The FDA has approved centanafadine (Simtriyo, Otsuka) as a first-in-class treatment of attention-deficit/hyperactivity disorder (ADHD) in adult and pediatric patients. 

The once-daily extended-release capsule is approved for adults and children aged 6 years and older who weigh at least 2 0kg (44.1 lb). It is the only norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) approved for this indication, the company reported in a statement. 

The approval is based on positive results from four phase 3 trials showing tolerability and significant and clinical improvement in ADHD symptoms across patient populations. As reported by Medscape Medical News, early findings from the studies were presented at the American Psychiatric Association (APA) 2025 Annual Meeting.

"Even when on treatment, because of the heterogenic nature of ADHD, many patients continue to experience symptoms that can interfere with daily functioning," co-investigator Lenard A. Adler, MD, director of the adult ADHD program at NYU Langone Health, New York City, said in the statement.

The FDA approval "introduces a novel mechanism of action and expands the range of options available to healthcare professionals and patients," Adler added. 

The medication will become available after US Drug Enforcement Administration scheduling, with expectations that it be released later this year, the manufacturer noted. 

More Choices 

In combined results from two phase 3 trials presented at APA 2025, with more than 800 adults total, more patients who received centanafadine had at least an 18-point improvement at week 6 on the ADHD Investigator Symptom Rating Scale total scores compared with patients who received placebo. Additionally, improvements were observed as early as week 1.

The investigators also presented results from two phase 3 trials with children between the ages of 6 and 12 years and adolescents between 13 and 17 years. Adolescents received either high-dose centanafadine (328.8 mg once daily), low-dose centanafadine (164.4 mg once daily), or placebo, while younger patients received placebo or a high or low dose of the NDSRI based on weight. Results showed significant improvements in ADHD Rating Scale-5 total scores in children and adolescents who received a high dose of the medication vs those receiving placebo. 

For the pediatric patients, rash and decreased appetite were the most commonly reported adverse events (AEs). The most commonly reported AEs for the adolescents were decreased appetite, nausea, rash, headache, and abdominal pain. Adults reported headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea. Still, the drug was considered to be "well tolerated" across all of the phase 3 trials.

"Having more therapeutic choices is important because ADHD is a highly individualized condition and treatment decisions should reflect the unique needs of each patient," Adler concluded.