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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 Mar 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

  • 20 Feb 2026 According to an Insmed media release, In March or April of 2026, the Company anticipates the topline readout of the Phase 3 ENCORE trial in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics.
  • 03 Feb 2026 Status changed from active, no longer recruiting to completed.
  • 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.

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