Ecopipam - (D1AMOND)

June 18, 2026: Teva Pharmaceutical Industries Ltd. (NYSE/TASE: TEVA) announced it has submitted a New Drug Application (NDA) to the U.S. FDA for ecopipam, a first-in-class selective dopamine D1 receptor antagonist, for the treatment of pediatric Tourette syndrome. Ecopipam has received FDA Orphan Drug and Fast Track designations for this indication.

The NDA is supported by positive Phase 3 data published in JAMA Neurology. In pediatric patients with Tourette syndrome who achieved a clinical response during an open-label period, ecopipam significantly delayed time to relapse versus placebo, meeting the primary efficacy endpoint (time to relapse based on the YGTSS-TTS scale; p=0.008). Ecopipam was generally well tolerated; common adverse events included somnolence (11.1%), anxiety (9.7%), headache (9.7%), insomnia (8.8%), tic (7.9%), and fatigue (6.5%).