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New injection aims to ease lung pressure in scarred lungs

NCT ID NCT07473700

Disease control Sponsor: Tectonic Operating Company, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This phase 2 trial tests an injected drug called TX000045 in 25 people who have high blood pressure in the lungs due to scarring lung disease. The main goal is to see if the drug lowers lung blood pressure and is safe over 16 weeks. Researchers will also check for side effects and changes in 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
TX000045 (injected drug)
What this could lead to
If it works, this could point toward a new treatment to lower blood pressure in the lungs for people with lung scarring.
What could go wrong
This is a small, early-phase trial with only 25 people, so results may not apply widely. The drug could cause side effects or fail to improve outcomes.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 80 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: * Confirmed diagnosis of ILD based on imaging: chest computed tomography (CT) performed within the past 12 months with fibrotic lung disease (greater than or equal to (\>=) 10 percent (%) lung parenchyma with fibrosis) consistent with idiopathic interstitial pneumonia, ILD in association with connective tissue disease, occupational ILD, or chronic hypersensitivity pneumonitis. Chest CTs will be centrally read for eligibility * 40% predicted less than or equal to (\<=) forced vital capacity (FVC) \<= 80% predicted at screening * At least ONE of the following is required to undergo the first screening visit: Documented diagnostic right heart catheterization (RHC) within 18 months of screening with mean pulmonary arterial pressure (mPAP) \>= 25 millimeters of mercury (mm Hg), pulmonary capillary wedge pressure (PCWP) \<=15 mm Hg, and pulmonary vascular resistance (PVR) \>=4 Wood units; Documented echocardiogram (ECHO) within 18 months of screening with right ventricular (RV) (or pulmonary artery) systolic pressure \>46 mm Hg or tricuspid annular plane systolic excursion (TAPSE)/ systolic pulmonary artery pressure (SPAP) \<=0.38 and absence of clinically significant left ventricular dysfunction as assessed by the investigator Exclusion Criteria: * Participants have a confirmed or suspected diagnosis of pulmonary hypertension in World Health Organization (WHO) Group 1, WHO Group 2, WHO Group 4, or WHO Group 5 * Participants have received phosphodiesterase type 5 inhibitors, endothelin receptor antagonists, soluble guanylate cyclase stimulators, intravenous (IV) or subcutaneous (SC) prostacyclin analogues within 30 days before the first screening visit, or sotatercept within 180 days before the first screening visit * Participants have any type of pulmonary and cardiovascular comorbidities as defined n protocol * Participants who are taking disease-modifying therapy for the underlying interstitial lung disease (ILD) (anti-fibrotics, immunosuppressives, and anti-inflammatory medications) who are not on stable doses for \>30 days before the first screening visit or have initiated new ILD-directed therapies within 90 days before the first screening visit

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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.

Hypertension, pulmonary Lung diseases, interstitial

How to take part

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

  1. The places running it

    16 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

  • Allen Park

    NOT_YET_RECRUITING

    Allen Park, Michigan, 48101, United States

  • Barcelona

    NOT_YET_RECRUITING

    Barcelona, 08002, Spain

  • Belgrade

    NOT_YET_RECRUITING

    Belgrade, 11000, Serbia

  • Bucharest

    NOT_YET_RECRUITING

    Bucharest, 50159, Romania

  • Gyeonggi-Do

    NOT_YET_RECRUITING

    Gyeonggi-do, 14353, South Korea

  • Idaho

    NOT_YET_RECRUITING

    Idaho Falls, Idaho, 83706, United States

  • Krakow

    NOT_YET_RECRUITING

    Krakow, 31-202, Poland

  • Lublin

    NOT_YET_RECRUITING

    Lublin, 20-950, Poland

  • Madrid

    NOT_YET_RECRUITING

    Madrid, 28046, Spain

  • Niš

    NOT_YET_RECRUITING

    Niš, 18000, Serbia

  • Phoenix

    RECRUITING

    Phoenix, Arizona, 85020, United States

  • San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • Santander

    NOT_YET_RECRUITING

    Santander, 39011, Spain

  • Seoul

    NOT_YET_RECRUITING

    Seoul, 05505, South Korea

  • Sremska Kamenica

    NOT_YET_RECRUITING

    Kamenitz, 21204, Serbia

  • Wroclaw

    NOT_YET_RECRUITING

    Wroclaw, 50-556, Poland

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