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BOSTON – Akili, Inc. (NASDAQ: AKLI), a digital medicine company, has announced that its Japanese partner, Shionogi & Co. Ltd, has submitted a request for marketing approval in Japan for SDT-001, a digital therapeutic aimed at improving attention in children with ADHD.
SDT-001 is a localized version of Akili’s EndeavorRx, the first prescription digital therapeutic for pediatric ADHD authorized by the FDA in the United States.
The submission is based on positive results from a Phase 3 clinical trial conducted in Japan. The trial involved 164 pediatric ADHD patients aged 6 to 17 who were receiving conventional…