Drug

Lenalidomide

Approved · FDA / EMA

ClassCRL4(CRBN) E3 ubiquitin ligase inhibitorEmerging researchLate-stage developmentCooling momentum

Also known as Lena, Revlimid, Lenalidomida, 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline+1 more

Lena, Revlimid, Lenalidomida, 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline, 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione.

RxNorm342369 ChEMBLCHEMBL848 ATCL04AX04UNIIF0P408N6V4

Research papers

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Daratumumab Versus Lenalidomide Maintenance Therapy for Multiple Myeloma: A Randomized Pilot Study Comparing Patient-Reported Health Related Quality of Life Measures With a Plant Based Nutrition Intervention Sub Study (NUTRIVENTION-4)

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Lenalidomide Maintenance in Plasma Cell Myeloma

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Label change: LENALIDOMIDE (NDA021880)

Regulatory2026-07-22FDA

Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

Clinical trial2026-07-21Results posted · ClinicalTrials.gov

Combination Post-transplant Consolidation Therapy With Isatuximab, Lenalidomide, Dexamethasone (IsaRD) in Multiple Myeloma Patients With Persistent Marrow Minimal Residual Disease (Elimination of MRD After Transplant; E-MAT)

Clinical trial2026-07-17Results expected Q3 2026 · ClinicalTrials.gov

Advanced hierarchical ZnFe-LDH@MnO₂ nanostructures for sensitive voltammetric determination of lenalidomide

Industry2026-06-29Nature — Environmental Sciences

Label change: LENALIDOMIDE (ANDA201452)

Regulatory2026-06-15FDA

Label change: LENALIDOMIDE (ANDA201452)

Regulatory2026-06-15FDA

Supplemental approval: LENALIDOMIDE (ANDA201452)

Regulatory2026-04-27FDA

AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma.

Research2019-03-21Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial.

Research2019-01-17Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma.

Research2017-08-28American journal of hematology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Lenalidomide

Aliases & brands

LenaRevlimidLenalidomida1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione

RxNorm CUI

342369

ChEMBL ID

CHEMBL848

ATC codes

L04AX04

UNII

F0P408N6V4

Primary mechanism

CRL4(CRBN) E3 ubiquitin ligase inhibitor

Regulatory jurisdictions

emamhrafda

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Protein cereblon

CRBN · Q96SW2

INHIBITORCRL4(CRBN) E3 ubiquitin ligase inhibitor

DNA damage-binding protein 1

DDB1 · Q16531

INHIBITORCRL4(CRBN) E3 ubiquitin ligase inhibitor

Cullin-4A

CUL4A · Q13619

INHIBITORCRL4(CRBN) E3 ubiquitin ligase inhibitor

E3 ubiquitin-protein ligase RBX1

RBX1 · P62877

INHIBITORCRL4(CRBN) E3 ubiquitin ligase inhibitor

Regulatory timeline

52 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2005-12-27 → 2007-06-14)

Approval / market entry confirmed across FDA and EMA (2018-09-20 → 2020-09-24)

Approval / market entry confirmed across FDA and EMA (2021-02-11 → 2021-08-05)

Earliest approval

2005-12-27

Latest approval

2026-04-27

Authorities

FDA · EMA · MHRA

Total events

fdaU.S. Food and Drug Administration· 46 events

2026-07-22Label change

Label change: LENALIDOMIDE (NDA021880)

Evidence ↗

2026-06-15Label change

Label change: LENALIDOMIDE (ANDA201452)

Evidence ↗

2026-06-15Label change

Label change: LENALIDOMIDE (ANDA201452)

Evidence ↗

emaEuropean Medicines Agency· 3 events

2021-02-11ApprovalMulti-authority

Approval: Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) (EMA)

Indication: Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous… Show full indication

Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1). Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a). Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1). Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Evidence ↗

2018-09-20ApprovalMulti-authority

Approval: Lenalidomide Accord (EMA)

Indication: Multiple myelomaLenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous… Show full indication

Multiple myelomaLenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphomaLenalidomide Accord in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Evidence ↗

2007-06-14ApprovalMulti-authority

Approval: Revlimid (EMA)

Indication: Multiple myeloma Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell… Show full indication

Multiple myeloma Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromes Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. Mantle cell lymphoma Revlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. Follicular lymphoma Revlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Evidence ↗

mhraMedicines and Healthcare products Regulatory Agency· 3 events

2014-12-11Safety communicationSafety

Drug Safety Update: Lenalidomide (Revlimid): risk of serious hepatic adverse drug reactions

Evidence ↗

2014-12-11Safety communicationSafety

Drug Safety Update: Lenalidomide (Revlimid▼): update on risk of second primary malignancy

Evidence ↗

2014-12-11Safety communicationSafety

Drug Safety Update: Lenalidomide: risk of thrombosis and thromboembolism

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

199 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

199

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 199

Early Phase 12Phase 131Phase 1 / 237Phase 288Phase 2 / 31Phase 334Phase 45Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Single-arm Prospective Study of the Treatment in High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection

RecruitingPH IVThe First Affiliated Hospital of Soochow Universityn=592027

An Open-Label, Non-Comparative, Two-Cohort, Multicenter Study to Evaluate the Effectiveness and Safety of Ixazomib (NINLARO®) in Combination With Pomalidomide and Dexamethasone (IPd, Cohort A) or With Lenalidomide and Dexamethasone (IRd, Cohort B) in Patients With Relapsed/Refractory Multiple Myeloma Previously Receiving a Parenteral Proteasome Inhibitor-based Treatment Regimen (US MM-7)

WithdrawnPH IVTakeda2026

Functional Cure Strategy and Clinical Study of AIDS--Study on the Reduction of HIV Viral Reservoir by Immunomodulators (IMs)

Unknown statusPH IVFirst Affiliated Hospital of Zhejiang Universityn=482024

A Multicenter, Open-label, Prospective Study of Ixazomib, Lenalidomide, and Ixazomib in Combination With Lenalidomide for Maintenance Therapy in Patients With Newly Diagnosed Multiple Myeloma

CompletedPH IVPeking Union Medical College Hospitaln=2112024

Phase II Study To Evaluate The Safety And Efficacy Of Lenalidomide For The Treatment Of Refractory Cutaneous Lupus

CompletedPH IVHospital Universitari Vall d'Hebron Research Instituten=152011

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

CompletedPH IIIJanssen Research & Development, LLCn=3952026

A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

CompletedPH IIICelgenen=3862026

Phase 2 Study of the Initial and Post-Transplant Treatment With Carfilzomib, Lenalidomide and Low Dose Dexamethasone (CRd) in Transplant Candidates With Newly Diagnosed, Multiple Myeloma Requiring Systemic Chemotherapy

CompletedPH IIUniversity of Chicagon=762026

A Phase II Study of Brentuximab Vedotin and Lenalidomide in Relapsed and Refractory T-Cell Lymphomas

CompletedPH IIJohn Reneaun=262025

A Single-arm, Multi-center, Phase II Clinical Trial of R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Medium to High Risk/High Risk Diffuse Large B Cell Lymphoma

CompletedPH IIHenan Cancer Hospitaln=602025

A Phase I/IB Pilot Study of CC-486 Combined With Lenalidomide and Obinutuzumab for Relapsed/Refractory Indolent B-Cell Lymphoma

CompletedPH IJoseph Tuscanon=82025

Research activity

17 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20062019

Most influential

Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma.

The New England journal of medicine · 2015 · 1,019 cites

Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion.

The New England journal of medicine · 2006 · 905 cites

Lenalidomide after stem-cell transplantation for multiple myeloma.

The New England journal of medicine · 2012 · 808 cites

AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019 · 309 cites

An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.

Annals of oncology : official journal of the European Society for Medical Oncology · 2011 · 296 cites

Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2008 · 295 cites

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Approved indications

Multiple Myeloma2

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Thalidomide

Acts on the same molecular target as Lenalidomide, with 2 overlapping disease areas.

4 shared targets2 shared diseases2 shared papers

Dexamethasone

Studied across the same disease area as Lenalidomide in the shared literature.

1 shared disease1 shared paper

Elotuzumab

Studied across the same disease area as Lenalidomide in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.