Mezigdomide FDA Approval Status
Last updated by Judith Stewart, BPharm on July 2, 2025.
FDA Approved: No
Generic name: mezigdomide
Company: Bristol-Myers Squibb Company
Treatment for: Multiple Myeloma
Mezigdomide is a CELMoD agent in development for the treatment of multiple myeloma.
- Mezigdomide is a CELMoD (Cereblon E3 Ligase Modulator) that works in the treatment of multiple myeloma by potently degrading the Ikaros and Aiolos transcription factors, thereby inhibiting the growth of myeloma cells.
- The mezigdomide development program includes the following studies:
- SUCCESSOR-1 (NCT05519085) Phase 3 study of people with relapsed or refractory multiple myeloma (RRMM) who have had 1-3 prior treatments including lenalidomide, comparing Mezi-Vd (mezigdomide, bortezomib, and dexamethasone) versus Pom-Vd (pomalidomide, bortezomib, and dexamethasone).
- SUCCESSOR-2 (NCT05552976) Phase 3 two-stage, randomized, multicenter, open-label study of people with RRMM who have had prior treatment with lenalidomide and an anti-CD38 monoclonal antibody, comparing Mezi-Kd (mezigdomide, carfilzomib, and dexamethasone) versus Kd (carfilzomib and dexamethasone).
Development timeline for mezigdomide
Date | Article |
---|---|
Jun 12, 2025 | Bristol Myers Squibb Presents Data Across Targeted Protein Degradation Research Including CELMoD™ Agents and BCL6 Ligand-Directed Degrader at EHA 2025 |
Further information
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