Revlimid(lenalidomide)
Lenalidomide, Revlimid (lenalidomide) is a small molecule pharmaceutical. Lenalidomide was first approved as Revlimid on 2005-12-27. It is used to treat b-cell lymphoma marginal zone, follicular lymphoma, mantle-cell lymphoma, multiple myeloma, and myelodysplastic syndromes in the USA. It has been approved in Europe to treat follicular lymphoma, mantle-cell lymphoma, multiple myeloma, and myelodysplastic syndromes. It is known to target protein cereblon.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Lenalidomide, Revlimid (discontinued: Lenalidomide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lenalidomide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| REVLIMID | Bristol Myers Squibb | N-021880 RX | 2005-12-27 | 6 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lenalidomide | ANDA | 2025-03-03 |
| revlimid | New Drug Application | 2023-03-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myelodysplastic syndromes | — | D009190 | D46 |
| multiple myeloma | — | D009101 | C90.0 |
| mantle-cell lymphoma | — | D020522 | C83.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LENALIDOMIDE, REVLIMID, BRISTOL MYERS SQUIBB | |||
| 2026-05-28 | ODE-241, ODE-245 | ||
| 2024-02-22 | ODE-131 | ||
HCPCS
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Clinical
Clinical Trials
1219 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 8 | 14 | 7 | — | 6 | 34 |
| Plasma cell neoplasms | D054219 | — | — | 7 | 13 | 5 | — | 6 | 30 |
| Lymphoma | D008223 | — | C85.9 | 2 | 1 | 1 | — | — | 3 |
| Residual neoplasm | D018365 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | — | — | 3 |
| Recurrence | D012008 | — | — | 2 | 2 | — | — | — | 3 |
| Smoldering multiple myeloma | D000075122 | — | — | — | 2 | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 2 | — | — | — | 2 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 2 | 1 | — | — | — | 2 |
| B-cell lymphoma | D016393 | — | — | 2 | 1 | — | — | — | 2 |
| Leukemia | D007938 | — | C95 | 1 | 1 | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | 1 | — | — | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | 1 | — | — | — | 1 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Central nervous system neoplasms | D016543 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lenalidomide |
| INN | lenalidomide |
| Description | Lenalidomide is a dicarboximide that consists of 1-oxoisoindoline bearing an amino substituent at position 4 and a 2,6-dioxopiperidin-3-yl group at position 2. It inhibits the secretion of TNF-alpha and has a role as an angiogenesis inhibitor, an antineoplastic agent and an immunomodulator. It is a member of isoindoles, a dicarboximide, a member of piperidones and an aromatic amine. Lenalidomide is a thalidomide analog with potential antineoplastic activity. Lenalidomide inhibits TNF-alpha production, stimulates T cells, reduces serum levels of the cytokines vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF), and inhibits angiogenesis. This agent also promotes G1 cell cycle arrest and apoptosis of malignant cells. |
| Classification | Small molecule |
| Drug class | thalidomide derivatives; narcotic agonists/antagonists (normorphine type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O |
Identifiers
| PDB | — |
| CAS-ID | 191732-72-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL848 |
| ChEBI ID | 63791 |
| PubChem CID | 216326 |
| DrugBank | DB00480 |
| UNII ID | F0P408N6V4 (ChemIDplus, GSRS) |
Target
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Revlimid – Bristol Myers Squibb
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Revlimid – Celgene
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PubMed Central
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Safety
Black-box Warning
Black-box warning for: Lenalidomide, Revlimid
Adverse Events
Top Adverse Reactions
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393,576 adverse events reported
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