New ADHD drug Simtriyo cleared for sale after US agency places it in Schedule III
A new medicine for attention deficit hyperactivity disorder (ADHD) can finally be sold in the United States, after the country’s drug enforcement agency cleared the last legal hurdle on Friday 30 October.
The US Drug Enforcement Administration (DEA) published an interim final rule placing centanafadine — sold under the brand name Simtriyo — in Schedule III of the Controlled Substances Act. The rule took effect the same day, although the public can still comment until 30 November.
Simtriyo was approved by the US Food and Drug Administration (FDA) on 24 July for ADHD in adults and children aged six and over weighing at least 20 kilograms. But it could not be marketed until the DEA decided how tightly it should be controlled. Its maker, Otsuka, had said it expected the drug to reach pharmacies later in 2026 once scheduling was complete.
Simtriyo is a once-daily capsule and the first drug of its kind, blocking the reuptake of three brain chemicals — dopamine, norepinephrine and serotonin — rather than the usual two. Its approval was backed by four phase 3 trials, which found it reduced ADHD symptoms compared with a placebo, with improvements seen as early as the first week. It was not tested against older ADHD drugs, so no direct comparison is available.
Why it matters
Schedule III is less strict than Schedule II, the category used for most ADHD stimulants, including Adderall and Ritalin. Unlike Schedule II prescriptions, which cannot be refilled, Schedule III prescriptions can be refilled — up to five times within six months — so patients will not need a brand-new prescription every month. It still carries boxed warnings for abuse and misuse, and for suicidal thoughts and behaviour in children, so doctors must monitor young patients closely.
What happens next
Otsuka can now launch it in the US, and it should reach pharmacies in the coming weeks. The DEA’s rule is interim, so the comment period running to 30 November could still lead to changes, but the rule is already in force. Patients and families should ask their doctor whether the new option suits them, rather than assuming it is better than existing treatments.
This article is for general information and education only. It is not legal or financial advice.
Sources
- https://internationaltradetoday.com/article/2026/10/30/dea-interim-rule-places-centanafadine-in-schedule-iii-2610300003?BC=bc_6ae5145209e65 (International Trade Today, 30 October 2026)
- https://bureaucracy.news/2026/10/30/federal-register-watch-october-30-2026/ (Bureaucracy Times, 30 October 2026)
- https://rltaab.com/posts/2026-10-31-breakthroughs-simtriyo-dea-schedule-iii.html (RLTAAB, 31 October 2026)
- https://www.pharmacytimes.com/view/fda-approves-first-in-class-centanafadine-for-adhd-in-adults-and-pediatric-patients (Pharmacy Times, 3 August 2026)
