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 approval date
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Completion date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Sarclisa
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| sarclisa | Biologic Licensing Application | 2025-06-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple myeloma | — | D009101 | C90.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
isatuximab, Sarclisa, Sanofi-Aventis U.S. LLC | |||
| 2028-03-31 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9227 | Injection, isatuximab-irfc, 10 mg |
Clinical
Clinical Trials
95 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 13 | 24 | 11 | — | 3 | 48 |
| Plasma cell neoplasms | D054219 | — | — | 11 | 17 | 9 | — | 3 | 37 |
| Smoldering multiple myeloma | D000075122 | — | — | — | 1 | 1 | — | — | 2 |
| Residual neoplasm | D018365 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 2 | 6 | — | — | — | 6 |
| Lymphoma | D008223 | — | C85.9 | 1 | 4 | — | — | — | 4 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | — | 3 | — | — | — | 3 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | 1 | 2 | — | — | — | 3 |
| Paraproteinemias | D010265 | — | D47.2 | — | 3 | — | — | — | 3 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | 1 | 1 | — | — | — | 2 |
| Recurrence | D012008 | — | — | 1 | 1 | — | — | — | 2 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | — | 2 | — | — | — | 2 |
| Hematologic neoplasms | D019337 | — | — | 1 | 2 | — | — | — | 2 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Isatuximab |
| INN | isatuximab |
| Description | Isatuximab, sold under the brand name Sarclisa, is a monoclonal antibody (mAb) medication for the treatment of multiple myeloma.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3545131 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14811 |
| UNII ID | R30772KCU0 (ChemIDplus, GSRS) |
Target
Agency Approved
CD38
CD38
Organism
Homo sapiens
Gene name
CD38
Gene synonyms
NCBI Gene ID
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
Mouse ortholog
Cd38 (12494)
ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 (Q8BFY8)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Sarclisa – Sanofi
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,964 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,843 adverse events reported
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