treprostinil palmitil inhalation (INS1009) / Insmed - LARVOL DELTA

PALM-PAH: A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - P3 | N=344 | Not yet recruiting | Sponsor: Insmed Incorporated

New P3 trial • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Population Pharmacokinetics Analysis of Treprostinil Using Data From Phase 1 and 2 Studies of Treprostinil Palmitil Inhalation Powder (ATS 2026) - No abstract available

Clinical • P1 data • PK/PD data • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Changes in Hemodynamic Parameters in a Phase 2 Study Investigating Treprostinil Palmitil Inhalation Powder (TPIP) in Patients with Pulmonary Arterial Hypertension (PAH) (ISHLT 2026) - P2 | "Effects of TPIP on exploratory hemodynamic parameters are summarized in the Figure.Conclusion TPIP showed improvements in cardiopulmonary hemodynamic parameters, with no impact on systemic vascular resistance. These changes are suggestive of vascular remodeling and favorable impacts on heart function."

Clinical • P2 data • Cardiovascular • Pulmonary Arterial Hypertension • Respiratory Diseases

INS1009-311: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of Trepostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (clinicaltrialsregister.eu) - P2/3 | N=251 | Not yet recruiting | Sponsor: Insmed Inc.

New P2/3 trial • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Insmed also announced timeline updates for key clinical trials… (Investing.com) - "...results from the Phase 2b CEDAR study of brensocatib in hidradenitis suppurativa expected in the second quarter of 2026....The company initiated its Phase 3 PALM-ILD study of TPIP in pulmonary hypertension associated with interstitial lung disease in the fourth quarter of 2025, with additional Phase 3 studies planned for 2026."

New P3 trial • P2b data • Trial status • Hidradenitis Suppurativa • Immunology • Interstitial Lung Disease • Pulmonary Disease

PALM-ILD: Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) (clinicaltrials.gov) - P3 | N=344 | Recruiting | Sponsor: Insmed Incorporated | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Study to Assess the Relative Bioavailability After a Single Inhalation Administration of Treprostinil Palmitil Inhalation Powder (TPIP) Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Insmed Incorporated | Recruiting ➔ Completed

Trial completion

An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) (clinicaltrials.gov) - P3 | N=344 | Not yet recruiting | Sponsor: Insmed Incorporated

New P3 trial • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Insmed plans to initiate a Phase 3 study of TPIP in patients with pulmonary arterial hypertension (PAH) in early 2026. (PRNewswire)

New P3 trial • Interstitial Lung Disease • Pulmonary Arterial Hypertension

The Company anticipates initiating additional Phase 3 studies of TPIP in progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) in the second half of 2026. (PRNewswire)

New P3 trial • Idiopathic Pulmonary Fibrosis

Insmed anticipates initiating PALM-ILD, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), in the fourth quarter of 2025. (PRNewswire)

New P3 trial • Interstitial Lung Disease • Pulmonary Arterial Hypertension

Late Breaking Abstract - A randomized, double-blind, placebo-controlled study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH) (ERS 2025) - No abstract available

Clinical • Late-breaking abstract • Cardiovascular • Pulmonary Arterial Hypertension • Respiratory Diseases

Insmed to Present Multiple Abstracts at the European Respiratory Society Congress 2025 (PRNewswire) - "Notably, data from the Phase 2 trial in treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH) will be highlighted in the Congress's Abstracts Leading to Evolution in Respiratory Medicine Trials (ALERT) session, which showcases important, late-breaking clinical data from all respiratory disease areas. In addition, presentations include three prespecified subgroup analyses from the Phase 3 ASPEN trial evaluating the efficacy and safety of brensocatib, including Japanese patient data, as well as Health Outcomes and Economic Research from The Health Improvement Network® (THIN) database in France and the United Kingdom in patients with non-cystic fibrosis bronchiectasis (NCFB)."

Clinical data • Interstitial Lung Disease • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Arterial Hypertension

A Study to Assess the Relative Bioavailability After a Single Inhalation Administration of Treprostinil Palmitil Inhalation Powder (TPIP) Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Insmed Incorporated | Not yet recruiting ➔ Recruiting

Enrollment open

PALM-ILD: Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) (clinicaltrials.gov) - P3 | N=344 | Not yet recruiting | Sponsor: Insmed Incorporated

New P3 trial • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Study to Assess the Relative Bioavailability After a Single Inhalation Administration of Treprostinil Palmitil Inhalation Powder (TPIP) Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: Insmed Incorporated

New P1 trial

Functional Respiratory Imaging (FRI) Markers Correlate With Clinical Endpoints in a Phase 2 Study of Treprostinil Palmitil Inhalation Powder in Patients With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) (ATS 2025) - P2 | "These findings support the use of quantitative HRCT parameters as markers of treatment response in pre-capillary PH. Further evaluation of FRI and TPIP effects in a larger trial may provide additional insights."

Clinical • P2 data • Cardiovascular • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Recent Progress and Anticipated Milestones by Program (PRNewswire) - "Insmed completed the Phase 2b study of treprostinil palmitil inhalation powder (TPIP) in pulmonary arterial hypertension (PAH), with topline data anticipated in June of 2025; The Company plans to initiate a Phase 3 study of TPIP in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the second half of 2025...Insmed initiated the Phase 1 ASCEND clinical study of INS1201, an intrathecally-delivered gene therapy for patients with Duchenne muscular dystrophy (DMD), in the first quarter of 2025, and expects to dose the first patient in the second quarter of 2025; The Company's next two gene therapy candidates, which target amyotrophic lateral sclerosis (ALS) and Stargardt disease, are currently advancing toward the clinic."

New P3 trial • P2b data • Pipeline update • Trial status • Amyotrophic Lateral Sclerosis • Duchenne Muscular Dystrophy • Genetic Disorders • Interstitial Lung Disease • Ophthalmology • Pulmonary Arterial Hypertension

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - P2/3 | N=91 | Active, not recruiting | Sponsor: Insmed Incorporated | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Post Trial Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: Insmed Incorporated

New trial • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

INS1009-202: A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension (clinicaltrials.gov) - P2 | N=102 | Completed | Sponsor: Insmed Incorporated | Trial primary completion date: Jul 2025 ➔ Mar 2025 | Active, not recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Mar 2025

Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Insmed to Present 11 Abstracts from Across Its Respiratory Portfolio at the American Thoracic Society 2025 International Conference (PRNewswire) - "Presentations include several prespecified subgroup analyses from the Phase 3 ASPEN study evaluating the efficacy and safety of brensocatib, new health economics and outcomes research in MAC lung disease, and clinical data from the Phase 2a study of treprostinil palmitil inhalation powder (TPIP) in pulmonary hypertension associated with interstitial lung disease (PH-ILD).1"

Clinical data • Bronchiectasis • Interstitial Lung Disease • Non‐Cystic Fibrosis Bronchiectasis

Insmed Reports Fourth-Quarter and Full-Year 2024 Financial Results and Provides Business Update (PRNewswire) - "ARIKAYCE global revenue grew 19% in 2024 compared to 2023...The Company continues to anticipate a topline readout for ENCORE in the first quarter of 2026, with the submission of a supplementary new drug application (sNDA) to the FDA for ARIKAYCE in all patients with MAC lung disease in the U.S. expected later in 2026...Regulatory submissions for brensocatib in the EU, UK, and Japan are planned for 2025, with commercial launches anticipated in 2026...The Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) remains on track to report topline results by the end of 2025...The Company plans to initiate a Phase 3 study of TPIP in patients with PH-ILD in the second half of 2025. Enrollment in the Phase 2b study of TPIP in pulmonary arterial hypertension (PAH) completed in December 2024...Insmed continues to anticipate topline data from the study in the middle of 2025."

Commercial • Filing • New P3 trial • P2b data • P3 data: top line • Infectious Disease • Nasal Polyps • Pulmonary Arterial Hypertension • Pulmonary Disease

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) (clinicaltrials.gov) - P2/3 | N=31 | Active, not recruiting | Sponsor: Insmed Incorporated | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Novel insights from functional respiratory imaging (FRI) analysis in phase 2 INS1009-211 study: Treprostinil palmitil inhalation powder (TPIP) impact on pulmonary vasculature in patients with PH-ILD (PVRI 2025) - No abstract available

Clinical • P2 data • Interstitial Lung Disease