Akili's Japan Partner Submits SDT-001 for Marketing Approval in Japan

By Chris Wack

Akili said that its Japanese partner, Shionogi & Co., has submitted Akili's digital therapeutic SDT-001 for marketing approval with the Ministry of Health, Labor, and Welfare.

The digital medicine company said SDT-001 is the Japanese, localized version of its AKL-T01, marketed as EndeavorRx the U.S.

EndeavorRx has previously been authorized by the U.S. Food and Drug Administration as the world's first prescription digital therapeutic for improving attentional functioning in pediatric ADHD patients aged 8 to 17.

The submission for marketing approval in Japan is based on the favorable results of the Phase 3 clinical trial conducted by Shionogi. The trial aimed to evaluate the efficacy and safety of SDT-001 in 164 pediatric ADHD patients aged 6 to 17 who received conventional treatments such as environmental adjustments and psychosocial therapies.

No safety concerns or serious adverse events related to SDT-001 were observed, and symptom improvements were sustained even after two cycles of SDT-001 use, with no safety concerns noted.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

02-26-24 0920ET