PARSIPPANY, N.J. — October 2, 2026

Teva Pharmaceuticals presented new efficacy and safety data for ecopipam, an investigational selective dopamine D1 receptor antagonist being developed for pediatric patients with Tourette syndrome, at the 2026 International Congress of Parkinson’s Disease and Movement Disorders in Seoul. A post hoc analysis found that approximately 70% of participants experienced clinically meaningful tic reduction within eight weeks of starting treatment. An interim analysis of an ongoing long-term open-label extension also showed sustained reductions in tic severity through 18 months, with no new safety signals identified. Ecopipam is currently under FDA Priority Review for pediatric Tourette syndrome.

Ecopipam Shows Early and Sustained Tic Reduction

A pooled post hoc analysis of 292 patients from Phase 2b and Phase 3 studies found that 69.8% achieved a clinically meaningful reduction in tic severity within eight weeks. Clinically meaningful improvement was defined as a reduction of at least 25% in the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS). The most commonly reported adverse events included somnolence and headache, with cross-trial adverse events occurring most frequently during the initial eight weeks of exposure. In an interim analysis of an ongoing 36-month open-label extension, 118 children, adolescents and adults maintained clinically meaningful tic suppression through 18 months. The most commonly reported adverse events in the long-term study included nasopharyngitis, upper respiratory tract infection, anxiety, diarrhea, influenza, pyrexia and insomnia.

Psychiatric Conditions Did Not Negatively Affect Outcomes

Additional analyses found that common co-occurring psychiatric conditions did not negatively affect ecopipam’s efficacy or safety profile. The post hoc analysis included 216 participants from the Phase 3 trial, comparing patients with ADHD, OCD, anxiety or depression against those without these conditions. During the 12-week open-label period, reductions in YGTSS-TTS were consistent between participants with at least one co-occurring psychiatric condition and those without. Overall safety and tolerability were also similar between the groups, supporting the potential use of ecopipam across pediatric Tourette syndrome patients with commonly associated psychiatric conditions..

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Ecopipam Advances Toward Potential Pediatric Approval

Ecopipam is designed to block dopamine signaling at the D1 receptor, with D1 receptor hypersensitivity potentially contributing to repetitive and compulsive behaviors associated with Tourette syndrome. Teva received FDA Priority Review and Orphan Drug designation for ecopipam in pediatric Tourette syndrome. The D1AMOND clinical program includes randomized Phase 2b and Phase 3 studies evaluating tic reduction and maintenance of efficacy, with the NDA and proposed indication focused exclusively on pediatric patients. If approved, Teva said ecopipam could represent the first new Tourette syndrome therapy in more than a decade and the first with a novel mechanism of action in more than 50 years. The newly presented data add longer-term and subgroup evidence as Teva advances ecopipam through the FDA review process.

Source: Teva Pharmaceuticals press release