The FDA has approved Otsuka Pharmaceutical’s SIMTRIYO (centanafadine) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults as well as children 6 years and older weighing at least 20kg.Why It’s Relevant
While there are multiple medication options for ADHD, current treatments primarily target dopamine and/or norepinephrine receptors, which regulate attention, motivation, and focus. Centanafadine is a triple-acting agent that targets dopamine, norepinephrine, and serotonin receptors—the latter of which regulate ADHD-relevant processes such as emotion regulation and impulse control.
By the Numbers
- In two clinical trials of adults ages 18 to 55, patients taking either 200mg or 400mg centanafadine daily experienced a 10-point reduction in adult ADHD Investigator Symptom Rating Scale scores after six weeks, compared with seven points among those taking placebo.
- In a trial of adolescents ages 13 to 17, patients taking 328.8mg centanafadine daily experienced a 19-point reduction in ADHD Rating Scale, version 5 (ADHD-RS-5) scores after six weeks, compared with a 14-point reduction among those taking placebo.
- Similar improvements were reported for children ages 4 to 12 taking high-dose centanafadine (82.2mg to 328.8mg daily depending on body weight): ADHD-RS-5 scores dropped 16 points after six weeks compared with 11 points in the placebo group.
- In both children and adolescents, low-dose centanafadine (up to 164.4mg daily based on body weight) was not superior to placebo.
What’s More
The most common side effect of high-dose centanafadine among all three age groups was decreased appetite (seen in 7% of adults, 8% of children, and 15% of adolescents). Nausea and headache were the next most reported side effects in adolescents and adults, whereas for children they were vomiting and rashes.
The Other Side
Though rare, suicidal ideation was observed at higher levels in children taking centanafadine (two incidents) versus placebo (zero), and the product contains a warning to closely monitor all pediatric patients for suicidal behaviors. Centanafadine also has stimulant properties and carries a warning for misuse and abuse.
Takeaway Message
According to Otsuka, SIMTRIYO will be commercially available later this year following its official drug scheduling by the U.S. Drug Enforcement Administration; current stimulant medications are Schedule II (high potential for abuse but recognized medical uses).
Related Information
Source
Ostuka-us.com. Otsuka receives FDA approval for first-in-class SIMTRIYO® (centanafadine) for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older. Published July 24, 2026.
