Akili, Inc., a leader in digital therapeutics, has announced FDA clearance for EndeavorOTCⓇ (AKL-T01), a groundbreaking digital treatment for adults with ADHD, delivered through an engaging video game.
EndeavorOTC stands as the first and only FDA-cleared over-the-counter digital therapeutic for adult ADHD. Designed to enhance attention function, it targets men and women with primarily inattentive or combined-type ADHD, addressing specific attention challenges.
EndeavorOTC, available now in the U.S., can be accessed on the Apple App Store for iOS and the Google Play Store for Android devices.
This FDA clearance of EndeavorOTC underscores its status as a scientifically and clinically validated digital therapy for adult ADHD. We are proud to lead the way in digital medicine,” said Matt Franklin, CEO of Akili.
The FDA clearance is backed by a clinical study involving 221 adults with verified inattentive or combined-type ADHD who used AKL-T01 for six weeks. Results showed that 83% of participants reported improved focus, as measured by the TOVAⓇ attentional control score. Additionally, 72.5% reported enhanced quality of life according to the validated Adult ADHD Quality of Life Scale (AAQoL), and 45.8% achieved clinically meaningful improvement.
Participants also demonstrated significant improvement in clinician-rated ADHD symptoms, measured by the ADHD-RS inattention subscale and total scale scores. Notably, 32.7% of participants showed at least a 30% reduction in their ADHD-RS total score.
This achievement marks Akili’s second digital ADHD therapeutic to gain FDA authorization, reflecting their commitment to innovative digital health solutions. The company extends its gratitude to the patients whose participation was crucial in achieving this milestone.
