SIMTRIYO (centanafadine) approved, first NDSRI approved for ADHD in adults and pediatric patients 6+ years (≥20kg) (Jul 24 2026)
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Key facts
FDA decision date2026-07-24
OutcomeApproved
Drug / candidateCentanafadine (SIMTRIYO)
IndicationADHD in adults and pediatric patients aged 6 years and older (≥20kg)
CompanyOtsuka Pharmaceutical
Market-cap tierLarge
Cohort decision-day move (history)1.0% median (n=834)
Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Yes. The FDA approved the application for Centanafadine (SIMTRIYO) on July 24, 2026. The primary source is linked on this page.
Which company is behind Centanafadine (SIMTRIYO)?
Centanafadine (SIMTRIYO) is a Otsuka Pharmaceutical (OTSKY) program. The FDA decision came on July 24, 2026; the company's own announcement is linked on this page.
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