Finafloxacin
Xtoro (finafloxacin) is a small molecule pharmaceutical. Finafloxacin was first approved as Xtoro on 2014-12-17. It is used to treat otitis externa and staphylococcal infections in the USA.
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Drug Products
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New Drug Application (NDA)
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Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Finafloxacin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XTORO | FONSECA BIOSCIENCES | N-206307 DISCN | 2014-12-17 | 1 products, RLD |
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Indications
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Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| otitis externa | EFO_0009560 | D010032 | H60 |
| staphylococcal infections | — | D013203 | A49.01 |
Agency Specific
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
90 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Iron-deficiency anemia | D018798 | HP_0001891 | D50 | — | 2 | 12 | 5 | 1 | 20 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 2 | 2 | 4 | 2 | — | 9 |
| Chronic renal insufficiency | D051436 | N18 | — | — | 1 | 1 | — | 2 | |
| Pregnancy rate | D018873 | — | — | 1 | 1 | — | 2 | ||
| Intracranial arteriosclerosis | D002537 | EFO_1000860 | I67.2 | 1 | — | — | 1 | — | 2 |
| Osteonecrosis | D010020 | EFO_0004259 | M87 | — | 1 | — | 1 | — | 2 |
| Inflammation | D007249 | — | 1 | — | 1 | — | 2 | ||
| Menorrhagia | D008595 | N92.0 | — | — | — | 1 | — | 1 | |
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | 1 | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 2 | 3 | — | — | 2 | 6 | |
| Glioblastoma | D005909 | EFO_0000515 | 3 | 1 | — | — | 2 | 6 | |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 3 | 2 | — | — | — | 5 |
| Prostatic neoplasms | D011471 | C61 | 2 | 1 | — | — | 1 | 4 | |
| Urinary bladder neoplasms | D001749 | C67 | 1 | 1 | — | — | — | 2 | |
| Aids dementia complex | D015526 | EFO_0002608 | 1 | 1 | — | — | — | 2 | |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | — | — | 1 | 2 |
| Non-small-cell lung carcinoma | D002289 | — | 1 | — | — | — | 1 | ||
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | 2 | — | — | — | 1 | 3 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | — | — | — | 1 | 3 |
| Esophageal neoplasms | D004938 | C15 | 2 | — | — | — | 1 | 3 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | 1 | 2 |
| Triple negative breast neoplasms | D064726 | 1 | — | — | — | — | 1 | ||
| Hypoxia | D000860 | R09.02 | 1 | — | — | — | — | 1 | |
| Fetal growth retardation | D005317 | EFO_0000495 | 1 | — | — | — | — | 1 | |
| Dental caries | D003731 | EFO_0003819 | K02 | 1 | — | — | — | — | 1 |
| Head and neck neoplasms | D006258 | 1 | — | — | — | — | 1 | ||
| Central nervous system vascular malformations | D020785 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Papillary thyroid cancer | D000077273 | — | — | — | — | 1 | 1 | ||
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | — | 1 | 1 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 1 | 1 |
| Migraine without aura | D020326 | EFO_0005296 | G43.0 | — | — | — | — | 1 | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 1 | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | — | 1 | 1 |
| Glioma | D005910 | EFO_0000520 | — | — | — | — | 1 | 1 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FINAFLOXACIN |
| INN | finafloxacin |
| Description | Finafloxacin is a quinolone that is 4-oxo-1,4-dihydroquinoline-3-carboxylic acid which is substituted at positions 1, 6, 7 and 8 by cyclopropyl, fluoro, hexahydropyrrolo[3,4-b][1,4]oxazin-6-yl and cyano groups respectively; an antibiotic used for treatment of acute otitis externa (swimmer's ear) caused by the bacteria Pseudomonas aeruginosa and Staphylococcus aureus. It has a role as an antimicrobial agent and an antibacterial drug. It is a quinolone, a monocarboxylic acid, an organofluorine compound, a secondary amino compound, a tertiary amino compound, a nitrile and a member of cyclopropanes. |
| Classification | Small molecule |
| Drug class | antibacterials (quinolone derivatives) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | N#Cc1c(N2C[C@@H]3NCCO[C@H]3C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12 |
Identifiers
| PDB | — |
| CAS-ID | 209342-40-5 |
| RxCUI | 1598641 |
| ChEMBL ID | CHEMBL1908370 |
| ChEBI ID | 85176 |
| PubChem CID | 11567473 |
| DrugBank | DB09047 |
| UNII ID | D26OSN9Q4R (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
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Safety
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Adverse Events
Top Adverse Reactions
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1,534 adverse events reported
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