Drugs / Ecopipam
Ecopipam
also known as
ecopipam HCl · Ecopipam Hydrochloride · PSYRX 101 · [14C]-Ecopipam · EBS-101 · SCH 39166
Small molecule targets DRD1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | Tourette syndrome | — | “a New Drug Application for ecopipam was submitted to the U.S. FDA in June 2026” tevapharm.com ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT06669091 | Nov → Dec 2024 | — | Emalex Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06194864 | Jan → May 2024 | — | Emalex Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05841160 | Mar → May 2023 | — | Emalex Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05334108 | Apr → Aug 2022 | — | Emalex Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04902105 | May → Jul 2021 | — | Emalex Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04881955 | May → Sep 2021 | — | Emalex Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04764851 | Feb → Apr 2021 | — | Emalex Biosciences Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT01065558 | Feb 2010 → Jan 2011 | Lesch-Nyhan syndrome | Psyadon Pharma | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03218969 | Sep 2017 → Sep 2018 | restless legs syndrome | William Ondo, MD | Completed | No outcome recorded |
| Phase 1/2 | NCT01244633 | Oct 2010 → Jul 2012 | Tourette syndrome | Psyadon Pharma | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary | ||||||
| Phase 2 | NCT04492956 | Oct 2020 → Mar 2022 | stutter disorder | Emalex Biosciences Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04114539 | Oct 2019 → Nov 2022 | Tourette syndrome | Emalex Biosciences Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04007991 | Jun 2019 → Sep 2021 | Tourette syndrome | Emalex Biosciences Inc. | Completed | Met primary |
| Phase 2 | NCT02102698 | Jun 2014 → Dec 2019 | Tourette syndrome | Emalex Biosciences Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01215357 | Oct 2010 → May 2012 | pathological gambling | Emalex Biosciences Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02909088 | Sep 2016 → Aug 2017 | stutter disorder | Gerald Maguire, MD | Unknown | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT06021522 | Aug 2023 → Dec 2026 expected | Tourette syndrome | Emalex Biosciences Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05615220 | Jan 2023 → Jan 2025 | Tourette syndrome | Emalex Biosciences Inc. | Completed | Met primary |
| Phase 3 | NCT01751802 | Dec 2012 → Dec 2013 | Lesch-Nyhan syndrome, stereotypic movement disorder | Emalex Biosciences Inc. | Terminated | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT07093541 | — | Tourette syndrome | Emalex Biosciences Inc. | Available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT01408394 Comparator | Aug 2011 → Feb 2012 | — | Emalex Biosciences Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-08-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory U.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette Syndrome tevapharm.com ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-19 | Teva Branded Pharmaceutical Products R&D, Inc. | U.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette Syndrome tevapharm.com ↗ |
| 2026-08-19 | Teva Branded Pharmaceutical Products R&D, Inc. | U.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette Syndrome tevapharm.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ecopipam | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04492956 ↗ |
| Known as | [14C]-Ecopipam | “Drug: [14C]-Ecopipam” NCT04881955 ↗ |
| Known as | EBS-101 | “Thorough QT/QTc Study to Evaluate the Effects of Ecopipam (EBS-101) on Cardiac Repolarization” NCT05841160 ↗ |
| Known as | ecopipam HCl | “Ecopipam HCl 12.5-, 37.5-. 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings.” NCT04114539 ↗6“Single 200 mg dose of ecopipam HCL given as 2 x 100 mg ecopipam HCL oral tablets and 4 placebo oral tablets” NCT05841160 ↗ “Ecopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks” NCT04492956 ↗ “A single ecopipam 89.6 mg tablet (equivalent to ecopipam HCl 100 mg)” NCT06669091 ↗ “single oral dose of 200 mg ecopipam HCl” NCT04881955 ↗ “ecopipam HCl ~2mg/kg/day” NCT07093541 ↗ “Drug: ecopipam HCL” NCT04902105 ↗ |
| Known as | Ecopipam Hydrochloride | “Drug: Ecopipam Hydrochloride” NCT05841160 ↗1“Drug: Ecopipam Hydrochloride” NCT05615220 ↗ |
| Known as | PSYRX 101 | “A Safety and Pilot Activity Study of Ecopipam (PSYRX 101) in the Symptomatic Treatment of Self-Injurious Behavior in Subjects With Lesch-Nyhan Disease” NCT01065558 ↗1“the study drug, Ecopipam (PSYRX 101), for the treatment of self-injurious behaviors” NCT01751802 ↗ |
| Known as | SCH 39166 | ChEMBL registry synonym — accepted as the source's own label CHEMBL298406 ↗ |
| Action | Inhibit | “ecopipam does this by stopping the chemical (dopamine) from binding to one of its family of receptors (i.e, the D1 family)” NCT01065558 ↗1“Dopamine D1 receptor antagonist” CHEMBL298406 ↗ |
| Modality | Small molecule | — CHEMBL298406 ↗ |
| Route | Oral | “Tablets, once daily, for two weeks up to 200 mg/day” NCT01065558 ↗ |
| Target | DRD1 | “Dopamine D1 receptor antagonist” CHEMBL298406 ↗ |