FDA approved SIMTRIYO (centanafadine) on July 24, 2026, as the first norepinephrine-dopamine-serotonin reuptake inhibitor (NDSRI) for ADHD in adults and pediatric patients aged 6+ (≥20 kg).
SIMTRIYO is a once-daily extended-release CNS stimulant with a boxed warning for abuse, misuse, addiction, and suicidal ideation in 6-12 year olds; it will launch after DEA scheduling in 2026.
Approval based on four Phase 3 trials showing significant symptom improvements via ADHD-RS-5/AISRS; common side effects include decreased appetite, nausea, rash, headache, insomnia, dry mouth, and diarrhea across age groups.
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