Zenapax(daclizumab)
Zenapax, Zinbryta (daclizumab) is an antibody pharmaceutical. Daclizumab was first approved as Zenapax on 1997-12-10. It is used to treat graft vs host disease and multiple sclerosis in the USA. It has been approved in Europe to treat graft rejection, kidney transplantation, and multiple sclerosis. The pharmaceutical is active against interleukin-2 receptor subunit alpha.
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
No data
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)
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple sclerosis | EFO_0003885 | D009103 | G35 |
| graft vs host disease | — | D006086 | D89.81 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J7513 | Daclizumab, parenteral, 25 mg |
Clinical
Clinical Trials
99 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | — | — | 1 | 1 | 2 | 3 | — | 6 |
| Heart transplantation | D016027 | EFO_0010673 | — | 1 | 1 | — | 2 | — | 3 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | 2 | — | 2 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | 1 | — | 1 |
| Fibrosis | D005355 | — | — | — | — | — | 1 | — | 1 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | — | — | 1 | — | 1 |
| Transplantation | D014180 | — | — | — | — | — | 1 | — | 1 |
| Immunosuppression therapy | D007165 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 2 | — | — | — | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 2 | — | — | — | 2 |
| Hypoglycemia | D007003 | — | E16.2 | 1 | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Daclizumab |
| INN | daclizumab |
| Description | Daclizumab (humanized mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >3NFS:H|Light chain of Fab fragment of daclizumab
QVQLVQSGAEVKKPGSSVKVSCKASGYTFTSYRMHWVRQAPGQGLEWIGYINPSTGYTEYNQKFKDKATITADESTNTAY
MELSSLRSEDTAVYYCARGGGVFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSG
ALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEP
>3NFS:L|Heavy chain of Fab fragment of daclizumab
DIQMTQSPSTLSASVGDRVTITCSASSSISYMHWYQQKPGKAPKLLIYTTSNLASGVPARFSGSGSGTEFTLTISSLQPD
DFATYYCHQRSTYPLTFGQGTKVEVKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQE
SVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGE |
Identifiers
| PDB | 3NFP, 3NFS |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201605 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00111 |
| UNII ID | CUJ2MVI71Y (ChemIDplus, GSRS) |
Target
Agency Approved
IL2RA
IL2RA
Organism
Homo sapiens
Gene name
IL2RA
Gene synonyms
NCBI Gene ID
Protein name
interleukin-2 receptor subunit alpha
Protein synonyms
CD25, IL-2 receptor subunit alpha, IL-2R subunit alpha, interleukin 2 receptor, alpha, p55, TAC antigen
Uniprot ID
Mouse ortholog
Il2ra (16184)
interleukin-2 receptor subunit alpha (Q61731)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
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Zinbryta – Biogen
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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 4,178 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,478 adverse events reported
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