Click Therapeutics Gains FDA Clearance for First Prescription Digital Migraine Prevention Tool

Click Therapeutics has secured a notable regulatory milestone with the U.S. Food and Drug Administration granting authorization for CT-132, the agency’s first prescription digital therapeutic specifically designed to aid in the prevention of episodic migraines. This decision marks a significant advancement in the realm of digital health tools, particularly those intended to work in concert with conventional medication-based treatments.
The therapeutic, delivered via a smartphone application, underwent a randomized, sham-controlled clinical trial that demonstrated measurable improvements in reducing the number of monthly migraine days experienced by adult participants. In addition to achieving its primary goal, the study revealed that users of CT-132 also reported better outcomes in migraine-related quality of life and general health assessments.

The FDA’s clearance was obtained through the de novo pathway, a regulatory route designed for novel medical devices with no existing predicate. This designation not only affirms the program’s clinical validity but also provides a potential template for future advancements in software-based therapies. According to Click Therapeutics, this authorization opens the door for continued development of CT-132 as part of a broader treatment strategy that could include both digital and pharmaceutical elements.
Commenting on the development, Click’s CEO David Benshoof Klein highlighted that CT-132’s approval builds on the company’s prior successes across different areas of healthcare. “With this first-in-class FDA decision in the field of episodic migraine, our digital interventions have now achieved substantial clinical outcomes across psychiatry, cardiometabolic disorders, and now neurology,” Klein said in a statement.
The company has been expanding its digital therapeutics portfolio over recent years. In 2023, Click received regulatory clearance for a depression-focused application co-developed with pharmaceutical partner Otsuka. That same year, it also acquired a diabetes-related digital platform by purchasing the assets of the now-defunct Better Therapeutics, further broadening its scope.
Klein also emphasized the significance of the CT-132 approval as the company’s inaugural entry into neurological care and its first success addressing a pain-associated condition. “This authorization demonstrates the ability of our technology platform to yield tangible health benefits across a diverse set of treatment domains,” he added.

Click has indicated that CT-132 works by addressing brain hypersensitivity, specifically by adjusting the individual’s behavioral responses to external and internal triggers. In a separate analysis, the digital tool was shown to offer comparable benefits in individuals who were already undergoing treatment with CGRP inhibitors, medications commonly prescribed for migraines.
Most recently, the company announced the completion of a Series C financing round. Though financial details were not disclosed, the investment came entirely from Dassault Systèmes and its subsidiary, Medidata Solutions. The funding round also included a development collaboration agreement, suggesting continued momentum in Click’s pipeline expansion and innovation efforts.