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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
Mapping the evidence supporting FDA-authorized digital therapeutics, before and after authorization
Melissa Amyx1,2, Farzaneh Alebouyeh3, Ngan Thi Thuy Phi3
1Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Center for Research in Epidemiology and Statistics (CRESS), Paris, France. melissa.amyx@inserm.fr.
NPJ Digital Medicine
|May 20, 2026
Summary
The evidence supporting FDA-authorized digital therapeutics (DTx) varies significantly. Many DTx lack robust data prior to market entry, necessitating improved transparency and evidence standards for informed decision-making.
Area of Science:
- Digital Health
- Regulatory Science
- Evidence Synthesis
Background:
- Digital therapeutics (DTx) are increasingly authorized by the U.S. Food and Drug Administration (FDA).
- The scope and quality of evidence supporting these DTx require comprehensive evaluation.
Purpose of the Study:
- To describe the totality of evidence supporting FDA-authorized digital therapeutics (DTx).
- To analyze the types and availability of studies for DTx from 2019-2022.
Main Methods:
- Identified FDA-authorized DTx (2019-2022) and associated studies.
- Classified studies into development/pilot, pivotal randomized controlled trials (RCTs), and real-world evidence (RWE)/post-market categories.
- Assessed evidence dossiers for initial indications and subsequent modifications.
Main Results:
- 45 DTx had 436 studies; evidence varied widely, with 31.1% having extensive dossiers and 11.1% having none.
- Half of DTx (46.7%) included a pivotal RCT.
- Over half (53.3%) lacked publicly available results before FDA authorization, with a significant lag for some.
Conclusions:
- The evidence base for FDA-authorized DTx is heterogeneous.
- Some DTx enter the market with limited data, highlighting the need for timely results dissemination.
- Consistent evidence standards, tailored to DTx risk, are crucial for clinical and regulatory decisions.
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