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Drug

Norfloxacin

Established medicine
ClassBacterial DNA gyrase inhibitorResearchOngoing clinical research
Also known as Chibroxin, NFLX, Noroxin, Norfloxacine+5 more

Chibroxin, NFLX, Noroxin, Norfloxacine, Norfloxacino, 1,4-Dihydro-1-ethyl-6-fluoro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid, 1-Ethyl-6-fluor-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-chinolincarbonsäure, 1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid, Norfloxacinum.

RxNorm7517ChEMBLCHEMBL9ATCJ01MA06ATCS01AE02UNIIN0F8P22L1P
1
Active clinical trials
4
Protein targets
1
Regulatory events
Latest activity
beta

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

Efficacy of Rifaximin vs Norfloxacin for Secondary Prophylaxis of SBP (NORRIF Trial): a Randomized Control Trial

Clinical trial2024-12-31Primary completion · ClinicalTrials.gov

Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Clinical trial2023-12-01Primary completion · ClinicalTrials.gov

Clinical Study to Evaluate the Possible Efficacy and Safety of Nitazoxanide in Secondary Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

Clinical trial2022-03-01Primary completion · ClinicalTrials.gov

Comparative Study Between Norfloxacin, Nitazoxanide and Colistin As Secondary Prophylactic Agents for Spontaneous Bacterial Peritonitis

Clinical trial2022-02-01Completed · ClinicalTrials.gov

Rifaximin Versus Norfloxacin in the Primary Prophylaxis of Spontaneous Bacterial Peritonitis

Clinical trial2021-11-20Primary completion · ClinicalTrials.gov

Comparative Study of Norfloxacin Versus Norfloxacin With Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Clinical trial2019-11-13Results expected Q4 2028 · ClinicalTrials.gov

Comparison of the Efficacy of Granulocyte - Macrophage Colony Stimulating Factor (GM-CSF) and Norfloxacin in Secondary Prophylaxis for Spontaneous Bacterial Peritonitis - A Randomised Controlled Trial

Clinical trial2019-07-31Completed · ClinicalTrials.gov

Noroxin Efficacy and Safety Trial

Clinical trial2018-06-10Primary completion · ClinicalTrials.gov

Comparison of Daily Norfloxacin Versus Weekly Ciprofloxacin for the Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

Clinical trial2016-04-01Completed · ClinicalTrials.gov

Randomized, Double-Blind, Placebo-Controlled Trial Assessing Norfloxacin in the Prevention of Complications in Patients With Cirrhosis and Severe Liver Failure

Clinical trial2015-11-01Terminated · ClinicalTrials.gov

A Phase III Non-Inferiority Open-label Multicenter Randomized Clinical Trial to Compare CEPHALOSPORIN to NORFLOXACIN in the Treatment of Acute Cystitis

Clinical trial2015-07-27Withdrawn · ClinicalTrials.gov

Drug Safety Update: Norfloxacin: restricted use in urinary infections

Regulatory2014-12-11MHRA

Profile

Identifiers & mechanism

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

Canonical name
Norfloxacin
Aliases & brands
ChibroxinNFLXNoroxinNorfloxacineNorfloxacino1,4-Dihydro-1-ethyl-6-fluoro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid1-Ethyl-6-fluor-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-chinolincarbonsäure1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acidNorfloxacinum
RxNorm CUI
7517
ChEMBL ID
CHEMBL9
ATC codes
J01MA06S01AE02
UNII
N0F8P22L1P
Primary mechanism
Bacterial DNA gyrase inhibitor
Regulatory jurisdictions
mhra

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

DNA gyrase subunit B
gyrB · P0AES6
INHIBITORBacterial DNA gyrase inhibitor
DNA gyrase subunit A
gyrA · P0AES4
INHIBITORBacterial DNA gyrase inhibitor
DNA topoisomerase 4 subunit A
parC · P0AFI2
INHIBITORTopoisomerase IV inhibitor
DNA topoisomerase 4 subunit B
parE · P20083
INHIBITORTopoisomerase IV 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
MHRA
Total events
1
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Norfloxacin: restricted use in urinary infections
Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

15 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
15
registered trials across all phases
LATEST COMPLETION 2022
1
Active studies
1
Recruiting
14
Late-stage (III+)
5
Completed
9
Discontinued
PHASE DISTRIBUTIONn = 15
Phase 21Phase 36Phase 45Phase N / A3

Late-stage studies

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

Comparative Study Between Norfloxacin, Nitazoxanide and Colistin As Secondary Prophylactic Agents for Spontaneous Bacterial Peritonitis

CompletedPH IVTanta Universityn=902022

Noroxin Efficacy and Safety Trial

Unknown statusPH IVKey trialOBS Pakistann=1,0002018

Comparison of Daily Norfloxacin Versus Weekly Ciprofloxacin for the Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

CompletedPH IVKorea Universityn=1242016

Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting. A Randomized, Double Blind Trial

TerminatedPH IVInsel Gruppe AG, University Hospital Bernn=2532015

Randomized Double-Blid Placebo Controlled Trial Assessing Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis In Advanced Cirrhosis

CompletedPH IVHospital Clinic of Barcelonan=702005

Recent completions

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

Comparative Study Between Norfloxacin, Nitazoxanide and Colistin As Secondary Prophylactic Agents for Spontaneous Bacterial Peritonitis

CompletedPH IVTanta Universityn=902022

Comparison of the Efficacy of Granulocyte - Macrophage Colony Stimulating Factor (GM-CSF) and Norfloxacin in Secondary Prophylaxis for Spontaneous Bacterial Peritonitis - A Randomised Controlled Trial

CompletedN/AInstitute of Liver and Biliary Sciences, Indian=1202019

Comparison of Daily Norfloxacin Versus Weekly Ciprofloxacin for the Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

CompletedPH IVKorea Universityn=1242016

A Pilot Study of Norfloxacin for Hepatopulmonary Syndrome

CompletedPH IIUnity Health Toronton=92009

Randomized Double-Blid Placebo Controlled Trial Assessing Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis In Advanced Cirrhosis

CompletedPH IVHospital Clinic of Barcelonan=702005
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.