Drug Profile


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

Latest Information Update: 09 Jan 2017

Price : $50

At a glance

  • Originator Wakunaga Pharmaceutical
  • Developer Abbott Laboratories; Melinta Therapeutics
  • 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.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Community-acquired pneumonia; Skin and soft tissue infections
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 05 Jan 2017 PDUFA action date of 19/06/2017 assigned by FDA for delafloxacin for Skin and soft tissue infections (IV, PO)
  • 01 Dec 2016 Phase-III clinical trials in Community-acquired pneumonia in USA (IV) (NCT02679573)
  • 26 Oct 2016 Safety and efficacy data from the phase III RX3341-303 trial in Skin and soft tissue infections were presented at the IDWeek-2016
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