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Drug

Cefixime

Approved medicine
ClassBacterial penicillin-binding protein inhibitorResearchOngoing clinical research
Also known as Suprax, (-)-cefixim, Cefixim, Cefixima+1 more

Suprax, (-)-cefixim, Cefixim, Cefixima, Cefiximum.

RxNorm25033ChEMBLCHEMBL1541ATCJ01DD08UNIIXZ7BG04GJX
1
Active clinical trials
7
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis

Clinical trial2026-05-04Results expected Q1 2027 · ClinicalTrials.gov

A Phase I Study Of Oral Irinotecan, Temozolomide, Cefixime In Children With Recurrent/Resistant High-Risk Neuroblastoma

Clinical trial2026-04-14Completed · ClinicalTrials.gov

Division of Microbiology and Infectious Diseases, (DMID) 21-0018: Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae

Clinical trial2026-02-05Completed · ClinicalTrials.gov

Azithromycin and Cefixime Combination Versus Azithromycin Alone for the Out-patient Treatment of Clinically Suspected or Confirmed Uncomplicated Typhoid Fever in South Asia; a Randomised Controlled Trial

Clinical trial2025-12-31Completed · ClinicalTrials.gov

Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis - a Randomized, Multicentre, Non-inferiority, Open Label Trial

Clinical trial2024-08-01Terminated · ClinicalTrials.gov

Recall (Class II): CEFIXIME

Regulatory2024-05-30FDA

Efficacy of the Application of Moxifloxacin and Cefixime in Reduction of Inflammatory Sequelae and Complications After Mandibular Third Molar Surgery

Clinical trial2023-12-31Primary completion · ClinicalTrials.gov

Cefixime 800 mg Plus Doxycycline 100 mg b.i.d. for 7 Days Compared to Ceftriaxone 1 g Plus Azithromycin 2 g for Treatment of Urogenital, Rectal and Pharyngeal Gonorrhoea: A Randomised Controlled Trial

Clinical trial2022-12-22Completed · ClinicalTrials.gov

Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis in Non-pregnant Women

Clinical trial2021-03-30Primary completion · ClinicalTrials.gov

Experimental Human Infection With Isogenic Mutants of Neisseria Gonorrhoeae

Clinical trial2021-03-23Results posted · ClinicalTrials.gov

Targeted Clinical Trials to Reduce the Risk of Antimicrobial Resistance The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"

Clinical trial2020-08-06Results posted · ClinicalTrials.gov

Efficacy of Empirical Ciprofloxacin Plus Metronidazole and Cefixime Plus Metronidazole Therapy for the Treatment of Liver Abscess: A Randomised Controlled Clinical Trial

Clinical trial2020-05-01Primary completion · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Cefixime
Aliases & brands
Suprax(-)-cefiximCefiximCefiximaCefiximum
RxNorm CUI
25033
ChEMBL ID
CHEMBL1541
ATC codes
J01DD08
UNII
XZ7BG04GJX
Primary mechanism
Bacterial penicillin-binding protein inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

7 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

D-alanyl-D-alanine carboxypeptidase DacB
dacB · P24228
INHIBITORBacterial penicillin-binding protein inhibitor
Peptidoglycan D,D-transpeptidase FtsI
ftsI · P0AD68
INHIBITORBacterial penicillin-binding protein inhibitor
Penicillin-binding protein 1A
mrcA · P02918
INHIBITORBacterial penicillin-binding protein inhibitor
Penicillin-binding protein 1B
mrcB · P02919
INHIBITORBacterial penicillin-binding protein inhibitor
D-alanyl-D-alanine carboxypeptidase DacA
dacA · P0AEB2
INHIBITORBacterial penicillin-binding protein inhibitor
Peptidoglycan D,D-transpeptidase MrdA
mrdA · P0AD65
INHIBITORBacterial penicillin-binding protein inhibitor
D-alanyl-D-alanine carboxypeptidase DacC
dacC · P08506
INHIBITORBacterial penicillin-binding protein inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
FDA
Total events
1
fdaU.S. Food and Drug Administration· 1 event
2024-05-30RecallSafety
Recall (Class II): CEFIXIME
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

18 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
18
registered trials across all phases
LATEST COMPLETION 2026
1
Active studies
1
Recruiting
8
Late-stage (III+)
11
Completed
6
Discontinued
PHASE DISTRIBUTIONn = 18
Phase 17Phase 1 / 21Phase 22Phase 34Phase 43Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Azithromycin and Cefixime Combination Versus Azithromycin Alone for the Out-patient Treatment of Clinically Suspected or Confirmed Uncomplicated Typhoid Fever in South Asia; a Randomised Controlled Trial

CompletedPH IVKey trialOxford University Clinical Research Unit, Vietnamn=2,1502025

Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis - a Randomized, Multicentre, Non-inferiority, Open Label Trial

TerminatedPH IVBulovka Hospitaln=612024

Cefixime 800 mg Plus Doxycycline 100 mg b.i.d. for 7 Days Compared to Ceftriaxone 1 g Plus Azithromycin 2 g for Treatment of Urogenital, Rectal and Pharyngeal Gonorrhoea: A Randomised Controlled Trial

CompletedPH IVBulovka Hospitaln=1612022

Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis

RecruitingPH IIIUniversity of Southern Californian=4002027

Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract

Unknown statusPH IIIFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinicon=2922025

Recent completions

Trials that read out recently, adding to the completed evidence base.

Division of Microbiology and Infectious Diseases, (DMID) 21-0018: Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae

CompletedPH IIUniversity of North Carolina, Chapel Hilln=652026

Azithromycin and Cefixime Combination Versus Azithromycin Alone for the Out-patient Treatment of Clinically Suspected or Confirmed Uncomplicated Typhoid Fever in South Asia; a Randomised Controlled Trial

CompletedPH IVKey trialOxford University Clinical Research Unit, Vietnamn=2,1502025

Cefixime 800 mg Plus Doxycycline 100 mg b.i.d. for 7 Days Compared to Ceftriaxone 1 g Plus Azithromycin 2 g for Treatment of Urogenital, Rectal and Pharyngeal Gonorrhoea: A Randomised Controlled Trial

CompletedPH IVBulovka Hospitaln=1612022

A Phase I/II Study of Eribulin in Combination With Oral Irinotecan for Adolescent and Young Adult Patients With Relapsed or Refractory Solid Tumors

CompletedPH IUniversity of Colorado, Denvern=22020

Experimental Human Infection With Isogenic Mutants of Neisseria Gonorrhoeae

CompletedPH INational Institute of Allergy and Infectious Diseases (NIAID)n=272019

Targeted Clinical Trials to Reduce the Risk of Antimicrobial Resistance The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"

CompletedPH IINational Institute of Allergy and Infectious Diseases (NIAID)n=7172019
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.