The FDA has approved Simtriyo (centanafadine), a first-in-class non-stimulant treatment for attention-deficit/hyperactivity disorder (ADHD) — the first new mechanism in the field in years.
Cleared on July 24, 2026, the once-daily extended-release capsule from Otsuka is approved for adults and children aged 6 and older weighing at least 20 kg.
A new mechanism
Simtriyo is the first drug in a class called NDSRI — a norepinephrine, dopamine, and serotonin reuptake inhibitor. By blocking the reuptake of all three neurotransmitters at once, it raises their availability in brain pathways that govern attention and behavior. No previously approved ADHD medication works on all three simultaneously, which is what makes it “first-in-class.”
The evidence
Approval was based on four Phase 3 trials showing significant improvement in ADHD symptoms with acceptable tolerability across age groups.
Why it matters
ADHD care leans heavily on stimulants, which don't suit everyone and carry misuse concerns. A non-stimulant with a genuinely new mechanism widens the options — particularly for patients who don't respond to or can't take existing drugs. As with any new medication, effectiveness and side effects vary by person, and treatment should be guided by a clinician. This article is general information, not medical advice.