FDA approves Simtriyo for adult and pediatric ADHD treatment

The U.S. Food and Drug Administration has approved Simtriyo (centanafadine) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 and older weighing at least 20 kilograms. Developed by Otsuka Pharmaceutical, the medication is an extended-release, once-daily treatment.

Simtriyo is classified by the FDA as a central nervous system (CNS) stimulant and is expected to be regulated as a controlled substance. It is described as a triple reuptake inhibitor because it acts on norepinephrine, dopamine, and serotonin transporters. However, pharmacological data indicates it is significantly more potent at the norepinephrine transporter, with much lower potency at the dopamine and serotonin transporters.

The approval follows four Phase 3 clinical trials that showed statistically significant improvements in ADHD symptoms compared to a placebo. While the drug offers a new pharmacological mechanism, clinical data suggests its effect size—ranging between 0.24 and 0.40—is lower than that of traditional amphetamines. The medication is expected to become commercially available in late 2026 following scheduling by the U.S. Drug Enforcement Administration.