On Jul. 24, 2026, Otsuka Pharmaceutical 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. 

Additional clinical research continues to expand the evidence base for centanafadine. In a recently completed Phase 3b study in adults with ADHD and comorbid anxiety, centanafadine demonstrated statistically significant improvements in ADHD symptoms compared with placebo, providing additional insight into its clinical profile.

ADHD is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity. The disorder can affect academic performance, occupational functioning, social relationships, and challenges that impact patients’ daily lives. Although ADHD is often diagnosed during childhood, symptoms frequently persist into adolescence and adulthood.

The FDA approval of SIMTRIYO is supported by results from four randomized, double-blind, placebo-controlled Phase 3 clinical trials evaluating the efficacy and safety of centanafadine in children, adolescents, and adults with ADHD.

In the two pivotal adult studies (NCT03605680 and NCT03605836), both centanafadine dose groups demonstrated statistically significant improvements in Adult ADHD Investigator Symptom Rating Scale (AISRS) total scores compared with placebo. Improvements were observed as early as Week 1 and maintained throughout the six-week treatment period. In the pivotal pediatric and adolescent studies (NCT05428033 and NCT05257265), high-dose centanafadine demonstrated statistically significant improvements in ADHD Rating Scale-5 (ADHD-RS-5) total scores compared with placebo. Improvements were observed as early as Week 1. 

Across the Phase 3 clinical development program, centanafadine was generally well-tolerated. Clinical and preclinical data demonstrated a well-studied and consistent safety profile. The most common adverse reactions were rash and decreased appetite in children 6 to 12 years of age; decreased appetite, nausea, rash, headache and abdominal pain in adolescents 13 to 17 years of age; and headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea in adults.