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Tysabri(natalizumab)
Tysabri (natalizumab) is an antibody pharmaceutical. Natalizumab was first approved as Tysabri on 2004-11-23. It is used to treat crohn disease and multiple sclerosis in the USA. It has been approved in Europe to treat multiple sclerosis. The pharmaceutical is active against integrin alpha-4.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
nervous system diseasesD009422
immune system diseasesD007154
Trade Name
FDA
EMA
Tysabri
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)
Natalizumab
Tradename
Proper name
Company
Number
Date
Products
TysabrinatalizumabBiogenN-125104 RX2004-11-23
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
tysabriBiologic Licensing Application2020-06-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
crohn diseaseEFO_0000384D003424K50
multiple sclerosisEFO_0003885D009103G35
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA23: Natalizumab
HCPCS
Code
Description
J2323
Injection, natalizumab, 1 mg
Clinical
Clinical Trials
87 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Relapsing-remitting multiple sclerosisD020529EFO_0003929257101236
Multiple sclerosisD009103EFO_0003885G3514291429
Crohn diseaseD003424EFO_0000384K50—23218
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic progressive multiple sclerosisD020528111——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rheumatoid arthritisD001172EFO_0000685M06.9—2———2
Ischemic strokeD000083242—2———2
EpilepsyD004827EFO_0000474G40.9—1———1
Graft vs host diseaseD006086D89.81—1———1
Multiple myelomaD009101C90.011———1
Demyelinating diseasesD003711—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F201————1
Inclusion body myositisD018979EFO_0007323G72.411————1
Sickle cell anemiaD000755EFO_0000697D571————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Progressive multifocal leukoencephalopathyD007968EFO_0007455A81.2————11
FatigueD005221HP_0012378R53.83————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNATALIZUMAB
INNnatalizumab
Description
Immunoglobulin G 4 (human-mouse monoclonal AN1002264-chain anti-human integrin 4), disulfide with human-mouse monoclonal AN100226 light chain, dimer
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)NATALIZUMAB
Structure (InChI/SMILES or Protein Sequence)
>6FG1:A|HEAVY CHAIN OF FAB NAA32 QVHLVQSGAEVKKPGASVKVSCKASGYTFTSYTMHWVRQAPGQRLEWMGWINAGHGTTKYSQKFQGRVTITRDTSASTAY MELSSLRSEDTAVYYCARPTSEGVAGPSRYYWYFDLWGRGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYF PEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTENLYF Q >6FG1:D|LIGHT CHAIN OF FAB NAA32 EIVMTQSPATLSVSPGERATLSCRASQSVSSNLAWYQQKPGQAPRLLIYGASTRATGIPARFSGSGSGTEFTLTISSLQS EDFAVYYCQQYNNWPPLTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNS QESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHEGLSSPVTKSFNRGEC >6FG1:H|HEAVY CHAIN OF FAB NATALIZUMAB QVQLVQSGAEVKKPGASVKVSCKASGFNIKDTYIHWVRQAPGQRLEWMGRIDPANGYTKYDPKFQGRVTITADTSASTAY MELSSLRSEDEAVYYCAREGYYGNYGVYAMDYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPV TVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPENLYFQ >6FG1:L|LIGHT CHAIN OF FAB NATALIZUMAB DIQMTQSPSSLSASVGDRVTITCKTSQDINKYMAWYQQTPGKAPRLLIHYTSALQPGIPSRFSGSGSGRDYTFTISSLQP EDIATYYCLQYDNLWTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQE SVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Identifiers
PDB4IRZ, 6FG1, 6FG2
CAS-ID189261-10-7
RxCUI354770
ChEMBL IDCHEMBL1201607
ChEBI ID—
PubChem CID—
DrugBankDB00108
UNII ID3JB47N2Q2P (ChemIDplus, GSRS)
Target
Agency Approved
ITGA4
ITGA4
Organism
Homo sapiens
Gene name
ITGA4
Gene synonyms
CD49D
NCBI Gene ID
3676
Protein name
integrin alpha-4
Protein synonyms
269C wild type, alpha 4 subunit of VLA-4 receptor, antigen CD49D, alpha-4 subunit of VLA-4 receptor, CD49 antigen-like family member D, CD49d, Integrin alpha-IV, very late activation protein 4 receptor, alpha 4 subunit, VLA-4 subunit alpha
Uniprot ID
Q7Z4L6
Mouse ortholog
Itga4 (16401)
integrin alpha-4 (Q00651)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Tysabri - Biogen
$
€
£
₣
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Tysabri - Elan Corporation
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,541 documents
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Safety
Black-box Warning
Black-box warning for: Tysabri
Adverse Events
Top Adverse Reactions
Mock data
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29,126 adverse events reported
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