Dragonfly submits ADHD clinical trial protocol to MFDS... Accelerates clinical progress

[Asia Economy Reporter Jang Hyowon] Dragonfly announced on the 29th that it has submitted a clinical trial plan for the ADHD-targeted digital therapeutic ‘Guardians DTx (tentative name)’ medical device to the Ministry of Food and Drug Safety (MFDS).

The digital therapeutic clinical trial applied for this time plans to evaluate the efficacy and safety of the medical device through ▲single institution ▲random assignment ▲double-blind ▲parallel design. The Guardians DTx, whose prototype has already been completed, targets ADHD (Attention Deficit Hyperactivity Disorder) patients aged 7 to under 13 years old. Currently, technology development is being accelerated in collaboration with the Department of Psychiatry at Pusan National University Hospital and the AI Convergence Research Center at Pusan National University.

Dragonfly’s digital therapeutic has already been confirmed as a medical device by the MFDS. According to the ‘Regulations on Medical Device Items and Their Grades,’ the MFDS classified Guardians DTx as ‘neuroscience clinical software.’ This means that Guardians DTx is recognized as a medical device rather than a consumer product or wellness product.

The clinical trial also received approval for compliance with the ‘Good Manufacturing Practice (GMP) for Medical Devices.’ The GMP compliance judgment means that Guardians DTx has sufficient systems as a medical device, a special product directly related to life. Dragonfly has met the necessary conditions for conducting clinical trials and will now proceed with the clinical trial in earnest based on this.

Digital therapeutics refer to software medical devices that utilize digital technologies such as information and communication technology (ICT) and artificial intelligence (AI), combined with medical and pharmaceutical technologies, to prevent, manage, and treat diseases or disabilities. To obtain approval for digital therapeutics from authorities, unlike drugs which are generally divided into phases 1, 2, and 3, the process is divided into two stages: exploratory clinical trials and confirmatory clinical trials.

Although no digital therapeutics have been commercialized domestically yet, more than 20 digital therapeutics have already received FDA approval in the United States and proven their efficacy, with active research and development ongoing. According to the ‘2020 Global Digital Therapeutics Report’ by market research firm Allied Market Research, the market is expected to reach $9.7609 billion (approximately 13.22 trillion KRW) by 2027.

A Dragonfly official said, “We have submitted the clinical trial plan for our game-type digital therapeutic medical device and are accelerating the clinical progress,” adding, “We hope to use accurate data to advance the commercialization timeline and provide a good treatment option for ADHD patients.”