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

About this update from Otsuka Holdings Co., Ltd.

PRINCETON, N.J. & TOKYO, July 25, 2026--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of SIMTRIYO® (centanafadine), a once-daily extended-release capsule for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older weighing at least 20kg. As the first and only approved norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI), SIMTRIYO introduces a new treatment approach for patients and healthcare professionals managing this complex and highly individualized condition. By inhibiting the reuptake of norepinephrine, dopamine, and serotonin, SIMTRIYO increases the availability of these neurotransmitters in pathways involved in attention and behavioral regulation. SIMTRIYO, an NDSRI and central nervous system (CNS) stimulant, is expected to be available later this year following scheduling by the U.S. Drug Enforcement Administration (DEA). The approval is supported by results from four pivotal Phase 3 clinical trials evaluating the efficacy and safety of SIMTRIYO across adult, adolescent, and pediatric patients. In these Phase 3 clinical studies, SIMTRIYO demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo, as measured by the ADHD Rating Scale-5 (ADHD-RS-5) in children and adolescents and the Adult ADHD Investigator Symptom Rating Scale (AISRS) in adults. In pediatric and adult studies, improvements in ADHD symptoms were seen as early as week 1. The most common adverse events include decreased appetite, nausea, rash, headache, and abdominal pain in children and adolescents, and headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea in adults. "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, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. "ADHD is a complex and highly individualized disorder that can affect people throughout childhood, adolescence, and adulthood. Today's approval reflects our commitment to advancing innovative treatment options that address the diverse needs of patients and families manag...

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