Drugs / Norfloxacin
Norfloxacin
also known as
Baccidal · Chibroxin · MK-366 · Norfloxacine · Norfloxacino · Noroxin · NSC-757250 · Quinabic · +1 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT00362752 | Oct 2006 → Jan 2009 | hepatopulmonary syndrome | Unity Health Toronto | Completed | Missed primary |
| 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 · 1 missed | ||||||
| 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 | Missed primary |
| 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 |
| Comparator or background therapy15 trials | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT00678613 Comparator | Jul 2007 → ? | cirrhosis of liver, infectious peritonitis | All India Institute of Medical Sciences | Unknown | No outcome recorded |
| 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 3 | NCT01037959 Comparator | Apr 2010 → Nov 2014 | cirrhosis of liver | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00947336 Comparator | Apr 2005 → Apr 2008 | cirrhosis of liver | Govind Ballabh Pant Hospital | Completed | No outcome recorded |
| 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 | Missed primary |
| Phase 4 | NCT01542801 Comparator | Aug 2011 → Jul 2015 | drug allergy | Korea University | Completed | No outcome recorded |
| — | 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.
| Field | Value | Cited text |
|---|---|---|
| Known as | Norfloxacin | “Nitrofurantoin (100mg 3x/day PO) or Norfloxacin (400mg 2x/day PO) for 5 days” NCT00826670 ↗ |
| 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 ↗ |