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Delafloxacin - Melinta Therapeutics

Drug Profile

Delafloxacin - Melinta Therapeutics

Alternative Names: ABT-492; Baxdela; Quofenix; RX-3341; RX-3341-83; WQ-3034

Latest Information Update: 05 Nov 2018

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At a glance

  • Originator Wakunaga Pharmaceutical
  • Developer Abbott Laboratories; Eurofarma; Melinta Therapeutics; Menarini
  • Class Antibacterials; Azetidines; Fluoroquinolones; Pyridines; Small molecules
  • Mechanism of Action DNA gyrase inhibitors; DNA topoisomerase IV inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Skin and soft tissue infections
  • Phase III Community-acquired pneumonia
  • Phase I Urinary tract infections
  • Discontinued Acute exacerbations of chronic bronchitis; Anthrax; Gonorrhoea; Intra-abdominal infections

Most Recent Events

  • 29 Oct 2018 Melinta Therapeutics announced intention to submit supplemental NDA to USFDA for community-acquired bacterial pneumonia in the first half of 2019
  • 29 Oct 2018 Efficacy and adverse events data from a phase III trial in Community-acquired bacterial pneumonia released by Melinta Therapeutics
  • 07 Aug 2018 Melinta Therapeutics completes the phase III DEFINE-CABP trial in Community-acquired pneumonia in Ukraine, Spain, Slovenia, Serbia, Russia, Romania, Poland, Latvia, Hungary, Germany, Georgia, Bulgaria, USA (IV) (NCT02679573)
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