08/27/2026
FDA Approves Drug to Treat ADHD
The U.S. Food and Drug Administration (FDA) has approved a new drug for the treatment of ADHD in adults and pediatric patients 6 years of age and older weighing at least 20 kg. Centanafadine (Simtriyo) is a norepinephrine-dopamine-serotonin reuptake inhibitor and central nervous system stimulant administered as an extended-release oral capsule.
The safety and efficacy of centanafadine (Simtriyo) were evaluated in two short-term, randomized, placebo-controlled studies (Studies 1 and 2). A total of 480 patients 6 to 12 years of age were randomized, 367 completed the study, and 90 were discontinued. The primary endpoint was the change from baseline at Week 6 (Day 42) in the symptoms total raw score on the ADHD Rating Scale Version 5 (ADHD-RS-5). Higher ADHD-RS-5 scores reflect more severe symptoms.
Warnings and precautions for centanafadine (Simtriyo) include a Boxed Warning for suicidal ideation and behaviors and abuse, misuse, and addiction. Other warnings and precautions include risks to patients with serious cardiac disease, increased blood pressure and heart rate, psychiatric adverse reactions, hypersensitivity reactions, long-term suppression of growth in pediatric patients, peripheral vasculopathy including Raynaud’s Phenomenon, serotonin syndrome, and motor and verbal tics and worsening of Tourette’s Syndrome. The most common adverse reactions (≥5% and greater than placebo) for centanafadine (Simtriyo) for patients ages 6 to 17 years old were rash, decreased appetite, nausea, rash, headache, abdominal pain. For adults, the common adverse reactions were headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea.
View the FDA’s announcement here:
https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
View centanafadine (Simtriyo) package insert here:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218145s000lbl.pdf
