FDA Approves Centanafadine for ADHD in Children, Adolescents, and Adults

Centanafadine (Simtriyo) has been approved by the US Food and Drug Administration (FDA) for treatment of attention-deficit/hyperactive disorder (ADHD) in adults and children aged 6 and older (>20 kg).¹ The nonstimulant medication, developed by Otsuka Pharmaceutical, is the first FDA-approved norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) for ADHD.

The approval is based on positive phase 3 data from 4 trials (2 in adults, 1 in adolescents, 1 in children) and post hoc analyses which showed improvement in patient-reported executive function and emotional dysregulation.² Most recent post hoc analysis reported improvement across measures of executive function, including time management, planning and prioritization, task initiation and completion, and working memory.

“The approval of SIMTRIYO marks an important milestone for people living with ADHD, as it introduces a novel treatment approach for this condition,” said John Kraus, MD, PhD, the executive vice president and chief medical officer of Otsuka. “ADHD is a complex and highly individualized disorder that can affect people throughout childhood, adolescence, and adulthood. Today’s approval reflects our commitment to advancing innovative treatment options that address the diverse needs of patients and families managing ADHD. We are deeply grateful to the patients, caregivers, investigators, and clinical teams whose participation made this achievement possible.”

Development of centanafadine has included phase 3 trials across age groups—in children aged 4 to 12, adolescents aged 13 to 17, and adults aged 18 to 55. Phase 3 trials in children and adolescents showed a statistically significant improvement in ADHD Rating Scale-5 score vs placebo at week 6 in the high-dose group. Across child and adolescent trials, the most common adverse effects were decreased appetite, nausea, headache, and rash. Phase 3 trials in adults showed improvement from baseline in ADHD Investigator Symptom Rating Scale score at week 6 compared with placebo. In adults, both the low (200 mg) and high (400 mg) dose groups showed significant and clinically meaningful improvement vs placebo. The most common adverse effects in adult trials were decreased appetite and headache.

“ADHD can significantly affect many aspects of daily life across school, work, and relationships,” said Lenard A. Adler, MD, the director of the adult ADHD program at NYU Langone Health. “Even when on treatment, because of the heterogenic nature of ADHD, many patients continue to experience symptoms that can interfere with daily functioning. The approval of Simtriyo introduces a novel mechanism of action and expands the range of options available to healthcare professionals and patients. Having more therapeutic choices is important because ADHD is a highly individualized condition and treatment decisions should reflect the unique needs of each patient.”

Centanafadine is a triple reuptake inhibitor of norepinephrine, dopamine, and serotonin. The drug has been demonstrated to have low potential for dependence and abuse.

A New Drug Application was submitted for centanafadine in November 2025 and was accepted for priority review in January 2026. Centanafadine’s clinical development program in ADHD has been comprehensive, with a phase 3 trials in patients from ages 4 to 55.

Investigators will release full study results at an upcoming scientific meeting.

Reference

1. Otsuka Receives FDA Approval for First-in-Class SIMTRIYO^® (centanafadine) for the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Adults and Pediatric Patients Aged 6 Years and Older. News release. July 24, 2026. Accessed July 24, 2026. https://www.otsuka-us.com/otsuka-shares-fda-review-update-for-centanafadine