Simtriyo clinical data: children
Support progress across a range of ADHD challenges in children
At school and at home, ADHD in children can show up in many ways. In a clinical trial, children (aged 6 through 12) taking Simtriyo demonstrated improvements in multiple symptoms, making Simtriyo an option for patients weighing >20 kg who are struggling with a range of ADHD challenges.1-4
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Children’s study design
- Randomized, double-blind, placebo-controlled study with patients aged 6 through 121,2
- Patients were randomized 1:1:1 at baseline to receive weight-based dose equivalent to 140 mg Simtriyo, weight-based dose equivalent to 280 mg Simtriyo, or placebo once daily for 6 weeks1
- Primary endpoint: Change from baseline vs placebo at Week 6 in the ADHD-RS-5 symptoms total raw score1,2
- Secondary endpoints: Change from baseline vs placebo in CGI-S-ADHD score and change from baseline vs placebo in the Conners 3 Parent Short Form T-scores (hyperactivity-impulsivity, inattention, defiance/aggression, and executive functioning)2
‡Or weight-based dose equivalent.
ADHD-RS-5=ADHD Rating Scale–5; CGI-S-[br-m]ADHD=Clinical Global Impressions–Severity of Illness–ADHD, LS=least squares.
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Could Simtriyo help patients like Milo?
An ADHD diagnosis explains why Milo, age 9,‖ has been struggling at school and at home. See how patients like Milo may be dealing with a range of ADHD challenges.
See challenges
‖Hypothetical patient.
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ADDITIONAL CLINICAL DATA IN CHILDREN
Key secondary & exploratory endpoints and open-label extension
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Learn More
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Key secondary & exploratory endpoints: Findings on associated features of ADHD in children
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Open-label extension study in pediatric patients
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Simtriyo: Designed with the patient in mind
See safety and tolerability data in pivotal studies of pediatric patients taking Simtriyo.
See children’s safety data
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See how Simtriyo performs across patient types
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REFERENCES
- Simtriyo Prescribing Information. Otsuka America Pharmaceutical, Inc. 2026.
- Ward CL, et al. Efficacy and safety of centanafadine for ADHD treatment in children: a randomized clinical trial. Pediatr Open Sci. 2025;1(3):1-11.
- Oberdhan D, et al. Efficacy of centanafadine on the Conners 3–Learning Problems Content Scale in pediatric patients with attention-deficit[span]/[/span]hyperactivity disorder. Poster presented at: Psych Congress 2024; October 29–November 2, 2024; Boston, MA.
- Turkoglu O, et al. Long-term safety and efficacy of centanafadine in children and adolescents with ADHD: results from a phase 3 open-label extension study. Poster presented at: APSARD 2026; January 15-18, 2026; San Diego, CA.
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