Simtriyo clinical data: adults
Designed to help manage a wide range of adult ADHD challenges
ADHD shows up in a variety of ways in adults. In clinical trials, adult patients taking Simtriyo demonstrated improvements across multiple areas, helping patients navigate the challenges ADHD throws at them in daily life.1,2
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Adult study design
- Study 1 and Study 2: Identically designed short-term, randomized, double-blind, placebo-controlled trials in adults aged 18 to 551,2
- Patients were randomized (1:1:1) to receive either sustained-release Simtriyo‡ twice daily at a total daily dose of 200 mg, 400 mg, or placebo1,2
- Primary endpoint: Change from baseline vs placebo at Day 42 in the AISRS total score1,2
- Secondary endpoints: Change from baseline vs placebo at Day 42 in the CGI-S score1
‡There are no expected differences in effectiveness of the low and high doses of the adult study formulation compared to Simtriyo 210 mg and 280 mg once daily, respectively, for the treatment of ADHD.[br-d][br-m]AISRS=Adult ADHD Investigator Symptom Rating Scale; CGI-S=Clinical Global Impressions–Severity of Illness; LS=least squares; TDD=total daily dose.
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Could Simtriyo help patients like Sarah?
Sarah, age 32,‖ was diagnosed with ADHD as an adult. See how patients like Sarah may be struggling with a range of ADHD challenges.
See challenges
‖Hypothetical patient.
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ADDITIONAL CLINICAL DATA IN ADULTS
Post-hoc analysis and open-label extension
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Learn More
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Post-hoc analysis: ASRS Expanded Version (self-report)
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Post-hoc analysis: ASRS item analysis (self-report)
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Open-label extension study
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Simtriyo: Designed with the patient in mind
See safety and tolerability data in pivotal studies of adults taking Simtriyo.
See adult 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.
- Adler LA, et al. Efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder: results of 2 Phase 3, randomized, double-blind, multicenter, placebo-controlled trials. J Clin Psychopharmacol. 2022;42(5):429-439.
- Oberdhan D, et al. Effect of centanafadine on AISRS over 6 weeks of treatment in adults with ADHD: a pooled analysis of two phase 3 trials. Poster presented at: NEI Congress 2024; November 7-10, 2024; Colorado Springs, CO.
- Oberdhan D, et al. Efficacy and safety of sustained-release centanafadine or the treatment of ADHD in adults: a pooled analysis of two phase 3 trials. Poster presented at: NEI Congress 2024; November 7-10, 2024; Colorado Springs, CO.
- Newcorn JH, et al. Emotional dysregulation symptom outcomes in adults with ADHD treated with centanafadine: a pooled post hoc analysis of two phase 3 trials. Poster presented at: Psych Congress 2026; September 15-19, 2026; New Orleans, LA.
- Newcorn JH, et al. Executive function symptom outcomes in adults with ADHD treated with centanafadine: a pooled post hoc analysis of two phase 3 trials. Poster presented at: Psych Congress 2026; September 15-19, 2026; New Orleans, LA.
- Newcorn JH, et al. ASRS outcomes across core and expanded symptom domains after 6 weeks of centanafadine treatment in adults with ADHD: a pooled post hoc analysis of two Phase 3 trials. Poster presented at: 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting; May 26-29, 2026; Miami Beach, FL.
- Mattingly GW, et al. 52-week open-label safety and tolerability study of centanafadine sustained release in adults with attention-deficit/hyperactivity disorder. J Clin Psychopharmacol. 2025;45(5):454-462.
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