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Sarclisa(isatuximab)
Sarclisa (isatuximab) is an antibody pharmaceutical. Isatuximab was first approved as Sarclisa on 2020-03-02. It is used to treat multiple myeloma in the USA. It has been approved in Europe to treat multiple myeloma. The pharmaceutical is active against ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Sarclisa
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)
Isatuximab
Tradename
Proper name
Company
Number
Date
Products
Sarclisaisatuximab-irfcSanofiN-761113 RX2020-03-02
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
sarclisaBiologic Licensing Application2021-03-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
multiple myeloma—D009101C90.0
Agency Specific
FDA
EMA
Expiration
Code
isatuximab, Sarclisa, Sanofi-Aventis U.S. LLC
2028-03-31Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FC: Cd38 (clusters of differentiation 38) inhibitors
— L01FC02: Isatuximab
HCPCS
Code
Description
J9227
Injection, isatuximab-irfc, 10 mg
Clinical
Clinical Trials
75 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 myelomaD009101C90.0163011—151
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8014———4
Immunoglobulin light-chain amyloidosisD00007536312———3
LymphomaD008223C85.922———3
ParaproteinemiasD010265D47.2—3———3
Myeloid leukemia acuteD015470C92.011———2
Hematologic neoplasmsD01933721———2
Renal insufficiencyD051437HP_0000083N19—2———2
Hematologic diseasesD006402EFO_0005803D75.9—2———2
Blood protein disordersD001796—2———2
Plasma cell neoplasmsD054219—2———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Large b-cell lymphoma diffuseD016403C83.31————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameISATUXIMAB
INNisatuximab
Description
Isatuximab, sold under the brand name Sarclisa, is a monoclonal antibody (mAb) medication for the treatment of multiple myeloma.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL3545131
ChEBI ID—
PubChem CID—
DrugBankDB14811
UNII IDR30772KCU0 (ChemIDplus, GSRS)
Target
Agency Approved
CD38
CD38
Organism
Homo sapiens
Gene name
CD38
Gene synonyms
NCBI Gene ID
952
Protein name
ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1
Protein synonyms
2'-phospho-ADP-ribosyl cyclase, 2'-phospho-ADP-ribosyl cyclase/2'-phospho-cyclic-ADP-ribose transferase, 2'-phospho-cyclic-ADP-ribose transferase, ADP-ribosyl cyclase 1, ADPRC 1, cADPR hydrolase 1, CD38, CD38 antigen (p45), cluster of differentiation 38, Cyclic ADP-ribose hydrolase 1, ecto-nicotinamide adenine dinucleotide glycohydrolase, NAD(+) nucleosidase, T10
Uniprot ID
Q96HY4
Mouse ortholog
Cd38 (12494)
ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 (Q8BFY8)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 969 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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6,518 adverse events reported
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