Click Therapeutics Secures FDA Approval for First-Ever Prescription Digital Migraine Therapy
In a significant milestone for digital health and the millions of people affected by migraine disorders, Click Therapeutics, Inc. has received marketing authorization from the U.S. Food and Drug Administration (FDA) for CT-132, its flagship prescription digital therapeutic (PDT) for the preventive treatment of episodic migraine. The FDA granted this approval under a De Novo Classification Request, marking CT-132 as the first prescription digital therapeutic specifically authorized for migraine prevention in adults aged 18 years and older.
This pivotal decision highlights the growing acceptance of digital therapeutics as legitimate, regulated treatment modalities alongside traditional pharmacological therapies. It also cements Click Therapeutics’ role as a trailblazer in the integration of digital technology into mainstream medical care, particularly for chronic conditions like migraine that significantly impact quality of life.
A New Chapter in Migraine Management
Migraines affect over 37 million adults in the United States alone, with a substantial proportion experiencing episodic migraines, defined as fewer than 15 headache days per month. While various acute and preventive medications exist—ranging from NSAIDs and triptans to CGRP inhibitors and beta-blockers—not all patients respond adequately to pharmacotherapy alone. Behavioral treatments such as cognitive behavioral therapy (CBT) and biofeedback have shown benefit, but accessibility is limited, especially in rural and underserved areas.
This is where Click Therapeutics’ CT-132 steps in. Designed as an adjunctive digital therapy, CT-132 is intended to be used in combination with existing migraine treatments, whether acute or preventive. The therapeutic is delivered via a mobile smartphone application, giving patients convenient and remote access to evidence-based care.
Dr. Shaheen Lakhan, MD, PhD, FAAN, Chief Medical and Scientific Officer of Click Therapeutics, emphasized the importance of this innovation:
“This marks a significant milestone for the more than 37 million adults in the US who live with migraine. As a groundbreaking digital therapeutic for migraine prevention, CT-132 offers eligible patients a new path to reducing the burden caused by migraine, one they can access anywhere via an evidence-based mobile application on their smartphone, significantly improving accessibility and expanding care to patients.”
Clinical Validation: The ReMMi-D and ReMMiD-C Trials
The FDA’s authorization of CT-132 was supported by a robust foundation of clinical evidence. Most notably, the ReMMi-D study—short for Reduction in Monthly Migraine Days (ClinicalTrials.gov Identifier: NCT05853900)—served as the pivotal trial. This study evaluated the efficacy of CT-132 in patients who were already receiving standard-of-care prescription migraine medications, including acute therapies (like triptans or NSAIDs) as well as first-line and second-line preventive agents (such as topiramate or CGRP-targeted therapies).
In the ReMMi-D trial, CT-132 successfully met its primary endpoint, demonstrating a statistically significant reduction in the number of monthly migraine days compared to control conditions. This finding confirmed the potential of digital therapeutics not only to supplement pharmacologic therapy but to enhance clinical outcomes in meaningful ways.
Additionally, the company submitted data from the ReMMiD-C bridging study (ClinicalTrials.gov Identifier: NCT06004388), which specifically assessed the digital therapeutic’s performance in patients concurrently using calcitonin gene-related peptide (CGRP) inhibitors. The results indicated consistent therapeutic benefit, reinforcing CT-132’s broad applicability across different patient subgroups and treatment regimens.
Real-World Clinical Reception
CT-132’s data and impact were recently presented at the American Academy of Neurology (AAN) Annual Meeting, where the response from the clinical community was overwhelmingly positive. Dr. Stewart J. Tepper, MD, Vice President of the New England Institute for Neurology and Headache and a scientific advisor to Click, offered a compelling endorsement in a post-conference interview with Medscape:
“I think this is very exciting as a clinician who takes care of patients because we don’t have anything like this in our migraine armamentarium. We know that behavioral techniques are helpful adjunctively, but large areas of the country just don’t have access to them.”
Dr. Tepper’s remarks underscore a long-standing gap in behavioral care for migraine—a gap that CT-132 is uniquely equipped to fill using digital delivery mechanisms that can scale widely and economically.
Beyond Migraine: A Growing Digital Therapeutics Portfolio
CT-132 represents Click Therapeutics’ first FDA authorization in the field of neurology, expanding a pipeline that already spans psychiatry and cardiometabolic disease. With this latest milestone, Click becomes one of the Click Therapeutics few digital health companies to demonstrate clinically meaningful outcomes across three major therapeutic domains.
CEO David Benshoof Klein noted:
“With this landmark, first-in-class FDA authorization in episodic migraine, Click’s interventions have now demonstrated clinically meaningful benefit across three unique therapeutic areas… As the first of our PDTs to target and successfully treat a pain-related Click Therapeutics condition, it confirms the power of Click’s platform to deliver meaningful outcomes across therapeutic areas.”
Click’s digital therapeutics platform leverages AI-driven personalization, behavioral science, and real-time data Click Therapeutics analytics to tailor treatments to individual patient needs. The company is known for blending storytelling and consumer technology—including game-like elements and user-friendly interfaces—to improve patient engagement, which is often a key predictor of success in digital health interventions.
The Emergence of Software-Enhanced Drug™ Therapies
In parallel with its PDTs, Click has been developing a new class of treatments known as Software-Enhanced Drug™ therapies. These combine pharmacological treatments with software-based interventions to enhance clinical effectiveness. CT-132 is among the first examples of this hybrid approach, as it demonstrated additional clinical benefit on top of pharmacotherapy in trial settings.
In October 2024, Click formally introduced Click SE™, its proprietary platform to develop and deliver these novel therapeutic combinations. The move aligns with emerging regulatory frameworks, including Click Therapeutics the FDA’s draft guidance on Prescription Drug-Use Related Software (PDURS), which seeks to define and standardize how digital interventions can augment pharmaceutical products.
By anticipating these regulatory trends, Click positions itself as both a regulatory pioneer and a market leader in the convergence of software and traditional therapeutics.
