The Drug Enforcement Administration issued an interim final rule on Thursday placing centanafadine in schedule III of the Controlled Substances Act. The Federal Register published the DEA's interim final rule on centanafadine's scheduling as a Public Inspection document on October 30, 2026, prior to its official publication in the Federal Register. Primary source: federalregister.gov

The Department of Health and Human Services recommended placing centanafadine in schedule III based on an eight-factor analysis of abuse potential and dependence liability. The Food and Drug Administration 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 on July 24, 2026.

Drug Enforcement Administration data show zero law enforcement encounters involving centanafadine in the United States. Three subjects in clinical studies were suspected of abusing or diverting centanafadine due to medication handling irregularities. Centanafadine produced full generalization to amphetamine in rat drug discrimination studies at a 10 mg/kg oral dose.

The rule applies to 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. Comments on the rule must be submitted electronically or postmarked on or before 30 days after the date of publication in the Federal Register. Requests for hearing and waivers of participation must be received on or before 30 days after the date of publication in the Federal Register.