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Emapalumab
Gamifant (emapalumab) is an antibody pharmaceutical. Emapalumab was first approved as Gamifant on 2018-11-20. It is used to treat hemophagocytic lymphohistiocytosis in the USA. The pharmaceutical is active against interferon gamma.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
Trade Name
FDA
EMA
Gamifant
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)
Emapalumab
Tradename
Proper name
Company
Number
Date
Products
Gamifantemapalumab-lzsgSwedish Orphan Biovitrum AB (publ)N-761107 RX2018-11-20
3 products
Labels
FDA
EMA
Brand Name
Status
Last Update
gamifantBiologic Licensing Application2020-06-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hemophagocytic lymphohistiocytosis—D051359D76.1
Agency Specific
FDA
EMA
Expiration
Code
emapalumab, Gamifant, Swedish Orphan Biovitrum AB (publ)
2025-11-20Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA39: Emapalumab
HCPCS
Code
Description
J9210
Injection, emapalumab-lzsg, 1 mg
Clinical
Clinical Trials
9 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Irritable bowel syndromeD043183EFO_0000555K58—232—7
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DiarrheaD003967HP_0002014R19.7—21——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urge urinary incontinenceD053202EFO_0006865N39.41—1———1
Fecal incontinenceD005242R15—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEMAPALUMAB
INNelenbecestat
Description
Emapalumab, sold under the brand name Gamifant, is an anti-interferon-gamma (IFNγ) antibody medication used for the treatment of hemophagocytic lymphohistiocytosis (HLH), which has no cure.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1709815-23-5
RxCUI—
ChEMBL IDCHEMBL3989977
ChEBI ID—
PubChem CID—
DrugBankDB14724
UNII IDRXJ96XL94H (ChemIDplus, GSRS)
Target
Agency Approved
IFNG
IFNG
Organism
Homo sapiens
Gene name
IFNG
Gene synonyms
NCBI Gene ID
3458
Protein name
interferon gamma
Protein synonyms
IFN-gamma, Immune interferon
Uniprot ID
Q53ZV4
Mouse ortholog
Ifng (15978)
interferon gamma (Q542B8)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 698 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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2,128 adverse events reported
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