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

SAFETY AND TOLERABILITY OF INHALED NINTEDANIB DRY POWDER IN PARTICIPANTS WITH IDIOPATHIC PULMONARY FIBROSIS: A RANDOMIZED PHASE 1B STUDY (CHEST 2026) - No abstract available

Clinical • Late-breaking abstract • P1 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

INFLO-2: Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=153 | Recruiting | Sponsor: Mannkind Corporation | Trial completion date: Dec 2028 ➔ Jun 2028

Trial completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Business Update and Upcoming Milestones (GlobeNewswire) - "Site activation and enrollment underway in the global Phase 2 INFLO-2 study."

Trial status • Idiopathic Pulmonary Fibrosis • Immunology

MannKind reports positive Phase 1b results for IPF treatment (Investing.com) - "The study met its primary objective, with nintedanib DPI demonstrating safety and tolerability in IPF patients. Key findings included no serious adverse events, no drug-related gastrointestinal side effects, no bronchospasm events, and no treatment discontinuations or dose reductions. The company reported that 90% of patients experienced no cough or mild cough, with cough events described as predominantly mild and transient."

P1 data • Idiopathic Pulmonary Fibrosis

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Mannkind Corporation | Recruiting ➔ Completed

Trial completion • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

INFLO-2: Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=210 | Recruiting | Sponsor: Mannkind Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

INFLO-2: Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=210 | Not yet recruiting | Sponsor: Mannkind Corporation

New P2 trial • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Safety and Pharmacokinetic Data for Inhaled Administration of Nintedanib Dry Powder Inhalation for Treatment of Pulmonary Fibrotic Diseases. (PubMed, J Aerosol Med Pulm Drug Deliv) - P1 | "Inhaled administration of nintedanib via DPI may offer advantages over oral therapies in patients with IPF, potentially reducing adverse effects associated with systemic exposure. Results of the preclinical and phase 1 studies support continued assessment of this formulation in patients with IPF and other pulmonary fibrotic diseases."

Clinical • First-in-human • Journal • PK/PD data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

MannKind Enters Data-Rich Development Period with Completion of Randomization in Phase 1b INFLO-1 Study and Enrollment of First Patient in Phase 2 INFLO-2 Trial for Nintedanib DPI in Patients with IPF (GlobeNewswire) - "MannKind expects to report data from the INFLO-1 study in the third quarter of 2026, which is expected to provide an initial clinical assessment of safety, tolerability, and pharmacokinetics in patients with IPF. INFLO-2 is expected to enroll approximately 210 participants across approximately 85 sites worldwide. The first patient was enrolled in Windsor, Canada."

Enrollment open • P1 data • Trial status • Idiopathic Pulmonary Fibrosis

Nintedanib DPI (MNKD-201) (GlobeNewswire) - "Completed enrollment of Cohort 1 in Phase 1b (INFLO-1) study with no discontinuations or serious adverse events in patients with idiopathic pulmonary fibrosis (IPF); topline data expected in Q3 2026...Anticipate Phase 2 clinical trial (INFLO-2) in IPF with first patient enrolled in Q2 2026."

New P2 trial • P1 data • Trial status • Idiopathic Pulmonary Fibrosis

Business Update and Upcoming Milestones (The Manila Times) - "Enrollment underway in Phase 1b (INFLO-1) study, top line data expected in 2H 2026; Initiated Phase 2 clinical trial (INFLO-2) in idiopathic pulmonary fibrosis (IPF) and plan to enroll first patient in Q2 2026."

P1 data • Trial status • Idiopathic Pulmonary Fibrosis

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Mannkind Corporation

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

A Comparative Study of Spray Drying and Jet Milling in the Preparation of Nintedanib Dry Powder for Inhalation. (PubMed, Pharm Dev Technol) - "Compared with conventional methods, the aqueous spray drying route delivered comparable or superior in vitro inhalation performance and delivery efficiency, while improving safety during preparation and usage process (such as reducing the risk of organic solvent residue and dust exposure). These results provide a practical strategy for safe, efficient nintedanib inhalation formulations and a platform to spray drying other poorly water-soluble drugs into DPI particles."

Journal

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