Drugs / ARO-DUX4
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | facioscapulohumeral muscular dystrophy | 2023-07-17 | “Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has filed an application for clearance to initiate a Phase 1/2 clinical trial of ARO-DUX4” arrowheadpharma.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06131983 | Feb 2024 → Dec 2026 expected | facioscapulohumeral muscular dystrophy | Arrowhead Pharmaceuticals | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-07-17 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Pharmaceuticals Files for Regulatory Clearance to Initiate a Phase 1/2 Study of ARO-DUX4 for Facioscapulohumeral Muscular Dystrophy arrowheadpharma.com ↗ |
| 2021-06-25 | Arrowhead Pharmaceuticals | Results Arrowhead Presents Preclinical Data on ARO-DUX4 at FSHD Society International Research Congress arrowheadpharma.com ↗
In our preclinical studies in relevant models, ARO-DUX4 achieved deep knockdown of DUX4 and its target genes. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-07-17 | Arrowhead Pharmaceuticals | Arrowhead Pharmaceuticals Files for Regulatory Clearance to Initiate a Phase 1/2 Study of ARO-DUX4 for Facioscapulohumeral Muscular Dystrophy arrowheadpharma.com ↗ |
| 2021-06-25 | Arrowhead Pharmaceuticals | Arrowhead Presents Preclinical Data on ARO-DUX4 at FSHD Society International Research Congress arrowheadpharma.com ↗ |
| 2021-04-15 | Arrowhead Pharmaceuticals | Arrowhead Announces ARO-DUX4 as First Muscle Targeted RNAi Candidate Using TRiMTM Platform arrowheadpharma.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ARO-DUX4 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06131983 ↗ |
| Route | Intravenous | “single or multiple doses of ARO-DUX4 by intravenous (IV) infusion” NCT06131983 ↗ |