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# Akili OTC App Cleared for ADHD
- URL: https://www.fdaweb.com/akili-otc-app-cleared-for-adhd/
- Published: 2024-06-18T12:00:00.000Z
- Updated: 2026-09-14T14:33:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157208

FDA has cleared an Akili 510(k) for EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder (ADHD). Delivered through a video game experience, EndeavorOTC is intended to improve attention function as measured by computer-based testing in men and women with primarily inattentive or combined-type ADHD. It is currently available on the Apple App Store for iOS and the Google Play Store for Android mobile devices.

Clearance was based on data from a [clinical study](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestors.akiliinteractive.com%2Fnews%2Fnews-details%2F2023%2FAdults-with-ADHD-See-Significant-Improvements-in-Attention-ADHD-Symptoms-and-Quality-of-Life-in-Clinical-Trial-of-Akilis-EndeavorRxVideo-Game-Based-Therapeutic%2Fdefault.aspx&esheet=54071249&newsitemid=20240618578815&lan=en-US&anchor=clinical+study&index=4&md5=930513a141aa3027a019ba3730995f4d&ref=fdaweb.com) of 221 adults with a verified diagnosis of inattentive or combined-type ADHD who all received EndeavorOTC for six weeks, according to the company. “Overall, 83% of study participants reported improvement in focus as measured by the TOVA attentional control score,” it says. “Nearly three-quarters (72.5%) of participants reported at least some improvement in their quality of life as measured by the [validated](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov%2F16411036%2F&esheet=54071249&newsitemid=20240618578815&lan=en-US&anchor=validated&index=5&md5=1cc80e3a4effcdbcd98d0834bcd96577&ref=fdaweb.com) Adult ADHD Quality of Life Scale (AAQoL), and nearly 50% (45.8%) of adults met a prespecified threshold for clinically meaningful improvement. In the same study, adults using AKL-T01 also showed significant improvement in clinician-rated ADHD symptoms, as measured by the Attention Deficit Hyperactive Disorder Rating Scale-5 (ADHD-RS) inattention subscale and total scale scores (p<0.0001 for both).”