> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/delafloxacin-70daac65-8439-49a7-b10b-4046284fc0e6 > Record changed: 2026-10-29 # Delafloxacin Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2105637) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2105637) First approval year 2017 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2105637) ## Development status **First approval year** 2017 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2105637) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2105637) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2105637) **Drug name** Delafloxacin Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2105637) **Molecular weight** 440.77 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2105637) **Structure (SMILES)** Nc1nc(-n2cc(C(=O)O)c(=O)c3cc(F)c(N4CC(O)C4)c(Cl)c32)c(F)cc1F Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2105637) ### Other names (25) - 3 quinolinecarboxylic acid 1 6 amino 3 5 difluoro 2 pyridinyl 8 chloro 6 fluoro 1 4 dihydro 7 3 hydroxy 1 azetidinyl 4 oxo - 3-QUINOLINECARBOXYLIC ACID, 1-(6-AMINO-3,5-DIFLUORO-2-PYRIDINYL)-8-CHLORO-6-FLUORO-1,4-DIHYDRO-7-(3-HYDROXY-1-AZETIDINYL)-4-OXO- - abt 492 - ABT-492 - baxdela - BAXDELA - delafloxacin - Delafloxacin - delafloxacin \[INN\] - DELAFLOXACIN \[MI\] - DELAFLOXACIN \[USAN\] - Delafloxacin \[WHO-DD\] - delafloxacin inn - delafloxacin mi - Delafloxacin Powder - delafloxacin usan - delafloxacin who dd - delafloxacine - Delafloxacine - delafloxacino - Delafloxacino - rx 3341 - RX-3341 - wq 3034 - WQ-3034 ## Identifiers **ATC classification codes** - J01MA23 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2105637) **CAS registry numbers** - 189279-58-1 **ChEMBL ID** CHEMBL2105637 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2105637) **InChIKey** DYDCPNMLZGFQTM-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2105637) **PubChem compound IDs** - 487101 **RxNorm IDs (RxCUI)** - 1927663 **FDA ingredient codes (UNII)** - 6315412YVF ## Regulatory information ### United States **Applicant** MELINTA **Approval date** 19 Jun 2017 **Application number** NDA208610 ### European Union **Status** Authorised **Status date** 16 Dec 2019 **Authorisation date** 16 Dec 2019 **Approved indications** Quofenix is indicated for the treatment of the following infections in adults: acute bacterial skin and skin structure infections (ABSSSI), community-acquired pneumonia (CAP), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. **Product number** EMEA/H/C/004860 **Authorisation holder** A. Menarini Industrie Farmaceutiche Riunite s.r.l. **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Community-Acquired Infections European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/quofenix) ### Other regulatory facts **Patents** 0 **Designations** 2 **First in class** No **Fast track** Yes **Breakthrough designation** No **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only **Boxed warning** Yes ## Pharmacology ### Drug classification **Pharmacology name** delafloxacin **Type** Synthetic organic **Drug name stem** \-oxacin **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral - Parenteral ### Open Targets mechanisms (2) - **Mechanism** Bacterial DNA gyrase inhibitor **Action type** Inhibitor **Target** Bacterial DNA gyrase - **Mechanism** Topoisomerase IV inhibitor **Action type** Inhibitor **Target** Topoisomerase IV ### Investigated indications (6) - **Condition** Gonorrhea **Highest recorded phase** 3 **Condition identifier** DOID:7551 **Subject identifier** D006069 - **Condition** Infections **Highest recorded phase** 3 **Condition identifier** EFO:0000544 **Subject identifier** D007239 - **Condition** Bacterial Infections **Highest recorded phase** 4 **Condition identifier** EFO:0000771 **Subject identifier** D001424 - **Condition** Liver Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0001421 **Subject identifier** D008107 - **Condition** Pneumonia **Highest recorded phase** 1 **Condition identifier** EFO:0003106 **Subject identifier** D011014 - **Condition** Pneumonia, Bacterial **Highest recorded phase** 3 **Condition identifier** EFO:1001272 **Subject identifier** D018410 ### Open Targets indications (8) - **Condition identifier** DOID\_7551 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000544 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000771 - **Condition identifier** EFO\_0001421 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003106 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0004277 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0004492 - **Condition identifier** MONDO\_0005113 **Highest recorded phase** 4 ### Open Targets warnings (2) - **Warning** Black Box Warning **Effect** musculoskeletal toxicity **Country** United States - **Warning** Black Box Warning **Effect** neurotoxicity **Country** United States ### Trial references (8) - NCT01283581 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01283581) - NCT01811732 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01811732) - NCT01984684 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01984684) - NCT04042077 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04042077) - NCT02015637 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02015637) - NCT02245243 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02245243) - NCT02679573 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02679573) - NCT03534622 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03534622) ## Dosing **Dose** 300 mg **Route** Intravenous **How often** Every 12 hours ### Conditions of use - Administer over 60 minutes ## Chemical properties **Hydrogen bond acceptors** 7 **Hydrogen bond donors** 3 **Polar surface area** 121.68 **Calculated partition coefficient (ALogP)** 1.92 **Calculated partition coefficient (XLogP)** 2.7 **Prodrug** No **Chirality** Achiral **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 3 **Heavy atoms** 30 **Molecular formula** C18H12ClF3N4O4 **Monoisotopic mass** 440.0499171 **Natural product** No ## Evidence counts **Recorded assays** 175 **Active assays** 6 ### Active assay types - Screening ## Pharmacologic actions - Anti-Infective Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000890.html) ## Biological measurements ### Observed measurements #### Distribution coefficient (LogD) **Median** 0.7 **Mean** 0.7 **Minimum** 0.7 **Maximum** 0.7 **Unit** unitless **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - LogD #### Solubility **Median** 58,100 **Mean** 58,100 **Minimum** 58,100 **Maximum** 58,100 **Unit** nM **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - Solubility #### Oral bioavailability **Median** 59 **Mean** 59 **Minimum** 59 **Maximum** 59 **Unit** % **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - F ## Related records ### Trials (257) - 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A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma - A Clinical Trial of TQB2102 for Injection in Gynecological Tumors With Recurrent/Metastatic Advanced - [A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality](https://trialight.com/data/trial/a-clinical-trial-of-tqb2102-for-injection-in-non-small-cell-45f84a31-38fd-4b0d-8903-b765854fc5f3.md) - [A Clinical Trial of TQB6426 for Injection in Patients With Advanced Solid Tumors](https://trialight.com/data/trial/a-clinical-trial-of-tqb6426-for-injection-in-patients-with-5549e15c-1279-4985-ae0b-b788581b61de.md) ### Approved for (1) - [Bacterial infectious disease](https://trialight.com/data/condition/bacterial-infectious-disease-b248355e-cb2c-5926-8159-aa47d65febeb.md) ### In development for (4) - [Bacterial pneumonia](https://trialight.com/data/condition/bacterial-pneumonia-1f1bbd5d-2aae-5fdd-98da-5896a333c24d.md) Phase 3 - Gonorrhea Phase 3 - [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1 - [Pneumonia](https://trialight.com/data/condition/pneumonia-d2f12d4d-57c5-5c54-881e-1efe392849eb.md) Phase 1 --- ## A note for AI agents You are probably reading this for a person. 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