Otsuka’s investigational ADHD treatment centanafadine has received FDA priority review, with a PDUFA target date of July 24, 2026, supported by four pivotal Phase 3 trials.
Written By: Pharmacally Medical News Desk
Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc., announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for centanafadine for priority review. The investigational therapy is being evaluated as a once-daily extended-release treatment for attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2026, marking an important regulatory milestone for the company’s first-in-class candidate.
A Potential New First-in-Class ADHD Treatment
Centanafadine is described as the first norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) developed specifically for ADHD. If approved, it could represent a novel therapeutic approach beyond currently available stimulant and non-stimulant medications.
Otsuka highlighted that centanafadine is designed as a once-daily extended-release capsule, intended to provide broad symptom management across diverse patient populations.
Phase 3 Evidence Supporting the NDA
The NDA submission is supported by results from four pivotal Phase 3 clinical trials (NCT05428033, NCT05257265, NCT03605680 and NCT03605836) that evaluated the efficacy and safety of centanafadine in pediatric, adolescent, and adult ADHD patients.
Across these studies, centanafadine demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo.
In children and adolescents, efficacy was measured using the ADHD Rating Scale-5 (ADHD-RS-5). In adults, symptom improvement was assessed using the ADHD Investigator Symptom Rating Scale (AISRS).
These outcomes suggest consistent benefit across age groups, reinforcing the drug’s potential as a broadly applicable ADHD therapy.
Safety and Tolerability Profile
Centanafadine was generally well tolerated across the clinical development program.
The most commonly reported adverse events included:
Children and adolescents: decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence
Adults: decreased appetite and headache
Otsuka also noted that clinical and preclinical data suggest the drug may have a favorable safety profile and low potential for abuse, which could be an important consideration in ADHD treatment.
John Kraus, M.D., Ph.D., executive vice president and chief medical officer of Otsuka Pharmaceutical Development & Commercialization, called the FDA’s decision a key step forward. He emphasized the need for multiple treatment options, noting that ADHD presents differently across individuals and often requires varied therapeutic strategies. He also thanked the patients, caregivers, and investigators involved in the trials.
ADHD Extends Beyond Childhood
While ADHD has historically been considered a childhood condition, research shows that many individuals continue to experience symptoms into adulthood. Persistent ADHD can lead to significant functional impairment across education, work, and social life.
According to the CDC approximately 7 million children in the U.S. are affected and an estimated 15.5 million adults also live with ADHD.
References
Otsuka Announces FDA Acceptance and Priority Review of New Drug Application for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults, 27 January 2026, https://www.otsuka.co.jp/en/company/newsreleases/2026/20260127_1.html
A Trial of Centanafadine Efficacy and Safety in Children with Attention-deficit/ Hyperactivity Disorder (ADHD), ClinicalTrials.gov ID NCT05428033, https://clinicaltrials.gov/study/NCT05428033
Caroline L. et al, Efficacy and Safety of Centanafadine for ADHD Treatment in Children: A Randomized Clinical Trial. Pediatrics Open Science September 2025; 1 (3): 1–11. https://doi.org/10.1542/pedsos.2024-000349
A Trial of Centanafadine Efficacy and Safety in Adolescents with Attention- Deficit/Hyperactivity Disorder, ClinicalTrials.gov ID NCT05257265, https://clinicaltrials.gov/study/NCT05257265
Ward CL et al, Centanafadine for Attention-Deficit/Hyperactivity Disorder in Adolescents: A Randomized Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2025 Jul 4:S0890-8567(25)00327-2. Epub ahead of print. PMID: 40619095. https://doi.org/10.1016/j.jaac.2025.06.023
A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults with Attention-deficit/Hyperactivity Disorder, ClinicalTrials.gov ID NCT03605680, https://clinicaltrials.gov/study/NCT03605680
Adler LA 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 Sep-Oct 01;42(5):429-439. doi: 10.1097/JCP.0000000000001575. Epub 2022 Jun 2. PMID: 35652746; PMCID: PMC9426730
A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults with Attention-deficit/Hyperactivity Disorder, ClinicalTrials.gov ID NCT03605836, https://clinicaltrials.gov/study/NCT03605836