Status: Recruiting

A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)

The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP compared with placebo on exercise capacity in adults with PAH.

Participants needed: 344

Trial details

Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Insmed IncorporatedUpdated: Aug 19, 2026Locations: 3

Eligibility criteria

Idiopathic PAH [+16]

Diagnosis of PH WHO Groups 2, 3, 4, or 5, or subtypes of PH WHO Group 1 other th... [+6]

Status: Recruiting

Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.

Participants needed: 344

Trial details

Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Insmed IncorporatedUpdated: Aug 14, 2026Locations: 145

Eligibility criteria

Diagnosis of PH World Health Organisation (WHO) Group 3 associated with ILD [inc... [+7]

Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5, or subtypes of PH... [+11]

Status: Recruiting

An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).

Participants needed: 344

Trial details

Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Insmed IncorporatedUpdated: Aug 13, 2026Locations: 9

Eligibility criteria

Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07... [+2]

Participants who experienced any adverse events (AEs) evaluated as causally rela... [+4]

Status: Not yet recruiting

A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of INS1033 in Healthy Participants

The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of INS1033 in healthy participants.

Participants needed: 116

Trial details

Phase: Phase 1Age: 18-50Biological sex: AllType: InterventionalSponsor: Insmed IncorporatedUpdated: Aug 14, 2026

Eligibility criteria

Healthy status as defined by the absence of evidence of any clinically significa... [+1]

Use of any investigational drug or device within 30 days of the first dose of IN... [+2]

Status: Recruiting

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

The primary purpose of the study is to determine the effect of mild, moderate, and severe hepatic impairment on the PK of total treprostinil palmitil (TP) and treprostinil (TRE) following a single dose of 80 micrograms (μg) TPIP, when compared to normal hepatic function.

Participants needed: 30

Trial details

Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Insmed IncorporatedUpdated: Aug 11, 2026Locations: 2

Eligibility criteria

Body mass index between 18.0 and 40.0 kilograms per square meter (kg/m²), inclus... [+4]

History of stomach or intestinal surgery or resection that would potentially alt... [+9]

Status: Available

An Expanded Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

The purpose of this study is to provide continued access to TPIP for participants who have successfully completed the open-label extension (OLE) studies of INS1009-203 for PAH or INS1009-212 for PH-ILD.

Trial details

Age: 18+Biological sex: AllType: Expanded AccessSponsor: Insmed IncorporatedUpdated: Jun 10, 2026

Eligibility criteria

The participant is ineligible for or cannot be treated satisfactorily with alter... [+6]

Clinical trials

A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)

Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of INS1033 in Healthy Participants

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

An Expanded Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)