Drugs / Gemifloxacin
Gemifloxacin
also known as
Factiv · Factive · Gemifloxacin mesilate · GEMIFLOXACIN MESYLATE · Gemifloxacin methanesulfonate · Gemifloxacine · Gemifloxacino · LB 20304A · +1 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | FACTIVE | — | 2003-07-25 – 2007-05-01 | fda.gov ↗ |
| Approved | US (FDA) | FACTIVE | — | 2003-04-04 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04692623 | Mar 2021 | hypoglycemia | Shaheed Benazir Bhutto University Sheringal Dir Upper | Completed | No outcome recorded |
| Phase 1 | NCT01879007 | Jan → Mar 2006 | infectious disease | LG Life Sciences | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02368470 | Feb → Aug 2015 | Helicobacter pylori infectious disease | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00926796 | Jun 2010 → Dec 2012 | gonorrhea | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 0 | NCT03326050 Comparator | Feb → Sep 2018 | rhinoscleroma | Assiut University | Unknown | No outcome recorded |
| Phase 3 | NCT04168099 Comparator | Dec 2018 → Dec 2028 expected | infectious peritonitis | Tanta University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 1999-12-16 | LG Life Sciences | Regulatory Market Application for LG Chemical lgchem.com ↗
LG Chemical is the first Korean company to succeed in discovering a new material that completed the clinical tests worldwide including U.S. and Europe and has applied to FDA. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-12-11 | Ache Laboratorios Farmaceuticos S.A. | Factive (mesilato de gemifloxacino) 320 mg – comprimido revestido ache.com.br ↗ |
| 1999-12-16 | LG Life Sciences | Market Application for LG Chemical lgchem.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gemifloxacin | “Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)” NCT01879007 ↗5“gemifloxacin (Factive®, LG Life Sciences, Ltd, Seoul, Korea) 320 mg once daily for 7 days” NCT02368470 ↗ |
| Known as | Factiv | ChEMBL registry synonym — accepted as the source's own label CHEMBL430 ↗ |
| Known as | Factive | “Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)” NCT01879007 ↗ |
| Known as | Gemifloxacin mesilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL430 ↗ |
| Known as | GEMIFLOXACIN MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL430 ↗ |
| Known as | Gemifloxacin methanesulfonate | ChEMBL registry synonym — accepted as the source's own label CHEMBL430 ↗ |
| Known as | Gemifloxacine | ChEMBL registry synonym — accepted as the source's own label CHEMBL430 ↗ |
| Known as | Gemifloxacino | ChEMBL registry synonym — accepted as the source's own label CHEMBL430 ↗ |
| Known as | LB 20304A | ChEMBL registry synonym — accepted as the source's own label CHEMBL430 ↗ |
| Known as | SB-265805-S | ChEMBL registry synonym — accepted as the source's own label CHEMBL430 ↗ |
| Modality | Small molecule | “Gemifloxacin (FACTIVE®) is an enhanced-affinity, broad-spectrum fluoroquinolone suitable for once-daily, oral dosing.” NCT02368470 ↗ |
| Route | Oral | “One 320 mg tablet administered orally.” NCT00926796 ↗ |