MannKind 获得 PMDA 批准用于氯法齐明吸入混悬液治疗 NTM 肺病的 3 期试验。 MannKind receives PMDA approval for Phase 3 trial of Clofazimine Inhalation Suspension for NTM lung disease.

MannKind Corporation 已获得日本 PMDA 的批准，开始氯法齐明吸入混悬液的 3 期试验，旨在治疗非结核分枝杆菌 （NTM） 肺病。 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. 这项研究(ICON-1)将在美国、日本、韩国和澳大利亚进行,台湾预计将在2024年底加入。 The study, ICoN-1, will take place in the U.S., Japan, South Korea, and Australia, with Taiwan anticipated to join in late 2024. 试验计划招收约230名参与者,与标准疗法一起评估治疗的功效。 The trial plans to enroll approximately 230 participants to assess the treatment's efficacy alongside standard therapy.