Centanafadine is NOT approved for children aged 6-12 years
Based on the FDA drug label, centanafadine (Simtriyo) explicitly states "DO NOT USE: CHILDREN UNDER 12 YEARS OLD, CONSULT A DOCTOR," which means it is contraindicated in the pediatric population you're asking about 1.
Age-Specific Approval Status
The FDA labeling is unequivocal—children under 12 years should not receive this medication 1. This is a hard stop, not a clinical judgment call.
Evidence in Children (Despite Lack of Approval)
While centanafadine is not approved for children 6-12 years, research trials have been conducted in this age group. A phase 3 trial (NCT05428033) enrolled 480 children aged 6-12 years and demonstrated efficacy on ADHD symptoms, executive functioning, and learning problems 3. However, this research evidence does not override the FDA contraindication 1.
What IS Approved for Children 6-12 Years
For this age group, stick with established ADHD medications 4:
- Stimulants: Methylphenidate and amphetamine formulations (first-line)
- Non-stimulants: Atomoxetine, extended-release guanfacine, extended-release clonidine
Clinical Bottom Line
Do not prescribe centanafadine to children under 12 years old. The FDA drug label explicitly prohibits this use 1. If you have an adolescent aged 13-17 years with ADHD, centanafadine 328.8 mg once daily is an appropriate option, showing separation from placebo as early as week 1 with generally acceptable tolerability 2.