Ozenoxacin
Xepi (ozenoxacin) is a small molecule pharmaceutical. Ozenoxacin was first approved as Xepi on 2017-12-11. It is used to treat impetigo in the USA.
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Commercial
Trade Name
FDA
EMA
Xepi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ozenoxacin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XEPI | Ferrer Internacional | N-208945 RX | 2017-12-11 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xepi | New Drug Application | 2020-01-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| impetigo | EFO_1000714 | D007169 | L01 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
43 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Narcolepsy | D009290 | EFO_0000614 | G47.4 | 3 | — | 4 | 1 | 1 | 9 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | — | — | 3 | — | 3 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | — | 1 | 1 | 2 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | 2 | — | 2 |
| Rem sleep behavior disorder | D020187 | EFO_0007462 | G47.52 | — | — | — | 1 | — | 1 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | — | 1 | — | 1 |
| Sleep | D012890 | GO_0030431 | — | — | — | 1 | — | 1 | |
| Palliative care | D010166 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | 4 | — | — | 5 |
| Idiopathic hypersomnia | D020177 | G47.11 | — | 1 | 1 | — | — | 1 | |
| Cluster headache | D003027 | HP_0012199 | G44.00 | — | — | 1 | — | — | 1 |
| Binge-eating disorder | D056912 | F50.2 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep initiation and maintenance disorders | D007319 | F51.01 | — | 2 | — | — | — | 2 | |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | — | — | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | — | — | — | 1 |
| Essential tremor | D020329 | EFO_0003108 | G25.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Traumatic brain injuries | D000070642 | S06 | 1 | — | — | — | — | 1 | |
| Disorders of excessive somnolence | D006970 | G47.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | — | — | — | — | 1 | 1 | ||
| Psychological trauma | D000067073 | — | — | — | — | 1 | 1 | ||
| Physiological stress | D013312 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | OZENOXACIN |
| INN | ozenoxacin |
| Description | Ozenoxacin is a member of quinolines. |
| Classification | Small molecule |
| Drug class | antibacterials (quinolone derivatives) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CNc1ncc(-c2ccc3c(=O)c(C(=O)O)cn(C4CC4)c3c2C)cc1C |
Identifiers
| PDB | — |
| CAS-ID | 245765-41-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3990047 |
| ChEBI ID | — |
| PubChem CID | 9863827 |
| DrugBank | DB12924 |
| UNII ID | V0LH498RFO (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Xepi - Biofrontera
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 272 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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58,017 adverse events reported
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