Summary
FDA approved Otsuka’s SIMTRIYO (centanafadine) on July 24, 2026, for ADHD treatment in patients aged ≥6 years weighing at least 20 kg.
First-in-class norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI), introducing a novel triple-mechanism approach.
Approval backed by four Phase 3 trials across age groups showing statistically significant symptom improvement vs placebo.
Additional Phase 3b data showed benefit in adults with ADHD and comorbid anxiety, an underserved segment.
For decades, ADHD treatment has largely orbited two lanes: stimulants like ADDERALL and VYVANSE, or non-stimulants like STRATTERA and INTUNIV. That lineup just g...
