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ceftolozane

Trade name: Zerbaxa

Small moleculeapprovedFast Track FDA

Approved

Dec 19, 2014

Ceftolozane is a novel a cephalosporin-class antibacterial drug. In combination with a beta-lactamase inhibitor tazobactam (ZERBAXA, ceftolozane/tazobactam ) ceftolozane, is currently indicated for the treatment of the adult patients with complicated intra-abdominal infections caused by designated Gram-negative and Gram-positive microorganisms and complicated urinary tract infections caused by certain Gram-negative bacteria, including those caused by multi-drug resistant Pseudomonas aeruginosa. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. Safety and effectiveness in pediatric patients have not been established. — NCATS

Clinical trial activity

27 trials · 21 clinical orgs · 3 marketing orgs

Phase 1
6
Phase 2
16
Phase 3
9
Phase 4
5

Earliest trial started Mar 1, 2005 (NCT00854880)

Timeline

2000s

  1. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Cubist — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2011

    Cubist — Earliest Phase 3 Sponsor(trial)

  3. Dec 19, 2014

    Earliest FDA Approval

  4. Dec 19, 2014

    Cubist — NDA Secondary Org

  5. Dec 19, 2014

    Merck — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • zerbaxa

    with tazobactam

    Also known as ceftolozane and tazobactam

Approval history

  • approvedPriority reviewFast trackDec 19, 2014

Chemistry & pharmacology

Loading structure…

SMILES

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
Mol. weight
666.7 g/mol
Lipinski Ro5
3 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • (6r,7r)-3-([3-amino-4-(2-aminoethylcarbamoylamino)-2-methylpyrazol-1-ium-1-yl]methyl)-7-([(2z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-(2-carboxypropan-2-yloxyimino)acetyl]amino)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
  • (6r,7r)-3-([3-amino-4-(2-aminoethylcarbamoylamino)-2-methylpyrazol-1-ium-1-yl]methyl)-7-([(2z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-(2-carboxypropan-2-yloxyimino)acetyl]amino)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
  • ceftolozane
  • ceftolozane
  • ceftolozane
  • ceftolozane
  • ceftolozane
  • ceftolozane
  • ceftolozane
  • ceftolozane
  • ceftolozane
  • ceftolozane sulfate
  • ceftolozane sulfate
  • ceftolozane sulfate
  • ceftolozane sulfate
  • ceftolozane sulfate / tazobactam sodium
  • cxa-101
  • cxa-101
  • cxa-101
  • cxa-101
  • cxa-101
  • cxa-201
  • cxa-201
  • fr264205
  • fr264205
  • fr 264205
  • fr 264205
  • fr-264205
  • fr-264205
  • fr-264205
  • fr-264205
  • fr26 4205
  • pdc339

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06342115Phase 4Oct 31, 2024Beneficência Portuguesa de Sao Paulo, Merck
NCT06422533N/ANov 7, 2023Government of Mexico
NCT06035055Phase 4Oct 31, 2023Sunshine Coast Hospital and Health Service, Sunshine Coast University, Australia, University of Queensland
NCT05061654Phase 4Feb 28, 2022Hamad Medical Corporation, Merck
NCT04673175Phase 1/Phase 2 (Phase 2)Dec 31, 2020Cornell University, Merck
NCT04238390Phase 3Jun 1, 2020Merck, University of Queensland
NCT04223752Phase 1May 26, 2020Merck
NCT03830333Phase 3Mar 20, 2019Merck
NCT03581370Phase 3Jul 31, 2018University of Toulouse
NCT03485950Phase 2May 16, 2018Merck, University of Texas at Houston
NCT03230838Phase 2Apr 26, 2018Merck
NCT03217136Phase 2Apr 3, 2018Merck
NCT03002506Phase 4Jan 1, 2017Merck, Texas Tech University, The University of Texas, Dallas
NCT02728089Phase 3Apr 14, 2016Merck
NCT02739997Phase 3Apr 8, 2016Merck
NCT02620774Phase 1Feb 19, 2016Merck, University of Connecticut
NCT02421120Phase 4Sep 1, 2015Cubist, Hartford Hospital, Indiana University, University of Connecticut, University of North Carolina at Chapel Hill
NCT02387372Phase 1Feb 5, 2015Cubist, Merck
NCT02070757Phase 3Sep 23, 2014Cubist, Merck
NCT02266706Phase 1Sep 17, 2014Cubist, Merck
Showing 20 of 27 trials
Page 1 / 2

Organizations

Research & Development (21)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit16642014
CubistFor profit10942009
University of ConnecticutAcademic/Hospital2122015
University of QueenslandAcademic/Hospital2122020
Beneficência Portuguesa de Sao PauloAcademic/Hospital1112024
Cornell UniversityAcademic/Hospital1112020
Government of MexicoGovernment1112023
Government of TaiwanGovernment1012005
Hamad Medical CorporationFor profit1112022
Hartford HospitalAcademic/Hospital1112015
Indiana UniversityAcademic/Hospital1012015
Justus Liebig University GiessenAcademic/Hospital1012009
Mississippi Medical Research, LLCFor profit1012009
National Taiwan UniversityAcademic/Hospital1112005
Sunshine Coast Hospital and Health ServiceAcademic/Hospital1112023
Sunshine Coast University, AustraliaAcademic/Hospital1012023
Texas Tech UniversityAcademic/Hospital1112017
The University of Texas, DallasAcademic/Hospital1012017
University of North Carolina at Chapel HillAcademic/Hospital1012015
University of Texas at HoustonAcademic/Hospital1112018
21 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
CubistFor profitNDA2Dec 19, 2014
MerckFor profitNDA2Dec 19, 2014
WyethFor profitNDA—