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Nintedanib dry powder inhaler (DPI), designated as MNKD-201, is an investigational inhaled formulation of nintedanib developed by MannKind Corporation. It is designed to deliver nintedanib directly to the lungs via a dry powder inhalation route, aiming to treat pulmonary fibrotic diseases such as idiopathic pulmonary fibrosis (IPF). The rationale for this formulation is to maintain the antifibrotic efficacy of oral nintedanib while reducing systemic side effects—particularly gastrointestinal and neurologic adverse events—by targeting drug delivery directly to lung tissue. In Phase 1 clinical trials in healthy adults, MNKD-201 demonstrated a favorable safety and tolerability profile with only mild, transient adverse events (cough and FEV1 drop) that were not dose-dependent and fully resolved. No serious or typical oral-nintedanib-related adverse events were observed. The mechanism of action involves inhibition of multiple tyrosine kinases implicated in fibrogenesis and angiogenesis, including vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs), fibroblast growth factor receptors (FGFRs), Src-family kinases, Lyn kinase, Lck kinase, and Fms-like tyrosine kinase 3[4][5][8].
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