Drugs / Delafloxacin
Delafloxacin
also known as
ABT-492 · Baxdela · Delafloxacine · Delafloxacino · Quofenix · RX-3341 · WQ-3034 · WQ-3034 AND ABT-492
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Quofenix | — | 2019-12-16 | europa.eu ↗ |
| Filed | EU (EMA) | Quofenix | acute bacterial skin and skin structure infections | 2017-03-06 | “on March 6th 2017 it has submitted a Marketing Authorization Application for delafloxacin at the European Medicines Agency (EMA) under the trade name Quofenix.” menarini.com ↗ |
| Filed | US (FDA) | Baxdela | acute bacterial skin and skin structure infections | — | “Melinta submitted NDAs (New Drug Applications) to the US FDA for the intravenous and oral formulations of Baxdela for the ABSSSI indication” menarini.com ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials · 1 met primary | ||||||
| Phase 1 | NCT06612255 | Jun → Sep 2024 | — | Melinta Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT03534622 | Apr → Jul 2018 | pneumonia | Melinta Therapeutics, Inc. | Completed | Met primary |
| 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 · 1 met primary | ||||||
| Phase 2 | NCT01283581 | Jan → Nov 2011 | skin disease caused by bacterial infection | Melinta Therapeutics, Inc. | Completed | Met primary |
| 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 · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT04042077 | Sep 2019 → Oct 2020 | — | Menarini Group | Terminated | Met primary |
| 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 | Met primary |
| Phase 3 | NCT02015637 | Jan → Nov 2014 | gonorrhea | Melinta Therapeutics, Inc. | Terminated | Missed primary |
| Phase 3 | NCT01811732 | Apr 2013 → Jul 2014 | skin disease caused by bacterial infection | Melinta Therapeutics, Inc. | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT05977868 Background | Aug 2023 → Feb 2025 | digestive system infectious disorder | West Virginia University | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2020-07-09 | Menarini Group | Results Menarini Ricerche Announces the Latest Findings of its Vaborem™ and Quofenix™ Clinical Studies menarini.com ↗
Menarini Ricerche, the R&D division of the Menarini Group, announces that it has published four abstracts presenting the latest findings related to its meropenem/vaborbactam (Vaborem ™ ) and delafloxacin (Quofenix ™ ) clinical studies, confirming Menarini’s commitment to fighting life-threatening bacterial infections. |
| 2018-03-09 | Menarini Group | Regulatory The Menarini Group announced marketing authorization Application for delafloxacin menarini.com ↗
The Menarini Group announced today that on March 6th 2017 it has submitted a Marketing Authorization Application for delafloxacin at the European Medicines Agency (EMA) under the trade name Quofenix. |
| 2016-10-24 | Ligand Pharmaceuticals | Regulatory Ligand Partner Melinta Therapeutics Submits Baxdela New Drug Application for Hospital-Treated Skin Infections ligand.com ↗
Ligand Partner Melinta Therapeutics Submits Baxdela New Drug Application for Hospital-Treated Skin Infections |
| 2015-01-08 | Ligand Pharmaceuticals | Results Ligand Partner Melinta Therapeutics Reports Positive Phase 3 Results for Captisol-enabled™ Delafloxacin IV ligand.com ↗
Delafloxacin met the study’s primary objective endpoint of a reduction in the measurement of lesion erythema at the primary infection site at 48- to- 72 hours, the endpoint required by the U.S. Food and Drug Administration (FDA). |
All press releases naming this drug 8 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Delafloxacin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06612255 ↗ |
| 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 |