What is the mechanism of action of this treatment?

Common treatments for Pulmonary Hypertension (PH) include prostacyclin analogs, phosphodiesterase-5 inhibitors (PDE5Is), and endothelin receptor antagonists (ERAs). Prostacyclin analogs, such as treprostinil and epoprostenol, promote vasodilation and inhibit platelet aggregation, reducing pulmonary arterial pressure and improving blood flow. PDE5Is, like sildenafil, enhance nitric oxide effects, leading to vasodilation and better exercise capacity. ERAs, such as bosentan, block endothelin-1, a potent vasoconstrictor, reducing vascular resistance. These mechanisms are vital for PH patients as they help tailor treatment to effectively manage symptoms and improve quality of life.

What side effects are associated with this type of intervention?

Common treatments for Pulmonary Hypertension, such as prostacyclin analogs like treprostinil and iloprost, often have side effects including headache, nausea, vomiting, diarrhea, flushing, jaw pain, and site-specific pain for subcutaneous administration. Inhaled formulations may cause cough and throat irritation. These side effects are generally related to the vasodilatory properties of the medications.

What prior FDA approvals exist?

The FDA has approved several prostacyclin analogs for the treatment of Pulmonary Hypertension (PH). These include treprostinil, available in oral, inhaled, subcutaneous, and intravenous forms, and epoprostenol, which is administered intravenously. These drugs function by promoting vasodilation and inhibiting platelet aggregation, thereby improving hemodynamic parameters and exercise capacity in patients with PH. Inhaled treprostinil, similar to the Treprostinil Palmitil Inhalation Powder being studied, offers an alternative for patients who cannot tolerate or prefer not to use intravenous or subcutaneous formulations.

What other types of research exist?

Promising alternatives to Treprostinil Palmitil Inhalation Powder for pulmonary hypertension patients include: 1) Epoprostenol (IV prostacyclin) which improves hemodynamics and functional capacity; 2) Sildenafil and Tadalafil (PDE5Is) which enhance pulmonary hemodynamics and exercise capacity; 3) Bosentan and Macitentan (ERAs) which improve exercise capacity and delay clinical worsening; 4) Riociguat (soluble guanylate cyclase stimulator) which improves exercise capacity and hemodynamics. These alternatives offer various administration routes and mechanisms of action, providing tailored options for PH management.

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Prostacyclin Analogue

Treprostinil for Pulmonary Hypertension

Phase 2

Waitlist Available

Research Sponsored by Insmed Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females must be ≥ 18 to ≤ 80 years of age at the time of signing the informed consent form (ICF).

Diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD) (including idiopathic interstitial pneumonia [IIP], idiopathic pulmonary fibrosis [IPF], connective tissue disease [CTD], sarcoidosis).

Must not have

Any form of congenital heart disease or congenital heart defect (repaired or unrepaired) other than a patent foramen ovale.

Supplemental oxygen requirement > 10L/min at rest at Screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing the safety and tolerability of an inhaled powder medication called TPIP. It is likely aimed at patients with lung conditions like pulmonary arterial hypertension. The medication works by helping to open up blood vessels in the lungs, making it easier for blood to flow.

Who is the study for?

Adults aged 18-80 with pulmonary hypertension linked to interstitial lung disease can join this trial. They must not have a primary COPD diagnosis, allergies to the study drug or its components, recent use of certain heart and lung medications, severe heart issues, high oxygen needs, or substance abuse history. Participants should be able to perform required tests like the 6-minute walk test.

What is being tested?

The trial is testing Treprostinil Palmitil inhalation powder against a placebo for safety and tolerability in patients with pulmonary hypertension due to interstitial lung disease. It aims to see if this new treatment is safe for patients and doesn't cause too many problems when used.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions related to Treprostinil Palmitil inhalation powder compared with those taking a placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have high blood pressure in my lungs due to lung disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a heart condition from birth, not including a patent foramen ovale.

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I need more than 10 liters of oxygen per minute to breathe at rest.

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I have a condition that makes it hard for me to walk or complete physical tests.

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I currently use marijuana by inhaling it.

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I have a history of significant heart disease.

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I have a known heart rhythm problem, excluding occasional atrial fibrillation.

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I am not allergic to TPIP, treprostinil, or mannitol.

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I currently have symptoms of COVID-19 or was previously hospitalized due to it.

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I have been diagnosed with COPD.

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I have not had worsening heart failure in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT03055221

31%

Pyrexia

25%

Catheter site infection

19%

Nausea

19%

Device-related infection

19%

Abdominal discomfort

19%

Catheter site pain

19%

Device dislocation

19%

Cough

13%

Device-related sepsis

13%

Diarrhoea

13%

Vomiting

13%

Pain in extremity

13%

Pain in jaw

13%

Dyspnea

13%

Oropharyngeal pain

13%

Bacteraemia

13%

Headache

Sepsis

Pyogenic granuloma

Endocarditis

Localized infection

Lower respiratory tract infection

Nasopharyngitis

Pleural effusion

Pleurisy

Pulmonary arterial hypertension

Abortion induced

Thrombophlebitis

Venous thrombosis

Cyanosis

Lacrimation increased

Local swelling

Wound infection

Wound haemorrhage

Weight decreased

Muscle spasms

Decreased appetite

Coagulopathy

Pulmonary hypertension

Cardiac failure acute

Cardiac failure congestive

Right ventricular failure

Vertigo

Catheter site swelling

Chills

Disease progression

Infusion site pain

Hepatomegaly

Atypical pneumonia

Pneumonia

Septic shock

Polymenorrhea

Interstitial lung disease

Lung consolidation

Musculoskeletal chest pain

Epistaxis

Productive cough

Rhinorrhoea

Chest pain

Haematuria

Pain

Oedema

Insomnia

Gynacomastia

100%

80%

60%

40%

20%

Study treatment Arm

Intravenous Treprostinil

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treprostinil PalmitilExperimental Treatment1 Intervention

Participants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be titrated up to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be administered a placebo matching TPIP once daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treprostinil Palmitil

2022

Completed Phase 2

~40

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pulmonary Hypertension (PH) include prostacyclin analogs, phosphodiesterase-5 inhibitors (PDE5Is), and endothelin receptor antagonists (ERAs). Prostacyclin analogs, such as treprostinil and epoprostenol, promote vasodilation and inhibit platelet aggregation, reducing pulmonary arterial pressure and improving blood flow. PDE5Is, like sildenafil, enhance nitric oxide effects, leading to vasodilation and better exercise capacity. ERAs, such as bosentan, block endothelin-1, a potent vasoconstrictor, reducing vascular resistance. These mechanisms are vital for PH patients as they help tailor treatment to effectively manage symptoms and improve quality of life.

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Who is running the clinical trial?

Insmed IncorporatedLead Sponsor

42 Previous Clinical Trials

7,163 Total Patients Enrolled

~15 spots leftby Sep 2025

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