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
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 |
|---|---|---|---|---|---|
| Gamifant | emapalumab-lzsg | Orphan Medical | N-761107 RX | 2018-11-20 | 3 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gamifant | Biologic Licensing Application | 2024-10-04 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hemophagocytic lymphohistiocytosis | — | D051359 | D76.1 |
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 | 5 | 1 | — | 7 |
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 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | 1 | — | — | 1 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graft rejection | D006084 | — | — | — | 1 | — | — | — | 1 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | 1 | — | — | — | 1 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Adult-onset still's disease | D016706 | EFO_0007135 | M06.1 | — | 1 | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | — | 1 | — | — | — | 1 |
| Follicular lymphoma | D008224 | — | C82 | — | 1 | — | — | — | 1 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | — | 1 | — | — | — | 1 |
| B-cell lymphoma | D016393 | — | — | — | 1 | — | — | — | 1 |
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 |
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
No data
Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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233 adverse events reported
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