Teva’s ecopipam shows rapid and sustained tic reduction in children with Tourette syndrome in new data presented at MDS 2026

Teva Pharmaceuticals has presented new data on ecopipam, a first in class investigational selective D1 dopamine receptor antagonist for children with Tourette syndrome. The results were shown at the International Congress of Parkinson’s Disease and Movement Disorders in Seoul, South Korea, held from 4 to 8 October 2026. They include a post hoc analysis of the first eight weeks of treatment, an interim analysis of a long term open label extension study, post hoc subgroup analyses and preclinical findings on receptor selectivity.

Eric Hughes, M.D., Ph.D., executive vice president of global R&D and chief medical officer at Teva, said Tourette syndrome is a complex neurodevelopmental disorder that creates significant daily challenges for children and their families. He said the new data strengthen the company’s confidence in ecopipam’s potential in paediatric care. If approved, he noted, it would be the first new Tourette therapy in more than 10 years and the first with a novel mechanism of action in more than 50 years. The application is currently under FDA Priority Review.

Key findings

Early tic reduction: A pooled post hoc analysis of 292 patients across Phase 2b and Phase 3 trials found that 69.8 per cent of participants had a clinically meaningful improvement of at least 25 per cent in the Yale Global Tic Severity Scale Total Tic Score within the first eight weeks of treatment. The most commonly reported adverse events were drowsiness and headache, and the most common events across trials mostly appeared in the first eight weeks of exposure.

Sustained benefit beyond one year: An interim analysis of an ongoing 36 month open label extension study covered 118 children, adolescents and adults who had completed the Phase 3 study and the Phase 2b extension. Patients received ecopipam titrated over three to four weeks and then kept on a target dose for up to 36 months, with a median treatment exposure of 14.9 months. Clinically meaningful tic suppression was maintained through 18 months, with a mean reduction in tic severity score of 45.6 per cent. The most commonly reported adverse events were nasopharyngitis, upper respiratory tract infection, anxiety, diarrhoea, influenza, fever and insomnia. No new safety signals were seen.

Co-occurring conditions: A post hoc analysis of 216 Phase 3 participants aged 6 and over compared those with common co-occurring psychiatric conditions (n=129), including ADHD, OCD, anxiety and depression, with those without (n=87). During the 12 week open label period, the presence of these conditions did not reduce the benefit on tic severity, with mean score reductions consistent between the two groups. Safety and tolerability were also similar.

Donald L. Gilbert, M.D., M.S., a paediatric movement disorders and Tourette syndrome specialist at Cincinnati Children’s Hospital Medical Center, said many children with Tourette syndrome go untreated, and among those treated, therapy is often stopped within a year because symptoms stay poorly controlled or side effects become hard to tolerate. He said children need options that work quickly, stay effective over time and are well tolerated, and that the findings are encouraging because, if approved, ecopipam may offer patients and families a meaningful new option.

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Related Topics and Keywords

MDS 2026, Teva, Teva’s ecopipam, Tourette syndrome