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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-center Study of an Inhaled Pan-Janus Kinase Inhibitor, TD-0903, to Treat Symptomatic Acute Lung Injury Associated with COVID-19

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Trial Profile

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-center Study of an Inhaled Pan-Janus Kinase Inhibitor, TD-0903, to Treat Symptomatic Acute Lung Injury Associated with COVID-19

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Feb 2023

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At a glance

  • Drugs Nezulcitinib (Primary)
  • Indications Acute lung injury; COVID 2019 infections; Respiratory insufficiency
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Therapeutic Use
  • Sponsors Theravance Biopharma

Most Recent Events

  • 21 Jun 2021 According to a Theravance Biopharma media release, the company will share these results with FDA and other regulatory agencies to seek input on protocols to further study nezulcitinib in acute hyperinflammation in the lung. A more detailed analysis of the data, including further pharmacokinetic and biomarker results, will be available in the future. The company will host a conference Call and Live Webcast today.
  • 21 Jun 2021 Primary endpoint (Part 2: Respiratory Failure-Free Days (RFDs)) has not been met as per Theravance Biopharma media release
  • 21 Jun 2021 Results published in the Theravance Biopharma Media Release

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