New pill aims to slow lung damage in scarring disease

NCT ID NCT06422884

Disease control Sponsor: Endeavor Biomedicines, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 2 trial tests an experimental drug called ENV-101 (taladegib) in 213 adults with idiopathic pulmonary fibrosis, a disease that causes lung scarring and makes breathing harder. Participants take either the drug or a placebo daily for several months. The main goal is to see if the drug improves lung function and is safe to use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ENV-101 (taladegib)
What this could lead to: If successful, this could point toward a new treatment option to slow lung function decline in people with idiopathic pulmonary fibrosis.
What could go wrong: This is a mid-stage trial with 213 participants, so results may not confirm benefit. The drug may cause side effects or fail to improve lung function compared to placebo.

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

213 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Oct 2026

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

40 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: * Patients ≥ 40 years old with an IPF diagnosis as confirmed by the Investigator. * Percent predicted FVC of ≥ 45% at study start. * Percent predicted diffusing capacity of lung for carbon monoxide (DLCO) ≥ 25%, adjusted for hemoglobin (Hgb) at study start. * Ability to perform spirometry tests. * Either stable treatment with standard of care (SoC) \[i.e., antifibrotics, immunosuppressants (PPF only)\] for at least 3 months prior to study start or not treated with SoC for at least 8 weeks prior to study start. Exclusion Criteria: * Evidence of other known causes of interstitial lung disease (ILD). * Forced expiratory volume in one second (FEV1)/FVC ratio \<0.7 at study start. * History of malignancy, including carcinoma during the preceding 5 years from study start, with the following exceptions: 1. Prior history of in situ melanoma, basal or squamous cell skin cancer if treated with curative therapy. 2. Patients with prostate cancer that are managed by surveillance. 3. Patients with ductal carcinoma in situ, treated surgically with curative intent. * Patients with moderate to severe hepatic impairment (Child-Pugh B and C). * Smoking (including vaping) within 6 months of study start; current smoker, or unwillingness to refrain from smoking during the clinical trial duration. * Active or suspected alcohol or drug abuse in the opinion of the Investigator. * Currently enrolled in another investigational device or drug trial, or less than 3 months from study start since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). * Presence of active infection at study start or confirmed active human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV). * Major surgery requiring hospitalization (according to the Investigator) performed within 3 months prior to study start or planned during the course of the trial. Being on a transplant list is allowed. * Occurrence of serious illness requiring hospitalization within 90 days prior to study start. * Current or previous use (within 28 days prior to study start) of the following: 1. Endothelin receptor antagonist 2. Riociguat 3. Prostacyclin or prostacyclin analogue 4. Radiation to the lungs 5. Oral corticosteroids \>15 mg/day * Use of cyclophosphamide or tocilizumab within 8 weeks, or rituximab within 6 months, prior to study start. * Use of drugs that are known moderate or stronger CYP3A4 inhibitors or inducers within 14 days prior to study start. Patients must also agree not to eat fruits that inhibit CYP3A4 such as grapefruit, Seville oranges, pomelo and star fruit. * Patients of reproductive potential who are sexually active and unwilling to use birth control for the duration of the study and for 3 months after their final dose of study drug. * Females that are pregnant or nursing. * Patients that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final dose of study drug. * Males who are unwilling to refrain from sperm donation and females who are unwilling to refrain from egg donation for the duration of the study and for 3 months after their final dose of study drug. * Patients with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of ENV-101. * Patients who have previously taken ENV-101.

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis pulmonary fibrosis

As listed by the trial registrant

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

Idiopathic pulmonary fibrosis Progressive fibrosing interstitial lung disease

Contacts and locations

Locations

Research Site

Quilmes, Buenos Aires, B1878FNR, Argentina
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Buenos Aires, 1888, Argentina
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Buenos Aires, C1426ABP, Argentina
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Mendoza, 5501, Argentina
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Mendoza, CP 5500, Argentina
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Camperdown, New South Wales, 2050, Australia
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Macquarie Park, New South Wales, 2109, Australia
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Brisbane, Queensland, 4032, Australia
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South Brisbane, Queensland, 4101, Australia
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Box Hill, Victoria, 3128, Australia
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Nedlands, Western Australia, 6009, Australia
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Graz, Styria, 8036, Austria
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Vienna, 1090, Austria
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Dinant, Namur, 5500, Belgium
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Edmonton, Alberta, T6G 2C8, Canada
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Vancouver, British Columbia, V6Z 2K5, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
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Angers, 49933, France
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Bordeaux, 33604, France
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Caen, 14033, France
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Dijon, 21000, France
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Montpellier, 34090, France
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Nantes, 44093, France
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Paris, 75014, France
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Paris, 94270, France
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Rennes, 35033, France
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Tours, 37044, France
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Giessen, Hesse, 35398, Germany
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Immenhausen, Hesse, 34376, Germany
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Hanover, Lower Saxony, 30625, Germany
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Essen, North Rhine-Westphalia, 45239, Germany
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Berlin, 13125, Germany
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Leipzig, 4103, Germany
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Dublin, Leinster, D05 AT88, Ireland
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Dublin, Leinster, D07 A8NN, Ireland
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Cork, Munster, T12 DC4A, Ireland
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Dublin, D04 T6F4, Ireland
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Bologna, Forli-Cesena, 47121, Italy
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Padova, Padua, 35128, Italy
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Florence, Tuscany, 50314, Italy
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Catania, 95123, Italy
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Milan, 20123, Italy
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Turin, 10126, Italy
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Kuala Lumpur, Selangor, 42300, Malaysia
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Kuala Lumpur, Selangor, 50590, Malaysia
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Kuala Lumpur, Selangor, 56000, Malaysia
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Monterrey, Nuevo León, 64060, Mexico
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Monterrey, Nuevo León, 64718, Mexico
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San Nicolás de los Garza, Nuevo León, 66465, Mexico
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San Juan del Río, Querétaro, 76800, Mexico
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Chihuahua City, 31230, Mexico
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Mexico City, 14080, Mexico
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Oaxaca City, 68000, Mexico
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Puebla City, 72180, Mexico
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Auckland, New Zealand
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Christchurch, 8011, New Zealand
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Hamilton, New Zealand
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Seoul, (Deogyang District), 10475, South Korea
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Ulsan, (Dong District), 44033, South Korea
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Busan, (Haeundae District), 48108, South Korea
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Seoul, (Seongbuk District), 02841, South Korea
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Seoul, (Songpa District), 05505, South Korea
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Seoul, (Yongsan District), 04401, South Korea
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Seoul, 16499, South Korea
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Belfast, BT9 7AB, United Kingdom
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Birmingham, B15 2GW, United Kingdom
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Birmingham, B9 5SS, United Kingdom
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Cambridge, CB2 0AY, United Kingdom
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Edinburgh, EH1 3EG, United Kingdom
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Exeter, EX2 5DW, United Kingdom
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Leicester, LE3 9QP, United Kingdom
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London, SW3 6NP, United Kingdom
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Londonderry, BT47 6SB, United Kingdom

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