Also known as: CC-220
Iberdomide is a Cereblon E3 ligase modulator (CELMoD) being developed for multiple myeloma. Its clinical program spans Phase 1/2 and Phase 3 studies, and an NDA for relapsed/refractory multiple myeloma combination therapy was accepted by the FDA with a PDUFA date in 2026. It is not yet FDA approved.
FDA approved iberdomide (Zenbexus) with daratumumab and dexamethasone for pretreated myeloma. The EXCALIBER-RRMM trial showed a 41% MRD-negative complete response rate vs 21%.
The FDA accepted Bristol Myers Squibb’s NDAs for iberdomide and mezigdomide, two CELMoD agents for relapsed/refractory multiple myeloma. Iberdomide has Priority Review and a PDUFA date of Aug. 17, 2026; mezigdomide’s is May 13, 2027. The filings are backed by Phase 3 data, including a 52% PFS risk reduction for mezigdomide.
The FDA has accepted an NDA for iberdomide in combination with anti-CD38 antibodies for relapsed or refractory multiple myeloma. A phase 2 study reports a 39% near complete response rate for the DaraKPd quadruplet therapy with durable MRD negativity. Preclinical research shows the RXR agonist IRX4204 sensitizes myeloma cells to ferroptosis and enhances lenalidomide efficacy.
BMS's mezigdomide doubled progression-free survival in relapsed/refractory multiple myeloma at ASCO, while the FDA reviews iberdomide with a decision due by August 17. C4 Therapeutics has dosed the first patient in its Phase 2 MOMENTUM trial of cemsidomide.
Phase 3 trial data show daratumumab reduced relapse risk by 74% in NMOSD. Separately, the FDA accepted an NDA for iberdomide plus daratumumab/dexamethasone in relapsed/refractory multiple myeloma, with a PDUFA date of August 17, 2026.
The FDA has granted fast track designation to QRX003 for Netherton Syndrome and IBI3003 for relapsed or refractory multiple myeloma, while also accepting regulatory applications for other therapies addressing serious conditions with unmet medical needs.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
Bristol Myers Squibb's growth portfolio increased 17% in 2025, partially offsetting a 15% decline in legacy products facing generic competition. The company's stock gained 11.4% in the past month on strong fourth-quarter results.
Bristol Myers Squibb and SystImmune reported that antibody-drug conjugate izalontamab brengitecan achieved statistically significant improvements in both progression-free and overall survival versus chemotherapy in a Phase III trial for triple-negative breast cancer.
Bristol Myers Squibb reported fourth quarter and full year 2025 results that beat consensus expectations, with total revenues of $48.3 billion. The company announced FDA acceptance of its new drug application for iberdomide and positive Phase 2 results for Reblozyl.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07727668 |
Iberdomide (CC-220) Priming to Improve T Cell Fitness Prior to Leukapheresis for Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Relapsed/Refractory Multiple Myeloma (RRMM) |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT07624513 |
Determination 2 - Isatuximab, Iberdomide, Bortezomib and Dexamethasone Induction, Followed by Risk- and Response-Adapted Consolidation and Maintenance Therapy, in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma |
NOT_YET_RECRUITING | PHASE3 |
| NCT07601100 |
Phase 1b/2: Isatuximab, Iberdomide, Bortezomib, Dexamethasone in Transplant Ineligible/Deferred Newly Diagnosed Myeloma |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07437963 |
Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07434960 |
Expanded Access for Iberdomide |
AVAILABLE | |
| NCT06896916 |
Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE1 |
| NCT06892522 |
A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-specific Antibodies Intravenously (IV)/Subcutaneously (SC) Alone or in Combinations |
RECRUITING | PHASE1/PHASE2 |
| NCT06785415 |
Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for the Treatment of Relapsed Multiple Myeloma |
RECRUITING | PHASE1/PHASE2 |
| NCT06762769 |
Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma |
RECRUITING | PHASE2 |
| NCT06518551 |
Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM |
RECRUITING | PHASE1/PHASE2 |
