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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Commercial
Therapeutic Areas
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 |
|---|---|---|---|---|---|
| Enjaymo | sutimlimab-jome | Bioverativ | N-761164 RX | 2022-02-04 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| enjaymo | Biologic Licensing Application | 2025-06-25 |
Indications
FDA
EMA
No data
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
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemolytic anemia autoimmune | D000744 | EFO_1001264 | D59.10 | 1 | — | 3 | — | — | 4 |
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 | N18.6 | 1 | — | — | — | — | 1 |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | 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 | DB14996 |
| 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
No data
Financial
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Enjaymo – 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 364 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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234 adverse events reported
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