FDA OKs Simtriyo, a first-in-class ADHD treatment for children and adults

The FDA approved Simtriyo (centanafadine) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older who weigh at least 20 kg. The extended-release capsule is taken once daily and is expected to become available later in 2026 after scheduling by the US Drug Enforcement Administration.

According to a manufacturer press release, centanafadine is the first FDA-approved norepinephrine-dopamine-serotonin reuptake inhibitor (NDSRI) for ADHD, introducing a mechanism distinct from currently available stimulant and nonstimulant therapies. Its approval adds a new treatment class for adults and children aged 6 years and older, potentially offering clinicians another option when balancing efficacy, tolerability, patient preference, and prior treatment response.

Approval was supported by four randomized, double-blind, placebo-controlled phase 3 trials in children, adolescents, and adults. In two 6-week adult studies (NCT03605680 and NCT03605836), both evaluated centanafadine dose groups produced statistically significant reductions in Adult ADHD Investigator Symptom Rating Scale scores compared with placebo. Symptom improvement emerged by week 1 and was maintained through week 6.

In adolescents aged 13 to 17 years, the higher dose reduced ADHD Rating Scale-5 scores by 18.50 points at week 6, compared with 14.15 points for placebo (P=.0006). The lower dose did not independently meet the primary endpoint. The higher dose also separated from placebo by week 1.

The pediatric study in children aged 6 to 12 similarly found a significant benefit with the higher dose (P=.0008), with improvement beginning at week 1. The lower dose did not achieve statistical significance on its own.

Common adverse reactions included decreased appetite and rash in children; decreased appetite, nausea, rash, headache, and abdominal pain in adolescents; and headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea in adults.

“Having more therapeutic choices is important because ADHD is a highly individualized condition,” said Lenard A. Adler, MD, of NYU Langone Health.

Source: Otsuka Pharmaceutical Co., Ltd. (2026 Jul 27). 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