Release
2026/06/05
‐ the first adjunctive therapy app in Japan for pediatric ADHD patients ‐
OSAKA, Japan, June 5, 2026 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced today that it has launched ENDEAVORRIDE® (hereafter “ENDEAVORRIDE”), a digital therapeutic app for the adjunctive treatment of pediatric attention-deficit/hyperactivity disorder (ADHD), in Japan. ENDEAVORRIDE (Development Code: SDT-001) is a product for which Shionogi holds exclusive development and commercialization rights in Japan and Taiwan from Akili, Inc. (Kirkland, Washington, USA; CEO: Dan Elenbaas, hereafter "Akili")1.
Based on the favorable results of a Phase 3 clinical trial conducted in Japan, ENDEAVORRIDE has been approved as the first digital therapeutic app in Japan2 for the adjunctive treatment of pediatric ADHD classified as a Software as a Medical Device. The study evaluated the efficacy and safety of ENDEAVORRIDE in 164 pediatric ADHD patients aged 6 to 17 who received conventional treatments such as environmental adjustments and psychosocial therapies. The primary endpoint—change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale IV (ADHD-RS-IV) inattention score—showed statistically significant improvement in the ENDEAVORRIDE group compared with the control group (continuing conventional treatments) at Week 6 (p < 0.05).
ADHD is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity that may impact daily functioning. In the treatment of ADHD, it has been reported that patients and caregivers differ in their perspectives on treatment and in their needs, and that selecting treatment accordingly is important3. The launch of ENDEAVORRIDE is expected to provide a new treatment option and contribute to addressing diverse patient needs.
Shionogi is committed to realizing the SHIONOGI Group Vision of “Building Innovation Platforms to Shape the Future of Healthcare” by transforming into a Healthcare as a Service (HaaS) company. By providing diverse treatment options beyond prescription pharmaceuticals, Shionogi aims to contribute to improving the quality of life of patients and their families.
【About Attention-Deficit/Hyperactivity Disorder (ADHD)】
ADHD is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity. The prevalence of ADHD among school-aged children is estimated to be approximately 7%5, and these symptoms may interfere with daily activities, including academic performance and work4,5.
【About ENDEAVORRIDE】
ENDEAVORRIDE is a digital therapeutic app targeting pediatric ADHD that is expected to improve symptoms of ADHD by engaging through smartphones and tablets. Based on the Akili Selective Stimulus Management Engine (SSMETM) core technology, ENDEAVORRIDE is designed to activate the brain's prefrontal cortex, which plays a crucial role in cognitive function. SSMETM stimulates the cerebral cortex by performing optimized dual tasks for each patient, aiming to improve inattention, hyperactivity, and impulsivity in patients.
【About Akili】
Akili is a company dedicated to developing digital therapeutic apps and advancing their application to medical innovation through innovative technology. Utilizing technology that directly targets the brain, Akili continues to approach new medicine validated through clinical trials, such as high-quality digital therapeutic apps and medical devices. Akili has obtained authorization from the U.S. Food and Drug Administration (FDA) for the world's first digital therapeutic app for improving inattention symptoms in pediatric ADHD patients aged 8-17, sold in the U.S. under the product name EndeavorRx🄬.
For more information about Akili, please visit www.akiliinteractive.com.
Reference:
1. Press release on March 7, 2019
Akili and Shionogi Announce Strategic Partnership to Develop and Commercialize Digital Therapeutics
in Key Asian Markets
2. Press release on February 18, 2025
Shionogi Obtains Domestic Manufacturing and Marketing Approval for the Digital Therapeutic App "ENDEAVORRIDE®" for Pediatric Attention-Deficit/Hyperactivity Disorder (ADHD)
3. Van Brunt K, Matza LS, Classi P, Johnston JA. Preferences related to attention-deficit/hyperactivity disorder and its treatment. Patient Prefer Adherence. 2011; 5:3
4. Standard Textbook of Psychiatry, 9th Edition. Supervisors: Ozaki N, Mimura Editors: Mizuno M, Murai T, Akechi T. Tokyo: Igaku-Shoin; 2024. pp. 261–262.
5. Research Group on Guidelines for the Diagnosis and Treatment of ADHD, Saito M, Iida J, editors. Guidelines for the Diagnosis and Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). 5th ed. Tokyo: Jiho; 2022. p. (7), 8–9, 11–12.
Forward-Looking Statements
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
For Further Information, Contact:
SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html