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The U.S. Food and Drug Administration has approved Simtriyo (centanafadine) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and children 6 years and older weighing ≥20 kg.
The once-daily extended-release capsule is the first and only approved norepinephrine, dopamine and serotonin reuptake inhibitor.
The approval is based on four pivotal phase 3 clinical trials, which showed statistically significant and clinically meaningful improvements in ADHD symptoms versus placebo. Across pediatric and adult populations, improvements in ADHD symptoms were seen as early as week 1. In children and adolescents, the most common adverse events included decreased appetite, nausea, rash, headache and abdominal pain. The most common adverse events in adults included headache, decreased appetite, insomnia, nausea, dry mouth and diarrhea.
“Approval of Simtriyo introduces a novel mechanism of action and expands the range of options available to health care professionals and patients,” Lenard A. Adler, M.D., from NYU Langone Health, said in a statement. “Having more therapeutic choices is important because ADHD is a highly individualized condition, and treatment decisions should reflect the unique needs of each patient.”
Approval of Simtriyo was granted to Otsuka Pharmaceutical.
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FDA approves Simtriyo for treating ADHD in children and adults (2026, July 30)
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