Top 6 Digital Therapeutics (DTx) Approved by the FDA in 2024 and What They Mean for Patient Care

Ever wondered how your smartphone could become a prescribed treatment for depression, anxiety, or ADHD? Welcome to the era of digital therapeutics (DTx). Here software is becoming as crucial as traditional pharmaceuticals in patient care.

The digital therapeutics market is experiencing remarkable growth, projected to reach $4.68 billion in 2024 and surge to $10.09 billion by 2029. But why is this revolution happening now, particularly in mental health and neurology?

The convergence of several factors has created the perfect storm:

• the global mental health crisis accelerated by the pandemic,
• increased acceptance of digital health solutions,
• and improved technology capabilities.

Additionally, psychiatry has evolved significantly, embracing digital tools as complementary to traditional treatments. With nearly 1 in 5 adults experiencing mental illness annually, digital therapeutics offer scalable, accessible solutions that can reach patients wherever they are.

In this article, we'll explore six groundbreaking digital therapeutics that received FDA approval in 2024. Each represents a significant advancement in how we treat central nervous system disorders. These innovations aren't just apps – they're clinically validated, prescription-grade treatments that are reshaping patient care as we know it.

Rejoyn™

Among the 2024 groundbreaking FDA approvals is Rejoyn™, developed by Otsuka Pharmaceutical Co., Ltd. It is the first prescription digital therapeutic authorized for adjunctive treatment of Major Depressive Disorder (MDD) symptoms. This DTx has set a precedent for the future of DTx in tackling one of the most pervasive mental health challenges globally.

Rejoyn™ targets a pressing issue in mental health: the significant portion of MDD patients who don’t achieve full relief from traditional antidepressants. This six-week digital program helps adults 22 and older who are already taking medication for mental health. It uses simple brain exercises and short therapy lessons to help people manage their emotions better. The program works through a mobile app, making it easy to use anywhere. It combines proven therapy methods with technology to help patients stay engaged in their mental health treatment.

A pivotal 13-week trial solidified Rejoyn™’s clinical credibility. Conducted remotely and involving 386 participants with MDD, the study demonstrated remarkable results: nearly 50% of participants using Rejoyn™ achieved a significant treatment response

Regulatory journey and challenges

What set Rejoyn™ apart in its FDA clearance journey was the compelling evidence from the Mirai study, a pivotal 13-week trial. Conducted remotely and involving 386 participants with MDD, the study demonstrated remarkable results: nearly 50% of participants using Rejoyn™ achieved a significant treatment response, compared to 38.7% in the control group using a sham app. These strong clinical outcomes helped distinguish it from the growing field of mental health apps and secure its groundbreaking FDA authorization.

EndeavorOTC®

In June 2024, EndeavorOTC®, developed by Akili Interactive, became the first OTC digital therapeutic authorized by the FDA to treat attention-deficit/hyperactivity disorder (ADHD) in adults. With its unique gamified approach, EndeavorOTC® marks a significant evolution in digital therapeutics, offering adults with ADHD a non-pharmacological tool to improve focus and attention.

EndeavorOTC® isn’t just an app—it’s a scientifically validated video game that uses adaptive algorithms and engaging gameplay to target the brain’s attention control systems. Delivered entirely through a smartphone or tablet, the therapeutic is designed to seamlessly integrate into users’ lives. This way it delivers measurable improvements in cognitive function. What sets EndeavorOTC® apart is its ability to adapt in real time to the user’s performance. Thus, it creates a personalized experience that challenges and strengthens attention skills.

From a technical perspective, EndeavorOTC® leverages Akili’s patented Selective Stimulus Management Engine (SSME). This core technology drives the game’s ability to activate neural systems involved in attention control by presenting a series of sensory stimuli that require rapid, precise responses. The gamification keeps users engaged while ensuring the therapeutic impact remains consistent.

EndeavorOTC® represents a paradigm shift in how ADHD is managed. Its gamified design and OTC availability remove traditional barriers to care, such as stigma or access to prescription medications. Adults with ADHD can now address their condition discreetly and on their own schedule, empowering them to take control of their treatment.

With the therapeutic priced competitively and available through app stores, EndeavorOTC® is positioned to democratize access to ADHD treatment. It also opens doors for employers and insurers to consider digital therapeutics as part of workplace wellness initiatives, further integrating ADHD management into broader health ecosystems.

CT-155

In January 2024, CT-155, a collaboration between Click Therapeutics and Boehringer Ingelheim, received Breakthrough Device designation from the FDA. This investigational prescription digital therapeutic (PDT) aims to treat the negative symptoms of schizophrenia. This is a condition that affects a patient’s motivation, emotional expression, and quality of life. It represents a novel approach to mental healthcare, addressing a gap in treatment that traditional antipsychotics often fail to fill.

CT-155 is a software-driven therapeutic designed to complement standard-of-care antipsychotic therapy. Using advanced cognitive behavioral therapy (CBT)-based frameworks, it focuses on improving motivation and pleasure (key aspects of negative symptoms) through interactive exercises and personalized feedback.

This digital therapeutic offers more than just symptom management. Its platform uses a data-driven approach, collecting real-time insights into user progress and engagement. These insights can help clinicians monitor treatment adherence and outcomes, providing a comprehensive tool for managing schizophrenia.

Regulatory path

Receiving the FDA’s Breakthrough Device designation comes with advantages but also challenges. CT-155 had to demonstrate its potential to provide a significant improvement over existing therapies. This included showing preliminary evidence of efficacy and safety while ensuring compliance with stringent data security and privacy standards. The designation allows for expedited review processes, but the bar for approval remains high, requiring robust, multi-phase clinical evidence.

MamaLiftPlus

Postpartum depression (PPD) is a complex and often under-treated condition affecting one in seven women after childbirth. In August 2024, MamaLift Plus™ marked a significant breakthrough as the first FDA-cleared prescription digital therapeutic for mild to moderate PPD. This milestone offers a non-pharmaceutical, accessible treatment option for women struggling with this condition.

The science behind MamaLift Plus™ is particularly compelling. The eight-week digital program combines multiple evidence-based approaches:

• Cognitive Behavioral Therapy (CBT)
• Behavioral Activation Therapy (BAT)
• Interpersonal Therapy (IPT)
• Dialectical Behavior Therapy (DBT)

Through the SuMMER study, the therapy demonstrated exceptional effectiveness. 86.3% of participants achieved clinically meaningful improvement in depressive symptoms.

What makes MamaLift Plus™ particularly innovative is its use of adaptive algorithms to personalize interventions based on user engagement and progress. The platform continuously adjusts its therapeutic approach to ensure relevance and effectiveness for each user. Clinicians can remotely monitor patient adherence and progress through a companion portal. This feature bridges the gap between traditional in-office care and digital solutions, ensuring continuous support and oversight throughout the treatment journey.

DaylightRx

In a groundbreaking development, DaylightRx by Big Health made history as the first FDA-cleared digital therapy that doctors can prescribe specifically for generalized anxiety disorder (GAD). The innovative solution marked a new era in anxiety treatment. This approval provides a non-pharmacological solution for adults struggling with anxiety.
DaylightRx delivers evidence-based Cognitive Behavioral Therapy (CBT) techniques specifically tailored for GAD. This eight-week program uses interactive tools to help patients manage anxiety symptoms. Through relaxation exercises, cognitive restructuring, and exposure-based techniques, patients can access support whenever they need it. This on-demand nature removes barriers such as scheduling conflicts or the stigma often associated with traditional therapy.
The platform stands out through its ability to adapt to individual needs. Using dynamic algorithms, DaylightRx personalizes each user's experience. A pivotal FDA clearance study with 256 participants with moderate-to-severe GAD symptoms demonstrated its effectiveness. Over 70% of participants using DaylightRx achieved remission of GAD symptoms.

SleepioRx

In a major leap forward for sleep medicine, Big Health's SleepioRx became the first FDA-cleared prescription digital solution to tackle chronic insomnia in adults. Unlike traditional sleeping pills, SleepioRx offers a medication-free way to treat insomnia. It's easy to access through your smartphone and aims to create lasting improvements in sleep quality, helping patients break free from sleep medication dependence.

What makes SleepioRx unique?

SleepioRx leverages the principles of Cognitive Behavioral Therapy for Insomnia (CBT-I), widely regarded as the gold standard for treating chronic insomnia. Delivered entirely through a mobile or web-based platform, SleepioRx personalizes the therapy experience using real-time data collected through user inputs and sleep tracking.

SleepioRx’s FDA clearance was backed by extensive clinical validation through more than 25 clinical trials. Key findings include:

• 76% of participants achieved healthy sleep patterns by the end of the program.
  Participants experienced a 54% reduction in time to fall asleep, a 62% decrease in nighttime awakenings, and a 45% improvement in next-day functioning.

Its scalable digital delivery model also reduces the burden on healthcare systems and increases accessibility for patients who may not have access to in-person CBT-I therapy.

The FDA approval of these six digital therapeutics in 2024 is more than just a tech breakthrough. It marks a new chapter in mental health treatment. These DTx solutions make treatment available anytime and anywhere. We're still learning about their long-term impact, but one thing is clear–these innovations are opening new doors for millions struggling with mental health.