New pill aims to slow lung decline in scarring disease
NCT ID NCT07503587
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tests whether HSK44459 tablets can slow the decline in lung function for adults with progressive pulmonary fibrosis, a condition where lung scarring worsens over time. About 378 participants will take the drug or a placebo twice daily for 52 weeks. The main goal is to measure changes in forced vital capacity, a key breathing test.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HSK44459 tablets
- What this could lead to
- If it works, this could provide a new treatment option to slow lung function decline in people with progressive pulmonary fibrosis.
- What could go wrong
- This is an early Phase 3 trial, so results are not yet known. The drug may not improve lung function or could cause side effects.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 378 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Adults aged ≥18 year. 2. Diagnosis of PPF other than IPF prior to screening or during the screening period. 3. Patients must meet either of the following conditions: 1\. not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period, and not planning to start or restart antiibrotic therapy. 2.on stable therapy with nintedanib or pirfenidone for at least 12 weeks prior to screening and during the screening period. 4.Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 5.Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin \[Hb\]) ≥ 25% and \<90% of predicted normal at screening period . Exclusion Criteria: 1. Clinically significant airways obstruction (Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) \< 0.7) at screening. 2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities. 3. Acute ILD exacerbation within 3 months prior to screening and/or during the screening period. 4. History of malignancy within 5 years prior to screening. 5. History of vasculitis.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Beyond the lungs: the hidden emotional toll of IPF medications
- What makes someone stop a lung fibrosis drug? a study asks patients directly
- Which finger or earlobe? a study tests the best spot for oxygen monitoring in lung disease