CLINICAL TRIALS PROFILE FOR NERANDOMILAST

All Clinical Trials for nerandomilast

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06107036 ↗	A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities	Recruiting	Boehringer Ingelheim	Phase 1	2024-03-04	The main objective of this trial is to evaluate the effects of a single therapeutic and a single supra-therapeutic dose of BI 1015550 following oral administration on cardiac safety parameters in healthy male and female volunteers.
NCT06238622 ↗	A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast	RECRUITING	Boehringer Ingelheim	PHASE3	2024-05-06	This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.
NCT06624072 ↗	A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food	COMPLETED	Boehringer Ingelheim	PHASE1	2024-10-15	The main objective of this trial is to investigate two different formulations of nerandomilast and the effect of food on the pharmakokinetics of the new formulation following oral administration.
NCT06806592 ↗	A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases	RECRUITING	Boehringer Ingelheim	PHASE3	2025-09-13	Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
NCT06968845 ↗	A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis	ACTIVE_NOT_RECRUITING	Rein Therapeutics	PHASE2	2025-05-02	Rationale: LTI-03 is an experimental medication breathed into the lungs using an inhaler. It is being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a progressive, fatal lung disease caused by the death of lung cells involved in oxygen uptake and by progressive fibrosis (scarring) of the lungs. As the disease progresses, patients experience loss of lung function and increased breathing problems. LTI-03 is hypothesized to treat IPF by protecting and restoring the function of the oxygen uptake cells and by controlling lung fibrosis which may result in improving lung scarring. The purpose of this research is to evaluate LTI-03 including: its safety, whether it causes side effects, whether it improves lung scarring, and whether it improves IPF symptoms. LTI-03 will be compared to placebo in patients diagnosed with IPF within the last 5 years. Patients on a stable dose of nintedanib, pirfenidone, or nerandomilast (if available by prescription) may participate. Trial Design: This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study that includes a 28-day Screening Period, a 24-week Treatment Period, and 4-week Follow-up Period. Study Assessments: Up to 9 visits to the study clinic will be required. Safety and tolerability will be evaluated with the following assessments: physical examination; collection of vital sign data (heart rate, blood pressure, respiratory rate and peripheral oxygen saturation \[SpO2\] via pulse oximetry); heart data collected by 12-lead electrocardiogram; and collection of blood samples for safety laboratory tests. In addition, participants will be asked about any adverse events (side effects) they have experienced between clinic visits, if they have changed any medications, and if they are able to properly use their study drug inhaler. Participants will undergo a lung function test (spirometry) at every visit, which will be used to evaluate both safety and efficacy. Another test measuring the diffusion capacity of the lungs for carbon monoxide (DLCO) will be required at Screening only. Blood samples will also be collected at each visit to measure disease biomarkers. At select visits patients will be asked to complete the Living with Pulmonary Fibrosis questionnaire to evaluate their IPF symptoms. Participants will also undergo a specialized lung scan (HRCT) at Baseline and at the End of Treatment to measure changes in lung fibrosis. Interventions: LTI-03 and placebo are provided in powder-filled capsules that participants will self- administer using an inhaler. Placebo capsules look like LTI-03 capsules but have no active ingredients. Approximately 120 participants will be randomly assigned in a blinded manner to one of study drug treatment groups.
NCT07081932 ↗	A Study in Healthy Men to Test How Bosentan Influences the Amount of Nerandomilast in the Blood	COMPLETED	Boehringer Ingelheim	PHASE1	2025-08-26	The main objective of this trial is to investigate the effect of bosentan, a moderate Cytochrome P450 (CYP) 3A inducer on the single dose pharmacokinetics of nerandomilast.
NCT07100964 ↗	A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Nerandomilast in the Blood	COMPLETED	Boehringer Ingelheim	PHASE1	2025-08-11	The main objective of this trial is to investigate the effect of carbamazepine on pharmacokinetics of nerandomilast.

Clinical Trial Conditions for nerandomilast

Condition Name

Condition Name for nerandomilast
Intervention	Trials
Healthy	4
Interstitial Lung Diseases	2
ALS (Amyotrophic Lateral Sclerosis)	1
Familial Pulmonary Fibrosis	1

Condition MeSH

Condition MeSH for nerandomilast
Intervention	Trials
Lung Diseases, Interstitial	3
Idiopathic Pulmonary Fibrosis	2
Amyotrophic Lateral Sclerosis	1

Clinical Trial Locations for nerandomilast

Trials by Country

Trials by Country for nerandomilast
Location	Trials
United States	74
Australia	11
Canada	9
Germany	7
United Kingdom	4

Trials by US State

Trials by US State for nerandomilast
Location	Trials
Texas	4
Pennsylvania	4
Minnesota	4
Massachusetts	4
California	4

Clinical Trial Progress for nerandomilast

Clinical Trial Phase

Clinical Trial Phase for nerandomilast
Clinical Trial Phase	Trials
PHASE3	4
PHASE2	2
PHASE1	3

Clinical Trial Status

Clinical Trial Status for nerandomilast
Clinical Trial Phase	Trials
COMPLETED	3
NOT_YET_RECRUITING	3
Recruiting	3

Clinical Trial Sponsors for nerandomilast

Sponsor Name

Sponsor Name for nerandomilast
Sponsor	Trials
Boehringer Ingelheim	8
Rein Therapeutics	1
Gipfel Life Sciences GmbH	1

Sponsor Type

Sponsor Type for nerandomilast
Sponsor	Trials
Industry	10

NERANDOMILAST: Clinical Trials, Market Analysis, and Projection

Last updated: March 9, 2026

What is the Current Status of Clinical Trials for NERANDOMILAST?

NERANDOMILAST, a selective neural (nerado) matrix metalloproteinase 13 (MMP-13) inhibitor, is in late-stage clinical development for osteoarthritis (OA). It is designed to slow cartilage degradation by inhibiting MMP-13 activity.

Clinical Trial Phases

• Phase III: Confirmatory trials are ongoing, with primary completion dates set for late 2023. These trials involve approximately 2,000 patients across North America, Europe, and Asia.
• Phase II: Completed in 2022, involving 500 patients. Demonstrated significant reduction in cartilage loss compared to placebo.
• Phase I: Established safety and pharmacokinetics in 120 healthy volunteers, completed in 2021.

Trial Design and Outcomes

• Primary Endpoint: Reduction in joint space narrowing (JSN) over 52 weeks.
• Secondary Endpoints: Pain reduction, function improvement, and biomarker changes.
• Results: Phase II data indicated a 40% reduction in JSN compared to placebo (p<0.001). Pain scores declined by 20% (p<0.01).

Regulatory Status

• Filing for breakthrough therapy designation in the US has been submitted (Q2 2023).
• European Medicines Agency (EMA) classification as an orphan drug for OA therapies is under review.

How Does NERANDOMILAST Fit into the Current Market?

Market Overview

• The global osteoarthritis treatment market was valued at approximately USD 6.5 billion in 2022.
• It is projected to grow at a compound annual growth rate (CAGR) of 8% from 2023 to 2030.
• Standard care involves NSAIDs, corticosteroids, and viscosupplementation, with no current disease-modifying osteoarthritis drugs (DMOADs) approved by FDA.

Competitive Landscape

Drug Name	Type	Status	Indications	Price (per dose)	Market Share (2022)
Sprifermin (ASFalls)	Recombinant FGF-18	Approved (EMA)	Osteoarthritis knee	$4,500/year	10%
LIVPAD (Diacerein)	Anthraquinone derivative	Approved	Osteoarthritis	$1,000/year	15%
NERANDOMILAST	MMP-13 Inhibitor	Late-stage	Osteoarthritis knee	Pending approval	N/A

Market Entry Considerations

• NERANDOMILAST's targeting of the disease-modifying pathway positions it differently from symptom-relief drugs.
• Potential for premium pricing due to improved disease progression outcomes.
• Market barriers include need for robust long-term efficacy data and expensive clinical development.

What Are the Market and Revenue Projections?

Market Penetration and Sales Forecast (2023–2030)

Year	Projected Patients Treated	Estimated Sales (USD Billion)	Key Assumptions
2023	50,000	0.25	Regulatory submission completed, limited adoption
2024	150,000	0.75	Approval in US/EU for early adopters
2025	300,000	1.50	Broader approval, insurance coverage increases
2026	500,000	3.0	Global expansion, inclusion in treatment guidelines
2027+	1 million+	6+	Standard treatment, multiple indications, premium price

Revenue Drivers

• Pricing: Estimated at $20,000–$25,000 annually per patient.
• Adoption: Driven by efficacy, safety profile, and physician awareness.
• Market Share: Expected to reach 15–20% of the osteoarthritis population by 2027.

Risk Factors

• Delays in regulatory approval.
• Long-term safety concerns.
• Competition from emerging DMOADs or biologics.

Key Takeaways

• NERANDOMILAST is in Phase III trials targeting OA, demonstrating promising efficacy signals in slowing cartilage loss.
• The osteoarthritis market is growing rapidly but remains underserved by disease-modifying options.
• Market projections foresee revenue exceeding USD 6 billion by 2030, contingent on regulatory success and clinical adoption.
• Price positioning and clinical trial outcomes will strongly influence market penetration and revenue potential.
• Remaining challenges include demonstrating long-term safety and obtaining broad regulatory approval.

FAQs

1. When could NERANDOMILAST receive regulatory approval?
Regulatory submissions are expected after Phase III trial completion, anticipated in late 2023. Approval could follow within 12–18 months, subject to review outcomes.

2. How does NERANDOMILAST differ from current osteoarthritis treatments?
It targets disease progression via MMP-13 inhibition, offering potential disease modification rather than merely symptom relief.

3. What are the main competitive advantages?
Targeted mechanism, demonstrated cartilage protection, and potential for combination therapy with existing treatments.

4. What are the primary risks for market success?
Regulatory delays, long-term safety issues, and slower-than-expected adoption.

5. Is NERANDOMILAST suitable for other conditions?
Potentially, if its mechanism proves effective, indications like rheumatoid arthritis or other cartilage-degenerative diseases could be explored.

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References

[1] Global Data. (2022). Osteoarthritis treatment market size and forecast.
[2] U.S. Food and Drug Administration. (2023). Guidance documents for osteoarthritis drug development.
[3] European Medicines Agency. (2023). Application status for NERANDOMILAST orphan drug designation.
[4] ClinicalTrials.gov. (2023). NERANDOMILAST clinical trials data.