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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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Trial Profile

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: 21 Nov 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

  • 30 Oct 2025 According to an Insmed media release, the company anticipates the topline readout of the trial in the first half of 2026. And assuming successful results, company plans to submit a supplementary new drug application (sNDA) to the U.S. FDA in the second half of 2026.
  • 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.

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