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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: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Sep 2026

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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

  • 03 Sep 2026 According to Insmed media release, data from the trial will be presented at the European Respiratory Society (ERS) Congress 2026 taking place Sept. 5-9, 2026, in Barcelona.
  • 06 Aug 2026 According to Insmed media release, in July 2026, Insmed submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in newly diagnosed patients with MAC lung disease.
  • 04 May 2026 According to an Insmed media release, data from the trial will be presented at the American Thoracic Society International Conference 2026 (ATS 2026), taking place May 17-20 in Orlando, Florida.

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