Glycopyrrolate - Sunovion Respiratory Development/PARI Pharma

Drug Profile

Glycopyrrolate - Sunovion Respiratory Development/PARI Pharma

Alternative Names: EP-101; Glycopyrrolate bromide; SUN-101; SUN-101/eFlow®

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Elevation Pharmaceuticals
  • Developer PARI Pharma GmbH; Sunovion Respiratory Development
  • Class Antiasthmatics; Antispasmodics; Pyrrolidines; Quaternary ammonium compounds; Skin disorder therapies; Small molecules
  • Mechanism of Action Muscarinic receptor antagonists
  • 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.

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Chronic obstructive pulmonary disease
  • Phase II Asthma

Most Recent Events

  • 13 Oct 2016 FDA assigns PDUFA action date of 29/05/2017 for glycopyrrolate for Chronic obstructive pulmonary disease
  • 29 Jul 2016 Preregistration for Chronic obstructive pulmonary disease in USA (Inhalation)
  • 27 Apr 2016 Sunovion announces intention to submit NDA for Chronic obstructive pulmonary disease to the US FDA in 2016
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