DRUG SPOTLIGHT: Centanafadine
Manufacturer: Otsuka Pharmaceutical
FDA Approval Date: Expected 2026
Centanafadine (centanafadine) is a novel, first-in-class, non-stimulant under development for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults. Its rapid onset & good safety profile would likely result in uptake for patients who do not respond to generic stimulant / non-stimulant therapy options.
Clinical Profile:
Centanafadine is a non-stimulant reuptake inhibitor of norepinephrine & dopamine (for ADHD symptoms) plus reuptake inhibition of serotonin (for control of anxiety, depression, sleep disturbances, & appetite changes).
Population:
15.5 million adults and 7.1 million children (2022) have been diagnosed with ADHD. 20-30% either do not adequately respond to stimulant therapy or have intolerable side effects.
Pricing and Availability:
The manufacturer stated it plans to submit centanafadine for regulatory review by the end of 2025, with potential approval in 2026.
Management Strategy:
ADHD drug therapy is dominated by generic products, but centanafadine will be most directly competing with the non-preferred brand + step therapy Qelbree (norepinephrine & dopamine reuptake inhibitor). Its better tolerability profile will provide potent competition to Qelbree for preferred formulary status – which would in turn provide lower net plan cost & better options for members.
References
IPD Analytics
Staley et al (2024)