MannKind Receives PMDA Clearance for Phase 3 Trial of Clofazimine Inhalation Suspension for NTM Lung Disease

MannKind Corporation has announced clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to begin the Phase 3 clinical trial (ICoN-1) of its Clofazimine Inhalation Suspension for treating nontuberculous mycobacterial (NTM) lung disease. This global trial is also approved in the U.S., South Korea, and Australia, with Taiwan expected to join by the end of 2024. The study will involve 230 participants across over 100 international sites.

The ICoN-1 trial is a randomized, double-blind, placebo-controlled study to evaluate Clofazimine Inhalation Suspension’s efficacy and safety. It targets patients with refractory NTM lung disease caused by mycobacterium avium complex (MAC), assessing sputum culture conversion and quality of life improvement. The trial follows the U.S. FDA’s Fast Track designation for Clofazimine, which also holds orphan drug and qualified infectious disease product (QIDP) status.

MannKind’s expansion into Japan and other countries highlights the increasing need for effective treatments for NTM lung infections, which are on the rise globally. If successful, the drug could secure long-term market exclusivity, further advancing care for patients with serious lung infections.