Baxdela, Quofenix(delafloxacin)
Baxdela, Quofenix (delafloxacin) is a small molecule pharmaceutical. Delafloxacin was first approved as Baxdela on 2017-06-19. It is used to treat bacterial infections, bacterial skin diseases, escherichia coli infections, klebsiella infections, and staphylococcal infections amongst others in the USA. It has been approved in Europe to treat community-acquired infections.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Baxdela
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Delafloxacin meglumine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BAXDELA | Melinta Therapeutics | N-208610 RX | 2017-06-19 | 1 products, RLD, RS |
| BAXDELA | Melinta Therapeutics | N-208611 RX | 2017-06-19 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| baxdela | New Drug Application | 2021-07-02 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DELAFLOXACIN MEGLUMINE, BAXDELA, MELINTA | |||
| 2027-06-19 | GAIN | ||
| 2022-06-19 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Delafloxacin Meglumine, Baxdela, Melinta | |||
| 9493582 | 2033-02-27 | DP | |
| 7728143 | 2031-06-19 | DP | |
| RE46617 | 2029-12-28 | DP | |
| 8871938 | 2029-09-23 | DP | |
| 7635773 | 2029-03-13 | DP | |
| 8410077 | 2029-03-13 | DP | |
| 9200088 | 2029-03-13 | DP | |
| 9750822 | 2029-03-13 | DP | |
| 8252813 | 2026-10-02 | DP | U-2028 |
| 8273892 | 2026-08-06 | DP | |
| 8648093 | 2025-10-07 | DP | U-2028 |
| 8969569 | 2025-10-07 | DP | U-2028 |
| 9539250 | 2025-10-07 | DS, DP | U-2028 |
HCPCS
Code | Description |
|---|---|
| C9462 | Injection, delafloxacin, 1 mg |
Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial infections | D001424 | — | A49 | — | 1 | 2 | — | — | 3 |
| Soft tissue infections | D018461 | — | — | — | — | 1 | — | — | 1 |
| Gonorrhea | D006069 | DOID_7551 | A54 | — | — | 1 | — | — | 1 |
| Surgical wound infection | D013530 | — | — | — | — | 1 | — | — | 1 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Staphylococcal skin infections | D013207 | EFO_1001849 | L00 | — | 1 | — | — | — | 1 |
| Bacterial skin diseases | D017192 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | D011014 | EFO_0003106 | — | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Delafloxacin |
| INN | delafloxacin |
| Description | Delafloxacin sold under the brand name Baxdela among others, is a fluoroquinolone antibiotic used to treat acute bacterial skin and skin structure infections.
|
| Classification | Small molecule |
| Drug class | antibacterials (quinolone derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1nc(-n2cc(C(=O)O)c(=O)c3cc(F)c(N4CC(O)C4)c(Cl)c32)c(F)cc1F |
Identifiers
| PDB | — |
| CAS-ID | 1256037-58-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2105637 |
| ChEBI ID | — |
| PubChem CID | 487101 |
| DrugBank | DB11943 |
| UNII ID | 6315412YVF (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
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Baxdela – Melinta Therapeutics /new/
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 775 documents
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Safety
Black-box Warning
Black-box warning for: Baxdela
Adverse Events
Top Adverse Reactions
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211 adverse events reported
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