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Review
. 2023 May 3;8(4):e10536.
doi: 10.1002/btm2.10536. eCollection 2023 Jul.

Digital therapeutics in the clinic

Philana Phan  1 , Samir Mitragotri  2   3 , Zongmin Zhao  1
Affiliations
Review

Digital therapeutics in the clinic

Philana Phan et al. Bioeng Transl Med. .

Abstract

Digital therapeutics are emerging as a new form of therapeutic interventions. Unlike conventional therapeutics, digital therapeutics deliver interventions directly to patients using an evidence-based, clinically evaluated software to treat, manage, or prevent diseases. Digital therapeutics manifest in diverse forms such as web-based applications, mobile applications on smart devices, virtual reality, and video games. As its own product category for FDA approval, digital therapeutics can function as stand-alone treatments or in combination with conventional therapeutics to improve adherence and/or efficacy. Here, we review the clinical landscape of digital therapeutics. We summarize FDA-approved products and their clinical use, overview >300 ongoing clinical trials, and discuss challenges for their clinical translation and strategies to overcome the same.

Keywords: digiceuticals; digital counseling; digital health; digital medicine; digital technology; digital therapeutics; prescription digital therapeutic.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Schematic depicting examples of digital health, digital medicine, and digital therapeutics as well as how they relate to one another in terms of requirements for approval and use within the general population. Created with BioRender.com.
FIGURE 2
FIGURE 2
Overview of the identified active DTx clinical trials. (a) Distribution of the trials across different disease areas. (b) Analysis of the trials according to their subtypes. (c) Further analysis of the subcategories within the Web Application specific subtype.
FIGURE 3
FIGURE 3
Representative disease areas of DTx utilized in the active DTx clinical trials. The disease areas depicted are those within (a) psychiatric indications, (b) oncology indications, (c) addiction indications, (d) neurological indications, and (e) endocrinological indications. ADHD, attention‐deficient hyperactivity disorder; OCD, obsessive‐compulsive disorder; OUD, opioid use disorder; PCOS, polycystic ovary syndrome; PTSD, post‐traumatic stress disorder.
FIGURE 4
FIGURE 4
Subtypes of DTx used in the specific psychiatric disease‐focused clinical trials of (a) insomnia, (b) depression, and (c) anxiety. The respective percentages of each type are delineated in the respective legends.
FIGURE 5
FIGURE 5
Subtypes of DTx used in the specific oncological disease‐focused trials of (a) breast cancer and (b) generalized cancer. The respective percentages of each type are delineated in the respective legends.
FIGURE 6
FIGURE 6
Subtypes of DTx used in the specific addiction‐focused trials of (a) opioid use disorder, (b) smoking, and (c) alcohol abuse. The respective percentages of each type are delineated in the respective legends.
See this image and copyright information in PMC

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