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ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

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ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Mar 2025

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At a glance

  • Drugs Amikacin (Primary) ; Azithromycin; Ethambutol
  • Indications Lung disorders; Mycobacterium avium complex infections; Nontuberculous mycobacterium infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ENCORE
  • Sponsors Insmed

    • Most Recent Events

    • 20 Feb 2025 According to an Insmed Incorporated media release, the topline data is expected in first quarter of 2026.
    • 10 Jan 2025 According to an Insmed Incorporated media release, The Company anticipates the submission of a supplementary new drug application (sNDA) for ARIKAYCE in all patients with MAC lung disease projected for later in 2026.
    • 25 Nov 2024 Status changed from recruiting to active, no longer recruiting.

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