Teva Pharmaceutical Industries filed an FDA application Monday for ecopipam, advancing the drug toward U.S. regulatory review on the strength of Phase III data showing rapid and sustained tic reduction in Tourette syndrome patients.

The late-stage trial demonstrated statistically significant improvement on the Yale Global Tic Severity Scale. Ecopipam, a selective dopamine D1 receptor antagonist, works differently from existing antipsychotic treatments that commonly cause weight gain and movement side effects.

Current approved therapies for Tourette syndrome, including haloperidol and aripiprazole, target the D2 dopamine receptor and are often poorly tolerated. Ecopipam's mechanism addresses this gap, offering an option for children and adults who cannot tolerate or discontinue standard drugs.

The FDA previously granted ecopipam breakthrough therapy designation for pediatric Tourette syndrome, which could accelerate the review timeline. Analysts view the drug as a potential growth driver as Teva diversifies its portfolio beyond generics.

Tourette syndrome affects an estimated one in 160 children in the United States, according to the U.S. Centers for Disease Control and Prevention. The Tourette Association of America has long advocated for better-tolerated treatments for the chronic neurological disorder.