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New inhaled powder shows promise for Long-Term PAH control

NCT ID NCT05649748

Disease control Sponsor: Insmed Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This study is testing the long-term safety and tolerability of an inhaled treprostinil powder (TPIP) in people with pulmonary arterial hypertension (PAH). About 91 participants who completed earlier TPIP studies will receive the drug for up to several years. Researchers will monitor side effects, walking distance, and blood markers of heart function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Treprostinil Palmitil (inhaled powder)
What this could lead to
If successful, this could confirm that long-term use of this inhaled treprostinil is safe and helps control pulmonary arterial hypertension symptoms.
What could go wrong
This is an open-label extension study with no placebo group, so results may be less reliable. Side effects from long-term use are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

91 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and female participants who completed end of treatment study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study. Participants for whom the OLE study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit. * Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study. Exclusion Criteria: * Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of studies INS1009-201, INS1009-202 or other TPIP studies. Initiation of inhaled prostacyclin analogues (eg, TRE \[Tyvaso\] or iloprost) and oral prostacyclin analogues (eg, TRE \[Orenitram\]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration. * Any new ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any new symptomatic bradycardia. * New-onset of heart disease including left ventricular ejection fraction (LVEF) ≤40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc). * New evidence of thromboembolic disease as assessed by ventilation/perfusion (VQ) scan, pulmonary angiography, or pulmonary computed tomography (CT) scan. * Active and current symptomatic coronavirus disease 2019 (COVID-19) or previous severe disease and/or hospitalization due to COVID-19. * Interval organ transplantation. * New active liver disease or hepatic dysfunction. * Interval malignancy with exception of completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin. * Use of any investigational drug/device or participation in any investigational study within 30 days prior to screening, not including TPIP of the lead-in study. * Current use of cigarettes (as defined by Centers for Disease Control and Prevention \[CDC\]) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime, who smokes either every day or some days. * Participants who currently inhale marijuana (recreational or medical). Note: Other inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension

Contacts and locations

Locations

  • ARG001

    Córdoba, X5000FPQ, Argentina

  • ARG004

    Córdoba, X5000DCE, Argentina

  • ARG006

    Rosario, Santa Fe Province, S2013KDS, Argentina

  • ARG007

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • ARG009

    Quilmes, Buenos Aires, B1878GEG, Argentina

  • AUT001

    Vienna, 1090, Austria

  • AUT002

    Linz, Upper Austria, 4020, Austria

  • BEL003

    Brussels, 1070, Belgium

  • BRA002

    Blumenau, Santa Catarina, 89030-101, Brazil

  • BRA004

    Belo Horizonte, Minas Gerais, 30430-142, Brazil

  • BRA006

    Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

  • DNK001

    Aarhus, Central Jutland, 8200, Denmark

  • ESP001

    Santander, 39008, Spain

  • ESP003

    Seville, 41009, Spain

  • GBR001

    Bath, Avon, BA1 3NG, United Kingdom

  • GER002

    Lübeck, Schleswig-Holstein, 23562, Germany

  • GER003

    München, Bavaria, 80639, Germany

  • GER005

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • ITA001

    Palermo, 90127, Italy

  • ITA002

    Pavia, Lombardy, 27100, Italy

  • ITA004

    Roma, 00161, Italy

  • ITA005

    Monza, 20900, Italy

  • JPN002

    Okayama, Okayama-ken, 701-1192, Japan

  • JPN003

    Suita-Shi, Osaka, 564-8565, Japan

  • JPN004

    Sapporo, Hokkaido, 060-8648, Japan

  • JPN005

    Sapporo, Hokkaido, 060-8543, Japan

  • JPN006

    Tsukuba, Ibaraki, 305-9576, Japan

  • JPN007

    Kurume-shi, Hukuoka, 830-0011, Japan

  • MEX001

    Monterrey, Nuevo León, 64718, Mexico

  • MEX003

    Mexico City, 14080, Mexico

  • MEX004

    San Luis Potosí City, 78250, Mexico

  • MEX005

    Lomas de Guevara, Jalisco, 44657, Mexico

  • MYS002

    Kuantan, Pahang, 25200, Malaysia

  • MYS004

    Sungai Buloh, Selangor, 47000, Malaysia

  • MYS005

    Alor Star, Kedah, 5460, Malaysia

  • PHL001

    Quezon City, National Capital Region, 1100, Philippines

  • PHL002

    Makati City, 1229, Philippines

  • SRB001

    Belgrade, 11000, Serbia

  • SRB003

    Belgrade, 11000, Serbia

  • USA001

    Chicago, Illinois, 60612, United States

  • USA005

    Jacksonville, Florida, 32224, United States

  • USA006

    Chicago, Illinois, 60611, United States

  • USA011

    Tampa, Florida, 33606, United States

  • USA016

    Dallas, Texas, 75246, United States

  • USA102

    New York, New York, 10021, United States

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