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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Tyruko, Tysabri
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tysabri | Biologic Licensing Application | 2025-03-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple sclerosis | EFO_0003885 | D009103 | G35 |
| crohn disease | EFO_0000384 | D003424 | K50 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2323 | Injection, natalizumab, 1 mg |
Clinical
Clinical Trials
149 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 sclerosis | D009103 | EFO_0003885 | G35 | 2 | 5 | 7 | 5 | 25 | 43 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 2 | 5 | 8 | 8 | 15 | 38 |
| Sclerosis | D012598 | — | — | 1 | 1 | — | 1 | 9 | 12 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 2 | 3 | 2 | 2 | 9 |
| Progressive multifocal leukoencephalopathy | D007968 | EFO_0007455 | A81.2 | — | — | — | 1 | 4 | 5 |
| Leukoencephalopathies | D056784 | — | R90.82 | — | — | — | 1 | 2 | 3 |
| Syndrome | D013577 | — | — | — | — | — | 1 | — | 1 |
| Immune reconstitution inflammatory syndrome | D054019 | — | D89.3 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | 1 | 1 | 1 | — | — | 3 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | 1 | — | — | 1 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | 1 | — | — | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | 1 | 1 | — | — | 2 | 3 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 2 | — | — | — | 2 |
| Ischemic stroke | D000083242 | — | — | — | 2 | — | — | — | 2 |
| Graft vs host disease | D006086 | — | D89.81 | — | 2 | — | — | — | 2 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 1 | — | — | — | 1 |
| Seizures | D012640 | — | G40.4 | — | 1 | — | — | — | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 1 | — | — | — | 1 |
| Immune system diseases | D007154 | — | D89.9 | — | 1 | — | — | — | 1 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatigue | D005221 | — | R53.83 | — | — | — | — | 2 | 2 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | — | — | 1 | 1 |
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Prenatal exposure delayed effects | D011297 | — | — | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Natalizumab |
| INN | natalizumab |
| 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 class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| 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
| PDB | 4IRZ, 6FG1, 6FG2 |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201607 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00108 |
| UNII ID | 3JB47N2Q2P (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
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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 12,187 documents
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Safety
Black-box Warning
Black-box warning for: Tysabri
Adverse Events
Top Adverse Reactions
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208,478 adverse events reported
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