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Lenalidomide Oral Capsule
Lenalidomide Oral Capsule is a Immunomodulatory agent (IMiD) Small molecule drug developed by The First Affiliated Hospital with Nanjing Medical University. It is currently in Phase 3 development for Multiple myeloma, Myelodysplastic syndromes with deletion 5q, Mantle cell lymphoma. Also known as: Revlimid, placebo.
Lenalidomide is an immunomodulatory agent that enhances T-cell proliferation and NK cell activation while inhibiting pro-inflammatory cytokine production.
Lenalidomide is an immunomodulatory agent that enhances T-cell proliferation and NK cell activation while inhibiting pro-inflammatory cytokine production. Used for Multiple myeloma, Myelodysplastic syndromes with deletion 5q, Mantle cell lymphoma.
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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 | Lenalidomide Oral Capsule |
|---|---|
| Also known as | Revlimid, placebo |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| 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 IKZF1 and IKZF3 proteins. This results in enhanced immune cell activation, increased IL-2 and TNF-α production by T cells, and direct anti-proliferative and pro-apoptotic effects on malignant cells. It also has anti-angiogenic properties that inhibit new blood vessel formation in tumors.
Approved indications
- Multiple myeloma
- Myelodysplastic syndromes with deletion 5q
- Mantle cell lymphoma
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Fatigue
- Constipation
- Diarrhea
- Neuropathy
- Venous thromboembolism
Key clinical trials
- A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant (PHASE2, PHASE3)
- A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma (PHASE2)
- A Study of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) for the Treatment of Participants With Multiple Myeloma (MM) (PHASE4)
- A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma (PHASE3)
- A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (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)
- Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome (PHASE1, PHASE2)
- A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (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:
- Lenalidomide Oral Capsule CI brief — competitive landscape report
- Lenalidomide Oral Capsule updates RSS · CI watch RSS
- The First Affiliated Hospital with Nanjing Medical University portfolio CI
Frequently asked questions about Lenalidomide Oral Capsule
What is Lenalidomide Oral Capsule?
How does Lenalidomide Oral Capsule work?
What is Lenalidomide Oral Capsule used for?
Who makes Lenalidomide Oral Capsule?
Is Lenalidomide Oral Capsule also known as anything else?
What drug class is Lenalidomide Oral Capsule in?
What development phase is Lenalidomide Oral Capsule in?
What are the side effects of Lenalidomide Oral Capsule?
What does Lenalidomide Oral Capsule target?
Related
- Drug class: All Immunomodulatory agent (IMiD) drugs
- Target: All drugs targeting Cereblon (CRBN)
- Manufacturer: The First Affiliated Hospital with Nanjing Medical University — 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
- Also known as: Revlimid, placebo
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing