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Drug ReportsOfatumumab
Arzerra(ofatumumab)
Kesimpta (ofatumumab) is an antibody pharmaceutical. Ofatumumab was first approved as Arzerra on 2009-10-26. It is used to treat lymphoid leukemia in the USA. It has been approved in Europe to treat b-cell chronic lymphocytic leukemia and relapsing-remitting multiple sclerosis. The pharmaceutical is active against B-lymphocyte antigen CD20.
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Novartis Pharmaceuticals
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
nervous system diseasesD009422
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Kesimpta (discontinued: Kesimpta)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Ofatumumab
Tradename
Proper name
Company
Number
Date
Products
KesimptaofatumumabNovartisN-125326 RX2020-08-20
1 products
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
arzerraBiologic Licensing Application2024-06-26
kesimptaBiologic Licensing Application2024-04-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
lymphoid leukemiaD007945C91
Agency Specific
FDA
EMA
Expiration
Code
ofatumumab, Arzerra, Novartis Pharmaceuticals Corporation
2123-01-19Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01F: Monoclonal antibodies and antibody drug conjugates
L01FA: Cd20 (clusters of differentiation 20) inhibitors
L01FA02: Ofatumumab
L04: Immunosuppressants
L04A: Immunosuppressants
L04AA: Selective immunosuppressants
L04AA52: Ofatumumab
HCPCS
Code
Description
J9302
Injection, ofatumumab, 10 mg
Clinical
Clinical Trials
186 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple sclerosisD009103EFO_0003885G352983352
SclerosisD0125982982948
Relapsing-remitting multiple sclerosisD020529EFO_00039291661124
Covid-19D000086382U07.1112
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell chronic lymphocytic leukemiaD015451C91.136413
LeukemiaD007938C9535412
Lymphoid leukemiaD007945C9135412
LymphomaD008223C85.955211
Non-hodgkin lymphomaD008228C85.94317
B-cell lymphomaD0163932215
PemphigusD010392EFO_1000749L1011
Follicular lymphomaD008224C8211
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Large b-cell lymphoma diffuseD016403C83.311
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD01200811
NeoplasmsD009369C8011
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neoplasm metastasisD009362EFO_000970811
Chronic progressive multiple sclerosisD020528EFO_000384011
PregnancyD011247EFO_0002950Z33.111
DiseaseD004194EFO_0000408R6911
Healthy volunteers/patients11
Optical coherence tomographyD04162311
Retinal degenerationD01216211
Visual acuityD01479211
AtrophyD00128411
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOfatumumab
INNofatumumab
Description
Immunoglobulin G1, anti-(human CD20 (antigen))(human monoclonal HuMax-CD20 heavy chain), disulfide with human monoclonal HuMax-CD20 kappa-chain, dimer
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
>3GIZ:H|Fab fragment of anti-CD20 antibody Ofatumumab, heavy chain EVQLVESGGGLVQPGRSLRLSCAASGFTFNDYAMHWVRQAPGKGLEWVSTISWNSGSIGYADSVKGRFTISRDNAKKSLY LQMNSLRAEDTALYYCAKDIQYGNYYYGMDVWGQGTTVTVSSASTKGPSVFPLAPGSSKSTSGTAALGCLVKDYFPEPVT VSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEP >3GIZ:L|Fab fragment of anti-CD20 antibody Ofatumumab, light chain EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPARFSGSGSGTDFTLTISSLEP EDFAVYYCQQRSNWPITFGQGTRLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNR
Identifiers
PDB3GIZ, 6Y92
CAS-ID
RxCUI
ChEMBL IDCHEMBL1201836
ChEBI ID
PubChem CID
DrugBankDB06650
UNII IDM95KG522R0 (ChemIDplus, GSRS)
Target
Agency Approved
MS4A1
MS4A1
Organism
Homo sapiens
Gene name
MS4A1
Gene synonyms
CD20
NCBI Gene ID
Protein name
B-lymphocyte antigen CD20
Protein synonyms
B-lymphocyte cell-surface antigen B1, B-lymphocyte surface antigen B1, Bp35, CD20, CD20 antigen, CD20 receptor, Leukocyte surface antigen Leu-16, Membrane-spanning 4-domains subfamily A member 1, membrane-spanning 4-domains, subfamily A, member 1
Uniprot ID
Mouse ortholog
Ms4a1 (12482)
B-lymphocyte antigen CD20 (P19437)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
Kesimpta Novartis
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,529 documents
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Safety
Black-box Warning
Black-box warning for: Arzerra
Adverse Events
Top Adverse Reactions
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30,915 adverse events reported
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