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
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| baxdela | New Drug Application | 2025-08-01 |
Indications
FDA
EMA
No data
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
13 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | 2 | 3 | 1 | — | 6 |
| Communicable diseases | D003141 | — | — | — | 2 | 1 | 1 | — | 4 |
| Soft tissue infections | D018461 | — | — | — | — | 1 | 1 | — | 2 |
| Pulmonary infarction | D054060 | EFO_1001408 | — | — | — | — | 1 | — | 1 |
| Gastroenteritis | D005759 | EFO_1001463 | K52.9 | — | — | — | 1 | — | 1 |
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 |
| Bacterial skin diseases | D017192 | — | — | — | 1 | 2 | — | — | 3 |
| Infectious skin diseases | D012874 | — | — | — | 1 | 1 | — | — | 2 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | — | 1 | — | — | 2 |
| 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 |
| Skin diseases | D012871 | — | L00-L99 | — | 1 | — | — | — | 1 |
| Cellulitis | D002481 | EFO_0003035 | L03.90 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic foot | D017719 | EFO_1001459 | — | — | — | — | — | 1 | 1 |
| Foot ulcer | D016523 | — | — | — | — | — | — | 1 | 1 |
| Osteitis | D010000 | — | — | — | — | — | — | 1 | 1 |
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
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Variants
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Baxdela – Melinta Therapeutics /new/
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 956 documents
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Safety
Black-box Warning
Black-box warning for: Baxdela
Adverse Events
Top Adverse Reactions
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243 adverse events reported
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