Shionogi Launches 'ENDEAVORRIDE®' ADHD Digital Treatment App in Japan

Q: What is the primary target and objective of ENDEAVORRIDE?

It is designed as a digital therapeutics prescription app to assist in the treatment of pediatric Attention-Deficit/Hyperactivity Disorder (ADHD) in patients aged 6 to 17.

Q: What were the specific clinical trial results that demonstrated the app's efficacy?

In a Phase 3 clinical trial conducted in Japan with 164 patients, the ENDEAVORRIDE group showed statistically significant improvement (p < 0.05) in the ADHD-RS-IV inattention score compared to the standard care group at week 6.

Q: How does the app's core technology work to improve ADHD symptoms?

Based on the Akili Selective Stimulus Management Engine (SSME) core technology, it is designed to activate the prefrontal cortex by delivering personalized, adaptive dual-tasks that stimulate the cerebral cortex.

Q: What is Akili's background and the regulatory status of the equivalent product in the US?

Akili, Inc., based in Washington, US, developed the technology. It previously received FDA approval for the world's first digital therapeutic for ADHD in pediatric patients (marketed as EndeavorRx in the US).

Q: When were the license agreement and Japanese regulatory approval obtained?

The licensing agreement with Akili was signed on March 7, 2019, and the manufacturing and marketing approval in Japan was granted on February 18, 2025.

June 5, 2026

Key facts

Shionogi Launches 'ENDEAVORRIDE®' ADHD Digital Treatment App in Japan
Shionogi & Co., Ltd. has launched ENDEAVORRIDE®, Japan's first approved digital treatment app for pediatric ADHD, developed by Akili, Inc., to improve inattention, hyperactivity, and impulsivity.
Source: PR Times
Date: June 5, 2026

Direct answer

Shionogi & Co., Ltd. has launched ENDEAVORRIDE®, Japan's first approved digital treatment app for pediatric ADHD, developed by Akili, Inc., to improve inattention, hyperactivity, and impulsivity.

Citation: Shionogi Launches 'ENDEAVORRIDE®' ADHD Digital Treatment App in Japan (June 5, 2026), PR Times
Source: PR Times
Date: June 5, 2026

Shionogi & Co., Ltd. has launched ENDEAVORRIDE®, Japan's first approved digital treatment app for pediatric ADHD, developed by Akili, Inc., to improve inattention, hyperactivity, and impulsivity.

medicalNQ 89/100出典：PR Times

📋 Article Processing Timeline

📰 Published: June 5, 2026 at 19:59
🔍 Collected: June 5, 2026 at 11:05
🤖 AI Analyzed: June 6, 2026 at 18:23 (31h 17m after Collected)

Shionogi & Co., Ltd. announced the launch of ENDEAVORRIDE® in Japan, a digital treatment app for pediatric ADHD. Shionogi holds exclusive development and commercialization rights for the product in Japan and Taiwan from Akili, Inc. ENDEAVORRIDE® is Japan's first approved medical device program designed as a treatment aid for pediatric ADHD (ages 6-17). The approval is based on a Phase 3 clinical trial in Japan involving 164 pediatric ADHD patients receiving standard treatment. The trial showed a statistically significant improvement in the ADHD-RS-IV Inattention score at 6 weeks compared to the control group (p<0.05). Built on Akili's SSMETM core technology, the app activates the prefrontal cortex via personalized dual-task exercises to improve symptoms. This launch offers a new digital therapeutic option to address diverse clinical needs in pediatric ADHD treatment alongside existing psychosocial and pharmacological therapies.

FAQ

What is the primary target and objective of ENDEAVORRIDE?

It is designed as a digital therapeutics prescription app to assist in the treatment of pediatric Attention-Deficit/Hyperactivity Disorder (ADHD) in patients aged 6 to 17.

What were the specific clinical trial results that demonstrated the app's efficacy?

In a Phase 3 clinical trial conducted in Japan with 164 patients, the ENDEAVORRIDE group showed statistically significant improvement (p < 0.05) in the ADHD-RS-IV inattention score compared to the standard care group at week 6.

How does the app's core technology work to improve ADHD symptoms?

Based on the Akili Selective Stimulus Management Engine (SSME) core technology, it is designed to activate the prefrontal cortex by delivering personalized, adaptive dual-tasks that stimulate the cerebral cortex.

What is Akili's background and the regulatory status of the equivalent product in the US?

Akili, Inc., based in Washington, US, developed the technology. It previously received FDA approval for the world's first digital therapeutic for ADHD in pediatric patients (marketed as EndeavorRx in the US).

When were the license agreement and Japanese regulatory approval obtained?

The licensing agreement with Akili was signed on March 7, 2019, and the manufacturing and marketing approval in Japan was granted on February 18, 2025.

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