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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Commercial
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 |
|---|---|---|---|
| graft vs host disease | — | D006086 | D89.81 |
| multiple sclerosis | EFO_0003885 | D009103 | G35 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J7513 | Daclizumab, parenteral, 25 mg |
Clinical
Clinical Trials
74 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 | 5 | 5 | 1 | 12 | ||
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 1 | 2 | 2 | 5 |
| Graft vs host disease | D006086 | D89.81 | — | — | 2 | 1 | — | 3 | |
| Heart transplantation | D016027 | EFO_0010673 | 1 | 1 | — | 2 | — | 3 | |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | — | 1 | — | 2 |
| Immunosuppression therapy | D007165 | — | 1 | — | 1 | — | 2 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | 1 | — | 1 |
| Transplantation | D014180 | — | — | — | 1 | — | 1 | ||
| Adult t-cell leukemia-lymphoma | D015459 | C91.5 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 7 | 1 | — | — | 8 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 4 | 4 | — | — | 8 | |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 2 | 1 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Uveitis | D014605 | EFO_1001231 | H20.9 | 2 | 3 | — | — | — | 5 |
| Lymphoma | D008223 | C85.9 | 2 | 3 | — | — | — | 3 | |
| Hodgkin disease | D006689 | C81 | 2 | 2 | — | — | — | 2 | |
| Leukemia | D007938 | C95 | 1 | 2 | — | — | — | 2 | |
| Myelodysplastic syndromes | D009190 | D46 | — | 2 | — | — | — | 2 | |
| Psoriasis | D011565 | EFO_0000676 | L40 | 2 | 2 | — | — | — | 2 |
| T-cell leukemia | D015458 | 2 | 1 | — | — | — | 2 | ||
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | 1 | — | — | — | 1 |
| Choroidal neovascularization | D020256 | — | 1 | — | — | — | 1 | ||
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| T-cell lymphoma cutaneous | D016410 | C84.A | 1 | — | — | — | — | 1 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasmapheresis | D010956 | — | — | — | — | 1 | 1 |
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 | 152923-56-3 |
| RxCUI | 190353 |
| 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
Clinical Variant
No data
Financial
Zinbryta - Biogen
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,704 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,288 adverse events reported
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