Cefiderocol - PharmaKB

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

YTD

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
infections	D007239
urogenital diseases	D000091642

Trade Name

FDA

EMA

Fetroja

Drug Products

FDA

EMA

New Drug Application (NDA)

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	2021-11-19

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

Patent Expiration

Patent	Expires	Flag	FDA Information
Cefiderocol Sulfate Tosylate, Fetroja, Shionogi Inc
9949982	2035-09-03	DP
10004750	2035-09-03	DS, DP
9238657	2033-11-14	DS, DP	U-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

18 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	HP_0100806	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 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Gram-negative bacterial infections	D016905	—	—	—	3	—	—	—	3
Intraabdominal infections	D059413	—	—	—	1	—	—	—	1

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

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Bacterial infections	D001424	—	A49	—	—	—	—	1	1
Respiratory distress syndrome	D012128	EFO_1000637	J80	—	—	—	—	1	1
Cross infection	D003428	—	—	—	—	—	—	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