Denileukin diftitox
Lymphir (denileukin diftitox) is a protein pharmaceutical. Denileukin diftitox was first approved as Ontak on 1999-02-05.
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Commercial
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Trade Name
FDA
EMA
Lymphir (discontinued: Ontak)
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 |
|---|---|---|---|---|---|
| Lymphir | denileukin diftitox-cxdl | Citius Pharmaceuticals | N-761312 RX | 2024-08-07 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lymphir | Biologic Licensing Application | 2025-01-23 |
Indications
FDA
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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Clinical
Clinical Trials
54 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 1 | 8 | 1 | 3 | 2 | 15 |
| T-cell lymphoma peripheral | D016411 | — | — | 1 | 4 | 2 | 1 | 2 | 10 |
| T-cell lymphoma | D016399 | — | — | 1 | 1 | 1 | 3 | 2 | 8 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | — | 1 | 1 | 3 | 3 | 8 |
| Sezary syndrome | D012751 | — | C84.1 | — | — | — | 2 | 2 | 4 |
| Mycosis fungoides | D009182 | — | C84.0 | — | — | — | 2 | 2 | 4 |
| Mycoses | D009181 | — | B35-B49 | — | — | — | 2 | 1 | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | 1 | — | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | 3 | 9 | — | — | — | 9 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 6 | — | — | — | 6 |
| Leukemia | D007938 | — | C95 | — | 6 | — | — | — | 6 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 3 | 3 | — | — | — | 5 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | 3 | — | — | — | 4 |
| Carcinoma | D002277 | — | C80.0 | 1 | 2 | — | — | — | 3 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 2 | — | — | — | 3 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | 2 | — | — | — | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 1 | — | — | — | 3 |
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | — | 1 | — | — | 1 | 2 |
Show 23 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | — | C34.90 | 2 | — | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | 1 | 2 |
| Endometrioid carcinoma | D018269 | — | — | 1 | — | — | — | — | 1 |
| Mucinous cystadenocarcinoma | D018282 | — | — | 1 | — | — | — | — | 1 |
| Serous cystadenocarcinoma | D018284 | — | — | 1 | — | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | 1 | — | — | — | — | 1 |
| Cystadenocarcinoma | D003536 | — | — | 1 | — | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Germ cell and embryonal neoplasms | D009373 | — | — | 1 | — | — | — | — | 1 |
| Germinoma | D018237 | — | — | 1 | — | — | — | — | 1 |
Show 4 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Extranodal nk-t-cell lymphoma | D054391 | — | C86.0 | — | — | — | — | 1 | 1 |
| Immunoblastic lymphadenopathy | D007119 | EFO_1001350 | C86.5 | — | — | — | — | 1 | 1 |
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 | DB00004 |
| UNII ID | 25E79B5CTM (ChemIDplus, GSRS) |
Target
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Safety
Black-box Warning
Black-box warning for: Lymphir
Adverse Events
Top Adverse Reactions
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276 adverse events reported
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