Pomalidomide
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2013
- First approval year
- 2013
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Pomalidomide
- Molecular weight
- 273.25
- Structure (SMILES)
- Nc1cccc2c1C(=O)N(C1CCC(=O)NC1=O)C2=O
- imnovid
- Imnovid
- Imnovid (previously pomalidomide celgene)
- imnovid previously pomalidomide celgene
- pomalidomide accord
- Pomalidomide accord
- pomalidomide krka
- Pomalidomide krka
- pomalidomide viatris
- Pomalidomide viatris
- pomalidomide zentiva
- Pomalidomide zentiva
- pomalyst
- Pomalyst
- 3 3 amino phtalamido glutarimide
- 3-(3-Amino)-Phtalamido-Glutarimide
- actimid
- Actimid
- cc 4047
- CC-4047
- imid 3
- IMID 3
- IMID-3
- imid3
- IMID3
- IMNOVID
- Imnovid (pomalidomide)
- Imnovid® (Pomalidomide) 4 mg Hard Capsule
- pomalidomida
- Pomalidomida
- pomalidomide
- Pomalidomide
- POMALIDOMIDE
- pomalidomide (CC-4047
- Pomalidomide (CC-4047)
- Pomalidomide [EMA EPAR]
- Pomalidomide [INN]
- Pomalidomide [JAN]
- Pomalidomide [MI]
And 22 more, listed on the interactive page.
- ATC classification codes
- L04AX06
Sources for recorded values
- CAS registry numbers
- 19171-19-8
- ChEMBL ID
- CHEMBL43452
- InChIKey
- UVSMNLNDYGZFPF-UHFFFAOYSA-N
- PubChem compound IDs
- 134780
- RxNorm IDs (RxCUI)
- 1369713
- FDA ingredient codes (UNII)
- D2UX06XLB5
- Applicant
- BRISTOL
- Approval date
- 8 Feb 2013
- Application number
- NDA204026
- Status
- Authorised
- Status date
- 5 Aug 2013
- Authorisation date
- 5 Aug 2013
- Approved indications
- Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
- Product number
- EMEA/H/C/002682
- Authorisation holder
- Bristol-Myers Squibb Pharma EEIG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 5
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Multiple Myeloma
European medicines record
- Patents
- 6
- Designations
- 4
- Earliest recorded loss of exclusivity
- 21 Dec 2031
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- pomalidomide
- 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
- 5.92
- 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
Open Targets mechanisms
- Mechanism
- CRL4(CRBN) E3 ubiquitin ligase inhibitor
- Action type
- Inhibitor
- 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
- Hodgkin Disease
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Neoplasms, Plasma Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000200
- Subject identifier
- D054219
- Condition
- Burkitt Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000309
- Subject identifier
- D002051
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Sarcoma, Kaposi
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000558
- Subject identifier
- D012514
- Condition
- Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Scleroderma, Systemic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000717
- Subject identifier
- D012595
- Condition
- Multiple Myeloma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Polycythemia Vera
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002429
- Subject identifier
- D011087
- Condition
- Primary Myelofibrosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002430
- Subject identifier
- D055728
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Medulloblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002939
- Subject identifier
- D008527
- Condition
- Smoldering Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003073
- Subject identifier
- D000075122
- Condition
- Lung Diseases, Interstitial
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004244
- Subject identifier
- D017563
- Condition
- Myeloproliferative Disorders
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004251
- Subject identifier
- D009196
- Condition
- Lymphoma, Non-Hodgkin
- Highest recorded phase
- 1
- Condition identifier
- EFO:0005952
- Subject identifier
- D008228
- Condition
- Leukemia, Plasma Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0006475
- Subject identifier
- D007952
- Condition
- Plasmacytoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0006738
- Subject identifier
- D010954
- Condition
- Waldenstrom Macroglobulinemia
- Highest recorded phase
- 1
- Condition identifier
- EFO:0009441
- Subject identifier
- D008258
- Condition
- Pulmonary Fibrosis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009448
- Subject identifier
- D011658
- Condition
- Central Nervous System Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000158
- Subject identifier
- D016543
- Condition
- Amyloidosis
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001875
- Subject identifier
- D000686
And 9 more, listed on the interactive page.
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000558
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000717
- Condition identifier
- EFO_0000768
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001378
- Condition identifier
- EFO_0002430
- Highest recorded phase
- 3
- Condition identifier
- EFO_0002939
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003895
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004244
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004251
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009441
- Highest recorded phase
- 1
- Condition identifier
- EFO_0009448
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000158
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001471
- Highest recorded phase
- 1
- Condition identifier
- EFO_1001968
- Highest recorded phase
- 2
- Condition identifier
- HP_0001891
- Condition identifier
- HP_0002239
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0000430
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0001325
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0001402
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0001528
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0002083
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002280
- Highest recorded phase
- 3
And 58 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Warning
- Black Box Warning
- Effect
- vascular toxicity
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- vascular toxicity
- Country
- United States
- Event
- condition aggravated
- Reports
- 44
- Reporting signal score
- 693.853
- Event
- drug interaction
- Reports
- 26
- Reporting signal score
- 616.574
- Event
- full blood count decreased
- Reports
- 1,049
- Reporting signal score
- 1,674.19
- Event
- injection site pain
- Reports
- 9
- Reporting signal score
- 667.887
- Event
- laboratory test abnormal
- Reports
- 902
- Reporting signal score
- 984.302
- Event
- neuropathy peripheral
- Reports
- 1,445
- Reporting signal score
- 951.132
- Event
- plasma cell myeloma
- Reports
- 2,229
- Reporting signal score
- 4,439.51
- Event
- pneumonia
- Reports
- 3,550
- Reporting signal score
- 2,252.23
- Event
- white blood cell count decreased
- Reports
- 2,038
- Reporting signal score
- 1,655.61
- NCT00072722
- NCT00463385
- NCT01178281
- NCT00482521
- NCT00537511
- NCT00540579
- NCT00558896
- NCT00833833
- NCT01053949
- NCT01159574
- NCT01166113
- NCT01177735
- NCT01212952
- NCT01311687
- NCT01319422
- NCT01324947
- NCT01421186
- NCT01432600
- NCT01464034
- NCT01497093
- NCT01522872
- NCT01537861
- NCT01541332
- NCT01562405
- NCT01568294
And 181 more, listed on the interactive page.
- Dose
- 4 mg
- Route
- Oral
- How often
- Once daily, Days 1 through 21 of each 28-day cycle
Conditions of use
- Take with or without food
- Hydrogen bond acceptors
- 5
- Hydrogen bond donors
- 2
- Polar surface area
- 109.57
- Calculated partition coefficient (ALogP)
- -0.33
- Calculated partition coefficient (XLogP)
- 0.2
- Prodrug
- No
- Chirality
- Racemic
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 1
- Heavy atoms
- 20
- Molecular formula
- C13H11N3O4
- Monoisotopic mass
- 273.07495584
- Natural product
- Yes
- 0480-2601
- 0480-4018
- 0480-4022
- 0480-4035
- 0781-2354
- 0781-2358
- 0781-2366
- 0781-2369
- 31722-770
- 31722-771
- 31722-772
- 31722-773
- 43598-517
- 43598-518
- 43598-519
- 43598-520
- 51991-342
- 51991-343
- 51991-344
- 51991-346
- 59572-501
- 59572-502
- 59572-503
- 59572-504
- 59651-194
And 15 more, listed on the interactive page.
- Recorded assays
- 729
- Active assays
- 97
- Confirmatory
- Screening
- Immunologic Factors
- Angiogenesis Inhibitors
These details could not be displayed.
Related records
Trials (281)
- 1454GCC: Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma
- A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
- 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
- A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing the Efficacy and Safety of F182112 Versus Standard of Care in Patients With Relapsed or Refractory Multiple Myeloma
- A Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
- A Phase 1 Open-Label Study to Evaluate the Effect of CYP450 and P-gp Inhibition and Induction on the Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
- A Phase 1 QT Study in Healthy Male Subjects
- A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma
- A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
- A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor
- A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study
- A Phase I/II Study to Determine the Maximum Tolerated Dose (MTD) and Safety of CC-4047 (Pomalidomide) Administered in Conjunction With Cisplatin and Etoposide
- A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis
- A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab
- A Phase II Study of Pomalidomide in Myelofibrosis With Myeloid Metaplasia
- A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
- A Pilot Bioequivalence Study of Pomalidomide
- A Pilot Bioequivalence Study of Pomalidomide
- A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma.
- A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Approved for (2)
In development for (32)
- Acquired polycythemia vera Phase 2
- AL amyloidosis Phase 2
- Amyloidosis Phase 2
- Bone marrow neoplasm Phase 2
- Burkitt lymphoma Phase 1
- Castleman disease Phase 1
- Central nervous system neoplasm Phase 2
- Diffuse large B-cell lymphoma Phase 2
- Exocrine pancreatic carcinoma Phase 1
- Graft versus host disease Phase 2
- Hereditary hemorrhagic telangiectasia Phase 2
- Hodgkins lymphoma Phase 1
- Interstitial lung disease Phase 2
- Kaposi's sarcoma Phase 2
- Lymphoma Phase 1
- Medulloblastoma Phase 2
- Myelofibrosis Phase 3
- Neoplasm Phase 1
- Non-Hodgkin lymphoma Phase 1
- Plasma cell leukemia Phase 2