Drugs / Besifloxacin
Besifloxacin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | BESIVANCE | — | 2012-09-18 | fda.gov ↗ |
| Approved | US (FDA) | BESIVANCE | — | 2009-05-28 | fda.gov ↗ |
Trials 13 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT01431170 | Sep 2011 → Jun 2014 | lacrimal duct obstruction | Rutgers, The State University of New Jersey | Completed | No outcome recorded |
| Phase 1 | NCT00905762 | Mar → Apr 2009 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT00824070 | Feb → Jul 2009 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT01120418 | May → Oct 2007 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT00407589 | Oct 2006 → Oct 2007 | bacterial conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00622908 | Dec 2004 → Jun 2005 | bacterial conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00972777 | Oct 2009 → Oct 2010 | bacterial conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT01740388 | Feb → Jul 2013 | bacterial conjunctivitis | Bausch & Lomb Incorporated | Terminated | No outcome recorded |
| Phase 3 | NCT01330355 | May 2011 → Jan 2013 | bacterial conjunctivitis | Bausch & Lomb Incorporated | Terminated | No outcome recorded |
| Phase 3 | NCT01175590 | Jun 2010 → Dec 2011 | bacterial conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT00348348 | Jun 2006 → Jul 2007 | bacterial conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT00347932 | Jun 2006 → Nov 2007 | bacterial conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02497365 | Sep 2015 → Jun 2019 | keratitis | McGill University Health Centre/Research Institute of the McGill University Health Centre | Completed | No outcome recorded |
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04542759 Comparator | Jan → Apr 2017 | infectious disease, senile cataract | Instituto de Oftalmología Fundación Conde de Valenciana | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01928693 Comparator | Jul 2013 → May 2014 | corneal ulcer | Cornea Consultants Of Nashville | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02717871 Comparator | Mar 2016 → Oct 2020 | keratitis | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT01478256 Comparator | Aug → Oct 2011 | blepharitis | John, George, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT01296542 Comparator | May 2011 → Jan 2013 | cataract | Bucci Laser Vision Institute | Completed | No outcome recorded |
| Phase 4 | NCT01296191 Comparator | May 2011 → Jan 2013 | cataract | Frank A. Bucci, Jr., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT01455233 Comparator | Sep 2010 → Feb 2011 | cataract, corneal disorder | Ophthalmology Consultants, Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00924729 Comparator | Sep → Oct 2009 | cataract | Johns Hopkins University | Completed | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | besifloxacin | “The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when...” NCT01330355 ↗14“The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.” NCT01175590 ↗ “Besifloxacin 0.6% Ophthalmic Suspension” NCT01928693 ↗ |
| Known as | Besifloxacin (as hydrochloride) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201760 ↗ |
| Known as | Besifloxacin hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201760 ↗ |
| Known as | Besifloxacin hydrochloride | “Drug: Besifloxacin hydrochloride” NCT00824070 ↗ |
| Known as | Besifloxacin Ophthalmic | “Drug: Besifloxacin Ophthalmic” NCT04542759 ↗ |
| Known as | Besifloxacin,Besivance | “Besifloxacin,Besivance” NCT01431170 ↗ |
| Known as | Besifloxacine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201760 ↗ |
| Known as | Besifloxacino | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201760 ↗ |
| Known as | Besifloxocin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01478256 ↗ |
| Known as | Besivance | “This research is associated with the marketed product Besivance® (besifloxacin ophthalmic suspension, 0.6%; Bausch & Lomb Incorporated; Rochester, NY).” PMID 32841261 ↗ Aug 20204“The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.” NCT01175590 ↗ |
| Known as | BOL-303224-A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00407589 ↗ |
| Known as | ISV-403 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00622908 ↗ |
| Known as | SS-734 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201760 ↗ |
| Modality | Small molecule | “Besifloxacin is a novel fluoroquinolone, specifically a chloro-fluoroquinolone” PMID 20629472 ↗ 2010 |
| Route | Other | “Systemic exposure following topical administration of besifloxacin ophthalmic suspension 0.6% was negligible” PMID 20629472 ↗ 2010 |