MannKind Discontinues Phase 3 Trial for Nontuberculous Mycobacterial Lung Disease Treatment
MannKind Corporation announced today the discontinuation of its Phase 3 ICoN-1 clinical trial evaluating a nebulized formulation of clofazimine for the treatment of refractory nontuberculous mycobacterial (NTM) lung disease, a chronic and often debilitating infection.
The decision, made following a futility determination based on data from the first 46 participants, means the drug did not show sufficient evidence of effectiveness. An independent Data Safety Monitoring Board (DSMB) reviewed the data yesterday, November 8, 2025, and concurred with MannKind’s decision, noting no safety concerns were identified during the study. The ICoN-1 trial was a multi-national, randomized, double-blind, placebo-controlled study focused on adults with NTM lung disease caused by Mycobacterium avium complex (MAC).
“We are disappointed that the nebulized formulation did not demonstrate efficacy in this patient population,” said Dr. Ajay Ahuja, Chief Medical Officer of MannKind Corporation. “However, we remain hopeful regarding the potential of MNKD-102, our dry powder inhalation (DPI) formulation of clofazimine, which has been progressing toward Phase 1 development.” MannKind is continuing to explore treatment options for NTM, which affects over 100,000 people in the U.S. alone, according to recent estimates. More information about this complex disease can be found at Learn About NTM.
Despite this setback, MannKind will host a conference call today at 9:00 AM EST to discuss the trial’s outcome and future plans for MNKD-102, its DPI formulation of clofazimine. Investors can find details about the webcast on the MannKind website.
