LENALIDOMIDE
LENALIDOMIDE is indicated for the treatment of Multiple Myeloma; Anemia; Myelodysplastic Syndromes; Mantle Cell Lymphoma.
How LENALIDOMIDE Works
Lenalidomide is a thalidomide analogue that functions by binding to cereblon, a component of the cullin ring E3 ubiquitin ligase enzyme complex. This binding triggers the ubiquitination and subsequent proteasomal degradation of specific substrate proteins, including Ikaros (IKZF1), Aiolos (IKZF3), and CK1α. In MM and MCL, this leads to direct inhibition of cell proliferation and induction of apoptosis. Its immunomodulatory effects include the activation of T cells and natural killer (NK) cells, enhancement of antibody-dependent cell-mediated cytotoxicity (ADCC), and inhibition of pro-inflammatory cytokines (e.g., TNF-α and IL-6). It also exhibits antiangiogenic properties by blocking the signals required for new blood vessel formation in the tumor microenvironment.
Details
- Status
- Prescription
- First Approved
- 2021-05-21
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
LENALIDOMIDE Approval History
What LENALIDOMIDE Treats
4 indicationsLENALIDOMIDE is approved for 4 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Myeloma
- Anemia
- Myelodysplastic Syndromes
- Mantle Cell Lymphoma
LENALIDOMIDE Boxed Warning
EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use lenalidomide capsules during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative p...
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use lenalidomide capsules during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting lenalidomide treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after lenalidomide capsules treatment [see Warnings and Precautions ( 5.1 ), and Medication Guide ( 17 )] . To avoid embryo-fetal exposure to lenalidomide, lenalidomide capsules are only available through a restricted distribution program, the Lenalidomide REMS program ( 5.2 ). Information about the Lenalidomide REMS program is available at www.lenalidomiderems.com or by calling the toll-free number 1-888-423-5436. Hematologic Toxicity (Neutropenia and Thrombocytopenia) Lenalidomide capsules can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q myelodysplastic syndromes had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q myelodysplastic syndromes should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors [see Dosage and Administration ( 2.2 )] . Venous and Arterial Thromboembolism Lenalidomide capsules have demonstrated a significantly increased risk of d
LENALIDOMIDE Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
LENALIDOMIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LENALIDOMIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LENALIDOMIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LENALIDOMIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
662 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06649812 | NCI-2024-08642 NCI-2024-08642, EA4231 | Ph 2 | recruiting | Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma |
| NCT04301076 | NCI-2020-01535 NCI-2020-01535, 10335 | Ph 1 | suspended | Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL) |
| NCT06169215 | NCI-2023-07073 NCI-2023-07073, 10612 | Ph 2 | active not recruiting | Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma |
| NCT06504199 ZGR | IIT2024010 | Ph 2 | active not recruiting | Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma |
| NCT05497804 | MC210811 P50CA186781, 22-002687 | Ph 2 | active not recruiting | Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial |
| NCT02160015 | NCI-2014-01157 NCI-2014-01157, 2015-00531 | Ph 1 | active not recruiting | Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery |
| NCT07095452 | M25-586 2025-520897-21, 2025-520897-21-00 | Ph 2, Ph 3 | recruiting | 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 |
| NCT03269669 | NCI-2017-00009 NCI-2017-00009, S1608 | Ph 2 | active not recruiting | Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma |
| NCT06015880 | NCI-2023-06477 NCI-2023-06477, PHI-141 | Ph 1 | recruiting | Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma |
| NCT07261163 | IIT2025103 | Ph 2 | recruiting | Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma |
| NCT01955499 | NCI-2013-01810 NCI-2013-01810, OSU 13022 | Ph 1 | active not recruiting | Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma |
| NCT06182774 | MY13 | Ph 3 | recruiting | Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma |
| NCT05669989 | LTS17704 U1111-1277-6635, 2023-507180-19 | Ph 2 | active not recruiting | International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab |
| NCT05849610 GEM-TECTAL | GEM-TECTAL | Ph 2 | active not recruiting | Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma |
| NCT05100862 MAHOGANY | BGB-3111-308 CTR20232545, 2022-502548-12-00 | Ph 3 | recruiting | A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma |
| NCT04923893 CARTITUDE-5 | CR109015 68284528MMY3004, 2021-001242-35 | Ph 3 | active not recruiting | A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy |
| NCT05050097 MonumenTAL-2 | CR108946 64407564MMY1004, 2020-004502-55 | Ph 1 | active not recruiting | A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma |
| NCT03901963 AURIGA results posted | CR108599 54767414MMY3021 | Ph 3 | active not recruiting | A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant |
| NCT06577025 aMMbition | 54767414MMY2093 54767414MMY2093, 2023-505792-71-00 | Ph 2 | active not recruiting | A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma |
| NCT05438043 | CR109200 54767414MMY3030, 2021-006494-33 | Ph 3 | recruiting | A Study of Daratumumab |
| NCT05552222 MajesTEC-7 | CR109237 64007957MMY3005, 2022-000909-28 | Ph 3 | recruiting | A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma |
| NCT04722146 MajesTEC-2 | CR108927 64007957MMY1004, 2020-004404-33 | Ph 1 | active not recruiting | A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma |
| NCT06768489 | 79635322MMY1002 79635322MMY1002, 2024-515316-44-00 | Ph 1 | recruiting | A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma |
| NCT04609046 | NCI-2020-08331 NCI-2020-08331, A051901 | Ph 1 | recruiting | Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma |
| NCT06191744 EPCORE™FL-2 | M22-003 2023-506906-38-00 | Ph 3 | recruiting | 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 |
| NCT04126200 DREAMM 5 results posted | 208887 2023-509550-55-00 | Ph 1, Ph 2 | active not recruiting | Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) |
| NCT05283720 | M22-132 2023-505347-38, 2023-505347-38-00 | Ph 2 | recruiting | 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 |
| NCT06149286 OLYMPIA-5 | R1979-ONC-22102 2022-503092-28-00 | Ph 3 | recruiting | A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma |
| NCT05660967 EPCORE DLBCL-3 | GCT3013-06 2021-005744-29, jRCT2021230015 | Ph 2 | active not recruiting | Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma |
| NCT04566328 | EAA181 NCI-2020-06647, EAA181 | Ph 3 | recruiting | Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial |
| NCT06112847 | 22509 NCI-2023-08814, 22509 | Ph 2 | active not recruiting | Lenalidomide and Epcoritamab for the Treatment of Previously Untreated Follicular Lymphoma |
| NCT04663347 EPCORE™ NHL-2 | GCT3013-02 2023-504805-35-00, 2020-000845-15 | Ph 1, Ph 2 | active not recruiting | Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) |
| NCT04623541 EPCORE™ CLL-1 | GCT3013-03 2020-000848-57, NL74221.056.20 | Ph 1, Ph 2 | active not recruiting | Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome |
| NCT03556332 | 17-493 | Ph 2 | active not recruiting | A Study of Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab for Patients With Relapsed/Refractory Myeloma With Salvage Autologous Hematopoietic Cell Transplantation |
| NCT03937635 | EAA173 NCI-2018-02611, EAA173 | Ph 3 | recruiting | Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma |
| NCT04712097 Celestimo | GO42909 2020-005239-53 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma |
| NCT03477539 results posted | MC1785 NCI-2018-00332, MC1785 | Ph 2 | completed | Daratumumab in Treating Transplant-Eligible Patients With Multiple Myeloma |
| NCT05429268 firmMIND | INCMOR 0208-305 2023-505579-53-00 | Ph 3 | active not recruiting | Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND) |
| NCT05623020 MagnetisMM-6 | C1071006 MAGNETISMM-6, 2024-514139-50-00 | Ph 3 | recruiting | A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant |
| NCT05848765 REFRACT | RG_22-020 | Ph 2 | recruiting | Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy |
| NCT04978584 | 2021-0046 NCI-2021-04298, 2021-0046 | Ph 2 | active not recruiting | Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study |
| NCT06348147 | LCCC2323 | Ph 2 | suspended | Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation |
| NCT05583617 PLYCOM | CO43923 2021-005918-34, 2023-504484-16-00 | Ph 1, Ph 2 | recruiting | A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma |
| NCT03173092 | C16038 U1111-1192-7696 | Ph 4 | terminated | A Study of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) for the Treatment of Participants With Multiple Myeloma (MM) |
| NCT06084936 GLOBRYTE | GO43878 | Ph 3 | recruiting | A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma |
| NCT02343042 STOMP | KCP-330-017 | Ph 1, Ph 2 | active not recruiting | Selinexor and Backbone Treatments of Multiple Myeloma Patients |
| NCT03319667 IMROZ | EFC12522 U1111-1194-2121, 2024-514417-34 | Ph 3 | active not recruiting | A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant |
| NCT07562022 | SCTB35-A301 | Ph 3 | not yet recruiting | A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma |
| NCT05182957 | R/R PTCL 01 | Ph 2 | recruiting | Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma |
| NCT07560449 | QLS4131-202 | Ph 2 | not yet recruiting | QLS4131 Combination Therapy in Malignant Plasma Cell Neoplasms |
Showing 50 of 662 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LENALIDOMIDE FDA Label Details
Indications & Usage
LENALIDOMIDE is indicated for the treatment of Multiple Myeloma; Anemia; Myelodysplastic Syndromes; Mantle Cell Lymphoma.
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use lenalidomide capsules during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratog...
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REVLIMID
Full clinical data, patents, trials, and competitive landscape for lenalidomide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.