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cefotaxime

Trade name: claforan

Small moleculeapproved

Approved

Mar 11, 1981

Cefotaxime sodium is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It’s a 3rd Generation Cephalosporin that is FDA approved for the treatment of lower respiratory tract infections, genitourinary infections, gynecologic infections, bacteremia/septicemia, skin and skin structure infections, intra-abdominal infections, bone and/or joint infections and central nervous system infections. The bactericidal activity of cefotaxime sodium results from inhibition of cell wall synthesis. Cefotaxime sodium has in vitro activity against a wide range of gram-positive and gram-negative organisms. Cefotaxime sodium has a high degree of stability in the presence of ß-lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria. Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics. Common adverse reactions include injection site pain, injection site phlebitis, rash, diarrhea, vomiting. Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics. — NCATS

Clinical trial activity

24 trials · 36 clinical orgs · 11 marketing orgs

Phase 1
2
Phase 2
7
Phase 3
5
Phase 4
10

Earliest trial started Jan 1, 1998 (NCT01559753)

Timeline

1980s

  1. Mar 11, 1981

    Validus Pharmaceuticals — Earliest FDA Approval

  2. Mar 11, 1981

    Validus Pharmaceuticals — Marketing Organization

  3. Mar 11, 1981

    Validus Pharmaceuticals — NDA Secondary Org

  4. Mar 11, 1981

    Validus Pharmaceuticals — NDA Organization

  5. Jan 13, 1987

    Sanofi-Aventis — Marketing Organization

2000s

  1. Mar 24, 2000

    Fresenius — Marketing Organization

  2. Nov 20, 2002

    Hikma — Marketing Organization

  3. Sep 24, 2003

    Lupin — Marketing Organization

  4. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  5. Jul 29, 2004

    B. Braun — NDA Secondary Org

  6. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  7. Aug 10, 2006

    Hospira — Marketing Organization

  8. Aug 29, 2006

    Wockhardt — Marketing Organization

  9. Nov 5, 2009

    Aurobindo Pharma — Marketing Organization

2010s

  1. Jan 25, 2010

    Cephazone Pharma — Marketing Organization

  2. Jan 1, 2012

    Earliest Phase 3 Sponsor(trial)

  3. Feb 19, 2016

    Pfizer — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMar 11, 1981

Chemistry & pharmacology

Loading structure…

SMILES

CO/N=C(\C(=O)N[C@@H]1C(=O)N2C(C(=O)O)=C(COC(C)=O)CS[C@H]12)c1csc(N)n1
Mol. weight
455.47 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • (6r,7r)-3-acetoxymethyl-7-{2-(2-amino-thiazol-4-yl)-2-[(z)-methoxyimino]-acetylamino}-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • (6r,7r)-3-acetoxymethyl-7-{2-(2-amino-thiazol-4-yl)-2-[(z)-methoxyimino]-acetylamino}-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • (6r,7r)-3-(acetoxymethyl)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • (6r,7r)-3-(acetoxymethyl)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • (6r,7r,z)-3-(acetoxymethyl)-7-(2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • (6r,7r,z)-3-(acetoxymethyl)-7-(2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • cefcil
  • cefotaxim
  • cefotaxim
  • cefotaxim
  • cefotaxima
  • cefotaxima
  • cefotaxime
  • cefotaxime
  • cefotaxime
  • cefotaxime
  • cefotaxime
  • cefotaxime
  • cefotaxime
  • cefotaxime
  • cefotaxime
  • cefotaxime
  • céfotaxime
  • céfotaxime
  • cefotaxime sodium
  • cefotaxime sodium
  • cefotaxime sodium
  • cefotaxime sodium
  • cefotaxime sodium salt
  • cefotaximum
  • cefotaximum
  • cephotaxime
  • cephotaxime
  • cephotaxime
  • claforan
  • claforan
  • claforan
  • hr-756
  • hr-756
  • pretor
  • pretor
  • ru-24756
  • ru-24756

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06712641Phase 4Jun 30, 2025Oslo Metropolitan University, University of Oslo
NCT05427747Phase 4Jan 1, 2023Assiut University
NCT05804123N/AOct 28, 2021Anabio, Thai Binh University of Medicine and Pharmacy
NCT04839653N/AMay 1, 2021Medsi Clinic #1, Moscow, MEDSI Clinical Hospital 1, ICU
NCT03903783N/AApr 30, 2019Groupe Hospitalier Paris Saint Joseph
NCT04168099Phase 3Dec 1, 2018Tanta University
NCT03922919Phase 4Apr 3, 2018University of Franche-Comté
NCT03310606N/AOct 24, 2017University of Lorraine
NCT02389036Phase 3Mar 1, 2017Medical Research Institute of New Zealand, University of New South Wales, University of Toronto
NCT02784821Phase 2Jan 1, 2017University of Florida
NCT02959957Phase 4May 1, 2016Government of Sweden, Linkoping University
NCT02659033Phase 3Mar 1, 2016University of Paris
NCT02735707Phase 4Dec 1, 2015Utrecht University
NCT02560207Phase 4Nov 1, 2015University of Groningen
NCT02388035N/AMar 1, 2015Nasser Institute For Research and Treatment
NCT02443285Phase 3Jan 1, 2015Tanta University
NCT01820026Phase 4Dec 1, 2012University of Roma La Sapienza
NCT01551394Phase 3Sep 1, 2012Chiesi, Institut National de la Santé Et de la Recherche Médicale, France, PENTA Foundation, University of Padova, University of Tartu
NCT01540838Phase 4Feb 1, 2012Foundation for Paediatric Research, Finland, University of Helsinki
NCT01059890Phase 1Sep 1, 2009University of Poitiers
Showing 20 of 24 trials
Page 1 / 2

Organizations

Research & Development (36)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Tanta UniversityAcademic/Hospital2212015
University of Franche-ComtéAcademic/Hospital2211998
AnabioFor profit1112021
Assiut UniversityAcademic/Hospital1112023
ChiesiFor profit1012012
Foundation for Paediatric Research, FinlandAcademic/Hospital1012012
French Society for Intensive CareAcademic/Hospital1011998
GlaxoSmithKlineFor profit1011998
Government of SwedenGovernment1112016
Groupe Hospitalier Paris Saint JosephAcademic/Hospital1112019
Institut National de la Santé Et de la Recherche Médicale, FranceAcademic/Hospital1012012
Korea UniversityAcademic/Hospital1112007
Linkoping UniversityAcademic/Hospital1012016
Medical Research Institute of New ZealandAcademic/Hospital1012017
Medsi Clinic #1, MoscowAcademic/Hospital1012021
MEDSI Clinical Hospital 1, ICUAcademic/Hospital1112021
Nasser Institute For Research and TreatmentAcademic/Hospital1112015
Oslo Metropolitan UniversityAcademic/Hospital1112025
PENTA FoundationAcademic/Hospital1112012
SmithKline BeechamFor profit1011998
36 organizations
Page 1 / 2

Marketing (15)

OrganizationOrg typeRelationshipDate
Aurobindo PharmaFor profitMKTGNov 5, 2009
Aurobindo PharmaFor profitSYNNov 5, 2009
B. BraunFor profitNDA2Jul 29, 2004
Cephazone PharmaFor profitMKTGJan 25, 2010
FreseniusFor profitMKTGMar 24, 2000
HikmaFor profitMKTGNov 20, 2002
HospiraFor profitSYNFeb 19, 2016
HospiraFor profitMKTGAug 10, 2006
LupinFor profitMKTGSep 24, 2003
PfizerFor profitMKTGFeb 19, 2016
Sanofi-AventisFor profitMKTGJan 13, 1987
Validus PharmaceuticalsFor profitMKTGMar 11, 1981
Validus PharmaceuticalsFor profitNDA2Mar 11, 1981
Validus PharmaceuticalsFor profitNDAMar 11, 1981
WockhardtFor profitMKTGAug 29, 2006