Drugs / Finafloxacin
Finafloxacin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | XTORO | — | 2014-12-17 | fda.gov ↗ |
Trials 11 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT01908764 | Nov 2014 → Jan 2015 | otitis media | Alcon Research | Withdrawn | No outcome recorded |
| Phase 1 | NCT01907867 | Jan → Feb 2012 | — | MerLion Pharmaceuticals GmbH | Completed | No outcome recorded |
| Phase 1 | NCT01910883 | Sep 2010 → Mar 2012 | — | MerLion Pharmaceuticals GmbH | Completed | No outcome recorded |
| Phase 1 | NCT01904162 | Feb 2010 | — | MerLion Pharmaceuticals GmbH | Completed | No outcome recorded |
| Phase 1 | NCT00483158 | Aug 2007 → May 2008 | Helicobacter pylori infectious disease, urinary tract infection | MerLion Pharmaceuticals GmbH | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT01908803 | Dec 2013 → Aug 2014 | otitis media | Alcon Research | Terminated | No outcome recorded |
| Phase 2 | NCT01928433 | Dec 2012 → Jun 2014 | acute pyelonephritis | MerLion Pharmaceuticals GmbH | Completed | No outcome recorded |
| Phase 2 | NCT00722735 | Oct 2008 → Apr 2009 | urinary tract infection | MerLion Pharmaceuticals GmbH | Completed | No outcome recorded |
| Phase 2 | NCT00723502 | Sep 2008 → Apr 2009 | Helicobacter pylori infectious disease, dyspepsia | MerLion Pharmaceuticals GmbH | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01535560 | Apr → Oct 2012 | acute otitis externa | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT01535599 | Mar 2012 → May 2013 | acute otitis externa | Alcon Research | Completed | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Finafloxacin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01907867 ↗ |
| Known as | AL-60371 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01535599 ↗ |
| Known as | AL-60371/AL-817 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01908803 ↗ |
| Known as | Finafloxacine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1908370 ↗ |
| Known as | Finafloxacino | ChEMBL registry synonym — accepted as the source's own label CHEMBL1908370 ↗ |
| Known as | Xtoro | ChEMBL registry synonym — accepted as the source's own label CHEMBL1908370 ↗ |
| Modality | Small molecule | “as a novel fluoroquinolone” NCT01907867 ↗ |
| Route | Oral | “Tablets, oral single dose and multiple dose once daily for 7d” NCT00483158 ↗ |