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Drug ReportsCefiderocol
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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
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
FETROJAShionogiN-209445 RX2019-11-14
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
fetrojaNew Drug Application2024-09-19
Agency Specific
FDA
EMA
Expiration
Code
CEFIDEROCOL SULFATE TOSYLATE, FETROJA, SHIONOGI INC
2029-11-14GAIN
2024-11-14NCE
Patent Expiration
Patent
Expires
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FDA Information
Cefiderocol Sulfate Tosylate, Fetroja, Shionogi Inc
99499822035-09-03DP
100047502035-09-03DS, DP
92386572033-11-14DS, DPU-282, U-3470, U-3471
ATC Codes
J: Antiinfectives for systemic use
J01: Antibacterials for systemic use
J01D: Other beta-lactam antibacterials in atc
J01DI: Other cephalosporins and penems in atc
J01DI04: Cefiderocol
HCPCS
Code
Description
J0699
Injection, cefiderocol, 10 mg
Clinical
Clinical Trials
20 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 infectionsD001424A4913127
PneumoniaD011014EFO_000310612216
Bacterial pneumoniaD018410EFO_1001272J15.91113
FibrosisD00535511
Cystic fibrosisD003550EFO_0000390E8411
BacteremiaD016470EFO_0003033R78.8111
Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gram-negative bacterial infectionsD016905336
Intraabdominal infectionsD05941311
PyelonephritisD011704EFO_1001141N10-N1611
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients11
PharmacokineticsD01059911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory distress syndromeD012128EFO_1000637J8011
Acute lung injuryD055371EFO_000461011
Cross infectionD00342811
Newborn respiratory distress syndromeD012127P2211
Multiple drug resistanceD01843211
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCefiderocol
INNcefiderocol
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 classcephalosporins
Image (chem structure or protein)Loading
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-ID1225208-94-5
RxCUI
ChEMBL IDCHEMBL3989974
ChEBI ID
PubChem CID77843966
DrugBankDB14879
UNII IDSZ34OMG6E8 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,282 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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278 adverse events reported
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