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aztreonam

Trade name: azactam

Small moleculeapproved

Approved

Dec 31, 1986

Aztreonam is the first monocyclic beta-lactam antibiotic (monobactam) originally isolated from Chromobacterium violaceum. Aztreonam has a high affinity for the protein-binding protein 3 (PBP-3) of aerobic gram-negative bacteria. Most of these organisms are inhibited and killed at low concentrations of the drug. Aztreonam must be administered as an intravenous or intramuscular injection (AZACTAM®), or inhaled (CAYSTON®). Aztreonam for injection is indicated for the treatment of the following infections caused by susceptible gram-negative microorganisms: urinary tract, lower respiratory tract, skin and skin-structure, intra-abdominal and gynecologic infections as well as for septicemia. Aztreonam for inhalation solution is indicated to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. — NCATS

Clinical trial activity

43 trials · 47 clinical orgs · 9 marketing orgs

Phase 1
6
Phase 2
23
Phase 3
19
Phase 4
6

Earliest trial started Nov 1, 2002 (NCT00228410)

Timeline

1980s

  1. Dec 31, 1986

    Squibb — Earliest FDA Approval

  2. Dec 31, 1986

    Bristol-Myers Squibb — NDA Secondary Org

  3. Dec 31, 1986

    Squibb — NDA Organization

2000s

  1. Jan 1, 2002

    Pfizer — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2003

    Gilead Sciences — Earliest Phase 2 Sponsor(trial)

2010s

  1. Feb 22, 2010

    Gilead Sciences — NDA Secondary Org

  2. Jun 18, 2010

    Fresenius — Marketing Organization

  3. Mar 23, 2011

    West-Ward Pharmaceutical — Marketing Organization

  4. Mar 23, 2011

    Hikma — Marketing Organization

  5. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Nov 8, 2021

    Hospira — Marketing Organization

  2. Nov 8, 2021

    Pfizer — Marketing Organization

  3. Feb 7, 2025

    AbbVie — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewDec 31, 1986

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H]1[C@H](NC(=O)C(=N/OC(C)(C)C(O)=O)\C2=CSC(N)=N2)C(=O)N1S(O)(=O)=O
Mol. weight
435.433 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral, Topical
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • 2-({[(1z)-1-(2-amino-1,3-thiazol-4-yl) -2- {[(2s,3s)-2-methyl-4-oxo-1-sulfoazetidin-3-yl]amino} -2- oxoethylidene]amino}oxy)-2-methylpropanoic acid
  • 2-({[(1z)-1-(2-amino-1,3-thiazol-4-yl) -2- {[(2s,3s)-2-methyl-4-oxo-1-sulfoazetidin-3-yl]amino} -2- oxoethylidene]amino}oxy)-2-methylpropanoic acid
  • azactam
  • azactam
  • azactam
  • azactam
  • azonam
  • azthreonam
  • aztreon
  • aztreonam
  • aztreonam
  • aztreonam
  • aztreonam
  • aztreonam
  • aztreonam
  • aztreonam
  • aztreonam
  • aztreonam
  • aztréonam
  • aztréonam
  • aztreonam lysine
  • aztreonam lysine
  • aztreonam lysine
  • aztreonam lysine
  • aztreonam lysine [usan]
  • aztreonamum
  • aztreonamum
  • cayston
  • cayston
  • cayston
  • cayston
  • cayston
  • cayston
  • monobactam
  • nebactam
  • primbactam
  • primbactam
  • primbactam
  • so-26776
  • so-26776
  • sq-26776
  • sq-26776
  • (z,)-2-((((2-amino-4-thiazolyl)(((2s,3s,)-2-methyl-4-oxo-1-sulfo-3-azetidinyl)carbamoyl)methylene)amino)oxy)-2-methylpropionic acid
  • (z,)-2-((((2-amino-4-thiazolyl)(((2s,3s,)-2-methyl-4-oxo-1-sulfo-3-azetidinyl)carbamoyl)methylene)amino)oxy)-2-methylpropionic acid

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06939829Phase 4May 1, 2025Southeast University
NCT06462235Phase 2Sep 25, 2024AbbVie, Pfizer
NCT05777603Phase 1Jan 3, 2024National Cancer Institute (NCI)
NCT05905055Phase 3Sep 22, 2023Meiji Seika Pharma Co., Ltd.
NCT05887908Phase 3May 23, 2023Meiji Seika Pharma Co., Ltd.
NCT05639647Phase 2Jan 23, 2023Pfizer
NCT05850871N/AJan 6, 2023Shandong first medical University, Shandong Province Qianfoshan Hospital
NCT07113574Phase 2/Phase 3 (Phase 3)Aug 31, 2021Karl Landsteiner Insitute for Nephrology and Haemato-Oncology, Karl Landsteiner Private University of Health Sciences, Medical University of Cologne, University of Vienna
NCT04973826Phase 1Aug 20, 2021Pfizer
NCT04486625Phase 1Aug 10, 2020Pfizer
NCT03696290Phase 2Jul 2, 2019Gilead Sciences, University of Dundee
NCT03978091Phase 1Jun 14, 2019National Institute of Allergy and Infectious Diseases (NIAID)
NCT03867734Phase 2/Phase 3 (Phase 3)Apr 5, 2019University of Washington
NCT03749226Phase 2/Phase 3 (Phase 3)Feb 5, 2019Hospital Joan XXIII de Tarragona, Tarragona, Spain
NCT03580044Phase 3Sep 30, 2018Allergan, Pfizer
NCT03329092Phase 3Apr 5, 2018Department of Health and Human Services, European Commission, Pfizer
NCT03219164Phase 3Nov 28, 2017Gilead Sciences
NCT03376529Phase 1Nov 10, 2017QPS, Simbec-Orion, Spero Therapeutics
NCT03158116Phase 4Jun 1, 2017Gilead Sciences, University of California, San Francisco
NCT02730793Phase 2Jan 1, 2017Eastern Virginia Medical School, Virginia Commonwealth University
Showing 20 of 43 trials
Page 1 / 3

Organizations

Research & Development (47)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Gilead SciencesFor profit9642003
PfizerFor profit7732002
Forest LaboratoriesFor profit6422007
AstraZenecaFor profit5432011
Duke UniversityAcademic/Hospital2122007
Karl Landsteiner Insitute for Nephrology and Haemato-OncologyAcademic/Hospital2212014
Karl Landsteiner Private University of Health SciencesAcademic/Hospital2012014
Medical University of CologneAcademic/Hospital2012014
Meiji Seika Pharma Co., Ltd.For profit2212023
Melinta TherapeuticsFor profit2212013
University of ViennaAcademic/Hospital2012014
University of WashingtonAcademic/Hospital2122003
AbbVieFor profit1012024
AllerganFor profit1012018
Chiltern InternationalFor profit1012008
ClinPhone, Inc.For profit1012008
CovanceFor profit1012008
Department of Health and Human ServicesGovernment1012018
Eastern Virginia Medical SchoolAcademic/Hospital1012017
European CommissionGovernment1012018
47 organizations
Page 1 / 3

Marketing (11)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Feb 7, 2025
Bristol-Myers SquibbFor profitNDA2Dec 31, 1986
FreseniusFor profitMKTGJun 18, 2010
Gilead SciencesFor profitNDA2Feb 22, 2010
HikmaFor profitSYNMar 23, 2011
HikmaFor profitMKTGMar 23, 2011
HospiraFor profitSYNNov 8, 2021
HospiraFor profitMKTGNov 8, 2021
PfizerFor profitMKTGNov 8, 2021
SquibbFor profitNDADec 31, 1986
West-Ward PharmaceuticalFor profitMKTGMar 23, 2011