Update on the FDA Acceptance of the New Drug Application for Ecopipam

September 1, 2026 – The Tourette Association of America (TAA) closely monitors emerging treatments for Tourette Syndrome (TS) and is excited to learn that the U.S. Food and Drug Administration (FDA) has accepted Teva Pharmaceuticals’ New Drug Application (NDA), granting Priority Review for ecopipam. Ecopipam is an investigational, first-in-class D1 (dopamine) receptor antagonist being studied as a treatment for pediatric patients with Tourette Syndrome (TS).

If approved, ecopipam would be the first new treatment option indicated for pediatric patients with TS in more than 10 years and the first novel mechanism of action in more than 50 years. According to Teva Pharmaceuticals, the NDA is supported by positive data from Phase 2b and Phase 3 clinical trials, and they report a targeted FDA action date in the first quarter of 2027.

“Advancements like these are a powerful reminder that TS is a treatable condition, and researchers are making important progress toward improving care outcomes,” said Ian Lang, the President & CEO of the TAA. “The development of new therapies has long been a primary focus of our community, and the TAA remains dedicated to advancing TS research with the goal of producing effective, new treatments.”

We are proud to pursue scientific breakthroughs by funding TS research, convening renowned scientific and medical experts, and sharing opportunities to participate in open clinical trials with our community – including trials related to ecopipam.

The TAA’s Scientific Advisory Board, Medical Advisory Board, and Centers of Excellence are closely following  the journey of ecopipam through the regulatory process, and they continue to evaluate the role of emerging therapies and the impacts they can have on the care of patients with TS and other Tic Disorders.

If you or a loved one has questions about ecopipam or any other medication or therapy, the TAA encourages you to speak with a qualified healthcare provider. If you need support, please contact support@tourette.org