From Migraine to Milestone: Click’s Vision for DTx Leadership

Click Therapeutics is expanding the frontiers of medicine by combing software and clinical research to offer a new method of treating illness. Through innovation and smart acquisitions, the company is growing its role in the U.S. for migraine by the launch of its CT-132 DTx.

• In April 2025, Click Therapeutics, Inc. had received FDA marketing authorisation for CT-132, the first prescription drug approved for use online to treat episodic migraine for adults who are eighteen years old and above.

“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, including psychiatry, cardiometabolic disease and now neurology,” said David Benshoof Klein, chief executive officer of Click Therapeutics.

Migraines are the second most common cause of disability in the U.S., Over 37 million people are affected by it in the country. Moderate-to-severe headache episodes are its hallmark, while nausea and heightened light and sound sensitivity are frequently present as well.

“This marks a significant milestone for the more than 37 million adults in the US who live with migraine,” said Shaheen Lakhan, MD, PhD, FAAN, chief medical and scientific officer of Click Therapeutics. 

Following Click Therapeutics March 2025 announcement of its Series C investment round, the FDA marketing authorisation for CT-132 was released. This suggests that the cash was raised deliberately to support CT-132 regulatory approvals, product launch, and commercialisation efforts.

• Click Therapeutics completed its Series-C round in March 2025, with the entire investment coming from Dassault Systems and its Medidata Solutions division. Through the issuance of Series C and C-1 preferred shares, a total of about USD 48.6 million was raised.

“DTx are beginning to transform the way customers think about their future clinical development programs and are providing demonstrable therapeutic benefits over drugs alone in many cases,” said Anthony Costello, CEO, Medidata. 

Key Impacts of Click’s CT-132 Launch:

• It offers migraine patients in U.S. a non-drug accessible treatment option.
• Improves outcomes with personalized, software-driven care.
• Validates digital therapeutics, encouraging further innovation.
• Supports future regulatory approvals and insurance coverage.
• Empowers patients with flexible, self-managed therapy.
• Attracts investment in digital health for broader disease areas.

Clicking Into the Future of Medicine:

The development in digital medicines, software-based therapies are now recognised as stand-alone solutions for long-term illnesses. These landmarks will accelerate the acceptance of medication & DTx combination models, boost the potential for international markets, and promote regulatory and reimbursement reforms. With scalable digital therapies that have been clinically verified, Click is well-positioned to spearhead the revolution of conventional care routes.