Innovations in Digital Therapeutics: An Analysis of Clinical Trials and Regulatory Status in Europe and the US

OBJECTIVES: Digital therapeutics (DTx) have emerged as a novel category of therapies, defined as “evidence‐based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders” by the Digital Therapeutics Alliance. This study aims to summarize current and emerging trends in the landscape of DTx in Europe and the United States.

METHODS: A search was conducted on ClinicalTrials.gov on June 18, 2024, using the keyword “digital therapeutics” without any timeframe restrictions. Phase 2 and phase 3 clinical trials were extracted. DTx were screened according to the Digital Therapeutics Alliance’s definition. Data related to study design, DTx characteristics, and regulatory status were extracted and analysed.

RESULTS: Out of 122 clinical trials retrieved, 30 investigated a treatment meeting the DTx definition criteria. Most studies were phase 3 randomised trials (n=27). Overall, 13 trials were ongoing, 10 were completed, and 2 were terminated. The majority of DTx were mobile applications (n=24), with the remainder being websites (n=2), virtual reality devices (n=1), digital platforms (n=1), video games (n=1), and mobile devices (n=1). DTx were used as standalone treatments (n=18) or in combination with conventional therapies (n=12) to enhance efficacy. They targeted disease treatment (n=9), specific symptom management (n=13) or disease prevention (n=8). The trials covered a wide spectrum of diseases, mostly addiction (n=8), mental health (n=8), and neurology (n=6), predominantly in adult patients (n=26). At least 9 DTx have gained FDA approval via 510(k), De Novo, or Emergency Use Authorisation pathways in the last 4 years especially, whereas none received regulatory approval in Europe.

CONCLUSIONS: DTx represent a promising area for growth, with expected increasing adoption and innovation, especially in the field of behavioural therapy and mobile applications. DTx constitute evidence-based solutions to empower patients and improve their outcomes, therefore, there is a need to understand payer requirements and rules to support value-based decision-making.