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
Therapeutic Areas
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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
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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
100 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 | 6 | 1 | 13 |
| Lymphoma | D008223 | — | C85.9 | 6 | 6 | — | 1 | 1 | 10 |
| Uveitis | D014605 | EFO_1001231 | H20.9 | 2 | 4 | — | 1 | 1 | 8 |
| Leukemia | D007938 | — | C95 | 3 | 3 | — | 1 | — | 6 |
| Graft vs host disease | D006086 | — | D89.81 | — | — | 4 | 1 | — | 5 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 1 | 2 | 2 | 5 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | — | 2 | — | 3 |
| Heart transplantation | D016027 | EFO_0010673 | — | 1 | 1 | — | 2 | — | 3 |
| Adult t-cell leukemia-lymphoma | D015459 | — | C91.5 | 2 | 1 | — | 1 | — | 3 |
| T-cell leukemia | D015458 | — | — | 2 | 1 | — | 1 | — | 3 |
Show 12 more
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 | 2 | 12 | 1 | — | — | 13 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | 6 | 4 | — | 1 | 12 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 1 | 4 | 4 | — | — | 9 |
| Sclerosis | D012598 | — | — | 1 | 2 | 2 | — | 1 | 6 |
| Hypoglycemia | D007003 | — | E16.2 | 1 | 4 | 1 | — | — | 5 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | 1 | 2 | — | — | 3 |
| Immune system diseases | D007154 | — | D89.9 | — | — | 1 | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hodgkin disease | D006689 | — | C81 | 3 | 4 | — | — | — | 4 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 2 | — | — | — | 3 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 2 | — | — | — | 2 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | 2 | — | — | — | 2 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 2 | — | — | — | 2 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | — | 2 | — | — | — | 2 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 1 | 2 | — | — | — | 2 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 2 | 2 | — | — | — | 2 |
| T-cell lymphoma | D016399 | — | — | 1 | 1 | — | — | — | 2 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | 1 | 1 | — | — | — | 2 |
Show 54 more
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 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
| Gliosarcoma | D018316 | — | — | 1 | — | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
| Drug therapy | D004358 | — | — | 1 | — | — | — | — | 1 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 1 | — | — | — | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasmapheresis | D010956 | — | — | — | — | — | — | 1 | 1 |
| Hereditary congenital and neonatal diseases and abnormalities | D009358 | — | — | — | — | — | — | 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 | — |
| 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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Estimated US medical usage
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,486 adverse events reported
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