Enspryng(satralizumab)
Enspryng (satralizumab) is an antibody pharmaceutical. Satralizumab was first approved as Enspryng on 2020-08-14. It is used to treat neuromyelitis optica in the USA. It has been approved in Europe to treat neuromyelitis optica.
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Commercial
Trade Name
FDA
EMA
Enspryng
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)
Satralizumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Enspryng | satralizumab-mwge | Genentech | N-761149 RX | 2020-08-14 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| enspryng | Biologic Licensing Application | 2020-08-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| neuromyelitis optica | EFO_0004256 | D009471 | G36.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
satralizumab, Enspryng, Genentech, Inc. | |||
| 2027-08-14 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
10 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | — | — | 4 | 1 | — | 5 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | — | 1 | — | — | 1 |
| Autoimmune diseases of the nervous system | D020274 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary arterial hypertension | D000081029 | — | 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 name | SATRALIZUMAB |
| INN | satralizumab |
| Description | Satralizumab, sold under the brand name Enspryng, is a humanized monoclonal antibody medication that is used for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disease. The drug is being developed by Chugai Pharmaceutical, a subsidiary of Roche.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1535963-91-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3833307 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15762 |
| UNII ID | YB18NF020M (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
No data
Financial
Enspryng - Roche
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€
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 331 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,259 adverse events reported
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