Denileukin diftitox
Ontak (denileukin diftitox) is a protein pharmaceutical. Denileukin diftitox was first approved as Ontak on 1999-02-05.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
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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)
Denileukin diftitox
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Ontak | denileukin diftitox | Eisai | N-103767 DISCN | 1999-02-05 | 1 products |
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FDA
EMA
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Indications
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EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
denileukin diftitox, Ontak, Eisai, Incorporated | |||
| 2106-02-05 | Orphan excl. | ||
Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J9160 | Injection, denileukin diftitox, 300 micrograms |
Clinical
Clinical Trials
10 clinical trials
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Indications Phases 4
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Staphylococcal skin infections | D013207 | EFO_1001849 | L00 | — | 1 | — | — | — | 1 |
| Bacterial skin diseases | D017192 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | 1 | — | — | — | — | 1 | ||
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DENILEUKIN DIFTITOX |
| INN | denileukin diftitox |
| Description | Ontak (denileukin diftitox) is a protein pharmaceutical. Denileukin diftitox was first approved as Ontak on 1999-02-05. |
| Classification | Protein |
| Drug class | interleukins: interleukin-2 analogues and derivatives |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201550 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | 25E79B5CTM (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 1,226 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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211 adverse events reported
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