Glycopyrrolate/indacaterol

Drug Profile

Glycopyrrolate/indacaterol

Alternative Names: Indacaterol maleate/glycopyrronium bromide; Indacaterol/glycopyrrolate; Indacaterol/NVA-237; NVA-237/indacaterol; NVA-237/QAB-149; QVA-149; Ultibro Breezhaler; Ultibro Inhalation Capsules; Ulunar Breezhaler; Utibron Neohaler; Xoterna Breezhaler

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Arakis Ltd; Novartis; Vectura
  • Developer Novartis; Pfizer; Sunovion Pharmaceuticals
  • Class Antiasthmatics; Antispasmodics; Bronchodilators; Indans; Pyrrolidines; Quaternary ammonium compounds; Small molecules
  • Mechanism of Action Beta 2 adrenergic receptor agonists; Muscarinic receptor antagonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Chronic obstructive pulmonary disease

Most Recent Events

  • 23 May 2017 Pooled efficacy and adverse events data from the phase III FLIGHT1 and FLIGHT2 trials in Chronic obstructive pulmonary disease presented at the American Thoracic Society 2017 International Conference (ATS-2017)
  • 03 Apr 2017 Launched for Chronic obstructive pulmonary disease in USA (Inhalation)
  • 03 Apr 2017 The approved label for glycopyrrolate/indacaterol has a black box warning
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