Drugs / SAR446268
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06844214 | Jul 2025 → Feb 2029 expected | myotonic dystrophy | Sanofi | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-09-23 | Sanofi | Regulatory Press Release: Sanofi’s SAR446268 earns US fast track designation for the treatment of non-congenital myotonic dystrophy type 1 sanofi.com ↗
The US Food and Drug Administration (FDA) has granted fast track designation to SAR446268, Sanofi's one-time AAV gene therapy for the treatment of non-congenital (juvenile and adult onset) DM1 myotonic dystrophy type 1 (DM1). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-09-23 | Sanofi | Press Release: Sanofi’s SAR446268 earns US fast track designation for the treatment of non-congenital myotonic dystrophy type 1 sanofi.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SAR446268 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06844214 ↗ |
| Action | Inhibit | “knocking down dystrophia myotonica protein kinase (DMPK) messenger ribonucleic acid (mRNA) levels” NCT06844214 ↗ |
| Modality | Gene therapy (AAV / viral vector) | “Adeno-associated Viral Vector-mediated Gene Therapy” NCT06844214 ↗ |
| Route | Intravenous | “Route of administration: IV infusion” NCT06844214 ↗ |
| Target | DMPK | “knocking down dystrophia myotonica protein kinase (DMPK) messenger ribonucleic acid (mRNA) levels” NCT06844214 ↗ |