Iberdomide FDA Approval Status

Last updated by Judith Stewart, BPharm on July 2, 2025.

FDA Approved: No
Generic name: iberdomide
Company: Bristol-Myers Squibb Company
Treatment for: Multiple Myeloma

Iberdomide is a CELMoD agent in development for the treatment of multiple myeloma.

Iberdomide 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 iberdomide development program includes the following studies:
- CC-220-MM-001 (NCT02773030) Phase 1/2 open-label dose escalation study.
- EXCALIBER RRMM (NCT04975997) Phase 3, two-stage, randomized, multicenter, open-label study of people with relapsed or refractory multiple myeloma (RRMM) comparing Iber-Dd (iberdomide, daratumumab, and dexamethasone) versus DVd (daratumumab, bortezomib, and dexamethasone).
- EXCALIBER Maintenance (NCT05827016) Phase 3 randomized, head-to-head study of people with newly diagnosed multiple myeloma (NDMM) post-stem cell transplant comparing iberdomide versus lenalidomide.

Development timeline for iberdomide

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
Jun 2, 2019	Celgene Presents Data from a Phase 1/2 Clinical Study of Iberdomide in Combination with Dexamethasone in Patients with Relapsed and Refractory Multiple Myeloma at ASCO 2019

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