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Federal Register: DEA Diversion Decisions · October 30, 2026 · Primary source

Schedules of Controlled Substances: Placement of Centanafadine in Schedule III

Score 85PRIMARYregulatoryFederal RegisterCSA

What the document says

On July 24, 2026, the FDA approved a new drug application for Simtriyo (centanafadine), chemically identified as (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older weighing at least 20 kg. Following FDA approval, HHS provided DEA with a scheduling recommendation to place centanafadine in Schedule III of the Controlled Substances Act (CSA). DEA acted on that recommendation pursuant to the CSA as amended by the Improving Regulatory Transparency for New Medical Therapies Act. DEA issued an interim final rule placing centanafadine, including its salts, isomers (optical, positional, or geometric), and salts of such isomers, in Schedule III of the CSA. The scheduling action covers all forms of the substance wherever such salts, isomers, and salts of isomers are chemically possible.

What this may mean

Applies to pharmacies, prescribers, DEA registrants, and manufacturers handling centanafadine (Simtriyo), which is now subject to Schedule III requirements under the CSA, including registration, recordkeeping, and dispensing restrictions. Puts any entity distributing or prescribing centanafadine outside Schedule III compliance at issue under DEA registrant obligations effective upon publication of the interim final rule.

Informational only. Not legal, medical, financial, or other professional advice. Always consult a qualified professional familiar with your specific facts before relying on any item.

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