CDEK
← All drugs Report issue

norfloxacin

Trade name: noroxin

Small moleculeapproved

Approved

Jan 1, 1983

Norfloxacin is an antibacterial agent, It inhibits inhibits DNA synthesis by inhibiting DNA gyrase enzyme. Norfloxacin was approved in 1986 for treatment of urinary tract infections, gynecological infections, prostatitis, gonorhhea and bladder infections. In ophtalmology, norfloxacin is used for treatment of conjunctivitus. — NCATS

Clinical trial activity

23 trials · 22 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
11
Phase 3
12
Phase 4
5

Earliest trial started Sep 1, 2000 (NCT00359853)

Timeline

1980s

  1. Jan 1, 1983

    Earliest FDA Approval

  2. Oct 31, 1986

    Merck — First NDA Organization

  3. Oct 31, 1986

    Merck — NDA Organization

2000s

  1. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2017

    Merck — Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJan 1, 1983

Chemistry & pharmacology

Loading structure…

SMILES

CCN1C=C(C(O)=O)C(=O)C2=C1C=C(N3CCNCC3)C(F)=C2
Mol. weight
319.3308 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Topical
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

Yes

Black box warning

Sources

Also known as

  • 1,4-dihydro-1-ethyl-6-fluoro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid
  • 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-chinolincarbonsaeure
  • 1-ethyl-6-fluor-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-chinolincarbonsaeure
  • 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid
  • 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid
  • baccidal
  • baccidal
  • chibroxin
  • chibroxin
  • mk-366
  • mk-366
  • nflx
  • nflx
  • norfloxacin
  • norfloxacin
  • norfloxacin
  • norfloxacin
  • norfloxacin
  • norfloxacin
  • norfloxacin
  • norfloxacin
  • norfloxacin
  • norfloxacine
  • norfloxacine
  • norfloxacine
  • norfloxacino
  • norfloxacino
  • norfloxacinum
  • norfloxacinum
  • noroxin
  • noroxin
  • noroxin
  • quinabic
  • quinabic
  • quinolone
  • quinolone
  • utinor
  • utinor

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06199843N/AJan 5, 2024Institute of Liver and Biliary Sciences, India
NCT04746937Phase 3Mar 31, 2021Tanta University
NCT06827756Phase 4Mar 1, 2021Tanta University
NCT04159870Phase 3Nov 5, 2019University of Foggia
NCT04161768Phase 3Dec 1, 2018Tanta University
NCT03702426N/ASep 1, 2018Institute of Liver and Biliary Sciences, India
NCT03506256Phase 4May 10, 2018OBS Pakistan
NCT03295266Phase 1Dec 19, 2017Merck
NCT03259087Phase 1Sep 1, 2017Merck
NCT03622450Phase 2/Phase 3 (Phase 3)Jan 2, 2016Ain Shams University
NCT03695705Phase 3Jan 1, 2016Postgraduate Institute of Medical Education and Research
NCT02120196Phase 3Jan 1, 2014Tanta University
NCT01527019Phase 3Oct 1, 2012Eurofarma Laboratorios S.A.
NCT01039545Phase 4Feb 1, 2012University of Bern
NCT01542801Phase 4Aug 1, 2011Korea University, Kyungpook University, Soonchunhyang University, Sungkyunkwan University
NCT01134692Phase 3Jun 1, 2010Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
NCT01037959Phase 3Apr 1, 2010University of Paris
NCT00678613Phase 2/Phase 3 (Phase 3)Jul 1, 2007All India Institute of Medical Sciences
NCT00362752Phase 2Oct 1, 2006University of Toronto
NCT00331916Phase 3Nov 1, 2005Alcon
Showing 20 of 23 trials
Page 1 / 2

Organizations

Research & Development (22)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Tanta UniversityAcademic/Hospital4422014
Govind Ballabh Pant Institute of Postgraduate Medical Education and ResearchAcademic/Hospital2212005
Institute of Liver and Biliary Sciences, IndiaAcademic/Hospital2212018
MerckFor profit2212017
Ain Shams UniversityAcademic/Hospital1112016
AlconFor profit1112005
All India Institute of Medical SciencesAcademic/Hospital1112007
Eurofarma Laboratorios S.A.For profit1112012
Jhaver Research Foundation LimitedAcademic/Hospital1012005
Korea UniversityAcademic/Hospital1112011
Kyungpook UniversityAcademic/Hospital1012011
Monash UniversityAcademic/Hospital1112005
OBS PakistanFor profit1112018
Postgraduate Institute of Medical Education and ResearchAcademic/Hospital1112016
Soonchunhyang UniversityAcademic/Hospital1012011
Sungkyunkwan UniversityAcademic/Hospital1012011
The Alfred HospitalAcademic/Hospital1012005
University of BarcelonaAcademic/Hospital1112000
University of BernAcademic/Hospital1112012
University of FoggiaAcademic/Hospital1112019
22 organizations
Page 1 / 2

Marketing (1)

OrganizationOrg typeRelationshipDate
MerckFor profitNDAOct 31, 1986