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Drug ReportsSutimlimab
Enjaymo(sutimlimab)
Enjaymo (sutimlimab) is an antibody pharmaceutical. Sutimlimab was first approved as Enjaymo on 2022-02-04. It has been approved in Europe to treat hemolysis and hemolytic anemia autoimmune. The pharmaceutical is active against complement C1s subcomponent.
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YTD
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
immune system phenomenaD055633
Trade Name
FDA
EMA
Enjaymo
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)
Sutimlimab
Tradename
Proper name
Company
Number
Date
Products
Enjaymosutimlimab-jomeBioverativN-761164 RX2022-02-04
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
enjaymoBiologic Licensing Application2024-02-21
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
sutimlimab, Enjaymo, Bioverativ Therapeutics, Inc.
2029-02-04Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA55: Sutimlimab
HCPCS
Code
Description
J1302
Injection, sutimlimab-jome, 10 mg
Clinical
Clinical Trials
6 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
Hemolytic anemia autoimmuneD000744EFO_1001264D59.121—3—15
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.31————1
ThrombocytopeniaD013921HP_0001873D69.61————1
Thrombocytopenic purpuraD011696——1————1
PurpuraD011693HP_0000979D69.21————1
Chronic kidney failureD007676EFO_0003884N18.91————1
Bullous pemphigoidD010391EFO_0007187L121————1
Hemolytic anemiaD000743—D55-D591————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSutimlimab
INNsutimlimab
Description
Sutimlimab, sold under the brand name Enjaymo, is a monoclonal antibody that is used to treat adults with cold agglutinin disease (CAD). It is given by intravenous infusion. Sutimlimab prevents complement-enhanced activation of autoimmune human B cells in vitro.
Classification
Antibody
Drug classmonoclonal antibodies
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4297832
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDGNWE7KJ995 (ChemIDplus, GSRS)
Target
Agency Approved
C1S
C1S
Organism
Homo sapiens
Gene name
C1S
Gene synonyms
NCBI Gene ID
Protein name
complement C1s subcomponent
Protein synonyms
basic proline-rich peptide IB-1, C1 esterase, Complement component 1 subcomponent s, complement component 1, s subcomponent
Uniprot ID
Mouse ortholog
C1s2 (317677)
complement C1s-1 subcomponent (Q8CFG8)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 285 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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118 adverse events reported
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