Drugs / Norfloxacin

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) NOROXIN 1991-11-26 – 1994-10-24 fda.gov
Label expansion US (FDA) CHIBROXIN 1993-04-27 fda.gov
Approved US (FDA) NOROXIN 1986-10-31 fda.gov

Trials 7 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT00362752 Oct 2006 → Jan 2009 hepatopulmonary syndrome Unity Health Toronto Completed No outcome recorded
Phase 32 trials
Phase 3 NCT03695705 Jan → Dec 2016 cirrhosis of liver Post Graduate Institute of Medical Education and Research, Chandigarh Completed No outcome recorded
Phase 3 NCT01134692 cirrhosis of liver, esophageal varices Govind Ballabh Pant Hospital Unknown No outcome recorded
Phase 44 trials
Phase 4 NCT03506256 May → Jun 2018 urinary tract infection OBS Pakistan Unknown No outcome recorded
Phase 4 NCT00826670 Jun 2009 → Aug 2012 bacterial infectious disease University Hospital, Geneva Completed No outcome recorded
Phase 4 NCT07436104 Jan 2004 → Dec 2015 asthma, chronic diarrheal disease, chronic obstructive pulmonary disease, hypertensive disorder +2 MAHAN Trust Completed No outcome recorded
Phase 4 NCT00359853 Sep 2000 → Mar 2005 cirrhosis of liver, hepatorenal syndrome, infectious peritonitis Hospital Clinic of Barcelona Completed No outcome recorded
Also used as a comparator or background therapy in 15 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02099240 Comparator Mar 2014 → Nov 2018 osteomyelitis University of Louisville Terminated No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT00678613 Comparator Jul 2007 → ? cirrhosis of liver, infectious peritonitis All India Institute of Medical Sciences Unknown No outcome recorded
Phase 37 trials
Phase 3 NCT04746937 Comparator Mar 2021 → Mar 2022 infectious peritonitis Tanta University Unknown No outcome recorded
Phase 3 NCT04159870 Comparator Nov 2019 → Nov 2021 infectious peritonitis Ospedali Riuniti di Foggia Unknown No outcome recorded
Phase 3 NCT04161768 Background Dec 2018 → Dec 2028 expected infectious peritonitis Tanta University Recruiting No outcome recorded
Phase 3 NCT02120196 Comparator Jan 2014 → Dec 2023 cirrhosis of liver, infectious peritonitis Tanta University Unknown No outcome recorded
Phase 3 NCT01527019 Comparator Oct 2012 cystitis Eurofarma Laboratorios S.A. Withdrawn No outcome recorded
Phase 43 trials
Phase 4 NCT06827756 Comparator Mar → Dec 2021 cirrhosis of liver, infectious peritonitis Tanta University Completed No outcome recorded
Phase 4 NCT01039545 Comparator Feb 2012 → Dec 2014 urinary tract infection Insel Gruppe AG, University Hospital Bern Terminated No outcome recorded
Phase 4 NCT01542801 Comparator Aug 2011 → Jul 2015 drug allergy Korea University Completed No outcome recorded
Phase not applicable3 trials
NCT06199843 Comparator Jan → Dec 2024 infectious peritonitis Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
NCT03702426 Background Jul 2018 → Jul 2019 infectious peritonitis Institute of Liver and Biliary Sciences, India Completed No outcome recorded
NCT00163982 Background portal hypertension Bayside Health Unknown No outcome recorded

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 23 sources stand behind the page.

FieldValueCited text
Known as Norfloxacin “Nitrofurantoin (100mg 3x/day PO) or Norfloxacin (400mg 2x/day PO) for 5 days” NCT00826670
21

Norfloxacin*” NCT02099240

NCT03695705

NCT01542801

NCT00362752

NCT04161768

NCT01134692

NCT03702426

NCT06199843

NCT07436104

NCT01527019

NCT06827756

NCT02120196

NCT00947336

NCT01037959

NCT00678613

NCT00359853

NCT04746937

NCT00163982

NCT01039545

NCT03506256

NCT04159870

Known as Baccidal ChEMBL registry synonym — accepted as the source's own label CHEMBL9
Known as Chibroxin ChEMBL registry synonym — accepted as the source's own label CHEMBL9
Known as MK-366 ChEMBL registry synonym — accepted as the source's own label CHEMBL9
Known as Norfloxacine ChEMBL registry synonym — accepted as the source's own label CHEMBL9
Known as Norfloxacino ChEMBL registry synonym — accepted as the source's own label CHEMBL9
Known as Noroxin “To determine the efficacy and safety of Norfloxacin (Noroxin)” NCT03506256
Known as NSC-757250 ChEMBL registry synonym — accepted as the source's own label CHEMBL9
Known as Quinabic ChEMBL registry synonym — accepted as the source's own label CHEMBL9
Known as Utinor ChEMBL registry synonym — accepted as the source's own label CHEMBL9
Action Inhibit “The drug antagonizes DNA gyrase, an enzyme essential for bacterial DNA replication” NCT03506256
Modality Small molecule “norfloxacin (a fluoroquinolone antibiotic)” NCT01037959
Route Oral oral administration of norfloxacin” NCT00359853