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 diseases | D006425 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gamifant | Biologic Licensing Application | 2024-10-04 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
emapalumab, Gamifant, Swedish Orphan Biovitrum AB (publ) | |||
| 2025-11-20 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9210 | Injection, emapalumab-lzsg, 1 mg |
Clinical
Clinical Trials
22 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemophagocytic lymphohistiocytosis | D051359 | — | D76.1 | — | 4 | 6 | 2 | 1 | 10 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Macrophage activation syndrome | D055501 | EFO_1001806 | — | — | 1 | 1 | — | — | 2 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 1 | — | — | 1 |
| Sars-cov-2 | D000086402 | — | — | — | 1 | 1 | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | 1 | — | — | 1 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | 1 | — | — | 1 |
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | — | — | 1 | — | — | 1 |
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | HP_0001903 | D64.9 | — | 2 | — | — | — | 2 |
| Pancytopenia | D010198 | HP_0001876 | D61.81 | — | 2 | — | — | — | 2 |
| Cytopenia | D000095542 | — | — | — | 2 | — | — | — | 2 |
| Graft rejection | D006084 | — | — | — | 1 | — | — | — | 1 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | 1 | — | — | — | 1 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Adult-onset still's disease | D016706 | EFO_0007135 | M06.1 | — | 1 | — | — | — | 1 |
| Granuloma | D006099 | — | — | 1 | 1 | — | — | — | 1 |
| Chronic granulomatous disease | D006105 | EFO_0000338 | D71 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rare diseases | D035583 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Emapalumab |
| INN | elenbecestat |
| 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 class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1709815-23-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3989977 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14724 |
| UNII ID | RXJ96XL94H (ChemIDplus, GSRS) |
Target
Variants
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Financial
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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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198 adverse events reported
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