Schedules of Controlled Substances: Placement of Centanafadine in Schedule III
Key claim: DEA is immediately placing the newly approved ADHD drug Simtriyo (centanafadine) in Schedule III, so it will be subject to the same prescribing, recordkeeping, and diversion-control rules as other Schedule III controlled substances.
Abstract
(Rule · Justice Department, Drug Enforcement Administration) 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.
Why this matters
Scheduling determines the prescribing and dispensing friction patients and clinicians face for a new ADHD drug: Schedule III status means refills are allowed (unlike Schedule II stimulants) but still requires DEA-registered prescribers, specific recordkeeping, and tighter pharmacy controls than non-controlled medications. The placement signals how DEA is treating a novel non-stimulant/stimulant-adjacent ADHD agent relative to existing Schedule II stimulants and non-scheduled alternatives.