New inhaled drug aims to help lung patients breathe and move easier

NCT ID NCT07179380

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

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This phase 3 trial tests an inhaled drug called treprostinil palmitil in 344 adults with pulmonary hypertension caused by interstitial lung disease. Participants take the drug or a placebo once daily for 24 weeks. The main goal is to see if the drug helps them walk farther 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 (a drug inhaled to open blood vessels in the lungs)
What this could lead to: If it works, this could offer a new daily inhaled treatment to help people with PH-ILD walk farther and delay worsening of 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 like cough or throat irritation are possible.

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

Jan 2026

Expected to finish

Dec 2028

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 * Diagnosis of PH World Health Organisation (WHO) Group 3 associated with ILD \[including but not limited to idiopathic interstitial pneumonia (IIP), chronic hypersensitivity pneumonitis (HSP), connective tissue disease-associated interstitial lung disease (CTD-ILD), combined pulmonary fibrosis and emphysema (CPFE)\]. * Confirmation of fibrotic interstitial lung disease by centrally overread computed tomography (CT) scan performed at Screening or within prior 12 months. * PH confirmed by right heart catheterization (RHC) at Screening or within 12 months prior to Screening, with the following hemodynamic findings: * Mean pulmonary arterial pressure (mPAP) \>20 millimetre of mercury (mmHg) and * Pulmonary capillary wedge pressure (PCWP) of ≤15 mmHg and * Pulmonary vascular resistance (PVR) ≥4 wood units (WU). * 6 Minute walking distance (6MWD) ≥100 and ≤500 meters at two 6MWTs at Screening performed at least 4 hours apart, with the difference between the 2 distances ≤15%. * Participants receiving chronic medication for underlying disease (e.g., antifibrotic, immunomodulators, immunosuppressants, etc.) and/or phosphodiesterase 5 (PDE5) inhibitors, should be on this treatment for ≥90 days and on a stable dose for ≥30 days prior to Screening. * Capable of giving signed informed consent as described in Section 10.1.5 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion criteria * Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease. * Primary diagnosis of chronic obstructive pulmonary disease (COPD) and/or forced expiratory volume in 1 second (FEV1)/FVC \<0.7 (based on screening or historical spirometry within the prior 6 months). * Clinically significant left heart disease: * evidence of clinically significant left-sided valvular heart disease, * left ventricular failure with left ventricular ejection fraction (LVEF) \<45%, or diagnosis of heart failure with preserved ejection fraction (HFpEF) * echocardiography findings at Screening suggestive for postcapillary PH * unstable ischemic heart disease * unstable arrhythmia, including uncontrolled atrial fibrillation (rate-controlled arrhythmia or paroxysmal atrial fibrillation is allowed) * 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). * Current use of cigarettes or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime and who currently smokes either every day or some days. * Current use of inhaled marijuana, recreational or medical (current use defined as used at least one or more times during the past 30 days prior to Screening) or expected use during the study. * 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.

interstitial lung disease pulmonary hypertension pulmonary hypertension owing to lung disease and/or hypoxia

As listed by the trial registrant

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

Interstitial lung disease Pulmonary hypertension

How to take part

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

The places running it

145 sites in 27 countries. The list below names each one and where it is.
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 ↗
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
NOT_YET_RECRUITING

Córdoba, X5003DCE, Argentina
ARG002
RECRUITING

CiudadAutonoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina
ARG003
RECRUITING

Río Cuarto, Córdoba Province, X5800AEV, Argentina
ARG004
NOT_YET_RECRUITING

Córdoba, X5000KEH, Argentina
ARG005
RECRUITING

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1060ABN, Argentina
ARG008
RECRUITING

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
AUS001
RECRUITING

Camperdown, New South Wales, 2050, Australia
AUS002
NOT_YET_RECRUITING

South Brisbane, Queensland, 4101, Australia
AUS003
NOT_YET_RECRUITING

Westmead, New South Wales, 2145, Australia
AUS005
RECRUITING

New Lambton Heights, New South Wales, 2305, Australia
AUS006
RECRUITING

Kingswood, New South Wales, 2747, Australia
AUT002
NOT_YET_RECRUITING

Innsbruck, 6020, Austria
BEL001
RECRUITING

Anderlecht, 1070, Belgium
BEL002
RECRUITING

Leuven, Vlaams Brabant, 3000, Belgium
BRA003
NOT_YET_RECRUITING

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
BRA007
NOT_YET_RECRUITING

Porto Alegre, Rio Grande do Sul, 90560-030, Brazil
BRA012
RECRUITING

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
CHE001
RECRUITING

Basel, 4031, Switzerland
CHE002
RECRUITING

Zurich, 8091, Switzerland
CZE001
RECRUITING

Prague, 14000, Czechia
DEU001
RECRUITING

Heidelberg, Baden-Wurttemberg, 69126, Germany
DEU002
NOT_YET_RECRUITING

Essen, North Rhine-Westphalia, 45239, Germany
DEU003
NOT_YET_RECRUITING

München, Bavaria, 80335, Germany
DEU004
NOT_YET_RECRUITING

Dresden, Saxony, 1307, Germany
DEU005
RECRUITING

Immenhausen, Baden-Wurttemberg, 34376, Germany
DEU006
RECRUITING

München, Bavaria, 80639, Germany
DEU008
NOT_YET_RECRUITING

Bonn, North Rhine-Westphalia, 53127, Germany
DEU009
NOT_YET_RECRUITING

Homburg, Saarland, 66424, Germany
DEU010
RECRUITING

Gauting, 82131, Germany
DEU011
NOT_YET_RECRUITING

Lübeck, Schleswig-Holstein, 23562, Germany
DEU012
NOT_YET_RECRUITING

Stuttgart, Baden-Wurttemberg, 70376, Germany
DNK001
RECRUITING

Aarhus N, Central Jutland, 8200, Denmark
ESP001
RECRUITING

Seville, 41009, Spain
ESP002
RECRUITING

Palma de Mallorca, Balearic Islands, 7120, Spain
ESP003
RECRUITING

Madrid, 28046, Spain
ESP004
RECRUITING

Barcelona, 8036, Spain
ESP005
RECRUITING

L'Hospitalet de Llobregat, Barcelona, 8907, Spain
ESP006
RECRUITING

Madrid, 28041, Spain
ESP007
RECRUITING

Toledo, 45007, Spain
ESP009
RECRUITING

Madrid, 28304, Spain
ESP010
NOT_YET_RECRUITING

Majadahonda, Madrid, 28222, Spain
ESP011
NOT_YET_RECRUITING

Santiago de Compostela, 15706, Spain
ESP012
RECRUITING

Barcelona, 8035, Spain
FRA001
RECRUITING

Poitiers, Vienne, 86000, France
FRA002
RECRUITING

Marseille, Bouches-du-Rhône, 13015, France
FRA003
RECRUITING

Le Kremlin-Bicêtre, Val-de-Marne, 94270, France
FRA004
RECRUITING

Angers, Maine-et-Loire, 49100, France
FRA005
RECRUITING

Pessac, 33604, France
FRA006
RECRUITING

Strasbourg, 67091, France
FRA007
NOT_YET_RECRUITING

Lille, Nord, 59037, France
FRA008
NOT_YET_RECRUITING

Saint Priest En Jarez, Pays de la Loire Region, 42270, France
FRA009
RECRUITING

Nice, Alpes-Maritimes, 6001, France
FRA010
NOT_YET_RECRUITING

Brest, 29200, France
FRA011
NOT_YET_RECRUITING

Bron, 69500, France
GBR001
NOT_YET_RECRUITING

Bath, BA1 3NG, United Kingdom
GBR002
NOT_YET_RECRUITING

London, NW3 2QG, United Kingdom
GBR004
RECRUITING

Sheffield, Yorkshire, S10 2JF, United Kingdom
GBR005
NOT_YET_RECRUITING

Southampton, SO16 6YD, United Kingdom
GBR007
NOT_YET_RECRUITING

Glasgow, G81 4DY, United Kingdom
GBR009
NOT_YET_RECRUITING

London, Greater London, W12 0HS, United Kingdom
GEO001
RECRUITING

Tbilisi, 0186, Georgia
GEO002
RECRUITING

Tbilisi, 0144, Georgia
GEO003
RECRUITING

Tbilisi, 0180, Georgia
GEO004
RECRUITING

Tbilisi, 0159, Georgia
GRC001
RECRUITING

Thessaloniki, 54636, Greece
GRC002
RECRUITING

Athens, Anatoliki Attiki, 106 76, Greece
GRC003
NOT_YET_RECRUITING

Pátrai, Achaia, 26504, Greece
GRC004
NOT_YET_RECRUITING

Heraklion, Crete, 71500, Greece
ISR001
RECRUITING

Haifa, 3436212, Israel
ISR002
NOT_YET_RECRUITING

Jerusalem, Jerusalem, 9112001, Israel
ISR003
NOT_YET_RECRUITING

Petah Tikva, Central District, 4941492, Israel
ISR004
NOT_YET_RECRUITING

Tel Aviv, 6423906, Israel
ISR005
RECRUITING

Haifa, 3109601, Israel
ITA001
RECRUITING

Pavia, 27100, Italy
ITA003
NOT_YET_RECRUITING

Roma, 161, Italy
ITA004
NOT_YET_RECRUITING

Rozzano, 20089, Italy
ITA005
RECRUITING

Monza, 20900, Italy
ITA008
NOT_YET_RECRUITING

Milan, 20123, Italy
ITA011
RECRUITING

Bologna, Emilia-Romagna, 40138, Italy
ITA012
NOT_YET_RECRUITING

Sassari, 07100, Italy
JPN001
NOT_YET_RECRUITING

Sapporo, Hokkaido, 060-8648, Japan
JPN002
RECRUITING

Narashino-shi, Chiba, 275-0006, Japan
JPN003
RECRUITING

Shibuya City, Tokyo, 151-8528, Japan
JPN004
RECRUITING

Narita-shi, Chiba, 286-8520, Japan
JPN005
RECRUITING

Nagano, Nagano, 380-0928, Japan
JPN006
RECRUITING

Nagakute, Aichi-ken, 480-1195, Japan
JPN007
RECRUITING

Yokohama, Kanagawa, 236-0051, Japan
JPN008
NOT_YET_RECRUITING

Kiyose, Tokyo, 204-0023, Japan
JPN009
NOT_YET_RECRUITING

Matsumoto, Nagano, 390-8621, Japan
JPN010
RECRUITING

Kyotoshi, Kyoto, 606-8507, Japan
JPN011
RECRUITING

Hirosaki, Aomori, 036-8563, Japan
JPN012
NOT_YET_RECRUITING

Seto, Aichi-ken, 489-8642, Japan
JPN013
NOT_YET_RECRUITING

Bunkyo-Ku, Tokyo, 113-8431, Japan
JPN014
NOT_YET_RECRUITING

Chiba, 260-8677, Japan
JPN015
RECRUITING

Sakai, Osaka, 590-0197, Japan
JPN016
NOT_YET_RECRUITING

Tsukuba, 305-8576, Japan
JPN017
RECRUITING

Suita, Osaka, 564-8565, Japan
KOR001
RECRUITING

Seoul, 03080, South Korea
KOR002
RECRUITING

Incheon, 21565, South Korea
KOR003
NOT_YET_RECRUITING

Seoul, 6591, South Korea
KOR004
RECRUITING

Seoul, 3722, South Korea
KOR005
NOT_YET_RECRUITING

Wŏnju, 26426, South Korea
KOR006
RECRUITING

Seoul, 6351, South Korea
MYS001
NOT_YET_RECRUITING

Kota Bharu, Kelantan, 15586, Malaysia
MYS002
NOT_YET_RECRUITING

Kuching, Sarawak, 93586, Malaysia
MYS003
RECRUITING

Kuantan, Pahang, 25200, Malaysia
MYS004
RECRUITING

Alor Star, Kedah, 5460, Malaysia
MYS005
RECRUITING

Kajang, Selangor, 43000, Malaysia
NZL001
RECRUITING

Christchurch, Canterbury, 8011, New Zealand
NZL002
RECRUITING

Dunedin, Otago, 9010, New Zealand
PHL001
NOT_YET_RECRUITING

Makati City, 1229, Philippines
PHL002
NOT_YET_RECRUITING

Iloilo City, 5000, Philippines
PRT001
NOT_YET_RECRUITING

Lisbon, 1769-001, Portugal
PRT002
RECRUITING

Almada, Setúbal District, 2805-267, Portugal
ROU001
RECRUITING

Timișoara, Timiș County, 300310, Romania
ROU002
RECRUITING

Târgu Mureş, Mureș County, 540136, Romania
ROU003
NOT_YET_RECRUITING

Bucharest, 11461, Romania
ROU004
NOT_YET_RECRUITING

Cluj-Napoca, Cluj, 400371, Romania
SRB001
RECRUITING

Belgrade, 11000, Serbia
SRB002
NOT_YET_RECRUITING

Kamenitz, 21102, Serbia
SRB003
NOT_YET_RECRUITING

Kragujevac, 34000, Serbia
TUR001
NOT_YET_RECRUITING

Bursa, 16059, Turkey (Türkiye)
TUR003
NOT_YET_RECRUITING

Adana, 1250, Turkey (Türkiye)
TUR004
NOT_YET_RECRUITING

Ankara, 6010, Turkey (Türkiye)
TUR005
RECRUITING

Kayseri, 38039, Turkey (Türkiye)
TUR009
RECRUITING

Kocaeli, 41380, Turkey (Türkiye)
TUR011
NOT_YET_RECRUITING

Trabzon, 61080, Turkey (Türkiye)
TUR012
NOT_YET_RECRUITING

Eskişehir, 26040, Turkey (Türkiye)
TWN001
RECRUITING

Kaohsiung City, 80756, Taiwan
TWN002
NOT_YET_RECRUITING

Taipei, 10002, Taiwan
TWN003
RECRUITING

Hsinchu, 300, Taiwan
TWN004
NOT_YET_RECRUITING

Douliu City Yunlin County, 640, Taiwan
TWN005
NOT_YET_RECRUITING

Taichung, 40447, Taiwan
TWN006
NOT_YET_RECRUITING

Taipei, 104, Taiwan
USA001
RECRUITING

Santa Barbara, California, 93105-4349, United States
USA002
NOT_YET_RECRUITING

Kansas City, Kansas, 66160, United States
USA003
RECRUITING

Bend, Oregon, 97701, United States
USA005
NOT_YET_RECRUITING

New York, New York, 10016, United States
USA006
RECRUITING

Naples, Florida, 34102-5412, United States
USA008
RECRUITING

Richmond, Virginia, 23230, United States
USA010
NOT_YET_RECRUITING

Los Angeles, California, 900275969, United States
USA013
RECRUITING

Philadelphia, Pennsylvania, 19140, United States
USA015
NOT_YET_RECRUITING

Cincinnati, Ohio, 45267, United States
USA017
NOT_YET_RECRUITING

Gainesville, Florida, 32610, United States
USA026
RECRUITING

St. Petersburg, Florida, 33707-6129, United States

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