Poteligeo(mogamulizumab)
Poteligeo (mogamulizumab) is an antibody pharmaceutical. Mogamulizumab was first approved as Poteligeo on 2018-08-08. It is used to treat mycosis fungoides and sezary syndrome in the USA. It has been approved in Europe to treat mycosis fungoides and sezary syndrome. The pharmaceutical is active against C-C chemokine receptor type 4.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Poteligeo
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)
Mogamulizumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Poteligeo | mogamulizumab-kpkc | Kyowa Kirin | N-761051 RX | 2018-08-08 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| poteligeo | Biologic Licensing Application | 2025-05-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| sezary syndrome | — | D012751 | C84.1 |
| mycosis fungoides | — | D009182 | C84.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
mogamulizumab, Poteligeo, Kyowa Kirin, Inc. | |||
| 2025-08-08 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9204 | Injection, mogamulizumab-kpkc, 1 mg |
Clinical
Clinical Trials
41 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 2 | 8 | 1 | — | 1 | 11 |
| T-cell lymphoma peripheral | D016411 | — | — | 2 | 6 | 1 | — | — | 8 |
| T-cell lymphoma | D016399 | — | — | 2 | 5 | 1 | — | — | 7 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | 1 | 2 | 1 | — | 1 | 5 |
| Tropical spastic paraparesis | D015493 | EFO_0007527 | G04.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 5 | 1 | — | — | — | 5 |
| Adult t-cell leukemia-lymphoma | D015459 | — | C91.5 | 1 | 3 | — | — | 1 | 5 |
| T-cell leukemia | D015458 | — | — | 1 | 2 | — | — | — | 3 |
| Carcinoma | D002277 | — | C80.0 | 2 | 1 | — | — | — | 2 |
| Leukemia | D007938 | — | C95 | — | 2 | — | — | — | 2 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | — | 1 | — | — | — | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | 1 | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | 1 | — | — | — | 1 |
| Extranodal nk-t-cell lymphoma | D054391 | — | C86.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mycosis fungoides | D009182 | — | C84.0 | 1 | — | — | — | 2 | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | — | — | — | — | 1 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | — | — | — | — | 1 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | — | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | — | — | — | 1 |
| Mouth neoplasms | D009062 | EFO_0003868 | C06.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sezary syndrome | D012751 | — | C84.1 | — | — | — | — | 2 | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | — | — | — | 1 | 1 |
| Mycoses | D009181 | — | B35-B49 | — | — | — | — | 1 | 1 |
| Syndrome | D013577 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Mogamulizumab |
| INN | mogamulizumab |
| Description | Mogamulizumab (humanized mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1743041 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12498 |
| UNII ID | YI437801BE (ChemIDplus, GSRS) |
Target
Agency Approved
CCR4
CCR4
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,658 adverse events reported
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