Fetroja, Fetcroja(cefiderocol)
Fetcroja, Fetroja (cefiderocol) is a small molecule pharmaceutical. Cefiderocol was first approved as Fetroja on 2019-11-14. It is used to treat bacterial infections, pyelonephritis, and urinary tract infections in the USA. It has been approved in Europe to treat gram-negative bacterial infections.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
infections | D007239 |
urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Fetroja
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cefiderocol sulfate tosylate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
FETROJA | Shionogi | N-209445 RX | 2019-11-14 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
fetroja | New Drug Application | 2020-09-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
bacterial infections | — | D001424 | A49 |
pyelonephritis | EFO_1001141 | D011704 | N10-N16 |
urinary tract infections | EFO_0003103 | D014552 | N39.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
CEFIDEROCOL SULFATE TOSYLATE, FETROJA, SHIONOGI INC | |||
2029-11-14 | GAIN | ||
2024-11-14 | NCE | ||
2023-09-25 | I-844 |
HCPCS
Code | Description |
---|---|
J0699 | Injection, cefiderocol, 10 mg |
Clinical
Clinical Trials
14 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | 1 | — | — | 1 | — | 2 |
Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Sepsis | D018805 | A41.9 | 1 | 2 | 1 | — | — | 4 | |
Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 3 | 1 | — | — | 4 |
Healthcare-associated pneumonia | D000077299 | — | 2 | 2 | — | — | 4 | ||
Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | 1 | 2 | — | — | 3 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | CEFIDEROCOL |
INN | cefiderocol |
Description | Cefiderocol, sold under the brand name Fetroja among others, is an antibiotic used to treat complicated urinary tract infections when no other options are available. It is indicated for the treatment of multi-drug-resistant Gram-negative bacteria including Pseudomonas aeruginosa. It is given by injection into a vein.
|
Classification | Small molecule |
Drug class | cephalosporins |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CC(C)(O/N=C(\C(=O)N[C@@H]1C(=O)N2C(C(=O)[O-])=C(C[N+]3(CCNC(=O)c4ccc(O)c(O)c4Cl)CCCC3)CS[C@H]12)c1csc(N)n1)C(=O)O |
Identifiers
PDB | — |
CAS-ID | 1225208-94-5 |
RxCUI | 2265702 |
ChEMBL ID | CHEMBL3989974 |
ChEBI ID | — |
PubChem CID | 77843966 |
DrugBank | DB14879 |
UNII ID | SZ34OMG6E8 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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