ofloxacin
Trade name: floxin
Approved
Dec 28, 1990
Ofloxacin is one of a new generation of fluorinated quinolones structurally related to nalidixic acid, primary mechanism of action is inhibition of bacterial DNA gyrase. It is an orally administered broad spectrum antibacterial drug active against most Gram-negative bacteria, many Gram-positive bacteria and some anaerobes. Clinical trials to date have demonstrated the efficacy of ofloxacin in the treatment of lower respiratory tract infections, urinary tract infections, and sexually transmitted diseases. Adverse effects to ofloxacin are usually mild and include gastrointestinal, central nervous system, and hypersensitivity reactions. Also available in solution for treatment of otic and ophthalmic bacterial infections. — NCATS
Clinical trial activity
33 trials · 42 clinical orgs · 28 marketing orgs
Earliest trial started Nov 1, 1993 (NCT00621387)
Timeline
1990s
- Dec 28, 1990
Johnson and Johnson — Earliest FDA Approval
- Dec 28, 1990
Johnson and Johnson — NDA Secondary Org
- Dec 28, 1990
Johnson and Johnson — NDA Organization
- Jul 30, 1993
Allergan — NDA Secondary Org
- Jul 30, 1993
SmithKline Beecham — NDA Secondary Org
- Jan 1, 1994
Earliest Phase 3 Sponsor(trial)
- Dec 16, 1997
Daiichi — NDA Secondary Org
2000s
- Jan 16, 2002
Bedford Pharmaceuticals — Marketing Organization
- Jun 17, 2003
Ranbaxy — Marketing Organization
- Sep 2, 2003
Larken Labs Inc — Marketing Organization
- Sep 2, 2003
Teva — Marketing Organization
- Sep 2, 2003
Chartwell Pharmaceuticals — Marketing Organization
- May 14, 2004
Epic Pharma Llc — Marketing Organization
- May 14, 2004
Apotex — Marketing Organization
- May 14, 2004
Bausch & Lomb — Marketing Organization
- May 14, 2004
Hi Tech Pharmaceuticals — Marketing Organization
- May 14, 2004
Novartis — Marketing Organization
- Aug 31, 2004
Alvogen — Marketing Organization
- Jan 1, 2006
Earliest Phase 1 Sponsor(trial)
- Feb 10, 2006
Dr. Reddy's Laboratories — Marketing Organization
- Jan 1, 2007
Earliest Phase 2 Sponsor(trial)
- Mar 17, 2008
Hikma — Marketing Organization
- Apr 15, 2008
Akorn, Inc. — Marketing Organization
- Apr 15, 2008
SENTISS — Marketing Organization
- Nov 25, 2008
Sandoz — Marketing Organization
- Feb 25, 2009
FDC — Marketing Organization
2010s
- Apr 29, 2013
Altair Therapeutics — Marketing Organization
- Sep 18, 2014
Cadila Healthcare — Marketing Organization
- Aug 30, 2019
Amneal Pharmaceuticals — Marketing Organization
2020s
- Jul 14, 2022
Mankind Pharma — Marketing Organization
- Jan 5, 2024
Caplin Point Laboratories — Marketing Organization
- Aug 1, 2024
Somerset Pharmaceuticals — Marketing Organization
- Apr 8, 2026
Micro Labs Ltd India — Marketing Organization
Indications
Approved for
Studied for
- Adenocarcinoma · Phase 1/Phase 2
- Amoxicillin · Phase 4
- Bacterial Infections · Phase 1
- Cataract · Phase 4
- Conjunctivitis · Phase 2
- Conjunctivitis, Bacterial · Phase 3
- Corneal Transplantation · Phase 4
- Diabetic Foot · Phase 3
- Dry Eye Syndromes · Phase 4
- Fever · Phase 4
- Glaucoma · Phase 3
- Glaucoma, Open-Angle · Phase 3
- Hearing Loss · Phase 1
- HIV Infections · Phase 4
- Infections · Phase 4
- Keratitis · Phase 3
- Macular Degeneration · Phase 1
- Metronidazole · Phase 4
- Multiple Myeloma · Phase 3
- Ocular Hypertension · Phase 3
- Ofloxacin · Phase 4
- Osteomyelitis · Phase 3
- Otitis Media · Phase 4
- Pelvic Inflammatory Disease · Phase 4
- Periodontitis · Phase 4
- Root Planing · Phase 4
- Short Bowel Syndrome · Phase 1
- Urinary Tract Infections · Phase 4
- Uterine Diseases · Phase 2
Mechanism of action
- Bacterial DNA gyraseINHIBITOR
Bacterial DNA gyrase inhibitor
Approval history
- approvedDec 28, 1990
Chemistry & pharmacology
SMILES
CC1COC2=C(N3CCN(C)CC3)C(F)=CC4=C2N1C=C(C(O)=O)C4=O- Mol. weight
- 361.3675 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral, Topical
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
Yes
Sources
- WikipediaOfloxacin ↗
- NCATSA4P49JAZ9H ↗
- ChEMBLCHEMBL4 ↗
Also known as
- 8-fluoro-3-methyl-9-(4-methyl-piperazin-1-yl)-6-oxo-2,3-dihydro-6h-1-oxa-3a-aza-phenalene-5-carboxylic acid
- 8-fluoro-3-methyl-9-(4-methyl-piperazin-1-yl)-6-oxo-2,3-dihydro-6h-1-oxa-3a-aza-phenalene-5-carboxylic acid
- dl-8280
- dl-8280
- exocin
- exocin
- floxin
- floxin
- floxin
- floxin
- floxin otic
- floxin otic
- gailuoxian
- gailuoxian
- gailuoxian
- gailuoxian
- gailuoxian
- gailuoxian
- hoe-280
- hoe-280
- ocuflox
- ocuflox
- ofloxacin
- ofloxacin
- ofloxacin
- ofloxacin
- ofloxacin
- ofloxacin
- ofloxacin
- ofloxacin
- ofloxacin
- (-)-ofloxacin
- (-)-ofloxacin
- ofloxacine
- ofloxacine
- ofloxacine
- ofloxacin hcl
- ofloxacin hydrochloride
- ofloxacino
- ofloxacino
- ofloxacin s-(-)-form
- ofloxacin s-(-)-form
- ofloxacinum
- ofloxacinum
- oflx
- oflx
- ovax
- oxaldin
- prifloxcin
- prifloxin
- (s)-ofloxacin
- (s)-ofloxacin
- (s)-ofloxacin
- tarivid
- tarivid
- tarivid 400
- tarivid i.v.
- visiren
- visiren
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05904691 | Phase 1 | Nov 1, 2023 | Ocugenix Corporation |
| NCT05816070 | Phase 2 | Jan 5, 2023 | IVIEW Therapeutics Inc. |
| NCT05302531 | Phase 1 | Apr 4, 2022 | Fresenius, Société Francophone Nutrition Clinique et Métabolisme, University of Lorraine |
| NCT05074147 | Phase 3 | Nov 30, 2021 | Centre Hospitalier de Tourcoing |
| NCT05946655 | N/A | Apr 1, 2021 | Jagiellonian University |
| NCT04496024 | N/A | Jun 2, 2020 | University of Picardie Jules Verne |
| NCT05213156 | Phase 4 | Sep 24, 2019 | University of Patras |
| NCT04005079 | Phase 3 | Jun 5, 2019 | Yeshiva University |
| NCT03933631 | Phase 3 | May 1, 2019 | Yeshiva University |
| NCT03655665 | Phase 4 | Dec 31, 2018 | Harvard University |
| NCT04353362 | Phase 4 | Apr 1, 2017 | Istanbul Medipol University |
| NCT02528123 | N/A | Apr 1, 2016 | London Vision Clinic |
| NCT02717871 | Phase 3 | Mar 1, 2016 | University of Geneva |
| NCT02357407 | Phase 4 | Jun 1, 2015 | University of Rennes |
| NCT02424461 | Phase 3 | Feb 1, 2015 | University of Paris |
| NCT02373137 | Phase 4 | Jan 1, 2015 | Oregon Health and Science University, Stanford University, University of California, San Francisco |
| NCT01573910 | Phase 3 | May 1, 2012 | Alcon |
| NCT01799356 | Phase 4 | Jun 1, 2010 | Bakirkoy Dr. Sadi Konuk Research and Training Hospital |
| NCT01241110 | Phase 4 | Jan 1, 2010 | Guilin University |
| NCT00873626 | Phase 4 | Jun 1, 2009 | University of Paris |
Organizations
Research & Development (42)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Alcon | For profit | 2 | 2 | 1 | 2005 |
| Genaera Corporation | For profit | 2 | 0 | 1 | 1994 |
| MacroChem Corporation | For profit | 2 | 2 | 1 | 1994 |
| University of Paris | Academic/Hospital | 2 | 2 | 2 | 2009 |
| Yeshiva University | Academic/Hospital | 2 | 2 | 1 | 2019 |
| AVAX Technologies | For profit | 1 | 1 | 1 | 2008 |
| Bakirkoy Dr. Sadi Konuk Research and Training Hospital | Academic/Hospital | 1 | 1 | 1 | 2010 |
| Bayer | For profit | 1 | 1 | 1 | 2003 |
| Boston University | Academic/Hospital | 1 | 0 | 1 | 2003 |
| Centre Hospitalier de Tourcoing | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Daiichi Sankyo | For profit | 1 | 1 | 1 | 2002 |
| Eastern Cooperative Oncology Group | Academic/Hospital | 1 | 0 | 1 | 1997 |
| Emek Medical Center | Academic/Hospital | 1 | 1 | 1 | 2007 |
| Free University of Brussels | Academic/Hospital | 1 | 0 | 1 | 2007 |
| Fresenius | For profit | 1 | 0 | 1 | 2022 |
| Guilin University | Academic/Hospital | 1 | 1 | 1 | 2010 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Indiana University | Academic/Hospital | 1 | 1 | 1 | 2002 |
| Istanbul Medipol University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| IVIEW Therapeutics Inc. | For profit | 1 | 1 | 1 | 2023 |
Marketing (34)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Akorn, Inc. | For profit | MKTG | Apr 15, 2008 |
| Allergan | For profit | NDA2 | Jul 30, 1993 |
| Altair Therapeutics | For profit | MKTG | Apr 29, 2013 |
| Alvogen | For profit | MKTG | Aug 31, 2004 |
| Amneal Pharmaceuticals | For profit | MKTG | Aug 30, 2019 |
| Amneal Pharmaceuticals | For profit | SYN | Aug 30, 2019 |
| Apotex | For profit | MKTG | May 14, 2004 |
| Bausch & Lomb | For profit | MKTG | May 14, 2004 |
| Bausch & Lomb | For profit | SYN | Mar 17, 2008 |
| Bedford Pharmaceuticals | For profit | MKTG | Jan 16, 2002 |
| Cadila Healthcare | For profit | MKTG | Sep 18, 2014 |
| Caplin Point Laboratories | For profit | MKTG | Jan 5, 2024 |
| Chartwell Pharmaceuticals | For profit | MKTG | Sep 2, 2003 |
| Daiichi | For profit | NDA2 | Dec 16, 1997 |
| Dr. Reddy's Laboratories | For profit | MKTG | Feb 10, 2006 |
| Epic Pharma Llc | For profit | MKTG | May 14, 2004 |
| FDC | For profit | MKTG | Feb 25, 2009 |
| Hi Tech Pharmaceuticals | For profit | MKTG | May 14, 2004 |
| Hikma | For profit | MKTG | Mar 17, 2008 |
| Johnson and Johnson | For profit | NDA2 | Dec 28, 1990 |
| Johnson and Johnson | For profit | SYN | Mar 31, 1992 |
| Johnson and Johnson | For profit | NDA | Dec 28, 1990 |
| Larken Labs Inc | For profit | MKTG | Sep 2, 2003 |
| Mankind Pharma | For profit | MKTG | Jul 14, 2022 |
| Micro Labs Ltd India | For profit | MKTG | Apr 8, 2026 |
| Novartis | For profit | MKTG | May 14, 2004 |
| Ranbaxy | For profit | MKTG | Jun 17, 2003 |
| SENTISS | For profit | MKTG | Apr 15, 2008 |
| Sandoz | For profit | MKTG | Nov 25, 2008 |
| Sandoz | For profit | SYN | May 14, 2004 |
| SmithKline Beecham | For profit | NDA2 | Jul 30, 1993 |
| Somerset Pharmaceuticals | For profit | MKTG | Aug 1, 2024 |
| Somerset Pharmaceuticals | For profit | SYN | Oct 15, 2024 |
| Teva | For profit | MKTG | Sep 2, 2003 |