Ofloxacin
Ocuflox, Ofloxacin (ofloxacin) is a small molecule pharmaceutical. Ofloxacin was first approved as Floxin on 1990-12-28. It is used to treat bacterial conjunctivitis, bacterial infections, bacterial skin diseases, bronchitis, and chlamydia infections amongst others in the USA.
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Commercial
Trade Name
FDA
EMA
Ocuflox, Ofloxacin (discontinued: Floxin, Ofloxacin)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ocuflox | New Drug Application | 2024-06-13 |
| ofloxacin | ANDA | 2025-06-12 |
| ofloxacin ophth soln | ANDA | 2025-01-22 |
| ofloxacin ophthalmic | ANDA | 2022-10-28 |
| ofloxacin otic | ANDA | 2025-01-17 |
Indications
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Agency Specific
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Patent Expiration
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ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01M: Quinolone antibacterials
— J01MA: Fluoroquinolone antibacterials, systemic
— J01MA01: Ofloxacin
— J01R: Combinations of antibacterials
— J01RA: Combinations of antibacterials
— J01RA09: Ofloxacin and ornidazole
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AE: Fluoroquinolone antiinfectives, ophthalmologic
— S01AE01: Ofloxacin
— S02: Otologicals
— S02A: Antiinfective drugs, otologic
— S02AA: Antiinfectives
— S02AA16: Ofloxacin
Clinical
Clinical Trials
427 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | — | 2 | 1 | — | 3 |
| Appendicitis | D001064 | EFO_0007149 | K37 | — | — | — | 1 | — | 1 |
| Critical illness | D016638 | — | — | — | — | — | 1 | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | 1 | 6 | — | — | 6 |
| Communicable diseases | D003141 | — | — | — | 1 | 5 | — | — | 5 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | 3 | — | 1 | 4 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | 3 | — | 1 | 4 |
| Bronchitis | D001991 | — | J40 | — | 1 | 3 | — | 1 | 4 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 1 | 4 | — | — | 4 |
| Chronic bronchitis | D029481 | — | J42 | — | 1 | 3 | — | — | 3 |
| Acute disease | D000208 | — | — | — | 1 | 3 | — | — | 3 |
| Skin diseases | D012871 | — | L00-L99 | — | 1 | 3 | — | — | 3 |
| Prostatitis | D011472 | EFO_0003830 | N41 | — | — | 2 | — | — | 2 |
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Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | — | — | — | 1 |
| Retinal diseases | D012164 | — | H35.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retinal detachment | D012163 | EFO_0005773 | H33.2 | — | — | — | — | 2 | 2 |
| Aortic dissection | D000784 | — | I71.0 | — | — | — | — | 1 | 1 |
| Dissociative disorders | D004213 | — | F44.1 | — | — | — | — | 1 | 1 |
| Musculoskeletal diseases | D009140 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ofloxacin |
| INN | ofloxacin |
| Description | Ofloxacin is a racemate comprising equimolar amounts of levofloxacin and dextrofloxacin. It is a synthetic fluoroquinolone antibacterial agent which inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication. It has a role as a DNA synthesis inhibitor, an antiinfective agent, an antibacterial drug, an EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor and a topoisomerase IV inhibitor. It is a quinolone antibiotic, a fluoroquinolone antibiotic and a racemate. It contains a levofloxacin and a dextrofloxacin. |
| Classification | Small molecule |
| Drug class | antibacterials (quinolone derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1COc2c(N3CCN(C)CC3)c(F)cc3c(=O)c(C(=O)O)cn1c23 |
Identifiers
| PDB | — |
| CAS-ID | 82419-36-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4 |
| ChEBI ID | 7731 |
| PubChem CID | 4583 |
| DrugBank | DB01165 |
| UNII ID | A4P49JAZ9H (ChemIDplus, GSRS) |
Target
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Estimated US medical usage
Ofloxacin
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Trends
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Additional graphs summarizing 19,965 documents
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Safety
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Adverse Events
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103,839 adverse events reported
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