Danbury, Conn. & Westlake Village, Calif., July 29, 2026
MannKind Corporation announced positive topline results from its Phase 1b INFLO-1 clinical trial, demonstrating that its investigational nintedanib dry powder inhalation (DPI) therapy was generally safe and well tolerated in patients with idiopathic pulmonary fibrosis (IPF). The randomized, double-blind, placebo-controlled study successfully met its primary objective, providing important clinical validation for MannKind’s Technosphere® dry powder inhalation platform. Across the Phase 1b study, nearly 450 inhalations were administered to patients with IPF, with no serious adverse events, bronchospasm, gastrointestinal side effects, or treatment discontinuations reported. Approximately 90% of patients experienced either no cough or only mild cough, supporting the potential of inhaled nintedanib as an alternative to oral therapy. Building on these encouraging findings, the company confirmed that its global Phase 2 INFLO-2 trial is actively enrolling patients to further evaluate the therapy’s safety, tolerability, and clinical efficacy.
INFLO-1 Demonstrates Strong Safety and Tolerability Profile
The Phase 1b INFLO-1 trial enrolled 27 patients across 10 U.S. clinical sites and evaluated multiple ascending doses of nintedanib DPI administered over seven days. The study produced a favorable safety profile, with no serious adverse events, no drug-related diarrhea, nausea or vomiting, no bronchospasm, no dose reductions, and no treatment discontinuations. Lung function assessments showed no meaningful differences in spirometry parameters between patients receiving nintedanib DPI and placebo, while cough events were predominantly mild, transient, and self-resolving. These results build upon the previously completed Phase 1a first-in-human study, where healthy volunteers also demonstrated favorable safety, rapid drug absorption, and dose-proportional pharmacokinetics. Together, the two studies have treated 48 individuals, including 18 patients with IPF, creating what MannKind describes as the largest reported clinical dataset for an inhaled nintedanib therapy in idiopathic pulmonary fibrosis to date.
Technosphere® Platform Targets Drug Delivery Directly to Diseased Lung Tissue
Nintedanib is currently available as an oral therapy for idiopathic pulmonary fibrosis but is frequently associated with systemic gastrointestinal side effects, including diarrhea and nausea, which can negatively impact long-term treatment adherence. MannKind’s investigational MNKD-201 (nintedanib DPI) utilizes the company’s proprietary Technosphere® dry powder inhalation technology to deliver the medication directly into the deep lung, where fibrotic disease develops. This targeted delivery strategy is designed to maximize drug concentration at the site of disease while minimizing systemic exposure, potentially reducing treatment-limiting adverse effects. The positive Phase 1 findings provide further clinical validation of MannKind’s inhalation platform, which has already been successfully utilized in FDA-approved dry powder inhalation therapies and supports the company’s strategy of developing patient-friendly treatments for chronic pulmonary diseases.
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Global Phase 2 INFLO-2 Trial Advances Development in IPF
Following the encouraging Phase 1b results, MannKind is actively advancing the global Phase 2 INFLO-2 study, a randomized, double-blind, placebo-controlled trial expected to enroll approximately 210 patients across nearly 85 clinical sites worldwide. Participants will receive either 2 mg nintedanib DPI four times daily, 4 mg twice daily, or placebo for 12 weeks, followed by a 24-week open-label extension during which all participants will receive active treatment. The study will primarily evaluate safety and tolerability, while secondary endpoints include forced vital capacity (FVC), disease progression, pulmonary exacerbations, exercise capacity, pharmacokinetics, and patient-reported outcomes. As idiopathic pulmonary fibrosis continues to carry high morbidity and mortality despite currently available therapies, successful development of inhaled nintedanib could provide patients with a more tolerable treatment option capable of improving long-term disease management.
Source: MannKind Corporation press release
