Lenalidomide
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2005
- First approval year
- 2005
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Lenalidomide
- Molecular weight
- 259.26
- Structure (SMILES)
- Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O
- lenalidomide accord
- Lenalidomide accord
- lenalidomide mylan
- Lenalidomide mylan
- revlimid
- Revlimid
- 10mg lenalidomide
- 5mg lenalidomide
- cc 5013
- CC 5013
- CC-5013
- CC-5013 (lenalidomide)
- CC-5013 (Revlimid™)
- CC-5103 (lenalidomide)
- cdc 501
- CDC-501
- Len (lenalidomide)
- lenalidomida
- Lenalidomida
- lenalidomide
- Lenalidomide
- LENALIDOMIDE
- Lenalidomide (CC-5013)
- Lenalidomide (Revlimid)
- lenalidomide (Revlimid®)
- Lenalidomide (Revlimid®)
- LENALIDOMIDE [EMA EPAR]
- lenalidomide [INN]
- LENALIDOMIDE [JAN]
- LENALIDOMIDE [MART.]
- LENALIDOMIDE [MI]
And 41 more, listed on the interactive page.
- CAS registry numbers
- 191732-72-6
- ChEMBL ID
- CHEMBL848
- InChIKey
- GOTYRUGSSMKFNF-UHFFFAOYSA-N
- PubChem compound IDs
- 216326
- RxNorm IDs (RxCUI)
- 342369
- FDA ingredient codes (UNII)
- F0P408N6V4
- L04AX04
- L04AX07
Sources for recorded values
- Applicant
- BRISTOL MYERS SQUIBB
- Approval date
- 27 Dec 2005
- Application number
- NDA021880
- Status
- Authorised
- Status date
- 14 Jun 2007
- Authorisation date
- 14 Jun 2007
- Approved indications
- 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).
- Product number
- EMEA/H/C/000717
- Authorisation holder
- Bristol-Myers Squibb Pharma EEIG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 4
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Lymphoma, Mantle-Cell
- Multiple Myeloma
- Myelodysplastic Syndromes
European medicines record
- Patents
- 2
- Designations
- 3
- Earliest recorded loss of exclusivity
- 8 Mar 2028
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- lenalidomide
- Type
- Synthetic organic
- Drug name stem
- -domide
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Binding
- Action type
- Binding
- Target
- cereblon
- Gene symbol
- CRBN
- Protein identifier
- Q96SW2
- Median affinity
- 5.82
- Affinity units
- pIC50
- Mechanism
- CRL4(CRBN) E3 ubiquitin ligase inhibitor
- Action type
- Inhibitor
- Target
- CRL4(CRBN) E3 ubiquitin ligase
- Protein identifier
- P62877
- Mechanism
- CRL4(CRBN) E3 ubiquitin ligase inhibitor
- Action type
- Inhibitor
- Target
- CRL4(CRBN) E3 ubiquitin ligase
- Protein identifier
- Q13619
- Mechanism
- CRL4(CRBN) E3 ubiquitin ligase inhibitor
- Action type
- Inhibitor
- Target
- CRL4(CRBN) E3 ubiquitin ligase
- Protein identifier
- Q16531
- Mechanism
- CRL4(CRBN) E3 ubiquitin ligase inhibitor
- Action type
- Inhibitor
- Target
- CRL4(CRBN) E3 ubiquitin ligase
- Protein identifier
- Q96SW2
- Mechanism
- CRL4(CRBN) E3 ubiquitin ligase inhibitor
- Action type
- Inhibitor
- Target
- CRL4(CRBN) E3 ubiquitin ligase
- Mechanism
- CRL4(CRBN) E3 ubiquitin ligase modulator
- Action type
- MODULATOR
- Target
- CRL4(CRBN) E3 ubiquitin ligase
DrugCentral mechanisms
- Action type
- MODULATOR
- Gene symbol
- CRBN
- Protein identifier
- Q96SW2
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- HIV Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000180
- Subject identifier
- D015658
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Hodgkin Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Lymphoma, B-Cell, Marginal Zone
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000191
- Subject identifier
- D018442
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Neoplasms, Plasma Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000200
- Subject identifier
- D054219
- Condition
- Leukemia, Biphenotypic, Acute
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000209
- Subject identifier
- D015456
- Condition
- Lymphoma, T-Cell, Peripheral
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000211
- Subject identifier
- D016411
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000294
- Subject identifier
- D001749
- Condition
- Burkitt Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000309
- Subject identifier
- D002051
- Condition
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000339
- Subject identifier
- D015464
- Condition
- Crohn Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Thrombocythemia, Essential
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000479
- Subject identifier
- D013920
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Sarcoma, Kaposi
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000558
- Subject identifier
- D012514
- Condition
- Leukemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Neuroblastoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000621
- Subject identifier
- D009447
And 67 more, listed on the interactive page.
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000096
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000183
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000191
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000198
- Condition identifier
- EFO_0000200
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000209
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000211
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000222
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000294
- Condition identifier
- EFO_0000384
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000398
- Condition identifier
- EFO_0000403
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000558
- Condition identifier
- EFO_0000565
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000621
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000638
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000673
- Condition identifier
- EFO_0000681
- Condition identifier
- EFO_0000707
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 3
And 166 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- hematological toxicity
- Warning
- Black Box Warning
- Effect
- musculoskeletal toxicity
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Warning
- Black Box Warning
- Effect
- vascular toxicity
- Warning
- Black Box Warning
- Effect
- hematological toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- musculoskeletal toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- vascular toxicity
- Country
- United States
- Event
- diarrhoea
- Reports
- 17,792
- Reporting signal score
- 5,132.75
- Event
- full blood count decreased
- Reports
- 5,330
- Reporting signal score
- 9,625.44
- Event
- injection site pain
- Reports
- 24
- Reporting signal score
- 2,770.51
- Event
- laboratory test abnormal
- Reports
- 3,338
- Reporting signal score
- 3,375.86
- Event
- neuropathy peripheral
- Reports
- 6,531
- Reporting signal score
- 4,843.35
- Event
- plasma cell myeloma
- Reports
- 5,730
- Reporting signal score
- 8,926.12
- Event
- platelet count decreased
- Reports
- 6,272
- Reporting signal score
- 3,791.82
- Event
- pneumonia
- Reports
- 10,551
- Reporting signal score
- 4,303.8
- Event
- thrombosis
- Reports
- 5,470
- Reporting signal score
- 5,037.45
- Event
- white blood cell count decreased
- Reports
- 7,478
- Reporting signal score
- 5,463.03
- NCT00036894
- NCT00044018
- NCT00051116
- NCT00056160
- NCT00064038
- NCT00065351
- NCT00091260
- NCT00091624
- NCT00098475
- NCT00112827
- NCT00151203
- NCT00153933
- NCT00179647
- NCT00305812
- NCT00306813
- NCT00378105
- NCT00378209
- NCT00396045
- NCT00398515
- NCT00405756
- NCT00410605
- NCT00415064
- NCT00420849
- NCT00424047
- NCT00430365
And 611 more, listed on the interactive page.
- Dose
- 25 mg
- Route
- Oral
- How often
- Once daily on Days 1-21 of repeated 28-day cycles
- Hydrogen bond acceptors
- 4
- Hydrogen bond donors
- 2
- Polar surface area
- 92.5
- Calculated partition coefficient (ALogP)
- 0.03
- Calculated partition coefficient (XLogP)
- -0.5
- Prodrug
- No
- Chirality
- Racemic
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 1
- Heavy atoms
- 19
- Molecular formula
- C13H13N3O3
- Monoisotopic mass
- 259.09569129
- Natural product
- Yes
- 0378-1935
- 0378-1936
- 0378-1937
- 0378-1940
- 0378-1941
- 0378-1942
- 0480-1241
- 0480-1242
- 0480-1243
- 0480-1244
- 0480-1245
- 0480-1246
- 0574-1402
- 0574-1405
- 0574-1410
- 0574-1415
- 0574-1420
- 0574-1425
- 16729-692
- 16729-693
- 16729-694
- 16729-695
- 16729-696
- 16729-697
- 31722-257
And 89 more, listed on the interactive page.
- Recorded assays
- 2,053
- Active assays
- 89
- Confirmatory
- Screening
- Immunologic Factors
- Angiogenesis Inhibitors
These details could not be displayed.
Related records
Trials (1,239)
- "Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab "
- [Effects of Selected Statins on Cardiovascular Parameters in Healthy Volunteers]
- 2015-09: a Phase II Randomized, Open-label Study of Anti-signaling Lymphocytic Activation Molecule Monoclonal Antibody During Maintenance Therapy
- 2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy
- 2017-03: A Single-Arm, Open-label Study of Anti-Signaling Lymphocytic Activation Molecule F7 (Anti-SLAMF7) Monoclonal Antibody (mAb) Therapy After Autologous Stem Cell Transplant in Patients With Multiple Myeloma
- 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting
- 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Non-Fasting
- 5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
- A 2 Stage Trial of Lenalidomide (REV) in Asymptomatic Ovarian Cancer Patients With Increasing CA 125 in Late Relapse
- A Clinical Study of Injectable IMM0306 in Combination With Lenalidomide
- A Clinical Trial of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-infected and HIV-uninfected Adults
- A Clinical Trial to Evaluate the Efficacy and Safety of TQB3909 Tablets Versus Investigator's Choice in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
- A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma
- A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
- A Dose Escalation Study of the Combination of Lenalidomide (Revlimid®), Dexamethasone and Cyclophosphamide in Patients Refractory or Relapsing From Stable Disease With Multiple Myeloma
- A Dose Range Finding Study of Lenalidomide in Non-5q Chromosome Deletion in Low and Intermediate Risk Myelodysplastic Syndrome (MDS) Patients
- A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide
- A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
- A Multi-Center, Individually-Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Superiority Trial to Evaluate the Efficacy of the Combination of Maraviroc and Atorvastatin for the Treatment of Subjects With Long COVID
- A Multicenter In-class Transition Study of Ixazomib Combined With Pomalidomide and Dexamethasone or With Lenalidomide and Dexamethasone in Adults With Relapsed/Refractory Multiple Myeloma
Approved for (5)
In development for (84)
- Acquired polycythemia vera Phase 2
- Acute lymphoblastic leukemia Phase 2
- Acute myeloid leukemia Phase 3
- Adult T-cell leukemia/lymphoma Phase 2
- AL amyloidosis Phase 3
- Amyloidosis Phase 3
- Anaplastic astrocytoma Phase 1
- Autism Phase 2
- B-cell chronic lymphocytic leukemia Phase 3
- B-cell non-Hodgkin lymphoma Phase 1
- Bone marrow neoplasm Phase 2
- Burkitt lymphoma Phase 1
- Cancer Phase 1
- Central nervous system neoplasm Phase 1
- Chronic myeloid leukemia Phase 1
- Chronic myelomonocytic leukemia Phase 2
- Colorectal cancer Phase 2
- Colorectal neoplasm Phase 2
- Complex regional pain syndrome Phase 2
- Crohn disease Phase 2
Other linked conditions (1)
- Dermatomyositis
Targets (4)
- CRBN CRL4(CRBN) E3 ubiquitin ligase inhibitor; CRL4(CRBN) E3 ubiquitin ligase modulator
- CUL4A CRL4(CRBN) E3 ubiquitin ligase inhibitor; CRL4(CRBN) E3 ubiquitin ligase modulator
- DDB1 CRL4(CRBN) E3 ubiquitin ligase inhibitor; CRL4(CRBN) E3 ubiquitin ligase modulator
- RBX1 CRL4(CRBN) E3 ubiquitin ligase inhibitor; CRL4(CRBN) E3 ubiquitin ligase modulator