Drugs / Gatifloxacin
Gatifloxacin
also known as
Zymar · AM-1155 · BMS-206584-01 · Gatiflo · Gatifloxacin (sesquihydrate) · Gatifloxacin anhydrous · Gatifloxacin hydrate · Gatifloxacine · +6 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ZYMAR | — | 2017-03-21 | fda.gov ↗ |
| Approved | US (FDA) | ZYMAR | — | 2003-03-28 | fda.gov ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00396084 | Feb 2004 → Nov 2007 | tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00651586 | Oct 2003 → Apr 2005 | corneal ulcer | Allergan | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT00518089 | Feb 2008 → Jan 2009 | bacterial conjunctivitis | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT00509873 | Aug 2007 → Jun 2008 | bacterial conjunctivitis | Allergan | Completed | Met primary |
| Phase 3 | NCT00216385 | Jan 2005 → Dec 2008 | tuberculosis | Research Institute for Development | Unknown | Missed primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT03237182 | Jun 2017 → Dec 2022 | multidrug-resistant tuberculosis | Centre for the AIDS Programme of Research in South Africa | Terminated | No outcome recorded |
| Phase 4 | NCT00410891 | Jul 2008 → Dec 2009 | — | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT00464438 | Jun 2007 → Sep 2008 | bacterial conjunctivitis | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00347828 | Jun 2006 | eye infectious disorder | Ophthalmic Consultants of Boston | Unknown | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT02196740 | Jun 2013 → Dec 2014 | periapical periodontitis | Lin Jiacheng | Unknown | No outcome recorded |
| — | NCT00466570 | Apr 2007 → ? | — | Stanford University | Withdrawn | No outcome recorded |
| — | NCT00335231 | Jun 2006 → Jun 2013 | endophthalmitis | Queen's University | Withdrawn | No outcome recorded |
| — | NCT00414011 | ? → Feb 2005 | corneal disorder | Walter Reed Army Medical Center | Completed | No outcome recorded |
| Comparator or background therapy18 trials | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00905762 Comparator | Mar → Apr 2009 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT00824070 Comparator | Feb → Jul 2009 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT02980523 Comparator | Mar 2015 → Jun 2016 | bacterial conjunctivitis | Laboratorios Sophia S.A de C.V. | Completed | No outcome recorded |
| Phase 2 | NCT01928693 Comparator | Jul 2013 → May 2014 | corneal ulcer | Cornea Consultants Of Nashville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03696342 Comparator | Oct 2018 → Mar 2020 | bacterial conjunctivitis | Laboratorios Sophia S.A de C.V. | Terminated | No outcome recorded |
| Phase 3 | NCT02717871 Comparator | Mar 2016 → Oct 2020 | keratitis | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 3 | NCT01330355 Comparator | May 2011 → Jan 2013 | bacterial conjunctivitis | Bausch & Lomb Incorporated | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01218737 Comparator | Jan → Jun 2009 | eye infectious disorder | Federal University of São Paulo | Completed | No outcome recorded |
| Phase 4 | NCT05771194 Background | Feb 2021 → Mar 2022 | eyelid disorder | Tianjin Medical University Eye Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03578276 Comparator | Jun 2018 → Dec 2019 | cataract | Carolina Eyecare Physicians, LLC | Completed | No outcome recorded |
| Phase 4 | NCT01421693 Comparator | Sep 2011 → Jul 2014 | typhoid fever | Oxford University Clinical Research Unit, Vietnam | Completed | No outcome recorded |
| Phase 4 | NCT00874887 Comparator | Mar → Sep 2009 | — | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00703313 Comparator | May → Jun 2008 | — | Santen Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00350363 Comparator | Jan 2007 → Dec 2010 | — | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT00433225 Background | — | macular retinal edema | Innovative Medical | Completed | No outcome recorded |
| Phase 4 | NCT00407017 Background | — | cataract | Innovative Medical | Completed | No outcome recorded |
| — | NCT00892918 Comparator | Jun 2009 → Jun 2010 | pterygium | Meir Medical Center | Unknown | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2005-10-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval of Gatifloxacin Tablets tevapharm.com ↗ |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gatifloxacin | “received gatifloxacin eye drops (Otsuka Pharmaceutical Co., Ltd.) 4 times daily and gatifloxacin eye ointment once every night” NCT05771194 ↗27“standard topical drops regimen that includes the topical use of Gatifloxacin, Bromfenac and Prednisolone acetate 1%.” NCT03578276 ↗ “ofloxacin, gatifloxacin, amikacin, capreomycin” NCT03237182 ↗ “Gatifloxacin 0.5% Ophthalmic Solution” NCT01928693 ↗ “Gatifloxacin” NCT02099240 ↗ |
| Known as | AM-1155 | ChEMBL registry synonym — accepted as the source's own label CHEMBL31 ↗ |
| Known as | BMS-206584-01 | ChEMBL registry synonym — accepted as the source's own label CHEMBL31 ↗ |
| Known as | Gatiflo | ChEMBL registry synonym — accepted as the source's own label CHEMBL31 ↗ |
| Known as | Gatifloxacin (sesquihydrate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL31 ↗ |
| Known as | Gatifloxacin anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL31 ↗ |
| Known as | Gatifloxacin hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL31 ↗ |
| Known as | Gatifloxacine | ChEMBL registry synonym — accepted as the source's own label CHEMBL31 ↗ |
| Known as | Gatifloxacino | ChEMBL registry synonym — accepted as the source's own label CHEMBL31 ↗ |
| Known as | NSC-758701 | ChEMBL registry synonym — accepted as the source's own label CHEMBL31 ↗ |
| Known as | PD-135432 | ChEMBL registry synonym — accepted as the source's own label CHEMBL31 ↗ |
| Known as | Tequin | ChEMBL registry synonym — accepted as the source's own label CHEMBL31 ↗ |
| Known as | Zymar | “About 20 patients treated by Gatifloxacin ophthalmic solution 0.3% (Zymar) 4 times a day (one drop each time) after pterygium excision with Mitomycin C application.” NCT00892918 ↗ |
| Known as | Zymaxid | ChEMBL registry synonym — accepted as the source's own label CHEMBL31 ↗ |
| Known as | Zymer | ChEMBL registry synonym — accepted as the source's own label CHEMBL31 ↗ |
| Modality | Small molecule | “4th generation fluoroquinolones” NCT00414011 ↗ |
| Route | Topical | “topical application of gatifloxacin prior to surgery” NCT00335231 ↗ |