Drugs / VX-670
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | adult-onset Steinert myotonic dystrophy | 2024-01-07 | “Vertex also submitted an Investigational New Drug (IND) application to the FDA for VX-670. The FDA requested additional information, which resulted in a clinical hold.” vrtx.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06185764 | Feb 2024 → Feb 2027 expected | myotonic dystrophy type 1 | Vertex Pharmaceuticals Incorporated | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06926621 | Apr 2025 → Jan 2029 expected | myotonic dystrophy type 1 | Vertex Pharmaceuticals Incorporated | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2024-01-07 | Vertex Pharmaceuticals Incorporated | Regulatory Vertex Provides Pipeline and Business Updates in Advance of Upcoming Investor Meetings vrtx.com ↗
Received clearances from Health Canada and Medicines and Healthcare Products Regulatory Agency (MHRA – UK) for Clinical Trial Applications (CTA) for VX-670 for patients with DM1. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2024-01-07 | Vertex Pharmaceuticals Incorporated | Vertex Provides Pipeline and Business Updates in Advance of Upcoming Investor Meetings vrtx.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VX-670 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06926621 ↗ |
| Route | Intravenous | “Solution for intravenous administration.” NCT06185764 ↗ |