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: Discontinued

Phase of Trial: Phase III

Latest Information Update: 17 Nov 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

12 Nov 2025 Actual primary completion date changed to 10 Nov 2025.
12 Nov 2025 Status changed from recruiting to discontinued because of futility.
05 Nov 2025 According to MannKind Corporation media release, interim analysis (study sample size re-estimation) expected mid-year 2026

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