FDA Approves First-in-Class ADHD Drug Simtriyo for Adults and Children
The FDA approved Simtriyo (centanafadine), the first norepinephrine, dopamine, and serotonin reuptake inhibitor for ADHD, on July 29, 2026. The daily tablet is approved for adults and children 6 and older who weigh at least 44 pounds. Four Phase 3 clinical trials showed statistically significant improvements in ADHD symptoms compared to placebo.
The Food and Drug Administration approved a new ADHD medication on July 29, 2026, giving doctors another option for patients who have not responded to existing treatments.
Otsuka Pharmaceutical received approval for Simtriyo (centanafadine), a once-daily extended-release tablet for adults and children 6 years and older who weigh at least 44 pounds. The company says it is the first norepinephrine, dopamine, and serotonin reuptake inhibitor, or NDSRI, approved to treat ADHD.
The FDA based its approval on data from four Phase 3 clinical trials involving adults, adolescents, and children. All four trials showed statistically significant improvements in ADHD symptoms compared to placebo, with effects observed as early as the first week of treatment. A fifth study found the drug also helped adults with ADHD and comorbid anxiety.
"The approval of Simtriyo marks an important milestone for people living with ADHD, as it introduces a novel treatment approach for this condition," said John Kraus, MD, executive vice president and chief medical officer for Otsuka.
The drug still needs a scheduling determination from the Drug Enforcement Administration before it becomes available as a prescription medication. Otsuka expects that to happen later in 2026.
Common side effects in children and adolescents include decreased appetite, nausea, rash, headache, and abdominal pain. Adults reported headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea. The drug carries a boxed warning for the risk of suicidal ideation in pediatric patients and for potential abuse and addiction.
Daniel Ganjian, MD, a pediatrician at Providence Saint John's Health Center in California, said he plans to use Simtriyo as a backup for patients who have not responded to current medications. "It's adding more tools to our arsenal," he said.
The CDC estimates 7 million children ages 3 to 17 and 15 million adults in the United States have an ADHD diagnosis.
