Ecopipam (EBS-101) - (D1AMOND)

Aug. 19, 2026: Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), said the FDA accepted the NDA for ecopipam (EBS-101) for pediatric Tourette syndrome and granted Priority Review, with a PDUFA target action date in late Q1 2027. Ecopipam is a first-in-class selective D1 dopamine receptor antagonist with Orphan Drug designation.

The filing is supported by positive Phase 2b and Phase 3 data. In the 12-week D1AMOND Phase 2b trial (153 pediatric patients), ecopipam produced a statistically significant and clinically meaningful improvement in Yale Global Tic Severity Scale-Total Tic Score versus placebo at Week 12 (p=0.01). A Phase 2b open-label extension showed durability of efficacy.

In the Phase 3 randomized withdrawal trial, published in JAMA Neurology, pediatric ecopipam responders had a 53% lower risk of relapse versus placebo over 12 weeks (p=0.008). Across the Phase 2b, open-label extension, and Phase 3 studies, the company reported no clinically meaningful changes in body weight/BMI Z-score, vitals/labs including metabolic parameters, ECGs, drug-induced movement disorder measures, or psychiatric comorbidity measures. Common adverse events were headache, insomnia, fatigue, somnolence, tics, anxiety, nausea, and restlessness.