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Inhaled drug tested for long-term safety in lung-related high blood pressure

NCT ID NCT07234032

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This phase 3 study tests the long-term safety of an inhaled drug called treprostinil palmitil for people with pulmonary hypertension caused by interstitial lung disease. About 344 adults who completed an earlier trial will take the drug for up to 2 years. Researchers will track side effects and measure changes in walking distance and lung 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 inhalation powder (TPIP)
What this could lead to
If successful, this could confirm a safe long-term treatment option to help manage pulmonary hypertension in people with interstitial lung disease.
What could go wrong
This is an extension study focused on safety, not on proving the drug works. It only includes people who already completed an earlier trial, so results may not apply to everyone.

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 2031

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 * Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380). * Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study. Exclusion Criteria * Participants who experienced any adverse events (AEs) evaluated as causally related to TPIP by the Investigator in a lead-in study, which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant. * Current use or expected need for pulmonary arterial hypertension (PAH)-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and/or soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed. * Diagnosis of Pulmonary Hypertension World Health Organisation (WHO) Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema). * Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH. * Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine). 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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites in 5 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ESP001

    NOT_YET_RECRUITING

    Seville, 41009, Spain

  • ESP003

    NOT_YET_RECRUITING

    Madrid, 28046, Spain

  • ESP006

    NOT_YET_RECRUITING

    Madrid, 28041, Spain

  • JPN004

    NOT_YET_RECRUITING

    Narita, Chiba, 286-8520, Japan

  • KOR001

    NOT_YET_RECRUITING

    Seoul, 3080, South Korea

  • KOR006

    NOT_YET_RECRUITING

    Seoul, 6351, South Korea

  • TWN003

    NOT_YET_RECRUITING

    Hsinchu, 30059, Taiwan

  • USA003

    RECRUITING

    Bend, Oregon, 97701, United States

  • USA006

    RECRUITING

    Naples, Florida, 34102, United States

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