U.S. FEDRegulation
DEA interim final rule places centanafadine in Schedule III of the Controlled Substances Act, effective October 30, 2026
The Drug Enforcement Administration published an interim final rule on October 30, 2026 placing centanafadine, including its salts, isomers and salts of isomers, in Schedule III of the Controlled Substances Act. The Food and Drug Administration approved Simtriyo (centanafadine) on July 24, 2026 for attention-deficit/hyperactivity disorder, and the Department of Health and Human Services recommended Schedule III placement. The rule takes effect October 30, 2026; comments are due November 30, 2026.
Key points
- Centanafadine is chemically (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane.Federal Register
- Simtriyo is approved for patients aged 6 years and older weighing at least 20 kilograms.Federal Register
- DEA acted under the Controlled Substances Act as amended by the Improving Regulatory Transparency for New Medical Therapies Act.Federal Register
- The rule amends 21 CFR Part 1308; it is docket DEA-1743, published at 91 FR 68470.Federal Register
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RegulationU.S.Schedules of Controlled Substances: Placement of Centanafadine in Schedule III (21 CFR Part 1308)HealthcareRegulatoryFor practitionersFor governance