FDA greenlights first prescription migraine app

The migraine world just got a digital upgrade. Click Therapeutics (Click) has scored FDA marketing authorization for CT-132, a first-of-its-kind prescription digital therapeutic aimed at preventing episodic migraines. It's a breakthrough moment — not just for Click, but for the 37 million adults in the U.S. who battle migraines like clockwork.

As Dr. Shaheen Lakhan, Chief Medical and Scientific Officer at Click, put it: "This marks a significant milestone... one they can access anywhere via an evidence-based mobile application on their smartphone." With CT-132, treatment is now just a tap away.

How does it work?

CT-132 is no ordinary app — it's software-as-treatment, clinically validated and FDA-cleared through the rigorous De Novo pathway for new medical devices. Here's the gist:

• It delivers science-backed behavioral therapy via smartphone.
• Patients complete daily lessons — 84 total over 12 weeks.
• It's designed for use alongside traditional migraine treatments like CGRP inhibitors or other prescription meds.

The tech behind it isn't just bells and whistles. It's built on Click's AI-driven platform, woven together with user-centric design, personalized storytelling, and behavioral science. In plain speak: it's made to stick, to engage, and to deliver results.

Why does it matter?

Migraines don't just hurt — they hijack lives. They interrupt careers, relationships, and entire days. Even with meds, many people still suffer. CT-132 steps in as a much-needed wingman. It doesn't replace drugs — it complements them.

• In clinical trials (ReMMi-D and ReMMiD-C), CT-132 reduced monthly migraine days significantly.
• Patients using CT-132 on top of medication saw a mean drop of 3.04 migraine days per month.
• No serious side effects, and engagement was sky-high (people actually used it).

Dr. Stewart Tepper nailed it when he said, "We don't have anything like this... behavioral techniques are helpful adjunctively, but large areas of the country just don't have access to them." CT-132 fills that access gap — no specialist appointments, no waitlists, just treatment in your pocket.

The context

This isn't Click's first rodeo. CT-132 marks their third major therapeutic success, with prior wins in psychiatry and cardiometabolic disease. But it is their first foray into pain — and their first big moment in neurology. As CEO David Benshoof Klein put it, this milestone "confirms the power of Click's platform to deliver meaningful outcomes across therapeutic areas."

Let's not forget the bigger picture either:

• Migraine is the second leading cause of disability in the U.S.
• Many folks on meds still endure frequent, life-disrupting attacks.
• Behavioral therapy helps — but it's out of reach for most Americans.

Click Therapeutics' CT-132 is another proof that software can be medicine. And for the millions who've tried everything and are still suffering, this could be the game-changer they didn't know they needed.