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CC-5013 (Revlimid™)
CC-5013 (Revlimid™) is a Immunomodulatory agent (IMiD) Small molecule drug developed by University of Arkansas. It is currently in Phase 3 development for Multiple myeloma, Myelodysplastic syndromes with deletion 5q, Mantle cell lymphoma.
CC-5013 (lenalidomide) is an immunomodulatory agent that enhances T-cell proliferation and NK cell activation while inhibiting TNF-α and IL-6 production, and also has direct anti-angiogenic and anti-proliferative effects on tumor cells.
CC-5013 (Revlimid) is a small molecule used in the treatment of multiple myeloma and plasma cell neoplasm, as well as other conditions such as intraocular melanoma and lymphoma. It has been studied in combination with other medications, including cyclophosphamide and sunitinib malate, in clinical trials.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | CC-5013 (Revlimid™) |
|---|---|
| Sponsor | University of Arkansas |
| Drug class | Immunomodulatory agent (IMiD) |
| Target | Cereblon (CRBN) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Lenalidomide binds to cereblon (CRBN), a component of an E3 ubiquitin ligase complex, leading to selective degradation of Ikaros and Aiolos proteins. This results in enhanced IL-2 and IFN-γ production by T cells, increased NK cell activity, and inhibition of pro-inflammatory cytokines. Additionally, it has direct cytotoxic effects on certain malignant cells and inhibits angiogenesis.
Approved indications
- Multiple myeloma
- Myelodysplastic syndromes with deletion 5q
- Mantle cell lymphoma
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Fatigue
- Constipation
- Diarrhea
- Neuropathy
- Thromboembolism
Key clinical trials
- A Phase 1/2, Open-label Study of Valemetostat in Combination With Rituximab and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (PHASE1, PHASE2)
- A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma (PHASE3)
- Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma (PHASE2)
- Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome (PHASE1, PHASE2)
- Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (PHASE1, PHASE2)
- Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma (PHASE3)
- Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma (PHASE2)
- Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL) (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CC-5013 (Revlimid™) CI brief — competitive landscape report
- CC-5013 (Revlimid™) updates RSS · CI watch RSS
- University of Arkansas portfolio CI
Frequently asked questions about CC-5013 (Revlimid™)
What is CC-5013 (Revlimid™)?
How does CC-5013 (Revlimid™) work?
What is CC-5013 (Revlimid™) used for?
Who makes CC-5013 (Revlimid™)?
What drug class is CC-5013 (Revlimid™) in?
What development phase is CC-5013 (Revlimid™) in?
What are the side effects of CC-5013 (Revlimid™)?
What does CC-5013 (Revlimid™) target?
Related
- Drug class: All Immunomodulatory agent (IMiD) drugs
- Target: All drugs targeting Cereblon (CRBN)
- Manufacturer: University of Arkansas — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma
- Indication: Drugs for Myelodysplastic syndromes with deletion 5q
- Indication: Drugs for Mantle cell lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing