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New inhaled drug could ease breathing for PAH patients

NCT ID NCT07481981

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 17, 2026 · Updated 6 times

Summary

This phase 3 trial is testing whether a once-daily inhaled medication called treprostinil palmitil can help adults with pulmonary arterial hypertension (PAH) walk farther. About 344 participants will receive either the drug or a placebo for 24 weeks. The main goal is to see if the drug improves the distance they can walk in six minutes.

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 inhalation powder
What this could lead to
If successful, this could provide a more convenient once-daily inhaled treatment option to help people with pulmonary arterial hypertension walk farther and manage their condition.
What could go wrong
This is a phase 3 trial, but the drug is still experimental. It may not improve exercise capacity more than placebo, and side effects from the inhaled medication could occur.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 344 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jan 2029

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 to 75 years

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 * Participants must have a diagnosis of World Health Organisation (WHO) Group 1 pulmonary hypertension (PAH) in any of the following subtypes, in accordance with European Society of Cardiology European Respiratory Society (ESC/ERS) Guidelines: * Idiopathic PAH * Heritable PAH * Drug/toxin-induced PAH * Connective tissue disease (CTD)-associated PAH * PAH associated with congenital heart disease-related to simple systemic-to-pulmonary shunt at least 1 year following repair. * PAH diagnosis for at least 3 months prior to Screening. * New York Heart Association (NYHA) or World Health Organization (WHO) functional class II-IV. * Participants must be on stable PAH therapy consisting of 1 to 3 medications from the following classes: * Endothelin receptor antagonists (eg, ambrisentan, bosentan, macitentan) for at least 90 days prior to Screening with the last 30 days on stable dose * Phosphodiesterase type 5 inhibitors (eg, sildenafil, tadalafil) for at least 90 days prior to Screening with the last 30 days on stable dose * Guanylate cyclase stimulator (eg, riociguat) for at least 90 days prior to Screening with the last 30 days on stable dose * Activin signaling inhibitor (e.g., sotatercept) for at least 6 months prior to Screening, with the last 3 months on stable dose and meeting all the following conditions: * no active clinically significant bleeding (eg, epistaxis and gingival bleeding requiring medical interventions) within the past 3 months. * no history of major bleeding events or risks (eg, gastrointestinal or intracranial bleeding) within the past 6 months. * platelet counts ≥100,000 per microlitre (μL) at Screening * For both 6-minute walk tests (6MWTs), the values of 6-minute walk distance (6MWD) should be ≥ 150 and ≤ 450 meters at Screening. * Right heart catheterization (RHC) at Screening (or within 6 months prior to Screening, if available). Prior RHC may be used provided there has been no change in background PAH therapy and doses. The RHC must meet all of the following hemodynamic criteria: * Mean pulmonary arterial pressure (PAP) \>20 millimetre of mercury (mmHg) at rest. * pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤15 mmHg. * pulmonary vascular resistance (PVR) of ≥5 wood units (WU). Exclusion Criteria * Diagnosis of PH WHO Groups 2, 3, 4, or 5, or subtypes of PH WHO Group 1 other than described in inclusion criterion 2 (eg, human immunodeficiency virus (HIV), complex congenital heart disease-associated PAH, portal hypertension-associated PAH, pulmonary veno-occlusive disease, Schistosomiasis associated PAH). * Clinically significant left heart disease, including left-sided valvular disease, left ventricular systolic or diastolic dysfunction, echocardiographic findings suggestive of post-capillary pulmonary hypertension, unstable ischemic heart disease, or unstable arrhythmias. * Evidence of airflow obstruction defined by forced expiratory volume in 1 second (FEV1) per forced vital capacity (FVC) \<0.7. * Evidence of significant restrictive lung disease as evidenced by FVC \<70% predicted normal. * Evidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism. * Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (e.g., mannitol, leucine). * Any other medical or psychological condition including relevant laboratory abnormalities at Screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease and/or may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial. Note: Other protocol-defined 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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ARG001

    RECRUITING

    Buenos Aires, Buenos Aires F.D., C1425AIN, Argentina

  • ARG004

    RECRUITING

    Río Cuarto, Córdoba Province, X5080AEV, Argentina

  • AUS002

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • AUS003

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • ISR001

    RECRUITING

    Jerusalem, 9112001, Israel

  • ISR003

    RECRUITING

    Tel Aviv, 6423906, Israel

  • ISR004

    RECRUITING

    Petah Tikva, 4941492, Israel

  • ISR005

    RECRUITING

    Ramat Gan, 5265601, Israel

  • JPN002

    RECRUITING

    Sapporo, Hokkaido, 060-8648, Japan

  • JPN003

    RECRUITING

    Okayama, Okayama-ken, 701-1192, Japan

  • JPN007

    RECRUITING

    Sapporo, Hokkaido, 060-8543, Japan

  • JPN011

    RECRUITING

    Narashino, Chiba, 275-8580, Japan

  • JPN014

    RECRUITING

    Kobe, Hyōgo, 650-0017, Japan

  • JPN015

    RECRUITING

    Yahatanishi-ku, Kita Kyushu-shi, Fukuoka, 807-8556, Japan

  • JPN017

    RECRUITING

    Minato-ku, Tokyo, 108-8329, Japan

  • NZL001

    RECRUITING

    Auckland, 2025, New Zealand

  • NZL002

    RECRUITING

    Hamilton, 3240, New Zealand

  • NZL003

    RECRUITING

    Dunedin, 9016, New Zealand

  • USA005

    RECRUITING

    Torrance, California, 90502, United States

  • USA006

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • USA007

    RECRUITING

    Anderson, South Carolina, 29621, United States

  • USA008

    RECRUITING

    Santa Barbara, California, 93105, United States

  • USA010

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • USA012

    RECRUITING

    Los Angeles, California, 90027, United States

  • USA013

    RECRUITING

    Rochester, New York, 14642, United States

  • USA028

    RECRUITING

    Omaha, Nebraska, 68198-6450, United States

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