treprostinil palmitil inhalation (INS1009) / Insmed - LARVOL DELTA

COMPERA 2.0 risk assessment of treprostinil palmitil inhalation powder (TPIP) for pulmonary arterial hypertension (PAH): a post hoc analysis of a phase 2 study (ERS 2026) - P2 | "The proportion of patients on TPIP in the lower risk groups increased by visit while those in the intermediate-high group decreased; shifts to lower risk were already noted at Week 5. These data suggest that TPIP treatment may contribute to a reduction in risk, by COMPERA 2.0 risk scores, for patients with PAH."

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

FUNCTIONAL RESPIRATORY IMAGING AND CLINICAL OUTCOME CORRELATIONS WITH TREPROSTINIL PALMITIL INHALATION POWDER (TPIP) TREATMENT FOR PULMONARY ARTERIAL HYPERTENSION (PAH) (CHEST 2026) - No abstract available

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

AN OPEN-LABEL EXTENSION STUDY OF TREPROSTINIL PALMITIL INHALATION POWDER (TPIP) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): 1-YEAR DATA FROM A 2-YEAR STUDY (CHEST 2026) - No abstract available

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

PALM-PPF: A Study to Assess the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Progressive Pulmonary Fibrosis (PPF) (clinicaltrials.gov) - P3 | N=800 | Not yet recruiting | Sponsor: Insmed Incorporated

New P3 trial • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

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 | 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 Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Insmed Incorporated | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology

Insmed continues to anticipate initiating a Phase 3 study of TPIP in patients with progressive pulmonary fibrosis (PPF) in the second half of 2026 and a Phase 3 study in patients with idiopathic pulmonary fibrosis (IPF) in the first half of 2027. (Insmed Press Release)

New P3 trial • Idiopathic Pulmonary Fibrosis

A Phase 2 Study of the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Patients With Pulmonary Hypertension Associated With Interstitial Lung Disease. (PubMed, Pulm Circ) - P2 | "Trends for improvement were observed in 6MWD and NT-proBNP with TPIP treatment. These results suggest that TPIP may be a suitable once-daily treatment for PH-ILD."

Journal • P2 data • Cardiovascular • Cough • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

PALM-PAH: Study Design of a Phase 3 Trial of Treprostinil Palmitil Inhalation Powder in Patients With Pulmonary Arterial Hypertension (PHA 2026) - P2 | "Randomization will be stratified by geographic region (Europe, Japan, North America, rest of world), World Health Organization (WHO) functional class (II, III, IV), sotatercept use (Yes/No), and baseline 6-minute walk distance (6MWD; =350 m and >350 m). This phase 3 trial aims to further evaluate efficacy, safety, and tolerability, of TPIP, administered once daily, in a broader group of patients with PAH already receiving background therapies."

Clinical • P3 data • Cardiovascular • Pulmonary Arterial Hypertension • Respiratory Diseases

A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Insmed Incorporated

New P1 trial • Hepatology

PALM-ILD: Study Design of a Phase 3 Trial of Treprostinil Palmitil Inhalation Powder in Patients With Pulmonary Hypertension Associated With Interstitial Lung Disease (PHA 2026) - P2, P3 | "PHA 2026 Conference: Abstracts This phase 3 trial aims to further evaluate the efficacy, safety, and tolerability of TPIP to support the development of a once-daily potential treatment option for patients with PH-ILD."

Clinical • P3 data • Cardiovascular • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Randomized, Double-Blind, Placebo-Controlled Study of Treprostinil Palmitil Inhalation Powder in Patients With Pulmonary Arterial Hypertension (PHA 2026) - P2 | "TPIP added to background therapy resulted in a statistically significant improvement in the primary endpoint (PVR) and showed numerical improvement in 6MWD and other prespecified efficacy measures approximately 24 hours after the prior dose. Safety outcomes were consistent with those expected for the inhaled prostanoid class. Figures/Images: Table."

Clinical • Cardiovascular • Cough • Pulmonary Arterial Hypertension • Respiratory Diseases

Investigational Treprostinil Palmitil Inhalation Powder (TPIP): An inhaled Prostacyclin Prodrug being studied for the once-daily treatment of PAH and PH-ILD (PHA 2026) - "Frantz will give a brief overview of PAH and PH-ILD, an overview of Treprostinil Palmatil Inhalation Powder (TPIP), an inhaled prostacyclin prodrug under investigation for a once-daily treatment of PAH and PH-ILD, and highlight the TPIP development program with a focus on the ongoing Phase 3 trial designs and how they were informed by the current clinical data. TPIP is an investigational product that is not approved for any condition or jurisdiction."

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

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 | Recruiting | Sponsor: Insmed Incorporated | Not yet recruiting ➔ Recruiting

Enrollment open • 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

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 | Completed | Sponsor: Insmed Incorporated | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

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

Trial initiation date • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

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

Trial initiation date • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • NPPB

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

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