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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Study first post date
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Start date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Sarclisa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| sarclisa | Biologic Licensing Application | 2023-11-13 |
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
82 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 | 16 | 32 | 13 | — | 3 | 58 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 4 | — | — | — | 4 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | 1 | 2 | — | — | — | 3 |
| Lymphoma | D008223 | — | C85.9 | 2 | 2 | — | — | — | 3 |
| Paraproteinemias | D010265 | — | D47.2 | — | 3 | — | — | — | 3 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | 1 | — | — | — | 2 |
| Hematologic neoplasms | D019337 | — | — | 2 | 1 | — | — | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 2 | — | — | — | 2 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | 2 | — | — | — | 2 |
| Blood protein disorders | D001796 | — | — | — | 2 | — | — | — | 2 |
| Plasma cell neoplasms | D054219 | — | — | — | 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 diffuse | D016403 | — | C83.3 | 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
No data
Trends
PubMed Central
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Additional graphs summarizing 1,347 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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921 adverse events reported
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