Click Therapeutics, Inc. has obtained FDA marketing authorisation for the first prescription digital therapeutic for the preventive treatment of episodic migraine.
The FDA granted the De Novo Classification Request for the company’s prescription digital therapeutic, CT-132, for the preventive treatment of episodic migraine in patients 18 years of age and older.
It is intended for adjunctive use alongside acute and/or other preventive treatments for migraine.
The marketing authorisation for CT-132 is based on data from the ReMMi-D study in patients taking standard-of-care prescription migraine medications (acute, preventive first-line, and preventive second-line), where CT-132 met its primary endpoint.
Clinical results from the ReMMiD-C bridging study, which showed that CT-132 performed similarly in patients taking calcitonin gene-related peptide (CGRP) inhibitors, were also submitted in the De Novo and included in the product’s FDA premarket review.
Shaheen Lakhan, MD, PhD, FAAN, is chief medical and scientific officer of Click Therapeutics.
Lakhan said: “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.”
Built on Click’s AI-enabled platform, CT-132 combines scientifically proven therapies with proprietary mechanisms of action to deliver clinically-meaningful interventions for patients with episodic migraine.
Click Therapeutics designs patient-centric applications like CT-132 by incorporating storytelling, user research, and elements of consumer technology to increase engagement and drive improved clinical outcomes, with the goal of delivering personalised treatment for effective migraine management.
Intended for adjunctive use alongside other treatments for migraine, CT-132 demonstrated in clinical testing the ability to add clinically meaningful benefit on top of background pharmacotherapy.
This marketing authorisation announcement follows Click’s recent Series C funding round news, announced in March 2025.
