Digital Therapeutics

Digital therapeutics, DTx, have emerged as technological innovations aiming to advance healthcare decision making and treatment. Digital therapeutics (DTx) are evidence-based software interventions designed to prevent, manage, or treat medical conditions.¹They utilize clinical data, behavioral science, and digital technology to deliver therapeutic outcomes through smartphones, tablets, and other devices. Important distinction: they are not programs such as wellness applications and fitness trackers. As healthcare increasingly shifts toward personalized and patient-centered care, pharmaceutical companies are exploring digital therapeutics as a complementary solution to traditional medications.²

The primary purpose of digital therapeutics is to improve patient outcomes by delivering clinically validated interventions through software. DTx can help patients manage chronic diseases, modify unhealthy behaviors, improve medication adherence, and monitor symptoms between healthcare visits.³ By providing continuous support outside the clinic, digital therapeutics aim to address gaps in care that medications alone may not solve. For example, while a medication may lower blood glucose levels, a digital therapeutic can help patients adopt healthier lifestyle habits that continue to improve disease management.

One of the major factors driving pharmaceutical investment in digital therapeutics is the growing prevalence of chronic diseases. Conditions such as diabetes, obesity, hypertension, insomnia, and mental health disorders often require long-term behavioral changes in addition to pharmacologic treatment. Pharmaceutical companies recognize that medications are one component of successful disease management. Digital therapeutics provide an opportunity to frequently engage patients, collect real-world data, and support treatment adherence. As a result, DTx aims to improve clinical outcomes as well as the value proposition of pharmaceutical products.

Early DTx pioneers included products designed for substance use disorder, opioid addiction, chronic insomnia, and attention deficit hyperactivity disorder, or ADHD. For example, in 2018 Pear Therapeutics and Sandoz launched reSET. Pear Therapeutics filed for bankruptcy in 2023 and was acquired by PursueCare. PursueCare relaunched RESET and RESET-O in 2024. Other DTx examples include Sleepio and its prescription version called SleepioRx to treat chronic insomnia as well as Nightware to interrupt trauma-induced nightmares for PTSD patients. Other digital health launches include indications for diabetes prevention, cardiovascular disease management, and mental health support. Although the market remains relatively young, these products have demonstrated that software can serve as a promising therapeutic intervention when supported by robust clinical evidence.

Prescription digital therapeutics represent a unique category within the broader digital health landscape. Similar to prescription drugs, software-based treatments require clinical validation, FDA approval, and a prescription from a healthcare provider. Some DTx also aim to provide a targeted approach where patients receive access codes that unlock therapeutic modules designed to treat specific medical conditions. A large foundation of DTx programs is behavioral medicine. DTx incorporates behavioral medicine principles such as cognitive behavioral therapy, motivational interviewing, habit formation, goal setting, and personalized feedback.⁴As a result, patients with diabetes, obesity, or cardiovascular disease can receive ongoing coaching and support designed to improve diet, exercise, medication adherence, and lifestyle choices. Through interactive exercises and educational content, these platforms encourage patients to adopt healthier behaviors that contribute to improved disease management and long-term health outcomes.

One of the primary challenges for DTx companies has been reimbursement.⁵ Unlike traditional pharmaceuticals, many digital therapeutics faced uncertainty regarding insurance coverage and payment models. Payers have questioned whether software interventions justify premium pricing, especially when lower-cost wellness applications have been readily available. Another challenge involved adoption among healthcare providers and patients. Physicians already face significant administrative burdens and may be hesitant to prescribe unfamiliar digital products. Additionally, patient engagement often declines over time, which reduces the effectiveness of software-based interventions. Companies must plan for maintaining long-term user participation and demonstrating measurable clinical outcomes in real-world settings. These operational challenges may contribute to delayed market adoption and financial difficulties for digital therapeutic developers. 

The future of digital therapeutics remains a high-potential healthcare option. Advances in artificial intelligence, remote patient monitoring, wearable technologies, and real-world evidence generation are creating new opportunities for innovation. Pharmaceutical companies continue to invest in digital health partnerships, especially in areas such as obesity, mental health, and cardiovascular disease. Rather than replacing medications, digital therapeutics are increasingly viewed as complementary tools that enhance patient care and patient outcomes. As reimbursement frameworks mature and technology continues to evolve, digital therapeutics may become an increasingly important component of modern healthcare delivery and pharmaceutical strategy.

References:

1. Wang C, Lee C, Shin H. Digital therapeutics from bench to bedside. NPJ Digit Med. 2023. 6(1):38.
2. Rajendran, A., Kella, A., & Narayanasamy, D. The Revolution of Digital Therapeutics (DTx) in the Pharmaceutical Industry and Their Quality Impacts. Cureus. 2024. 16(8): e66792.
3. Chengyu Z, Xueyan H, Ying F. Research on disease management of chronic disease patients based on digital therapeutics: A scoping review. Digit Health. 2024. 10:20552076241297064.
4. Phan P, Mitragotri S, Zhao Z. Digital therapeutics in the clinic. Bioeng Transl Med. 2023. 8(4):e10536.
5. Tohme S, LeLaurin JH, Dallery J, Salloum RG. Informing the future of digital therapeutics: lessons learnt. Mhealth. 2025. 11:43.

*Information presented on RxTeach does not represent the opinion of any specific company, organization, or team other than the authors themselves. No patient-provider relationship is created.