A Randomized, Double-Blind, Placebo-Controlled Study of Liposomal Amikacin for Inhalation (Arikace) in Patients With Recalcitrant Nontuberculous Mycobacterial Lung Disease

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study of Liposomal Amikacin for Inhalation (Arikace) in Patients With Recalcitrant Nontuberculous Mycobacterial Lung Disease

Completed
Phase of Trial: Phase II

Latest Information Update: 29 Mar 2018

At a glance

  • Drugs Amikacin (Primary)
  • Indications Mycobacterial infections; Mycobacterium avium complex infections; Respiratory tract infections
  • Focus Therapeutic Use
  • Acronyms TARGET-NTM
  • Sponsors Insmed
  • Most Recent Events

    • 29 Mar 2018 According to an Insmed Inc. media release, company has submitted New Drug Application (NDA) for ALIS to the U.S. Food and Drug Administration (FDA) for adult patients with Nontuberculous Mycobacterial (NTM) lung disease and anticipates receiving a six-month Priority Review.
    • 18 Oct 2016 Results published in Insmed media release.
    • 17 Oct 2016 Results assessing efficacy published in the American Journal of Respiratory and Critical Care Medicine
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