Teva reports 69.8% of 292 participants achieved clinically meaningful tic reduction with ecopipam within 8 weeks, with interim results through 18 months.
Written By: Aasritha Thippavajjala, PharmD
Reviewed By: Pharmacally Editorial Team
Teva Pharmaceuticals reported new efficacy and safety data for ecopipam, an investigational selective dopamine D1 receptor antagonist being developed for pediatric patients with Tourette syndrome. The findings come from the Phase 2b and Phase 3 D1AMOND trials and their open-label extensions (OLEs) and are scheduled for presentation at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Seoul, South Korea, October 4–8, 2026.
In a post hoc pooled analysis of 292 participants from the Phase 2b and Phase 3 studies, 69.8% achieved at least a 25% improvement in the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS) within the first eight weeks of treatment. Teva classifies this level of improvement as clinically meaningful. An interim analysis from the ongoing long-term extension also showed clinically meaningful tic suppression through 18 months, with a reported mean reduction in tic severity of 45.6%.
D1AMOND Program: Study Design and Participants
The D1AMOND program includes a Phase 2b randomized, double-blind, placebo-controlled trial and a Phase 3 randomized-withdrawal study.
The Phase 2b (NCT04007991) trial enrolled 153 pediatric participants at 68 sites across North America and Europe for 12 weeks. Its primary endpoint was change from baseline in YGTSS-TTS, which measures motor and vocal tic severity. An associated OLE enrolled 121 pediatric participants and followed them for up to 12 months to assess longer-term safety and tolerability.
The Phase 3 study (NCT05615220) evaluated maintenance of efficacy following an open-label stabilization period. Of 216 pediatric and adult participants who entered the open-label period, 104 were subsequently randomized, including 90 pediatric and 14 adult participants, across 77 sites in North America and Europe. Relapse was assessed using changes in YGTSS-TTS or an increase in Tourette-specific care.
Tic Severity Reduction Within Eight Weeks
The pooled post hoc analysis included 292 participants from the Phase 2b and Phase 3 studies. Teva reported that 69.8% achieved at least a 25% improvement in YGTSS-TTS within the first eight weeks of ecopipam treatment.
Because the analysis was conducted post hoc, the finding does not represent a prespecified primary efficacy outcome. The release also does not provide confidence intervals, baseline scores or additional statistical comparisons for the analysis.
Interim Findings Through 18 Months
Long-term findings came from an ongoing 36-month OLE involving participants who completed the Phase 3 study and the Phase 2b OLE. The interim analysis included 118 children, adolescents and adults who received at least one dose of ecopipam, with a median treatment exposure of 14.9 months.
Participants underwent dose titration over approximately three to four weeks before continuing at the target dose. Teva reported that clinically meaningful tic suppression was maintained through 18 months, with a mean reduction in tic severity scores of 45.6%.
Because the 36-month OLE remains ongoing, the 18-month findings are interim. The release does not provide an 18-month denominator, confidence intervals, baseline scores or detailed statistical analyses for the reported reduction.
Safety and Tolerability
In the pooled eight-week analysis, the most commonly reported adverse events were somnolence and headache. In the OLE, commonly reported events included nasopharyngitis, upper respiratory tract infection, anxiety, diarrhea, influenza, pyrexia and insomnia. Teva reported no new safety signals in the longer-term analysis.
The October 2 release does not provide incidence rates or detailed information on serious adverse events, grade 3 or 4 events, treatment discontinuations or deaths. It also does not provide a recommended dose.
Findings in Participants with Psychiatric Comorbidities
Teva also reported a post hoc analysis of 216 Phase 3 participants aged 6 years or older. Of these, 129 had co-occurring psychiatric conditions and 87 did not. The reported conditions included attention-deficit/hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), anxiety and depression.
During the 12-week open-label period, Teva reported consistent mean reductions in YGTSS-TTS among participants with and without psychiatric comorbidities, with similar overall safety and tolerability. The release does not provide numerical group-level results or statistical comparisons, making the analysis descriptive.
Regulatory Status and Ongoing Follow-up
Ecopipam remains investigational and is not approved for Tourette syndrome. Teva’s new drug application for pediatric Tourette syndrome has been accepted by the U.S. Food and Drug Administration (FDA) and is under Priority Review. The drug also has Orphan Drug designation for pediatric Tourette syndrome.
The ongoing 36-month OLE is expected to provide additional information on long-term safety and durability of treatment effects. The current 18-month findings therefore remain interim.
According to Teva Chief Medical Officer Eric Hughes, M.D., Ph.D., if approved, ecopipam could represent the first new Tourette syndrome therapy in more than 10 years and the first treatment with a novel mechanism of action in more than 50 years. These statements represent the company’s characterization of ecopipam’s potential clinical significance.
Reference
Teva Presents New Efficacy and Safety Data with Ecopipam, an Investigational Treatment for Pediatric Patients with Tourette Syndrome, Teva, 02 October 2026
Ecopipam Tablets to Study Tourette’s Syndrome in Children and Adolescents (D1AMOND), ClinicalTrials.gov ID NCT04007991
Ecopipam Tablets to Study Tourette’s Disorder in Children, Adolescents and Adults (D1AMOND), ClinicalTrials.gov ID NCT05615220
About the Writer
Aasritha Thippavajjala (Linkedin) is a pharm D student and aspiring medical writer with medical writing, clinical training experience and a strong interest in clinical research and patient safety She has hands-on exposure to clinical pharmacy activities including medication profile assessment, clinical case review, identification of potential drug-related problems, ADR awareness, patient counselling, and clinical documentation. She has also gained experience in medical literature review, evidence synthesis, and scientific communication through her published review article on digital twin-based patient simulation and her poster presentation at the 74th Indian Pharmaceutical Congress. Certified in ICH Good Clinical Practice (E6(R3)) and Scientific Writing in Health Research, she is passionate about applying her clinical knowledge and research skills to medical writing ,clinical research and contributing to accurate, evidence-based healthcare.