Teva submits NDA for ecopipam to treat pediatric Tourette syndrome

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ecopipam, an investigational treatment for pediatric Tourette syndrome, the company announced June 18, 2026.

Ecopipam is a selective dopamine D1 receptor antagonist and has received FDA Orphan Drug and Fast Track designations for the treatment of pediatric patients with Tourette syndrome. Orphan Drug designation applies to conditions affecting populations of 200,000 or fewer.

The NDA is supported by Phase 3 data published in JAMA Neurology, which showed ecopipam significantly delayed time to relapse compared with placebo in pediatric patients who had achieved a clinical response during an open-label treatment period. The study met its primary efficacy endpoint with statistical significance (p = 0.008).

The most common adverse events reported in the Phase 3 study included somnolence (11.1%), anxiety (9.7%), headache (9.7%), insomnia (8.8%), tic (7.9%), and fatigue (6.5%).

"The NDA submission for ecopipam is a significant milestone for a potential first-in-class treatment option in pediatric Tourette syndrome," said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer of Teva.

Tourette syndrome is a neuro-developmental disorder characterized by involuntary motor and vocal tics beginning in childhood, often between ages 5 and 10. If approved, ecopipam would be the first FDA-approved treatment for pediatric Tourette syndrome in more than a decade, according to the company's statement.

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