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SDT-001 is a digital therapeutic application developed by Akili and exclusively licensed to Shionogi for clinical development, commercialization, and distribution in Japan and Taiwan. It is designed as a smartphone or tablet app to improve attentional functioning in pediatric patients with attention-deficit/hyperactivity disorder (ADHD). The therapy utilizes Akili's Selective Stimulus Management Engine (SSME) core technology to deliver optimized dual tasks tailored to individual patients, aiming to activate the prefrontal cortex—a key region for cognitive functions—thereby improving attentional control. In Phase 3 clinical trials involving children aged 6–17 with ADHD who were also receiving conventional treatments, SDT-001 demonstrated statistically significant improvements in inattentiveness and hyperactivity/impulsivity scores compared to controls. No serious adverse events or safety concerns were observed. The product has been submitted for marketing approval in Japan based on these results[1][3][5].
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