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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Enjaymo
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 |
|---|---|---|
| enjaymo | Biologic Licensing Application | 2024-02-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hemolysis | — | D006461 | — |
| hemolytic anemia autoimmune | EFO_1001264 | D000744 | D59.12 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
sutimlimab, Enjaymo, Bioverativ Therapeutics, Inc. | |||
| 2029-02-04 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1302 | Injection, sutimlimab-jome, 10 mg |
Clinical
Clinical Trials
6 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hemolytic anemia autoimmune | D000744 | EFO_1001264 | D59.12 | 1 | — | 3 | — | 1 | 5 |
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 idiopathic | D016553 | EFO_0007160 | D69.3 | 1 | — | — | — | — | 1 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | 1 | — | — | — | — | 1 |
| Thrombocytopenic purpura | D011696 | — | — | 1 | — | — | — | — | 1 |
| Purpura | D011693 | HP_0000979 | D69.2 | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | 1 | — | — | — | — | 1 |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | 1 | — | — | — | — | 1 |
| Hemolytic anemia | D000743 | — | D55-D59 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sutimlimab |
| INN | sutimlimab |
| 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 class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297832 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | GNWE7KJ995 (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
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Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 271 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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