ceftazidime

Trade name: fortaz

Small moleculeapproved

Approved

Jul 19, 1985

Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic, used especially for Pseudomonas and other gram-negative infections in debilitated patients. Ceftazidime is used to treat lower respiratory tract, skin, urinary tract, blood-stream, joint, and abdominal infections, and meningitis. The drug is given intravenously (IV) or intramuscularly (IM) every 8–12 hours (two or three times a day), with dose and frequency varying by the type of infection, severity, and/or renal function of the patient. Injectable formulations of ceftazidime are currently nebulized "off-label" to manage Cystic Fibrosis, non-Cystic Fibrosis bronchiectasis, drug-resistant nontuberculous mycobacterial infections, ventilator-associated pneumonia, and post-transplant airway infections. Ceftazidime is generally well-tolerated. When side effects do occur, they are most commonly local effects from the intravenous line site, allergic reactions, and gastrointestinal symptoms. According to one manufacturer, in clinical trials, allergic reactions including itching, rash, and fever, happened in fewer than 2% of patients. Rare but more serious allergic reactions, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme, have been reported with this class of antibiotics, including ceftazidime. Gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain, were reported in fewer than 2% of patients. — NCATS

Clinical trial activity

75 trials · 98 clinical orgs · 13 marketing orgs

Phase 1
15
Phase 2
30
Phase 3
19
Phase 4
17

Earliest trial started Mar 1, 2001 (NCT00173901)

Timeline

1980s

  1. Jul 19, 1985

    Teligent Pharmaceuticals — Earliest FDA Approval

  2. Jul 19, 1985

    Pharmaceutical Associates — Marketing Organization

  3. Jul 19, 1985

    Teligent Pharmaceuticals — NDA Organization

  4. Jul 19, 1985

    Teligent Pharmaceuticals — NDA Secondary Org

  5. Jul 19, 1985

    Pharmaceutical Associates — NDA Secondary Org

  6. Nov 20, 1985

    ACS Dobfar — Marketing Organization

  7. Nov 20, 1985

    Eli Lilly — Marketing Organization

  8. Mar 6, 1986

    Hospira — Marketing Organization

1990s

  1. Sep 27, 1990

    GlaxoSmithKline — NDA Secondary Org

  2. Apr 29, 1993

    Baxalta — Marketing Organization

  3. Apr 29, 1993

    Baxter — Marketing Organization

2000s

  1. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

  4. Oct 15, 2008

    Wockhardt — Marketing Organization

2010s

  1. May 28, 2010

    Aurobindo Pharma — Marketing Organization

  2. Jun 13, 2011

    B. Braun — NDA Secondary Org

  3. Feb 25, 2015

    AbbVie — NDA Secondary Org

  4. Feb 25, 2015

    Allergan — Marketing Organization

  5. Feb 25, 2015

    Allergan — NDA Secondary Org

Indications

Mechanism of action

Combination products

  • avycaz

    with avibactam

    Also known as avibactam and ceftazidime, zavicefta, ceftazidime-avibactam

Approval history

  • approvedPriority reviewJul 19, 1985

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)(O/N=C(\C(=O)N[C@@H]1C(=O)N2C(C(=O)[O-])=C(C[n+]3ccccc3)CS[C@H]12)c1csc(N)n1)C(=O)O
Mol. weight
546.59 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • biotum
  • caz
  • caz
  • cefazid
  • ceftacidin
  • ceftazidim
  • ceftazidim
  • ceftazidim
  • ceftazidima
  • ceftazidima
  • ceftazidime
  • ceftazidime
  • ceftazidime
  • ceftazidime
  • ceftazidime
  • ceftazidime
  • ceftazidime
  • ceftazidime
  • ceftazidime
  • ceftazidime anhydrous
  • ceftazidime anhydrous
  • ceftazidime (arginine formulation)
  • ceftazidime (arginine formulation)
  • ceftazidime / avibactam
  • ceftazidime hydrate
  • ceftazidime hydrate
  • ceftazidime hydrate
  • ceftazidime hydrate
  • ceftazidime hydrate
  • ceftazidime hydrate
  • ceftazidime pentahydrate
  • ceftazidime sodium
  • ceftazidime sodium
  • ceftazidime sodium
  • ceftazidime sodium
  • ceftazidimum
  • ceftazidimum
  • ceftazidine
  • ceptaz
  • ceptaz
  • fortam
  • fortam
  • fortaz
  • fortaz
  • fortaz
  • fortum
  • fortum
  • gr-20263
  • gr-20263
  • kefazim
  • ly-139381
  • ly-139381
  • pentacef
  • pentacef
  • tazicef
  • tazicef
  • tazicef
  • tazidime
  • tazidime
  • tazidime

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07085624N/AJan 31, 2026Government of France, University Clermont Auvergne, University of Lyon
NCT07016165Phase 4Jun 1, 2025Gadjah Mada University
NCT07089186Phase 3Apr 12, 2025Qilu Pharmaceutical Co., Ltd.
NCT06818565N/AFeb 10, 2025Institute of Liver and Biliary Sciences, India
NCT06633718Phase 3Oct 31, 2024Qilu Pharmaceutical Co., Ltd.
NCT06528028Phase 4Jul 1, 2024Nanjing University
NCT05850871N/AJan 6, 2023Shandong first medical University, Shandong Province Qianfoshan Hospital
NCT05258851Phase 3Jun 1, 2022King Faisal University
NCT05105035Phase 2May 31, 2022Arrevus Inc.
NCT04927312Phase 3Oct 1, 2021Pfizer
NCT04882085Phase 4Aug 26, 2021Pfizer
NCT04948463Phase 4Jul 31, 2021Murdoch University
NCT04774094Phase 4May 21, 2021Pfizer
NCT04126031Phase 2Mar 10, 2020Allergan, Pfizer
NCT04040621Phase 1Nov 27, 2019Allergan, Pfizer
NCT03978091Phase 1Jun 14, 2019National Institute of Allergy and Infectious Diseases (NIAID)
NCT04187755Phase 4Mar 1, 2019University of Indonesia
NCT03754387N/AJan 1, 2019Binzhou Medical University, Children's hospital of Dalian, Children's hospital of guiyang, Guizhou Medical University, people hospital of Suiyang, Zunyi Medical College
NCT03409679Phase 3Mar 23, 2018Polyphor Ltd.
NCT03439124Phase 3Nov 27, 2017Basilea Pharmaceutica
Showing 20 of 75 trials
Page 1 / 4

Organizations

Research & Development (98)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit171732008
Forest LaboratoriesFor profit7132012
PfizerFor profit6642004
Basilea PharmaceuticaFor profit4412005
IQVIAFor profit4012011
AllerganFor profit3022016
Johnson and JohnsonFor profit3012005
University of ParisAcademic/Hospital3132001
Chulalongkorn UniversityAcademic/Hospital2222012
Cystic Fibrosis Foundation TherapeuticsAcademic/Hospital2022004
Novexel IncFor profit2112008
Pharmaceutical Research Associates, Inc. (PRA)For profit2012015
Qilu Pharmaceutical Co., Ltd.For profit2212024
University Clermont AuvergneAcademic/Hospital2122007
University of WashingtonAcademic/Hospital2112004
Arrevus Inc.For profit1112022
Association Nationale pour les Traitements A Domicile, les Innovations et la RechercheAcademic/Hospital1112001
BaxaltaFor profit1012001
Belgische Vereniging voor Strijd tegen MucoviscidoseAcademic/Hospital1012016
Binzhou Medical UniversityAcademic/Hospital1012019
98 organizations
Page 1 / 5

Marketing (17)

OrganizationOrg typeRelationshipDate
ACS DobfarFor profitMKTGNov 20, 1985
AbbVieFor profitNDA2Feb 25, 2015
AllerganFor profitMKTGFeb 25, 2015
AllerganFor profitNDA2Feb 25, 2015
Aurobindo PharmaFor profitMKTGMay 28, 2010
B. BraunFor profitNDA2Jun 13, 2011
BaxaltaFor profitMKTGApr 29, 1993
BaxterFor profitMKTGApr 29, 1993
Eli LillyFor profitMKTGNov 20, 1985
GlaxoSmithKlineFor profitNDA2Sep 27, 1990
GlaxoSmithKlineFor profitMKTG
HospiraFor profitMKTGMar 6, 1986
Pharmaceutical AssociatesFor profitMKTGJul 19, 1985
Pharmaceutical AssociatesFor profitNDA2Jul 19, 1985
Teligent PharmaceuticalsFor profitNDAJul 19, 1985
Teligent PharmaceuticalsFor profitNDA2Jul 19, 1985
WockhardtFor profitMKTGOct 15, 2008