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Drug ReportsNatalizumab
Tysabri(natalizumab)
Tyruko, 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 and relapsing-remitting multiple sclerosis. The pharmaceutical is active against integrin alpha-4.
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Target
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Events Timeline
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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
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
nervous system diseasesD009422
immune system diseasesD007154
Trade Name
FDA
EMA
Tyruko, 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 Application2024-10-24
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
148 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_0003885G35412142670124
SclerosisD012598410142360109
Relapsing-remitting multiple sclerosisD020529EFO_00039292511132859
Crohn diseaseD003424EFO_0000384K5023229
LeukoencephalopathiesD056784HP_0002352145
Progressive multifocal leukoencephalopathyD007968EFO_0007455A81.2145
SleepinessD000077260R40.011
SyndromeD01357711
Immune reconstitution inflammatory syndromeD05401911
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic progressive multiple sclerosisD020528EFO_00038401124
Neoplasm metastasisD009362EFO_000970811
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rheumatoid arthritisD001172EFO_0000685M06.922
ArthritisD001168HP_0001369M05-M1422
Ischemic strokeD00008324222
StrokeD020521EFO_0000712I63.922
IschemiaD007511EFO_000055622
Cerebral infarctionD002544I6322
Graft vs host diseaseD006086D89.8122
Demyelinating diseasesD003711112
OsteosarcomaD012516111
EpilepsyD004827EFO_0000474G40.911
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F2011
MyositisD009220EFO_0000783G72.4911
Inclusion body myositisD018979EFO_0007323G72.4111
Sickle cell anemiaD000755EFO_0000697D5711
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FatigueD005221HP_0012378R53.8333
AtrophyD00128422
Inflammatory bowel diseasesD015212EFO_000376711
Squamous intraepithelial lesionsD00008148311
Cognitive dysfunctionD060825HP_0001268G31.8411
Nerve degenerationD009410HP_000218011
RecurrenceD01200811
AggressionD000374EFO_000301511
Prenatal exposure delayed effectsD01129711
PregnancyD011247EFO_0002950Z33.111
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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)Loading
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-ID
RxCUI
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
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
Mouse ortholog
Itga4 (16401)
integrin alpha-4 (Q00651)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
Tysabri Biogen
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Tysabri Elan Corporation
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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 11,093 documents
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Safety
Black-box Warning
Black-box warning for: Tysabri
Adverse Events
Top Adverse Reactions
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203,204 adverse events reported
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