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Drug ReportsSatralizumab
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
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
eye diseasesD005128
immune system diseasesD007154
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
Enspryngsatralizumab-mwgeGenentechN-761149 RX2020-08-14
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
enspryngBiologic Licensing Application2023-07-12
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
satralizumab, Enspryng, Genentech, Inc.
2027-08-14Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AC: Interleukin inhibitors
— L04AC19: Satralizumab
HCPCS
No data
Clinical
Clinical Trials
15 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 opticaD009471EFO_0004256G36.0——41—5
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Graves ophthalmopathyD049970EFO_1001466———2——2
Eye diseasesD005128EFO_0003966H44——2——2
Thyroid diseasesD013959HP_0000820E00-E07——2——2
Myasthenia gravisD009157EFO_0004991G70.0——1——1
Muscle weaknessD018908HP_0001324———1——1
Autoimmune diseases of the nervous systemD020274————1——1
Hashimoto diseaseD050031EFO_0003779E06.3——1——1
EncephalitisD004660HP_0002383———1——1
Partial epilepsiesD004828EFO_0004263———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Muscular dystrophiesD009136HP_0003560G71.0—2———2
HypertensionD006973EFO_0000537I10—1———1
Pulmonary arterial hypertensionD000081029———1———1
Familial primary pulmonary hypertensionD065627—I27.0—1———1
Facioscapulohumeral muscular dystrophyD020391EFO_0000491G71.02—1———1
Duchenne muscular dystrophyD020388EFO_0000429——1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HemorrhageD006470MP_0001914R581————1
Subarachnoid hemorrhageD013345EFO_0000713I601————1
Cerebral infarctionD002544—I631————1
Brain ischemiaD002545EFO_0003883I67.821————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Demyelinating diseasesD003711——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSatralizumab
INNsatralizumab
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 classmonoclonal antibodies
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1535963-91-7
RxCUI—
ChEMBL IDCHEMBL3833307
ChEBI ID—
PubChem CID—
DrugBankDB15762
UNII IDYB18NF020M (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Enspryng – Roche
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 528 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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741 adverse events reported
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