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Lenalidomide PO (25mg)
Lenalidomide PO (25mg) is a Immunomodulatory agent (IMiD) Small molecule drug developed by University Hospital, Lille. It is currently in Phase 3 development for Multiple myeloma, Myelodysplastic syndromes with deletion 5q, Mantle cell lymphoma.
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 PO (25mg) |
|---|---|
| Sponsor | University Hospital, Lille |
| 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, and direct anti-proliferative effects on tumor 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
- Thromboembolism
Key clinical trials
- Compare Lenalidomide and Subcutaneous Daratumumab vs Lenalidomide and Dexamethasone in Frail Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy (PHASE3)
- Pola-ZR2P in Previously Untreated DLBCL (PHASE2)
- G-Pola-ZLP in Diffuse Large B-Cell Lymphoma (PHASE2)
- Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma (PHASE1, PHASE2)
- Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection (PHASE4)
- Lenalidomide Plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma: A Phase 1 / 2 Study (PHASE1, PHASE2)
- REST - Replacing Steroids in the Transplant Ineligble (PHASE2)
- Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL) (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 PO (25mg) CI brief — competitive landscape report
- Lenalidomide PO (25mg) updates RSS · CI watch RSS
- University Hospital, Lille portfolio CI
Frequently asked questions about Lenalidomide PO (25mg)
What is Lenalidomide PO (25mg)?
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Who makes Lenalidomide PO (25mg)?
What drug class is Lenalidomide PO (25mg) in?
What development phase is Lenalidomide PO (25mg) in?
What are the side effects of Lenalidomide PO (25mg)?
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Related
- Drug class: All Immunomodulatory agent (IMiD) drugs
- Target: All drugs targeting Cereblon (CRBN)
- Manufacturer: University Hospital, Lille — 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