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Shionogi Secures Japan's First ADHD Digital Therapeutic Approval with ENDEAVORRIDE

• Shionogi has received Japanese regulatory approval for ENDEAVORRIDE, marking the country's first digital therapeutic application specifically designed for pediatric ADHD patients.

• The app, developed by Akili Inc., utilizes proprietary SSME technology to target the prefrontal cortex, aiming to improve attention, hyperactivity, and impulsivity symptoms in children.

• Following successful Phase 3 trials in Japan, ENDEAVORRIDE will be available as an adjunctive therapy, expanding treatment options beyond traditional pharmacological and psychosocial interventions.

In a groundbreaking development for digital therapeutics in Japan, Shionogi & Co., Ltd. has secured manufacturing and marketing approval for ENDEAVORRIDE, the country's first digital therapeutic application specifically designed for pediatric attention-deficit/hyperactivity disorder (ADHD). The approval, granted on February 13, 2025, represents a significant milestone in expanding treatment options for young ADHD patients in Japan.

Novel Digital Therapeutic Platform

ENDEAVORRIDE, developed by U.S.-based Akili Inc., leverages the company's proprietary Selective Stimulus Management Engine (SSME) technology. The platform is designed to activate the prefrontal cortex through smartphone and tablet-based interactions, targeting core ADHD symptoms including inattention, hyperactivity, and impulsivity. The technology employs optimized dual tasks customized for each patient, providing a personalized therapeutic approach.

Clinical Validation and Therapeutic Position

The approval follows successful Phase 3 clinical trials conducted in Japan, establishing ENDEAVORRIDE's efficacy as an adjunctive therapy for pediatric ADHD patients. While Japan has previously approved digital therapeutics for conditions such as nicotine dependence and hypertension, ENDEAVORRIDE marks the first such intervention specifically developed for pediatric ADHD patients.

Expanding Treatment Options

This digital therapeutic approval significantly broadens the treatment landscape for ADHD in Japan. ENDEAVORRIDE will complement existing treatment modalities, including:
  • Psychosocial interventions and counseling
  • Traditional pharmacological treatments
  • Behavioral therapy approaches
The introduction of this digital platform is expected to enhance treatment satisfaction and provide new opportunities for symptom management in the pediatric ADHD population.

Strategic Partnership and Market Impact

The approval stems from a strategic partnership between Shionogi and Akili, established in 2019, granting Shionogi exclusive development and commercialization rights for Japan and Taiwan. This collaboration aligns with Shionogi's vision of "Building Innovation Platforms to Shape the Future of Healthcare" and its transformation into a Healthcare as a Service (HaaS) company.

Future Implications

The successful introduction of ENDEAVORRIDE in Japan could pave the way for broader adoption of digital therapeutics in pediatric mental health treatment. This development represents a significant step forward in providing innovative, non-pharmacological treatment options for ADHD, potentially improving outcomes for patients and their families through technology-enabled therapeutic interventions.
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