The FDA has authorized the marketing of CT-132, a prescription digital therapeutic (DTx) developed by Click Therapeutics for the preventive treatment of episodic migraine in adults.
CT‑132 is the first FDA-cleared digital therapeutic for migraine prevention, expanding treatment options beyond conventional medications. It also aligns with the growing interest in software-based interventions.
The FDA classifies CT‑132 under its Prescription Digital Use‑Related Software (PDURS) category, highlighting its role as a prescribed digital intervention. Click Therapeutics describes these products as Software-Enhanced Drug therapies — digital programs designed to complement medications and improve clinical outcomes.
Clinicians can use digital therapeutics — clinically validated software applications — to prevent, manage or treat medical conditions. Digital therapeutics undergo rigorous trials and FDA review, often under the Software as a Medical Device (SaMD) pathway. This process distinguishes them from general health apps.
The FDA cleared CT‑132 through the De Novo route, which regulators typically reserve for first‑of‑a‑kind technologies. This decision came after two randomized trials demonstrated its efficacy.
Delivered via smartphone, CT-132 guides patients through a 12-week program designed to reduce brain hypersensitivity linked to migraines. It uses behavioral and cognitive strategies to help patients manage triggers and minimize attacks.
The CT‑132 prescription digital therapeutic is designed for adults 18 and over. It is intended to be used alongside pharmacologic treatments, including newer therapies like calcitonin gene‑related peptide (CGRP) inhibitors.
In the pivotal ReMMi-D trial, CT-132 users experienced a statistically significant reduction in monthly migraine days compared to a sham control group, with no device-related adverse events.
A second study, ReMMiD-C, confirmed those benefits in patients already taking preventive migraine medications.
Launch timing is expected to follow shortly, with CT-132 offering a scalable, non-invasive complement to drug therapies.
Other Digital Therapeutics
Click Therapeutics has developed other FDA-cleared DTx for major depressive disorder and type 2 diabetes.
The company recently partnered with Dassault Systèmes to extend DTx use beyond trials into real-world care. This collaboration emphasizes long-term value and patient experience.
The global DTx sector may exceed $30 billion by 2029, driven by chronic disease demand and smartphone penetration.
Investors are increasingly backing DTx startups worldwide. In 2024, Belgium-based Minze Health raised $5.3 million to expand its prescription digital therapeutic for urology into US and European markets. Meanwhile, XRHealth’s acquisition of RealizedCare created the largest AI-driven extended reality DTx platform globally, signaling diversification in delivery formats.
Pediatric studies have also explored a software-based program to slow myopia progression in young children using eye movement exercises in a game-like format.
In mental health research, a global analysis highlighted growing interest in DTx for child and adolescent psychiatry, including AI-driven tools and gamified interventions designed to improve access and engagement in mental health care.
As digital therapeutics move into mainstream care, the supporting infrastructure is also advancing. Koneksa’s new syndication model aims to speed the validation of digital biomarkers by pooling real-time data across sponsors and technology partners.
Medable, a leader in decentralized trials, reported 80% revenue growth in 2024, driven by enterprise-wide adoption of its electronic clinical outcomes (eCOA) assessment platform.
Together, these developments signal growing readiness for scalable, software-based treatments like CT-132.
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