RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Priority Review (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC20H25ClN6O2S

InChIKeyUHYCLWAANUGUMN-SSEXGKCCSA-N

CAS Registry1423719-30-5

Clinical Trials associated with Nerandomilast

NCT07201922

/ Not yet recruitingPhase 3

A Double Blind, Randomized, Placebo-controlled Exploratory Trial to Investigate the Efficacy and Safety of Nerandomilast Over 24 Months When Administered in Individuals With Interstitial Lung Abnormalities and a Family History of Pulmonary Fibrosis to Reduce the Risk of Worsening (DROP-FPF)

This study is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe. People can join if a lung scan shows early changes in the lung, called interstitial lung abnormalities, which may lead to lung scarring. People with family members who have pulmonary fibrosis are more likely to develop it themselves. That is why it is important to check early for lung changes and find ways to prevent the condition from getting worse. The purpose of this study is to find out whether a medicine called nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis.
Participants are put into one of 2 groups randomly, which means the group is chosen 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 twice a day for about 2 to 3 years. There is a 3 out of 5 chance that participants will receive nerandomilast instead of the placebo.
Participants are in the study for about 2 to 3 years. Participants visit the study site multiple times: more frequently during the first 2 years (about every 3 months), and then every 6 months thereafter. In the 3rd year, participants also have phone calls with the site staff every 3 months.
Doctors regularly test lung function and take chest scans to see if the treatment works. The results are compared between the 2 groups to see if nerandomilast helps. The doctors also check participants' health and take note of any unwanted effects.

Start Date23 Jan 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06241560

/ Not yet recruitingPhase 2

An Open-label, Single-group Trial to Evaluate the Effect of Pirfenidone on the Pharmacokinetics of a Single Oral Dose of BI 1015550

This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are 40 years and older. The purpose of this study is to find out whether a medicine called pirfenidone changes the amount of a medicine called BI 1015550 in the blood. Some people may take more than one medicine at a time. Therefore, it is important to understand how different medicines influence one another.
Participants take one dose of BI 1015550 as a tablet. Participants then take one tablet of pirfenidone 3 times a day for one week. The dose is then increased to 2 tablets 3 times a day for the second week. In the third week the dose is increased further to 3 tablets 3 times a day. Participants then take another dose of BI 1015550 as a tablet.
Participants are in the study for a little over 1 month. During this time, they visit the study site 15 times. Two of the visits include overnight stays at the study site. The study staff also contacts the participants by phone. During the visits, the doctors collect information about participants' health and take blood samples from the participants. They compare the amount of pirfenidone and BI 1015550 in the blood. Doctors also regularly check participants' health and take note of any unwanted effects.

Start Date09 Jan 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06806592

/ RecruitingPhase 3

A Double Blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nerandomilast Over at Least 26 Weeks in Patients With Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (SARD-ILD)

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.

Start Date13 Sep 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Nerandomilast

100 Translational Medicine associated with Nerandomilast

100 Patents (Medical) associated with Nerandomilast

Literatures (Medical) associated with Nerandomilast

01 Nov 2025·AUTOIMMUNITY REVIEWS

Unmet needs and emerging pharmacotherapies for autoimmune connective tissue disease-associated interstitial lung diseases

Review

Author: Kondoh, Yasuhiro ; Inoue, Yoshikazu ; Fujii, Takao ; Atsumi, Tatsuya

Autoimmune connective tissue disease associated with interstitial lung disease (CTD-ILD) includes rheumatoid arthritis-associated ILD, systemic sclerosis-associated-ILD, and several other ILDs. Many patients with CTD-ILD-as well as individuals with other ILDs-develop a progressive pulmonary fibrosis (PPF) similar to idiopathic pulmonary fibrosis (IPF). PPF is characterized by worsening respiratory symptoms, declining lung function despite current pharmacotherapies, and ultimately early death. Current pharmacotherapies for CTD-ILD and PPF include glucocorticoids, immunosuppressants, and anti-fibrotic agents. Due to the scarcity of randomized clinical trials for CTD-ILD, many pharmacotherapies are generally administered off-label (although several are approved in Japan), with notable exceptions including nintedanib, an anti-fibrotic agent approved for SSc-ILD and chronic progressive fibrosing ILD in several countries. As the available agents only slow the decline of pulmonary function and are associated with treatment-limiting side effects, there is a need for more efficacious and tolerable pharmacotherapies for CTD-ILD and PPF. Promising compounds in clinical trials include nerandomilast (a preferential phosphodiesterase 4B inhibitor), admilparant (a lysophosphatidic acid receptor 1 antagonist), and inhaled treprostinil (a prostacyclin analogue). Nerandomilast may have both anti-fibrotic and immunomodulatory properties; in preclinical models of PPF, it reduced neutrophils and macrophages and down-regulated pro-fibrotic signaling pathways. Hopefully, therefore, this pipeline will produce new medications to ease the collectively large burden of CTD-ILD and PPF.

01 Nov 2025·AMERICAN JOURNAL OF RESPIRATORY CELL AND MOLECULAR BIOLOGY

Insights into the Cellular and Molecular Mechanisms behind the Antifibrotic Effects of Nerandomilast

Article

Author: Herrmann, Franziska E. ; Geillinger-Kästle, Kerstin ; Wolf, Felix ; Mayr, Christoph H. ; Wespel, Susanne L. ; Reininger, Dennis ; Dick, Alec ; Laufhaeger, Nadine ; Nickolaus, Peter ; Gantner, Florian

The quest for innovative pharmacologic interventions in idiopathic pulmonary fibrosis (IPF) is a challenging journey. The complexity of the disease demands a comprehensive approach that targets multiple cell types and pathways. This study examined the antifibrotic properties of nerandomilast, a preferential phosphodiesterase 4B inhibitor, focusing on its effects on myofibroblasts (MFs) and endothelial cells. Using cytokine-stimulated human IPF lung fibroblasts and RNA sequencing, we assessed the effects of nerandomilast on MF contractility, MF markers, and differentiation mechanisms. In addition, using human microvascular endothelial cells, we assessed endothelial barrier integrity and monocyte adhesion in a three-dimensional microfluidic chip. Our results show that nerandomilast significantly inhibited MF contractility and marker expression in cytokine-stimulated human IPF lung fibroblast cells. Treatment with nerandomilast significantly activated cAMP-associated pathways and G-protein-coupled receptor signaling events while inhibiting mitogen-activated protein kinase signaling pathways and transforming growth factor β signaling. Nerandomilast also significantly reduced microvascular permeability in cytokine-stimulated human lung microvascular endothelial cells. Finally, in an adeno-associated virus-human diphtheria toxin receptor/diphtheria toxin mouse model of acute lung injury, nerandomilast significantly inhibited total protein in lavage, total macrophages, neutrophils, cell count, and VCAM-1 expression. In summary, our results demonstrate that nerandomilast induces the dedifferentiation of human IPF lung MFs and diminishes their contractility in vitro by interfering with transforming growth factor β, mitogen-activated protein kinase phosphatase-1, and G-protein-coupled receptor signaling pathways. It also mitigates vascular dysfunction by strengthening endothelial junctions and inhibiting adhesion protein expression. These findings highlight nerandomilast's potential therapeutic use in IPF by providing insights into its cellular and molecular actions.

01 Nov 2025·AMERICAN JOURNAL OF RESPIRATORY CELL AND MOLECULAR BIOLOGY

Nerandomilast – A Multifrontal Therapeutic Approach to Lung Fibrosis

Communications

Author: Kalina, Daniel ; Wygrecka, Malgorzata

News (Medical) associated with Nerandomilast

19 Dec 2025

·www.einpresswire.com

FDA Approves Drug to Treat Chronic, Progressive Lung Disease

Action Today, the U.S. Food and Drug Administration (FDA) approved Jascayd (nerandomilast) tablets to treat adults with progressive pulmonary fibrosis (PPF). Jascayd was previously approved to treat idiopathic pulmonary fibrosis (IFP) in adults. Disease or Condition PPF is a chronic disease characterized by gradual, irreversible scarring of the lungs, which can lead to progressive breathing difficulties. PPF is an umbrella term that can describe progressive lung scarring in many interstitial lung diseases. Data Supporting Jascayd Jascayd’s efficacy for PPF was demonstrated in FIBRONEER-ILD (NCT05321082), a randomized, double-blind, placebo-controlled study that enrolled 1,178 adults with PPF. Participants were randomly assigned 1:1:1 to receive twice daily administration of Jascayd 9 mg, Jascayd 18 mg, or placebo, for at least 52 weeks. Patients treated with either dose of Jascayd showed significantly slower rates of lung function decline compared to placebo, based on the primary endpoint of absolute change in forced vital capacity (FVC) — the maximum amount of air a person can forcefully exhale after taking the deepest possible breath — at 52 weeks. The adjusted, average decline in patients receiving 18 mg or 9 mg Jascayd was -72 mL and -85 mL, respectively, whereas the placebo group had a -151 mL decline. Additionally, patients receiving Jascayd had fewer events of either interstitial lung disease exacerbations, respiratory hospitalizations, or death over the course of the trial. The recommended dosages for Jascayd are 9 mg or 18 mg orally twice a day, approximately 12 hours apart. Safety Information The safety of Jascayd in patients with PPF was generally consistent with that observed in patients with IFP, a previously approved indication. Side effects include diarrhea, decreased weight, decreased appetite, and nausea. See the prescribing information for more safety information. Designation Jascayd received a Breakthrough Therapy Designation for the PPF indication. Content current as of: 12/19/2025 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical ResultDrug ApprovalBreakthrough TherapyPriority ReviewPhase 3

19 Dec 2025

·firstwordpharma.com

FDA expands Jascayd label to progressive pulmonary fibrosis

Less than three months after earning an FDA nod for idiopathic pulmonary fibrosis (IPF), Boehringer Ingelheim's Jascayd (nerandomilast) has secured an expanded label to include use in adults with progressive pulmonary fibrosis (PPF).Approval is based on results from the Phase III FIBRONEER-ILD trial, where patients on the oral PDE4B inhibitor experienced a smaller decline in forced vital capacity (FVC) after a year than those receiving placebo, the trial's primary endpoint. Adjusted mean FVC declines were 86 mL with the 18-mg dose and 69 mL with the 9-mg dose, compared with a 152-mL decline in the placebo arm, translating into treatment differences of 65 mL and 83 mL, respectively.Secondary outcomes were more mixed. The trial did not meet a key composite endpoint that measured time to the first occurrence of any of the components of the composite up to 109 weeks; namely, time to acute exacerbation of interstitial lung disease (ILD), respiratory hospitalisations, or death. An exploratory analysis did, however, show a nominally significant reduction in acute ILD exacerbations with the higher dose.Meanwhile, a broader pooled analysis combining data from FIBRONEER-ILD and the companion FIBRONEER-IPF study also suggested that Jascayd was associated with a nominally significant reduction in all-cause mortality risk in patients with IPF and PPF."[Friday's] US approval…is an important step forward to help slow lung function decline for people living with PPF, providing a new, well-tolerated treatment option," said Shashank Deshpande, head of human pharma at Boehringer.Regulators in China approved the drug for PPF earlier this month.For related analysis, see – KOL Views Q&A: Boehringer's nerandomilast works in IPF but needs to get in line and KOL Views Q&A: Tyvaso headed for market in IPF but commercial landscape far from certain.

Clinical ResultPhase 3Drug ApprovalAccelerated Approval

11 Dec 2025

·www.globenewswire.com

JASCAYD® (nerandomilast) receives first regulatory approval for progressive pulmonary fibrosis in China

The approval marks the first new treatment option for people living with progressive pulmonary fibrosis (PPF) in more than five years. PPF is a rare lung condition, more life-threatening than many forms of cancer, causing a continuous decline in lung function.1,2,3 PPF is the second approved indication in China for nerandomilast, following recent approvals in the U.S. and China for the treatment of idiopathic pulmonary fibrosis (IPF).4,5 China’s National Medical Products Administration (NMPA) has approved JASCAYD® (nerandomilast) as the first new treatment for adults with progressive pulmonary fibrosis (PPF) in more than five years, marking a breakthrough for millions affected by the life-threatening lung condition.4 The approval, based on the largest clinical trial program in PPF to date, offers new hope for patients facing limited options and declining lung function. Nerandomilast is the only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory, vascular, and antifibrotic effects to be approved in this indication.6,7 “PPF may lead to a continuous decline in lung function, posing a serious threat to patients' lives,” said Professor Xu Zuojun, Chief Physician of the Department of Respiratory and Critical Care Medicine of Peking Union Medical College Hospital. “Current treatment options for PPF are very limited, and there is an urgent need to improve both the survival time and quality of life for these patients. We are pleased to see that nerandomilast has demonstrated highly encouraging results in Phase III clinical trials, significantly slowing the decline in lung function while showing good safety and tolerability. This will help improve adherence to long-term treatment and brings new hope for patients.” Affecting up to 5.6 million people worldwide, PPF may develop in people with underlying conditions, such as rheumatoid arthritis or systemic sclerosis. It can also be caused by environmental exposure to asbestos, silica or other toxins.1,8,9 As PPF progresses, everyday activities become increasingly difficult and the risk of death increases.2,8,10 Unfortunately, people with PPF often delay or discontinue treatment, leaving them vulnerable to worsening symptoms and reduced quality of life as the disease progresses.11,12 “For the first time, people living with PPF will have access to a new treatment option for this progressive and life-threatening condition – a major advancement in a field where innovation has been scarce,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “While this initial approval in China represents a pivotal milestone for the PPF community, we are working tirelessly to ensure patients around the world can benefit from JASCAYD as quickly as possible.” The approval is based on results from the pivotal Phase III clinical trial FIBRONEERTM-ILD. Results showed that nerandomilast met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity (FVC) [mL] at week 52 versus placebo.7 FVC is a key measure of lung function, and the findings indicate that the drug effectively slows the decline of lung function in PPF patients.7 Furthermore, nerandomilast demonstrated favorable safety and tolerability, with low discontinuation rates and no requirement for liver monitoring.7 In the FIBRONEER™-ILD trial, nerandomilast also improved survival shown by a nominally significant reduced risk of death.4 "I deeply understand the immense challenges that patients with PPF face in their daily lives. We have long been awaiting advancements that can address some of the challenges related to existing treatment options,” said Alison Zheng, Founder of the Chinese Organization for Scleroderma, China’s first scleroderma patient organization. “The approval of nerandomilast for the treatment of PPF brings new hope and reflects the urgent need to address longstanding challenges facing people living with the condition.” The approval of nerandomilast in PPF in China comes just seven weeks after its approval by the NMPA in IPF. Progressive pulmonary fibrosis (PPF) affects up to 5.6 million people worldwide.8 It is progressive and ultimately fatal, associated with irreversible scarring in the lungs that worsens over time.8 The lung scarring may be linked to an underlying disease such as rheumatoid arthritis or systemic sclerosis, or result from exposure to inhaled substances.1,8,9 Chronic scarring of lung tissue in these diseases is often the key driver of early mortality.8 Approximately half of people with PPF lose their life within five years of diagnosis.2 On average, diagnosis is delayed by up to two years and up to half of those diagnosed remain untreated.13,14 Nerandomilast is an oral, preferential PDE4B inhibitor approved in China for the treatment of adult patients with IPF and PPF. It was also approved by the U.S. Food and Drug Administration (FDA) for IPF after securing Priority Review and Breakthrough Therapy Designation and is under priority review by the FDA for the treatment of adults with PPF. Regulatory submissions for nerandomilast in IPF and PPF are also under review in the European Union, the UK, Japan and other countries with additional approvals anticipated in 2026. Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com. References 1Kondoh Y, Inoue Y. Progressive Pulmonary Fibrosis: Current Status in Terminology and Future Directions. Adv Ther. 2025;42(7):2988–3001 2Cen Z, et al. Outcomes and predictors of progression in progressive pulmonary fibrosis. Ann Med. 2024;56(1):2406439. 3Siegel RL, et al. Cancer statistics, 2024. CA: A Cancer Journal for Clinicians. 2024;74(1):12–49. 4JASCAYD® (nerandomilast). Package Insert of Nerandomilast Tablets. China. (Last updated: Dec 2025) 5JASCAYD® (nerandomilast). Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 202. (Last updated: Oct 2025). 6Ofev SmPC — Boehringer Ingelheim, 2025. 7Maher T, et al. Nerandomilast in Patients with Progressive Pulmonary Fibrosis. N Engl J Med. 2025 Jun 12;392(22):2193-2202. 8Cottin V, et al. The Burden of Progressive-Fibrosing Interstitial Lung Diseases. Front Med (Lausanne). 2022;9:799912. 9Wang J, et al. Pathogenesis and therapeutic targets in pulmonary fibrosis. MedComm. 2024;5:e744. 10Nasser M, Larrieu S, Boussel L, et al. Estimates of epidemiology, mortality and disease burden associated with progressive fibrosing interstitial lung disease in France (the PROGRESS study). Respir Res 2021. 22 :162 11Torrisi S, et al. HRCT and histology in the evaluation of fibrotic lung diseases: A correlation study. Eur Respir Rev. 2017;26(145). 12Levra S et al. Long-term safety of antifibrotic drugs in IPF: a real-world experience. Biomedicines. 2022;10(12):3229. 13Chaudhuri et al. Respiratory Research 2024; 25:364 14Wijsenbeek M et al. Current Medical Research and Opinion 2019; 35 (11): 2015-2024 The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalClinical ResultBreakthrough TherapyPriority Review

100 Deals associated with Nerandomilast

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Progressive pulmonary fibrosis	China	Boehringer Ingelheim International GmbH	09 Dec 2025
Idiopathic Pulmonary Fibrosis	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	07 Oct 2025
Idiopathic Pulmonary Fibrosis	United States	Boehringer Ingelheim Norway KS	07 Oct 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Interstitial Pneumonias	Phase 3	United States	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	Japan	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	Argentina	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	Belgium	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	Canada	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	France	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	Germany	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	Italy	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	Netherlands	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	South Korea	Boehringer Ingelheim GmbH	23 Jan 2026

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06070610 (CTgov)	Phase 1	-	14	Pirfenidone+Nintedanib (Pirfenidone/Nintedanib alone (Reference))	rpofthetmi(ceoqlxgyri) = qyablqoazh gvrjvkdtjs (dtxltelzpy, NA) View more	-	02 Dec 2025
				Pirfenidone+Nerandomilast+Nintedanib (Pirfenidone/Nintedanib in combination with Nerandomilast (Test))	rpofthetmi(ceoqlxgyri) = lccygcksli gvrjvkdtjs (dtxltelzpy, NA) View more
NCT06393127 (CTgov)	Phase 1	-	64	nerandomilast (Test treatment (T))	umdcyaount(tztbqrsbme) = etqovvkror trhfudevxd (ibjsjubafa, NA) View more	-	01 Dec 2025
				nerandomilast (Reference treatment (R))	umdcyaount(tztbqrsbme) = tnbahclano trhfudevxd (ibjsjubafa, NA) View more
NCT05550636 (CTgov)	Phase 1	-	15	Midazolam (Midazolam (R))	bldywjggyi(vvyjnghcfh) = rjulqjexat ksttesgeni (lxkfaygojq, NA) View more	-	01 Dec 2025
				Midazolam (T+BI 1015550 (BI 1015550 + Midazolam (T))	bldywjggyi(vvyjnghcfh) = zjsrwcgrdn ksttesgeni (lxkfaygojq, NA) View more
NCT06415045 (CTgov)	Phase 1	-	18	Nerandomilast (Nerandomilast fasted state (Reference (R)))	fmajxoiapj(njleloghxe) = rtjpzlotlt gnrunbydwb (urpljuoqvk, NA) View more	-	01 Dec 2025
				Nerandomilast (Nerandomilast fed state (Test (T)))	fmajxoiapj(njleloghxe) = pnwmdtlwqv gnrunbydwb (urpljuoqvk, NA) View more
NCT06408870 (CTgov)	Phase 1	-	64	BI 1015550 (BI 1015550 Formulation C1 (Reference, R))	iqqejrrntr(hxafyquoiz) = iaktlftgou hfcbnshvsh (mdokgthfbp, na) View more	-	01 Dec 2025
				BI 1015550 (BI 1015550 Formulation C2 (Test, T))	iqqejrrntr(hxafyquoiz) = ctkyrokzka hfcbnshvsh (mdokgthfbp, na) View more
NCT06139302 (CTgov)	Phase 1	-	12	Nerandomilast (Nerandomilast 9 mg)	qfxasscgkr(oqghdcjdug) = dlvfqiqrcn mpusdavrih (ttbfjrosmi, 13.8) View more	-	01 Dec 2025
				Nerandomilast (Nerandomilast 18 mg)	qfxasscgkr(oqghdcjdug) = cjznqlqgmi mpusdavrih (ttbfjrosmi, 52.8) View more
NCT05718648 (CTgov)	Phase 1	Renal Insufficiency	26	BI 1015550 (BI 1015550 Severe renal impairment)	sneqqgwfkz(pebkhtkbyc) = tlxruznkmn xnowrmxhgc (ewsrsbrahy, NA) View more	-	28 Nov 2025
				BI 1015550 (BI 1015550 Moderate renal impairment)	sneqqgwfkz(pebkhtkbyc) = jsthdxmiqn xnowrmxhgc (ewsrsbrahy, NA) View more
NCT03542344 (CTgov)	Phase 1	-	16	Placebo (Placebo)	iyafawofpv = gfbgmrgaap jmwhhtokkt (khvvnmnzbs, igdlfykzvp - nlgelowras) View more	-	28 Nov 2025
				BI 1015550 6 mg (BI 1015550 12mg)	iyafawofpv = qyrqfmztiz jmwhhtokkt (khvvnmnzbs, gbpomsldcf - tlqekwzjtw) View more
NCT03302078 (CTgov)	Phase 1	-	12	BI 1015550 (BI 1015550 24 mg fed (Test, T))	ujumqfxayx(pljogtvsjv) = rjgebeekma clmtdoiwua (itgqqbfafx, NA) View more	-	28 Nov 2025
				BI 1015550 (BI 1015550 24 mg fast (Reference, R))	ujumqfxayx(pljogtvsjv) = dcirukpeeu clmtdoiwua (itgqqbfafx, NA) View more
NCT04771286 (CTgov)	Phase 1	-	6	BI 1015550 (C-14)	kyredabzvf(swnpvghztw) = ejfkpqrtuf ekwsbyhaat (lyhcfbhold, 11.8) View more	-	28 Nov 2025

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