nintedanib dry powder (MNKD-201) / MannKind - LARVOL DELTA

Nintedanib DPI (MNKD-201) (GlobeNewswire) - "Initiated IPF Phase 2 clinical trial (INFLO) and plan to enroll first patient in Q1 2026."

New P2 trial • Idiopathic Pulmonary Fibrosis

Nintedanib DPI (MNKD-201) (GlobeNewswire) - "Expect to initiate Phase 2 clinical trial for IPF by YE 2025; Research and development expenses increased by $1.9 million, or 16%, for the three months ended June 30, 2025 compared to the same period in the prior year. The increase was primarily attributable to continued patient enrollment in the ICoN-1 study for MNKD-101, clinical production scale up for MNKD-201, and personnel costs primarily due to additional headcount as a result of the Pulmatrix transaction completed in the third quarter of 2024, which bolstered research capabilities and capacity."

Commercial • New P2 trial • Idiopathic Pulmonary Fibrosis

Inhaled nintedanib dry powder formulation for the treatment of idiopathic pulmonary fibrosis: Pharmacodynamic and pharmacokinetic study. (PubMed, Int J Pharm) - "In conclusion, the pulmonary delivered nintedanib achieved comparable antifibrotic efficacy to oral nintedanib, but at a much lower dose and with reduced systemic exposure. These results underscore the potential of SD-NTB as a safe and effective inhalation therapy for IPF, offering substantial advantages over conventional oral delivery."

Journal • PK/PD data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

MannKind Corporation Reports Second Quarter 2025 Financial Results And Provides Business Update (GlobeNewswire) - "Nintedanib DPI (MNKD-201): Expect to initiate Phase 2 clinical trial for IPF by YE 2025."

New P2 trial • Idiopathic Pulmonary Fibrosis

MannKind Corporation Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Nintedanib DPI (MNKD-201): Planning to advance into the next phase of global development in 2H 2025."

Clinical • Respiratory Diseases

MannKind Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Requested meeting with the U.S. Food and Drug Administration ('FDA') in 1H 2025 to discuss data submission for potential approval of Afrezza in the pediatric population. Expect twelve-month data set with safety extension in 1H 2025. Anticipate supplemental new drug application filing in 1H 2025 pending FDA feedback. Clofazimine Inhalation Suspension Phase 3 (ICON-1) global clinical trial (MNKD-101)...Expect to meet the interim enrollment target by YE 2025....Nintedanib DPI Phase 1 clinical trial (MNKD-201)...Expect to meet with the FDA in 1H 2025 to advance MNKD-201 into next phase of development..."

Enrollment status • FDA event • Idiopathic Pulmonary Fibrosis • Nontuberculous Mycobacterial Disease • Type 2 Diabetes Mellitus

Dry Powder Inhalation of Nintedanib in Dibasic Calcium Phosphate for Targeting the Lungs in Pulmonary Fibrosis. (PubMed, Mol Pharm) - "We prepared three variants of nintedanib dry powder inhalations (DPIs), one with dibasic calcium phosphate dihydrate (CaHPO4·2H2O) and two with lactose monohydrate as the carrier. Lung fibrosis induced in rats using bleomycin was resolved equally well by the two interventions administered q12h for 14 days. We submit that the reduction in systemic exposure to nintedanib and enhanced exposure to target tissue could offer significant therapeutic and safety advantages, and CaHPO4 can be easily developed as an excipient for DPIs."

Journal • Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

MannKind Successfully Completes Phase 1 Trial of Nintedanib DPI for Pulmonary Fibrotic Diseases (GlobeNewswire) - P1 | N=40 | NCT06532942 | Sponsor: Mannkind Corporation | "MannKind Corporation...announced the successful completion of its first-in-human Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF)....Nintedanib DPI was shown to be safe and well tolerated in healthy volunteers with the tested doses and study duration; Participants did not experience typical adverse events seen with oral nintedanib; specifically, no GI or neurologic adverse events (AEs) were reported...No serious adverse events or study drug discontinuation."

P1 data • Idiopathic Pulmonary Fibrosis • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Mannkind Corporation

New P1 trial

MannKind to Proceed With Phase 1 Nintedanib Dpi (Mnkd-201) Study for Pulmonary Fibrotic Diseases (Mannkind Corp Press Release) - "Enrollment of first study participant anticipated in June 2024...MannKind Corporation...announced today that it will proceed with a first-in-human Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF)....The Phase 1 randomized, double-blind, placebo-controlled, single- (SAD) and multiple-ascending dose (MAD) study will evaluate the safety, tolerability, and pharmacokinetics (PK) of nintedanib inhalation powder (MNKD-201) in healthy volunteers."

New P1 trial • Idiopathic Pulmonary Fibrosis • Pulmonary Disease • Respiratory Diseases