Drugs / Clemizole
Clemizole
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04069689 | Aug → Nov 2019 | Dravet syndrome | Epygenix | Completed | No outcome recorded |
| Phase 1 | NCT00945880 | Jul 2009 → Aug 2010 | chronic hepatitis C virus infection | Eiger BioPharmaceuticals | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03069508 | Feb → Dec 2017 | hepatocellular carcinoma | Eiger Group International, Inc. | Unknown | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05066217 | Apr 2025 → Nov 2026 expected | Lennox-Gastaut syndrome | Epygenix | Recruiting | No outcome recorded |
| Phase 3 | NCT04462770 | Sep 2020 → Apr 2027 expected | Dravet syndrome | Epygenix | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-12-08 | Harmony Biosciences Management, Inc. | Results Harmony Biosciences Presents Clinically Meaningful Open-Label Extension Study Effectiveness Data for EPX-100 in Dravet Syndrome harmonybiosciences.com ↗
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced the presentation of initial open-label extension (OLE) data from the company’s ongoing Phase 3 ARGUS trial investigating EPX-100 (clemizole hydrochloride) for the treatment of Dravet syndrome (DS), which showed clinically meaningful reductions in seizure activity in participants with DS along with a favorable benefit-risk profile. |
| 2024-10-01 | Harmony Biosciences Management, Inc. | Results HARMONY BIOSCIENCES HIGHLIGHTS NEW DATA, ROBUST LATE-STAGE PIPELINE WITH NEAR-TERM VALUE CREATION OPPORTUNITIES AND ITS BOLD NEW VISION AT INVESTOR DAY harmonybiosciences.com ↗
EPX-100 Data Demonstrates Favorable Preliminary Safety and Tolerability Compared to Select Approved Drugs for Rare Epilepsies |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-08 | Harmony Biosciences Management, Inc. | Harmony Biosciences Presents Clinically Meaningful Open-Label Extension Study Effectiveness Data for EPX-100 in Dravet Syndrome harmonybiosciences.com ↗ |
| 2024-10-01 | Harmony Biosciences Management, Inc. | HARMONY BIOSCIENCES HIGHLIGHTS NEW DATA, ROBUST LATE-STAGE PIPELINE WITH NEAR-TERM VALUE CREATION OPPORTUNITIES AND ITS BOLD NEW VISION AT INVESTOR DAY harmonybiosciences.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Clemizole | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04462770 ↗ |
| Known as | AL-20 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1407943 ↗ |
| Known as | Clemizol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1407943 ↗ |
| Known as | clemizole hydrochloride | “This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as...” NCT04462770 ↗1“EPX-100 (Clemizole Hydrochloride)” NCT04069689 ↗ |
| Known as | EPX-100 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04069689 ↗ |
| Known as | NSC-46261 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1407943 ↗ |
| Modality | Small molecule | — CHEMBL1407943 ↗ |
| Route | Oral | “Two 50 mg capsules containing clemizole hydrochloride are to be administered orally twice a day for 28 days” NCT00945880 ↗ |