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Zerbaxa(ceftolozane)
Zerbaxa (ceftolozane) is a small molecule pharmaceutical. Ceftolozane was first approved as Zerbaxa on 2014-12-19. It is used to treat bacterial infections, bacteroides infections, escherichia coli infections, intraabdominal infections, and klebsiella infections amongst others in the USA. It has been approved in Europe to treat bacterial infections.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
Trade Name
FDA
EMA
Combinations
Zerbaxa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ceftolozane sulfate
+
Tazobactam sodium
Tradename
Company
Number
Date
Products
ZERBAXACubist PharmaceuticalsN-206829 RX2014-12-19
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
zerbaxaNew Drug Application2020-09-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacterial infections—D001424A49
bacteroides infectionsEFO_1000832D001442—
escherichia coli infectionsEFO_1001318D004927B96.20
intraabdominal infections—D059413—
klebsiella infectionsEFO_1001353D007710—
proteus infectionsEFO_1001130D011512—
pseudomonas infectionsEFO_0001076D011552—
streptococcal infectionsEFO_1001476D013290—
urinary tract infectionsEFO_0003103D014552N39.0
Agency Specific
FDA
EMA
Expiration
Code
CEFTOLOZANE SULFATE / TAZOBACTAM SODIUM, ZERBAXA, CUBIST PHARMS LLC
2025-04-21NPP
2024-12-19GAIN
2019-12-19NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Ceftolozane Sulfate / Tazobactam Sodium, Zerbaxa, Cubist Pharms Llc
101251492035-08-14DP
103764962034-09-09U-2610, U-2611
109330532034-09-09U-3090, U-3091
89068982034-05-28DS, DP
89687532034-03-14U-1672, U-1673, U-3360, U-3361
93207402034-03-14DP
98729062034-03-14DP
104208412034-03-14U-1672, U-2631, U-3360, U-3361
112786222034-03-14U-3335, U-3336
84764252032-09-27DP
86859572032-09-27DPU-36
97243532032-09-07U-2565, U-2566
100289632032-09-07U-2565, U-2566
71292322028-05-15DS, DPU-36, U-1676, U-3360, U-3361
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
— J01DI54: Ceftolozane and beta-lactamase inhibitor
HCPCS
Code
Description
J0695
Injection, ceftolozane 50 mg and tazobactam 25 mg
Clinical
Clinical Trials
26 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD01933711—1—2
Pseudomonas infectionsD011552EFO_0001076———112
PharmacokineticsD01059911—1—2
BurnsD002056T30.0———1—1
Cystic fibrosisD003550EFO_0000390E84———1—1
Febrile neutropeniaD064147———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Intraabdominal infectionsD059413—22——4
Ventilator-associated pneumoniaD053717EFO_1001865J95.851——2—13
Urinary tract infectionsD014552EFO_0003103N39.0—21——3
Healthcare-associated pneumoniaD0000772991—1——2
PyelonephritisD011704EFO_1001141N10-N16—11——2
BacteremiaD016470EFO_0003033R78.81——1——1
Lung diseasesD008171EFO_0003818J98.4——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PneumoniaD011014EFO_0003106J1821———2
Pseudomonas aeruginosaD011550NCBITaxon_28711——12
Communicable diseasesD003141—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
Wound infectionD0149461————1
Critical illnessD0166381————1
Bacterial infectionsD001424A491————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544————11
Respiratory distress syndromeD012128EFO_1000637J80————11
Cross infectionD003428————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCEFTOLOZANE
INNceftolozane
Description
Ceftolozane is a fifth-generation cephalosporin antibiotic having (5-amino-4-{[(2-aminoethyl)carbamoyl]amino}-1-methyl-1H-pyrazol-2-ium-2-yl)methyl and [(2Z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-{[(2-carboxypropan-2-yl)oxy]imino}acetyl]amino side groups located at positions 3 and 7 respectively; developed for the treatment of infections with gram-negative bacteria that have become resistant to conventional antibiotics. It is a cephalosporin and a member of thiadiazoles.
Classification
Small molecule
Drug classcephalosporins
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cn1c(N)c(NC(=O)NCCN)c[n+]1CC1=C(C(=O)O)N2C(=O)[C@@H](NC(=O)/C(=N\OC(C)(C)C(=O)[O-])c3nsc(N)n3)[C@H]2SC1
Identifiers
PDB—
CAS-ID689293-68-3
RxCUI1597609
ChEMBL IDCHEMBL2103872
ChEBI ID—
PubChem CID53234134
DrugBankDB09050
UNII ID37A4IES95Q (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Zerbaxa - Merck Sharp & Dohme
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,451 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,575 adverse events reported
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