptoms of ADHD.⁶

The Prescription Drug User Fee Act target action date is set for July 24, 2026.

References

1. Otsuka announces FDA acceptance and priority review of new drug application for centanafadine for the treatment of ADHD in children, adolescents, and adults. News release. January 27, 2026. Accessed January 27, 2026. https://www.otsuka.co.jp/en/company/newsreleases/2026/20260127_1.html

2. Otstuka Pharmaceutical submits New Drug Application to US FDA for centanafadine for the treatment of ADHD in children, adolescents, and adults. Press release. November 24, 2025. Accessed January 27, 2026. https://www.otsuka.co.jp/en/company/newsreleases/2025/20251125_1.html

3. Ward CL, Wilens TE, Jin N, et al. Efficacy and safety of centanafadine for ADHD treatment in children: a randomized clinical trial. Pediatrics Open Science. 2025;1(3):1-11.

4. Ward CL, Childress AC, Jin N, et al. Centanafadine for attention-deficit/hyperactivity disorder in adolescents: a randomized clinical trial. J Am Acad Child Adolesc Psychiatry. 2025:S0890-8567(25)00327-2.

5. Adler LA, Adams J, Madera-McDonough J, et al. Efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder: results of 2 phase 3, randomized, double-blind, multicenter, placebo-controlled trials. J Clin Psychopharmacol. 2022;42(5):429-439.

6. Walters J. Centanafadine pharmacological profile affirms potential for treatment of ADHD. Psychiatric Times. January 15, 2026. https://www.psychiatrictimes.com/view/centanafadine-pharmacological-profile-affirms-potential-for-treatment-of-adhd