Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis

This trial is a randomized, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of inhaled Nintedanib Dry Powder Inhalation (DPI) in adults with idiopathic pulmonary fibrosis (IPF). Participants are randomized to receive either 2 mg QID, 4 mg BID, or matching placebo for 12 weeks, followed by a 24-week open-label extension in which all participants receive active treatment. The primary focus is on safety-particularly bronchospasm events, lung function changes (FEV1, FEV1/FVC), and adverse event rates and assessing the effectiveness of nintedanib DPI in treating IPF.

NCT Number	NCT07679893
Lead Sponsor	Mannkind Corporation
Conditions	Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
Enrollment	210 participants
Start Date	2026-06-30
Primary Completion	2028-01-30 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-24