Drugs / SAR446523
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06630806 | Oct 2024 → May 2031 expected | plasma cell myeloma | Sanofi | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-07-30 | Sanofi | Regulatory Press Release: Sanofi’s SAR446523, a GPRC5D monoclonal antibody, earns orphan drug designation in the US for multiple myeloma sanofi.com ↗
The US Food and Drug Administration (FDA) has granted orphan drug designation to SAR446523, an IgG1-based Antibody-Dependent Cellular Cytotoxicity-enhanced (ADCC) monoclonal antibody (mAb) targeting G-protein coupled receptor family C group 5 member D (GPRC5D) for the potential treatment of patients with relapsed or refractory multiple myeloma (R/R MM). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-07-30 | Sanofi | Press Release: Sanofi’s SAR446523, a GPRC5D monoclonal antibody, earns orphan drug designation in the US for multiple myeloma sanofi.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SAR446523 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06630806 ↗ |
| Modality | Monoclonal antibody | “an Anti-GPRC5D ADCC-enhanced Monoclonal Antibody” NCT06630806 ↗ |
| Route | Subcutaneous | “Route of administration: Subcutaneous (SC)” NCT06630806 ↗ |
| Target | GPRC5D | “Anti-GPRC5D” NCT06630806 ↗ |