What Is Nerandomilast?
Nerandomilast is a drug currently under investigation in clinical trials. It is being studied for its potential to treat various conditions, particularly those affecting the lungs. The drug has been described in trials as Nerandomilast, and also as a component in a Galunisertib + Nerandomilast Combination. It is often administered as film-coated tablets. Research into Nerandomilast began with the first trial on 2023-11-18, and the latest trial is expected to conclude on 2026-03-27. A total of 12 trials have been conducted or are ongoing, involving 3,246 participants. These trials are sponsored primarily by Boehringer Ingelheim, with additional contributions from Gipfel Life Sciences GmbH and the Scleroderma Research Foundation, Inc.
Uses and Conditions Under Study
Nerandomilast is being investigated for its potential therapeutic effects across a range of conditions, with a significant focus on lung diseases. The most prominent area of study is Interstitial Lung Diseases (ILDs), a group of conditions that cause progressive scarring of lung tissue. This includes studies for general Interstitial Lung Diseases (2 trials), Fibrosing Interstitial Lung Disease (1 trial), Idiopathic Pulmonary Fibrosis (1 trial), Interstitial Lung Abnormalities (1 trial), and Progressive Pulmonary Fibrosis (1 trial).
Beyond general ILDs, Nerandomilast is also being explored for ILDs linked to systemic conditions. This includes Interstitial Lung Disease Due to Systemic Disease (1 trial), Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (1 trial), and Scleroderma (1 trial), a chronic autoimmune disease that can affect the lungs. These investigations aim to determine if Nerandomilast can help manage the lung complications associated with these broader systemic illnesses.
Additionally, Nerandomilast is being studied for Amyotrophic Lateral Sclerosis (ALS), a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord (1 trial). A significant number of trials (5 trials) have also enrolled healthy participants. These studies typically assess the drug's safety, how it is absorbed and eliminated by the body, and its effects on healthy individuals, which is crucial for understanding its overall profile before broader patient use.
Dosing
Nerandomilast has been studied in various forms and strengths, primarily as film-coated tablets. The dosages investigated include 9 mg and 18 mg of Nerandomilast. Some trials have also explored combination therapies, such as Galunisertib + Nerandomilast Combination, or sequences involving Nerandomilast alone followed by nerandomilast + bosentan or nerandomilast + carbamazepine.
Dosing regimens have also included specific sequences like Nerandomilast (18 mg) in treatment sequence R-T1-T2, T1-T2-R, or T2-R-T1, and comparisons between test and reference treatments (T-R or R-T). While specific instructions for administration (e.g., with or without food, frequency per day) are not detailed in the provided data, the variety of sequences suggests careful evaluation of how the drug is best given.
Clinical trials for Nerandomilast have included diverse age groups, with specific dosing strategies for pediatric populations. These include participants aged 2 to <6 years, and two distinct groups for participants aged 6 to <18 years. This indicates that researchers are investigating appropriate and safe dosages across a broad range of ages, from young children to adolescents, in addition to adult participants.
Side Effects
The provided clinical trial data for Nerandomilast focuses on how the drug is absorbed and processed in the body (pharmacokinetics) in healthy volunteers. This data does not include information on side effects or adverse events, nor does it compare side effect rates between Nerandomilast and a placebo. Therefore, a summary of side effects cannot be generated from the provided information.
Clinical Trial Results
The provided data details pharmacokinetic results from studies in healthy volunteers, which examine how Nerandomilast is taken up and processed by the body. These studies do not report clinical efficacy outcomes for specific conditions or patient populations. Therefore, a summary of clinical trial results regarding treatment effectiveness for any specific disease cannot be generated from the provided information.
Studies investigating the pharmacokinetics of Nerandomilast include:
- A study in healthy Japanese men (NCT06139302) evaluated different doses.
- The geometric mean for the total exposure (AUC0-inf) was 3740 hours*nanomoles/Liter for the 18 mg dose and 2070 hours*nanomoles/Liter for the 9 mg dose.
- The maximum concentration (Cmax) was 628 nanomoles/Liter for the 18 mg dose and 455 nanomoles/Liter for the 9 mg dose.
Another study (NCT06393127) compared two different high-dose formulations of Nerandomilast in healthy people:
- The total exposure (AUC0-∞) for the reference treatment was 2189.77 hour*nanomole/Liter, while the test treatment was 2298.06 hour*nanomole/Liter.
- The exposure up to the last measurable point (AUC0-tz) was 2166.70 hour*nanomole/Liter for the reference treatment and 2275.77 hour*nanomole/Liter for the test treatment.
- The maximum concentration (Cmax) was 368.38 nanomole/Liter for the reference treatment and 417.47 nanomole/Liter for the test treatment.
A third study (NCT06624072) compared two different formulations of Nerandomilast tablets when taken with or without food in healthy people:
- When comparing an 18 mg pediatric (Ped) formulation in a fasted state (Treatment T1) to an 18 mg adult formulation in a fasted state (Reference R), the total exposure (AUC0-∞) was 2748.78 h·nmol/L for T1 and 2667.20 h·nmol/L for R. The maximum concentration (Cmax) was 501.74 nmol/L for T1 and 480.85 nmol/L for R.
- When comparing the 18 mg Ped formulation in a fed state (Treatment T2) to the same formulation in a fasted state (Treatment T1), the total exposure (AUC0-∞) was 2631.39 h·nmol/L for T2 and 2748.78 h·nmol/L for T1. The maximum concentration (Cmax) was 344.76 nmol/L for T2 and 501.74 nmol/L for T1.
Currently Recruiting Trials
Several clinical trials are currently seeking participants to study Nerandomilast, an investigational medicine being explored for various lung conditions. These studies aim to understand how well Nerandomilast works and its safety profile in different patient populations.
One ongoing Phase 3 study, NCT07201922, is titled "A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis." This trial is open to individuals aged 40 years or older who have at least one family member with pulmonary fibrosis and show early lung changes, known as interstitial lung abnormalities, on a lung scan. The study plans to enroll 80 participants and is sponsored by Boehringer Ingelheim.
Another Phase 3 trial, NCT06806592, is investigating whether Nerandomilast can help people with lung fibrosis related to rheumatic diseases. Adults aged 18 years or older with lung fibrosis linked to systemic autoimmune rheumatic disease may be eligible, especially if their lung function has not improved after standard immunosuppressant treatment. This study, also sponsored by Boehringer Ingelheim, aims to include 400 participants.
For those who have previously participated in a Nerandomilast study, a follow-up Phase 3 study, NCT06238622, is available. This trial is designed to assess the long-term effects of Nerandomilast (or BI 1015550) in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). Sponsored by Boehringer Ingelheim, this study has a target enrollment of 1700 participants.
Finally, the "Platform Clinical Study for Conquering Scleroderma," NCT06195072, is a Phase 2 trial exploring multiple investigational products, including BI 1015550 (Nerandomilast). This study focuses on participants with interstitial lung disease secondary to systemic sclerosis, aiming to evaluate changes in lung capacity. The Scleroderma Research Foundation, Inc. sponsors this trial, which plans to enroll 400 individuals.
Where to Participate
Clinical trials for Nerandomilast are actively recruiting across a wide geographic area, making participation accessible to many individuals. Studies are currently being conducted at 101 sites in 64 cities across 36 states.
The top locations with the most recruiting sites include:
- Boston, Massachusetts (9 sites)
- Los Angeles, California (8 sites)
- Philadelphia, Pennsylvania (7 sites)
- New York, New York (7 sites)
- Chicago, Illinois (4 sites)
- Kansas City, Kansas (4 sites)
- Atlanta, Georgia (4 sites)
- Nashville, Tennessee (4 sites)
- Houston, Texas (3 sites)
- Birmingham, Alabama (3 sites)
General eligibility for these studies requires participants to be 18 years of age or older. All genders are welcome to participate, but these trials are not open to healthy volunteers or children.
Development Timeline
The journey of Nerandomilast began with its first clinical trial on November 18, 2023, marking the start of its development. Since then, a total of 12 trials have been initiated, with an overall enrollment target of 3,246 participants. The latest trial is projected to conclude on March 27, 2026.
Boehringer Ingelheim has been the primary driver of Nerandomilast's development, sponsoring 10 of the 12 trials. Other sponsors include Gipfel Life Sciences GmbH and the Scleroderma Research Foundation, Inc. The drug's development has progressed through various phases, with 5 trials in Phase 1, 1 trial in Phase 2, 1 trial in Phase 2/Phase 3, and 5 trials in Phase 3, indicating a significant advancement in its clinical evaluation.
Initially, the research for Nerandomilast focused on conditions such as IBS-C and hyperphosphatemia. However, the pipeline has significantly expanded to explore its potential in a broader range of serious conditions. These now include Fibrosing Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Interstitial Lung Abnormalities, Interstitial Lung Disease Due to Systemic Disease, Progressive Pulmonary Fibrosis, Scleroderma, Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases, ALS (Amyotrophic Lateral Sclerosis), Systemic Sclerosis, and Familial Pulmonary Fibrosis. This expansion highlights a strategic shift towards addressing various complex and often debilitating lung and systemic conditions.