cefixime

Trade name: suprax

Small moleculeapproved

Approved

Apr 28, 1989

Cefixime, an antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Cefixime is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall. Like all beta-lactam antibiotics, cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefixime interferes with an autolysin inhibitor. Cefixime is sold under the brand name Suprax, indicated for the treatment of: Uncomplicated Urinary Tract Infections Otitis Media Pharyngitis and Tonsillitis Acute Exacerbations of Chronic Bronchitis Uncomplicated Gonorrhea (cervical/urethral) — NCATS

Clinical trial activity

31 trials · 48 clinical orgs · 11 marketing orgs

Phase 1
11
Phase 2
10
Phase 3
6
Phase 4
6

Earliest trial started Aug 1, 1999 (NCT00004216)

Timeline

1980s

  1. Apr 28, 1989

    Lederle — Earliest FDA Approval

  2. Apr 28, 1989

    Lederle — NDA Organization

  3. Apr 28, 1989

    American Cyanamid — NDA Secondary Org

1990s

  1. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Feb 12, 2004

    Lupin — Marketing Organization

2010s

  1. Jan 1, 2010

    Earliest Phase 3 Sponsor(trial)

  2. Oct 25, 2010

    Lupin — NDA Secondary Org

  3. Jan 1, 2012

    Earliest Phase 2 Sponsor(trial)

  4. Apr 14, 2015

    Aurobindo Pharma — Marketing Organization

  5. Feb 6, 2017

    Belcher Pharmaceuticals — Marketing Organization

  6. Feb 6, 2017

    AJENAT PHARMS — Marketing Organization

  7. Nov 17, 2017

    Sandoz — Marketing Organization

  8. Nov 17, 2017

    Chartwell Pharmaceuticals — Marketing Organization

  9. Nov 17, 2017

    Novartis — Marketing Organization

  10. Oct 9, 2018

    Alkem Labs Ltd — Marketing Organization

2020s

  1. Dec 17, 2024

    FDC — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedApr 28, 1989

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC(=CS1)C(=N\OCC(O)=O)\C(=O)N[C@H]2[C@H]3SCC(C=C)=C(N3C2=O)C(O)=O
Mol. weight
453.45 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • cefixim
  • cefixim
  • cefixim
  • (-)-cefixim
  • (-)-cefixim
  • cefixima
  • cefixima
  • cefixime
  • cefixime
  • cefixime
  • cefixime
  • cefixime
  • cefixime
  • cefixime
  • cefixime
  • cefixime
  • cefixime
  • cefixime
  • céfixime
  • céfixime
  • cefiximine
  • cefiximum
  • cefiximum
  • cefixoral
  • cefspan
  • cefspan
  • cl-284635
  • cl-284635
  • fk-027
  • fk-027
  • fr-17027
  • fr-17027
  • oroken
  • oroken
  • suprax
  • suprax
  • suprax

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06847126Phase 3Feb 25, 2025Postgraduate Institute of Medical Education and Research
NCT05294588Phase 2Apr 18, 2022National Institute of Allergy and Infectious Diseases (NIAID), University of North Carolina at Chapel Hill
NCT05216744Phase 2Jul 15, 2021Hai Phong Medical University
NCT06907316Phase 4Jul 13, 2021Bulovka Hospital, Orebro University
NCT04958122Phase 3Jun 20, 2021AIDS Healthcare Foundation, Cayetano Heredia University, University of Southern California
NCT06090565Phase 4Apr 1, 2021Bulovka Hospital, Orebro University
NCT04349826Phase 4Sep 1, 2020Government of United Kingdom, Medical Research Council, University of Oxford, Wellcome Trust
NCT04982861N/AJun 15, 2020PT Bernofarm, PT Pharma Metric Labs, PT. Pharma Metric Labs
NCT03969758Phase 3Jun 30, 2019Postgraduate Institute of Medical Education and Research
NCT05027893N/AJun 7, 2019University of Novi Sad
NCT03752112Phase 1/Phase 2 (Phase 2)Apr 1, 2019World Health Organization
NCT03660488Phase 2Sep 30, 2018AIDS Healthcare Foundation, University of California, Los Angeles
NCT03716804Phase 4Jun 6, 2018Bangladesh Medical University
NCT03408392Phase 1Feb 8, 2018GlaxoSmithKline
NCT03329547Phase 1Jan 11, 2018GlaxoSmithKline
NCT03840811Phase 1Apr 23, 2017National Institute of Allergy and Infectious Diseases (NIAID)
NCT03084601Phase 2/Phase 3 (Phase 3)Dec 1, 2016Cairo University
NCT02830230N/AJul 1, 2016HBT Medical College & R.N.Cooper Muncipal Hospital, Tata Memorial Hospital
NCT02708992Phase 1Apr 28, 2016National Institute of Allergy and Infectious Diseases (NIAID)
NCT02596503Phase 1Oct 1, 2015University of Colorado, Denver, University of Kentucky
Showing 20 of 31 trials
Page 1 / 2

Organizations

Research & Development (48)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government6432010
AIDS Healthcare FoundationAcademic/Hospital2022018
Bulovka HospitalAcademic/Hospital2212021
GlaxoSmithKlineFor profit2212018
Orebro UniversityAcademic/Hospital2012021
Postgraduate Institute of Medical Education and ResearchAcademic/Hospital2212019
University of CincinnatiAcademic/Hospital2112004
University of Southern CaliforniaAcademic/Hospital2222004
AstraZenecaFor profit1012003
Bangladesh Medical UniversityAcademic/Hospital1112018
Baskent UniversityAcademic/Hospital1012013
Cairo UniversityAcademic/Hospital1112016
Cayetano Heredia UniversityAcademic/Hospital1012021
Government of ItalyGovernment1012013
Government of MexicoGovernment1112015
Government of United KingdomGovernment1012020
Hai Phong Medical UniversityAcademic/Hospital1112021
HBT Medical College & R.N.Cooper Muncipal HospitalAcademic/Hospital1012016
Hospital Juarez de MexicoAcademic/Hospital1012015
IL Sogno di StefanoAcademic/Hospital1012013
48 organizations
Page 1 / 3

Marketing (14)

OrganizationOrg typeRelationshipDate
AJENAT PHARMSFor profitMKTGFeb 6, 2017
Alkem Labs LtdFor profitMKTGOct 9, 2018
American CyanamidFor profitNDA2Apr 28, 1989
Aurobindo PharmaFor profitMKTGApr 14, 2015
Belcher PharmaceuticalsFor profitSYNFeb 6, 2017
Belcher PharmaceuticalsFor profitMKTGFeb 6, 2017
Chartwell PharmaceuticalsFor profitMKTGNov 17, 2017
FDCFor profitMKTGDec 17, 2024
LederleFor profitNDAApr 28, 1989
LupinFor profitNDA2Oct 25, 2010
LupinFor profitMKTGFeb 12, 2004
NovartisFor profitMKTGNov 17, 2017
SandozFor profitMKTGNov 17, 2017
SandozFor profitSYNNov 17, 2017