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Drug ReportsMogamulizumab
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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Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
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
Poteligeomogamulizumab-kpkcKyowa KirinN-761051 RX2018-08-08
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
poteligeoBiologic Licensing Application2023-04-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sezary syndrome—D012751C84.1
mycosis fungoides—D009182C84.0
Agency Specific
FDA
EMA
Expiration
Code
mogamulizumab, Poteligeo, Kyowa Kirin, Inc.
2025-08-08Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FX: Other monoclonal antibodies and antibody drug conjugates in atc
— L01FX09: Mogamulizumab
HCPCS
Code
Description
J9204
Injection, mogamulizumab-kpkc, 1 mg
Clinical
Clinical Trials
38 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
T-cell lymphoma cutaneousD016410——3611212
MycosesD009181—B35-B4955—1211
Mycosis fungoidesD009182—C84.055—1211
Sezary syndromeD012751—C84.135—129
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.95131—219
T-cell lymphomaD016399——591—114
T-cell lymphoma peripheralD016411——381—112
Bone marrow diseasesD001855————1——1
Spinal cord diseasesD013118HP_0002196G95.9——1——1
Tropical spastic paraparesisD015493EFO_0007527G04.1——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8072———7
Adult t-cell leukemia-lymphomaD015459—C91.533——17
T-cell leukemiaD015458——33———6
SyndromeD013577——34——16
LeukemiaD007938—C9523———5
RecurrenceD012008——42———4
Non-hodgkin lymphomaD008228—C85.921———2
CarcinomaD002277—C80.021———2
Large b-cell lymphoma diffuseD016403—C83.311———1
B-cell lymphomaD016393——11———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung neoplasmsD008175HP_0100526C34.902————2
Non-small-cell lung carcinomaD002289——1————1
Stomach neoplasmsD013274EFO_0003897C161————1
Esophageal neoplasmsD004938—C151————1
Kidney neoplasmsD007680EFO_0003865C641————1
Mouth neoplasmsD009062EFO_0003868C06.91————1
AsthmaD001249EFO_0000270J451————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GlioblastomaD005909EFO_0000515—————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMogamulizumab
INNmogamulizumab
Description
Mogamulizumab (humanized mab)
Classification
Antibody
Drug classmonoclonal antibodies
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1743041
ChEBI ID—
PubChem CID—
DrugBankDB12498
UNII IDYI437801BE (ChemIDplus, GSRS)
Target
Agency Approved
CCR4
CCR4
Organism
Homo sapiens
Gene name
CCR4
Gene synonyms
CMKBR4
NCBI Gene ID
Protein name
C-C chemokine receptor type 4
Protein synonyms
C-C CKR-4, CCR-4, CD194, chemokine (C-C motif) receptor 4, chemokine (C-C) receptor 4, K5-5
Uniprot ID
Mouse ortholog
Ccr4 (12773)
C-C chemokine receptor type 4 (Q14A03)
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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1,422 adverse events reported
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