Drugs / Delafloxacin

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Quofenix 2019-12-16 europa.eu

Trials 11 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT06612255 Jun → Sep 2024 Melinta Therapeutics, Inc. Terminated No outcome recorded
Phase 1 NCT03534622 Apr → Jul 2018 pneumonia Melinta Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT02505997 Jun → Jul 2015 Melinta Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT02245243 Sep 2014 → Feb 2015 Melinta Therapeutics, Inc. Completed No outcome recorded
Phase 22 trials
Phase 2 NCT01283581 Jan → Nov 2011 skin disease caused by bacterial infection Melinta Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT00719810 Jun → Oct 2008 skin disease caused by bacterial infection, skin infection, staphylococcal infection Melinta Therapeutics, Inc. Completed No outcome recorded
Phase 35 trials
Phase 3 NCT04042077 Sep 2019 → Oct 2020 Menarini Group Terminated No outcome recorded
Phase 3 NCT02679573 Dec 2016 → Jul 2018 bacterial pneumonia Melinta Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT01984684 May 2014 → Dec 2015 skin disease caused by bacterial infection Melinta Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT02015637 Jan → Nov 2014 gonorrhea Melinta Therapeutics, Inc. Terminated No outcome recorded
Phase 3 NCT01811732 Apr 2013 → Jul 2014 skin disease caused by bacterial infection Melinta Therapeutics, Inc. Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 4 NCT05977868 Background Aug 2023 → Feb 2025 digestive system infectious disorder West Virginia University Terminated No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as Delafloxacin ClinicalTrials.gov intervention name — accepted as the source's own label NCT02679573
11

NCT00719810

NCT01283581

NCT02245243

NCT06612255

NCT01984684

NCT02015637

NCT01811732

NCT04042077

NCT02505997

NCT03534622

NCT05977868

Known as ABT-492 ChEMBL registry synonym — accepted as the source's own label CHEMBL2105637
Known as Baxdela ChEMBL registry synonym — accepted as the source's own label CHEMBL2105637
Known as Delafloxacine ChEMBL registry synonym — accepted as the source's own label CHEMBL2105637
Known as Delafloxacino ChEMBL registry synonym — accepted as the source's own label CHEMBL2105637
Known as Quofenix ChEMBL registry synonym — accepted as the source's own label CHEMBL2105637
Known as RX-3341 ChEMBL registry synonym — accepted as the source's own label CHEMBL2105637
Known as WQ-3034 ChEMBL registry synonym — accepted as the source's own label CHEMBL2105637
Known as WQ-3034 AND ABT-492 ChEMBL registry synonym — accepted as the source's own label CHEMBL2105637
Modality Small molecule “RX-3341 (delafloxacin), a fluoroquinolone” NCT00719810
Route Intravenous “delafloxacin 300mg intravenous (IV) every 12h” PMID 25448332 Oct 2014