Overview
Shionogi has launched Endeavorride, Japan’s first Software as a Medical Device (SaMD) digital therapeutic app for the adjunctive treatment of pediatric ADHD.
The app, licensed from Akili for Japan and Taiwan, received approval based on positive Phase 3 clinical trial results demonstrating significant improvements in ADHD symptoms.
Endeavorride expands treatment options for children with ADHD by complementing conventional therapies and supporting personalized care.
The News
Shionogi has commercially launched ENDEAVORRIDE (SDT-001), a prescription digital therapeutic app designed as an adjunctive treatment for pediatric attention-deficit/hyperactivity disorder (ADHD) in Japan. The app, for which Shionogi holds exclusive development and commercialization rights in Japan and Taiwan from Akili, becomes the first digital therapeutic approved in Japan as a Software as a Medical Device (SaMD) for pediatric ADHD. Approval was supported by a Phase 3 clinical trial involving 164 patients aged 6–17 years receiving standard care, including psychosocial therapies and environmental interventions. The study met its primary endpoint, with the ENDEAVORRIDE group demonstrating a statistically significant improvement in ADHD-RS-IV inattention scores at Week 6 compared with the control group (p<0.05). By complementing existing treatment approaches, ENDEAVORRIDE offers a new evidence-based option for children with ADHD while addressing the diverse treatment preferences and needs of patients and caregivers.
Industry Perspective
Digital therapeutics are gaining momentum as validated, non-pharmacological interventions that complement conventional treatments for neurodevelopmental and behavioral disorders. Regulatory approvals for software-based therapies are expanding globally, reflecting growing confidence in digital health solutions to improve patient outcomes and personalize care.
Strategic Impact
The launch strengthens Shionogi’s transition toward its Healthcare as a Service (HaaS) strategy by expanding beyond traditional pharmaceuticals into digital therapeutics. Introducing Japan’s first approved digital therapeutic for pediatric ADHD enhances the company’s digital health portfolio, broadens treatment options for clinicians and patients, and reinforces its commitment to delivering innovative, patient-centered healthcare solutions.
Source: Shionogi
