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A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

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Trial Profile

A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Mar 2025

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At a glance

  • Drugs Ensifentrine (Primary)
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms ENHANCE-2
  • Sponsors Verona Pharma

    • Most Recent Events

    • 27 Feb 2025 According to a Verona Pharma media release, the company is initiating activities with regulatory authorities in the European Union and the UK for potential marketing authorization application submissions for Ohtuvayre.
    • 07 Feb 2025 According to a Nuance Pharma media release, the company announced that the Pharmaceutical Administration Bureau Macau approved Ohtuvayre™ (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. The approval in Macau SAR, China, was based on extensive data including the Global Phase 3 ENHANCE trials, the results of which were published in the American Journal of Respiratory and Critical Care Medicine.
    • 05 Sep 2024 According to a Veronce Pharma media release, data from the study will be presented at the European Respiratory Society International Congress 2024.

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