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ICoN-1: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Clofazamine Inhalation Suspension When Added to Guideline-Based Therapy in Participants With Nontuberculous Mycobacterial Infection

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Trial Profile

ICoN-1: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Clofazamine Inhalation Suspension When Added to Guideline-Based Therapy in Participants With Nontuberculous Mycobacterial Infection

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Jun 2025

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At a glance

  • Drugs Clofazimine (Primary)
  • Indications Mycobacterium avium complex infections; Nontuberculous mycobacterium infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ICoN-1
  • Sponsors MannKind Corporation

Most Recent Events

  • 08 May 2025 According to a MannKind Corporation media release, 85% of anticipated sites have been activated in five countries (U.S., Japan, Australia, South Korea, Taiwan) 55 patients randomized in four countries (U.S., Japan, Australia, South Korea). Expect to meet the interim enrollment target of 100 patients by YE 2025.
  • 26 Feb 2025 According to a MannKind Corporation media release, Approximately 70% of anticipated sites have been activated in four countries (U.S., Japan, Australia, South Korea) with Patients randomized in two countries (U.S. and Australia) and company expects to meet the interim enrollment target by YE 2025
  • 07 Nov 2024 According to a MannKind Corporation media release, approximately 230 participants to be randomized at 100+ sites for a minimum of 180 evaluable participants.

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