Sylvant(siltuximab)
Sylvant (siltuximab) is an antibody pharmaceutical. Siltuximab was first approved as Sylvant on 2014-04-23. It is used to treat castleman disease in the USA. It has been approved in Europe to treat focal nodular hyperplasia. The pharmaceutical is active against interleukin-6.
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Commercial
Trade Name
FDA
EMA
Sylvant
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)
Siltuximab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Sylvant | siltuximab | EUSA Pharma | N-125496 RX | 2014-04-23 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| sylvant | Biologic Licensing Application | 2020-02-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| castleman disease | EFO_1001332 | D005871 | D47.Z2 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
siltuximab, Sylvant, EUSA Pharma (UK) Limited | |||
| 2121-04-23 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2860 | Injection, siltuximab, 10 mg |
Clinical
Clinical Trials
33 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 |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | C90.0 | 3 | 5 | 1 | — | — | 9 | |
| Covid-19 | D000086382 | U07.1 | — | 1 | 1 | — | — | 2 | |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | 1 | — | — | 1 |
| Respiratory tract infections | D012141 | J06.9 | — | — | 1 | — | — | 1 | |
| Respiratory tract diseases | D012140 | — | — | 1 | — | — | 1 | ||
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 1 | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | C61 | 1 | 2 | — | — | — | 3 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 2 | 1 | — | — | — | 3 | |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 2 | — | — | — | 2 |
| Colorectal neoplasms | D015179 | 1 | 1 | — | — | — | 1 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 1 |
| Head and neck neoplasms | D006258 | 1 | 1 | — | — | — | 1 | ||
| Lung neoplasms | D008175 | C34.90 | 1 | 1 | — | — | — | 1 | |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | 1 | — | — | — | 1 | ||
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | 1 | — | — | — | 1 |
| Psychotic disorders | D011618 | F20.81 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Polycythemia vera | D011087 | D45 | 1 | — | — | — | — | 1 | |
| Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 | |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | 1 | — | — | — | — | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Plasma cell neoplasms | D054219 | 1 | — | — | — | — | 1 | ||
| Monoclonal gammopathy of undetermined significance | D008998 | D47.2 | 1 | — | — | — | — | 1 | |
| Castleman disease | D005871 | EFO_1001332 | D47.Z2 | 1 | — | — | — | — | 1 |
| Large granular lymphocytic leukemia | D054066 | 1 | — | — | — | — | 1 | ||
| Myeloid leukemia acute | D015470 | C92.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SILTUXIMAB |
| INN | siltuximab |
| Description | Siltuximab (chimeric mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 541502-14-1 |
| RxCUI | 1535218 |
| ChEMBL ID | CHEMBL1743070 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09036 |
| UNII ID | T4H8FMA7IM (ChemIDplus, GSRS) |
Target
Agency Approved
IL6
IL6
Organism
Homo sapiens
Gene name
IL6
Gene synonyms
IFNB2
NCBI Gene ID
Protein name
interleukin-6
Protein synonyms
B-cell differentiation factor, B-cell stimulatory factor 2, BSF-2, CDF, CTL differentiation factor, Hybridoma growth factor, IFN-beta-2, Interferon beta-2, interleukin BSF-2
Uniprot ID
Mouse ortholog
Il6 (16193)
interleukin-6 (P08505)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,589 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,121 adverse events reported
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