Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
✓ APPROVED
Centanafadine was approved by the FDA on July 24, 2026 for ADHD in adults and pediatric patients aged 6 years and older (≥20kg), the 29th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
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=837)
Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
FDA record of the action: the FDA approved on July 24, 2026, per NDA 218145 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Questions
Was Centanafadine (SIMTRIYO) approved by the FDA?
Yes. The FDA approved the application for Centanafadine (SIMTRIYO) on July 24, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind Centanafadine (SIMTRIYO)?
Centanafadine (SIMTRIYO) is an 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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