MannKind receives PMDA approval for Phase 3 trial of Clofazimine Inhalation Suspension for NTM lung disease.

MannKind Corporation has received approval from Japan's PMDA to start a Phase 3 trial for Clofazimine Inhalation Suspension, aimed at treating nontuberculous mycobacterial (NTM) lung disease. The study, ICoN-1, will take place in the U.S., Japan, South Korea, and Australia, with Taiwan anticipated to join in late 2024. The trial plans to enroll approximately 230 participants to assess the treatment's efficacy alongside standard therapy.

September 18, 2024
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