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# Emalex’ Ecopipam Meets Tourette Study Endpoints
- URL: https://www.fdaweb.com/emalex-ecopipam-meets-tourette-study-endpoints/
- Published: 2025-02-25T12:00:00.000Z
- Updated: 2026-09-14T14:53:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158720

Emalex Biosciences says its lead candidate drug ecopipam, a novel dopamine-1 receptor antagonist, met its primary and secondary endpoints in a Phase 3 Tourette syndrome study. Company officials [say](https://emalexbiosciences.com/news/emalex-biosciences-lead-candidate-meets-primary-and-secondary-endpoints-in-phase-3-tourette-syndrome-study/?ref=fdaweb.com) they plan to meet with FDA to discuss submitting an NDA later this year for ecopipam to treat patients with Tourette syndrome.

Some 167 pediatric and 49 adult subjects with Tourette syndrome were enrolled in the Phase 3 study, the company says. The primary efficacy endpoint was time to relapse for pediatric subjects following randomization to ecopipam or placebo, while the secondary endpoint was time to relapse for both pediatric and adult subjects following randomization. The company says the drug was well tolerated in the study. The most common adverse effects were somnolence, insomnia, anxiety, fatigue, and headache, it says.