Final rule · 2026-22208

Schedules of Controlled Substances: Placement of Centanafadine in Schedule III

On July 24, 2026, the United States Food and Drug Administration (FDA) approved a new drug application for Simtriyo (centanafadine) for the treatment of attention-deficit/hyperactivity disorder in adults and pediatric patients aged 6 years and older, weighing at least 20 kg. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place centanafadine, chemically known as (1R,5S)-1- (naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane, in schedule III of the Controlled Substances Act (CSA). In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing centanafadine, including its salts, isomers (whether optical, positional, or geometric), and salts of such isomers whenever the existence of such salts, isomers, and salts of isomers is possible in schedule III of the CSA.