FDA Approves Centanafadine for ADHD - Takeaways - MDSpire

FDA Approves Centanafadine for ADHD

The first approved norepinephrine, dopamine, and serotonin reuptake inhibitor for ADHD demonstrated symptom improvements as early as week 1 in phase 3 trials.

  • By

  • Kathryn Wighton

  • July 27, 2026

  • 3 min

Share

  • 1

    The FDA has approved centanafadine (SIMTRIYO) for treating ADHD in patients aged 6 years and older.

  • 2

    Centanafadine's approval is based on four phase 3 randomized, double-blind, placebo-controlled trials.

  • 3

    Statistically significant improvements in ADHD symptoms were observed in both adult and pediatric studies.

  • 4

    Common adverse reactions included rash, decreased appetite, and headache, varying by age group.

  • 5

    ADHD affects approximately 7 million pediatric patients and 15.5 million adults in the US.

Original Source(s)

FDA Approves Centanafadine for ADHD

  • by Kathryn Wighton

  • July 27, 2026

Related Content

Associations of mobile internet use and depressive symptoms with cognitive performance among Chinese adolescents: a cross-sectional study

Prevalence and factors associated with bullying based on the Indonesian version of revised Olweus/Bully Victim Questionnaire (OBVQ-R) among senior high school students

Comparative meta-analysis of task-related functional brain abnormalities in nonsuicidal self-injury and suicide attempt