Drugs / Ofloxacin
Ofloxacin
also known as
Floxin · DL-8280 · Exocin · Floxin otic · HOE 280 · J01MA01 · NSC-727071 · NSC-758178 · +8 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | FLOXIN OTIC | — | 2003-09-30 | fda.gov ↗ |
| Label expansion | US (FDA) | FLOXIN | — | 1996-12-19 | fda.gov ↗ |
| Label expansion | US (FDA) | OCUFLOX | — | 1996-05-22 | fda.gov ↗ |
| Approved | US (FDA) | FLOXIN | — | 1990-12-28 | fda.gov ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05302531 | Dec 2022 → Dec 2024 overdue | bacterial infectious disease, short bowel syndrome | Central Hospital, Nancy, France | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07454772 | Mar 2026 → Apr 2027 expected | granulomatous mastitis | All India Institute of Medical Sciences, Bhubaneswar | Not yet recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00781521 | Nov 2002 → Apr 2003 | otitis media | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00002850 | Mar 1997 → Apr 2011 | bacterial infectious disease, plasma cell myeloma | Gary Morrow | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT05213156 | Sep 2019 → Jan 2022 | dry eye syndrome | University Hospital of Patras | Completed | No outcome recorded |
| Phase 4 | NCT03655665 | May 2019 → Jun 2024 | otitis media | Boston Children's Hospital | Terminated | No outcome recorded Stop: Enrollment |
| 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 | NCT04353362 | Apr 2017 → Jan 2020 | periodontitis | Istanbul Medipol University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02357407 | Jun 2015 → Dec 2016 | infectious disease | Rennes University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00480376 | Jun 2007 → Mar 2008 | infectious disease | HaEmek Medical Center, Israel | Unknown | No outcome recorded |
| Phase 4 | NCT00392275 | Nov 2002 → May 2006 | cataract | Indiana University | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT05946655 | Apr 2021 → Oct 2022 | female infertility, uterine disorder | Jagiellonian University | Completed | No outcome recorded |
| — | NCT04496024 | Jun 2020 → Jun 2026 overdue | bacterial infectious disease | Centre Hospitalier Universitaire, Amiens | Recruiting | No outcome recorded |
| — | NCT00621387 | Nov 1993 → Jun 1998 | reactive arthritis | University of Helsinki | Completed | No outcome recorded |
| Comparator or background therapy21 trials | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00584155 Background | Jul 2006 → Jun 2010 | hearing loss disorder | University of Oklahoma | Withdrawn | No outcome recorded |
| Phase 2 | NCT05816070 Comparator | Jan → Nov 2023 | bacterial conjunctivitis | IVIEW Therapeutics Inc. | Completed | Met primary |
| Phase 2 | NCT01757236 Comparator | Oct 2012 → Apr 2016 | periprosthetic joint infection | University Hospital, Tours | Unknown | No outcome recorded |
| Phase 3 | NCT07708142 Background | Jan 2026 → Jul 2027 expected | retinal vein occlusion | SANGMYUNG innovation | Recruiting | No outcome recorded |
| Phase 3 | NCT05074147 Background | May 2022 → Nov 2024 | osteomyelitis | Tourcoing Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04005079 Background | Jun 2019 → Jan 2021 | ocular hypertension, open-angle glaucoma | Montefiore Medical Center | Withdrawn | No outcome recorded |
| Phase 3 | NCT03933631 Background | May 2019 → Jun 2028 expected | glaucoma | Montefiore Medical Center | Recruiting | No outcome recorded |
| Phase 3 | NCT02717871 Comparator | Mar 2016 → Oct 2020 | keratitis | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 3 | NCT02424461 Comparator | Jan 2015 → Feb 2019 | urinary tract infection | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT01573910 Comparator | May 2012 → Apr 2014 | bacterial conjunctivitis | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT00578474 Comparator | Dec 2005 → Aug 2008 | otitis media | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT00683865 Comparator | Apr 2003 → Oct 2004 | pelvic inflammatory disease | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00563433 Comparator | Aug 1994 → Jul 1996 | ulcer of lower limbs | Abeona Therapeutics, Inc | Completed | No outcome recorded |
| Phase 3 | NCT00563394 Comparator | Aug 1994 → Jul 1996 | ulcer of lower limbs | Abeona Therapeutics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT02373137 Background | Jan 2015 → Apr 2018 | corneal disorder | Oregon Health and Science University | Unknown | No outcome recorded |
| Phase 4 | NCT01799356 Comparator | Jun 2010 → Mar 2013 | pelvic inflammatory disease | Istanbul Bakirkoy Maternity and Children Diseases Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01241110 Comparator | Jan → Aug 2010 | pelvic inflammatory disease | Guilan University of Medical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT00873626 Comparator | Jun 2009 → Aug 2011 | urinary tract infection | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| — | NCT02528123 Background | Apr 2016 → Dec 2020 | myopia | London Vision Clinic | Completed | No outcome recorded |
| — | NCT02567825 Comparator | Nov 2015 → Mar 2020 | otitis media | Alejandro Hoberman | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2003-09-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Ofloxacin Tablets 200 mg, 300 mg, and 400 mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has approved the company's ANDA for Ofloxacin Tablets, 200 mg, 300 mg and 400 mg. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2006-08-03 | Daiichi Sankyo | Daiichi Wins FLOXIN® Otic Patent Challenge by Generic Manufacturer Apotex daiichisankyo.com ↗ |
| 2003-09-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval of Ofloxacin Tablets 200 mg, 300 mg, and 400 mg tevapharm.com ↗ |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ofloxacin | “Before surgery, patients will be assigned to receive one drop of commercially available topical ofloxacin solution 0.3% at monodoses without preservatives (Oxatrex, Zwitter...” NCT05213156 ↗34“dual oral antibiotic therapy with Ofloxacin 400mg and Clarithromycin 500mg will be used” NCT07454772 ↗ “Standard of care post op drops-Prednisolone acetate and Ofloxacin, without pilocarpine” NCT04005079 ↗ “Each patient will receive a bottle containing normal saline and 0.03% ofloxacin.” NCT00584155 ↗ “oral fluoroquinolone (Ofloxacin 200 mg every 12 hours)” NCT01757236 ↗ “moxifloxacin, ofloxacin, gatifloxacin, amikacin” NCT03237182 ↗ “Pre-treatment: Ofloxacin (3mg/mL) Eye Drop” NCT07708142 ↗ “* Ofloxacin (PO) : 200Mg/8h” NCT05074147 ↗ “Ofloxacin” NCT02099240 ↗ |
| Known as | DL-8280 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4 ↗ |
| Known as | Exocin | “Ofloxacin (Exocin) eye drops will be used four times a day for 1 week after the procedure” NCT02528123 ↗ |
| Known as | Floxin | “Groups 4, 5 and 6 received the same treatment with the corresponding oral dose of ofloxacin 400 mg (Floxin), ciprofloxacin 400 mg (Cipro) and levofloxacin 250 mg (Levaquin).” PMID 18211932 ↗ Jan 20081“treated with topical ofloxacin (Floxin® 0.3%, 5 mL) 5 drops into the affected ear twice daily for 10 days” NCT02567825 ↗ |
| Known as | Floxin otic | ChEMBL registry synonym — accepted as the source's own label CHEMBL4 ↗ |
| Known as | HOE 280 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4 ↗ |
| Known as | J01MA01 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4 ↗ |
| Known as | NSC-727071 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4 ↗ |
| Known as | NSC-758178 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4 ↗ |
| Known as | Ocuflox | “Groups 1, 2 and 3 received topical ofloxacin 0.3% (Ocuflox), ciprofloxacin 0.3% (Ciloxan) and levofloxacin (Quixin) respectively;” PMID 18211932 ↗ Jan 2008 |
| Known as | Ofloxacine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02424461 ↗ |
| Known as | Ofloxacino | ChEMBL registry synonym — accepted as the source's own label CHEMBL4 ↗ |
| Known as | Oxatrex | “Before surgery, patients will be assigned to receive one drop of commercially available topical ofloxacin solution 0.3% at monodoses without preservatives (Oxatrex, Zwitter...” NCT05213156 ↗ |
| Known as | Tarivid | ChEMBL registry synonym — accepted as the source's own label CHEMBL4 ↗ |
| Known as | Tarivid 400 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4 ↗ |
| Known as | Tarivid i.v. | ChEMBL registry synonym — accepted as the source's own label CHEMBL4 ↗ |
| Known as | Visiren | ChEMBL registry synonym — accepted as the source's own label CHEMBL4 ↗ |
| Modality | Small molecule | “oral fluoroquinolone antibiotic” NCT00563433 ↗ |
| Route | Oral | “Begin oral ofloxacin” NCT00002850 ↗ |