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

Structure/Sequence

Molecular FormulaC20H25ClN6O2S

InChIKeyUHYCLWAANUGUMN-SSEXGKCCSA-N

CAS Registry1423719-30-5

Clinical Trials associated with Nerandomilast

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 Date01 Sep 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT07081932

/ Not yet recruitingPhase 1

The Effect of Multiple Oral Doses of Bosentan on the Single Oral Dose Pharmacokinetics of Nerandomilast in Healthy Male Subjects (an Open-label, Two-treatment, Two-period Fixed Sequence Trial)

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.

Start Date26 Aug 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06806592

/ Not yet 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 Date21 Aug 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 Aug 2025·Nature Reviews Rheumatology

Nerandomilast slows progression of pulmonary fibrosis.

Article

Author: Papatriantafyllou, Maria

12 Jun 2025·NEW ENGLAND JOURNAL OF MEDICINE

Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis

Article

Author: Schlecker, Christina ; Valenzuela, Claudia ; Clerisme-Beaty, Emmanuelle ; Gordat, Maud ; Kreuter, Michael ; Zoz, Donald F. ; Oldham, Justin M. ; Stowasser, Susanne ; Maher, Toby M. ; Martinez, Fernando J. ; Wachtlin, Daniel ; Richeldi, Luca ; Azuma, Arata ; Liu, Yi ; Wijsenbeek, Marlies S. ; Cottin, Vincent

BACKGROUND:

Nerandomilast (BI 1015550) is an orally administered preferential inhibitor of phosphodiesterase 4B with antifibrotic and immunomodulatory effects. In a phase 2 trial involving patients with idiopathic pulmonary fibrosis, treatment with nerandomilast stabilized lung function over a period of 12 weeks.

METHODS:

In this phase 3, double-blind trial, we randomly assigned patients with idiopathic pulmonary fibrosis in a 1:1:1 ratio to receive nerandomilast at a dose of 18 mg twice daily, nerandomilast at a dose of 9 mg twice daily, or placebo, with stratification according to background antifibrotic therapy (nintedanib or pirfenidone vs. none). The primary end point was the absolute change from baseline in forced vital capacity (FVC), measured in milliliters, at week 52.

RESULTS:

A total of 1177 patients underwent randomization, of whom 77.7% were taking nintedanib or pirfenidone at enrollment. Adjusted mean changes in FVC at week 52 were -114.7 ml (95% confidence interval [CI], -141.8 to -87.5) in the nerandomilast 18-mg group, -138.6 ml (95% CI, -165.6 to -111.6) in the nerandomilast 9-mg group, and -183.5 ml (95% CI, -210.9 to -156.1) in the placebo group. The adjusted difference between the nerandomilast 18-mg group and the placebo group was 68.8 ml (95% CI, 30.3 to 107.4; P<0.001), and the adjusted difference between the nerandomilast 9-mg group and the placebo group was 44.9 ml (95% CI, 6.4 to 83.3; P = 0.02). The most frequent adverse event in the nerandomilast groups was diarrhea, reported in 41.3% of the 18-mg group and 31.1% of the 9-mg group, as compared with 16.0% in the placebo group. Serious adverse events were balanced across trial groups.

CONCLUSIONS:

In patients with idiopathic pulmonary fibrosis, treatment with nerandomilast resulted in a smaller decline in the FVC than placebo over a period of 52 weeks. (Funded by Boehringer Ingelheim; FIBRONEER-IPF ClinicalTrials.gov number, NCT05321069.).

12 Jun 2025·NEW ENGLAND JOURNAL OF MEDICINE

Nerandomilast in Patients with Progressive Pulmonary Fibrosis

Article

Author: Gu, Hui ; Richeldi, Luca ; Valenzuela, Claudia ; Clerisme-Beaty, Emmanuelle ; Coeck, Carl ; Hoffmann-Vold, Anna-Maria ; Voss, Florian ; Oldham, Justin M. ; Kreuter, Michael ; Schlosser, Arno ; Zoz, Donald F. ; Assassi, Shervin ; Ritter, Ivana ; Stowasser, Susanne ; Wijsenbeek, Marlies S. ; Weimann, Gerrit ; Azuma, Arata ; Martinez, Fernando J. ; Cottin, Vincent ; Maher, Toby M.

BACKGROUND:

Nerandomilast (BI 1015550) is an orally administered preferential inhibitor of phosphodiesterase 4B with antifibrotic and immunomodulatory properties. Nerandomilast has been shown to slow the progression of idiopathic pulmonary fibrosis, but an assessment of its effects in other types of progressive pulmonary fibrosis is needed.

METHODS:

In a phase 3, double-blind trial, we randomly assigned patients with progressive pulmonary fibrosis in a 1:1:1 ratio to receive nerandomilast at a dose of 18 mg twice daily, nerandomilast at a dose of 9 mg twice daily, or placebo, with stratification according to background therapy (nintedanib vs. none) and fibrotic pattern on high-resolution computed tomography (usual interstitial pneumonia-like pattern vs. other patterns). The primary end point was the absolute change from baseline in the forced vital capacity (FVC), measured in milliliters, at week 52.

RESULTS:

A total of 1176 patients received at least one dose of nerandomilast or placebo, of whom 43.5% were taking background nintedanib therapy at baseline. The adjusted mean change in the FVC at week 52 was -98.6 ml (95% confidence interval [CI], -123.7 to -73.4) in the nerandomilast 18-mg group, -84.6 ml (95% CI, -109.6 to -59.7) in the nerandomilast 9-mg group, and -165.8 ml (95% CI, -190.5 to -141.0) in the placebo group. The adjusted difference between the nerandomilast 18-mg group and the placebo group was 67.2 ml (95% CI, 31.9 to 102.5; P<0.001), and the adjusted difference between the nerandomilast 9-mg group and the placebo group was 81.1 ml (95% CI, 46.0 to 116.3; P<0.001). The most frequent adverse event was diarrhea, reported in 36.6% of the patients in the nerandomilast 18-mg group, 29.5% of those in the nerandomilast 9-mg group, and 24.7% of those in the placebo group. Serious adverse events occurred in similar percentages of patients in the trial groups.

CONCLUSIONS:

In patients with progressive pulmonary fibrosis, treatment with nerandomilast led to a smaller decline in the FVC than placebo over a period of 52 weeks. (Funded by Boehringer Ingelheim; FIBRONEER-ILD ClinicalTrials.gov number, NCT05321082.).

News (Medical) associated with Nerandomilast

24 Jul 2025

·www.globenewswire.com

First half of 2025: Solid growth, investments and pipeline progress pave the way for two key launches in H2

Group net sales grow by 6.3%* to EUR 14.0 billion, driven by Human Pharma (EUR 11.3 billion) and Animal Health (EUR 2.6 billion)Regulatory submissions underway for zongertinib and nerandomilast, with launches expected in H2 2025 Strategic investments in R&D and global manufacturing to drive innovation and support future growth Boehringer Ingelheim, a leading research-driven biopharmaceutical company, reported positive growth in the first half of 2025, with group net sales growing by 6.3%* to EUR 14.0 billion. This performance was driven by strong demand for key products in Human Pharma, namely JARDIANCE® with EUR 4.3 billion and OFEV® with EUR 2.0 billion, which continue to make a meaningful difference for patients worldwide. Building on this momentum, the company is advancing its late-stage pipeline with several therapies nearing regulatory approval. Among these are zongertinib for HER2-mutant lung cancer and nerandomilast for pulmonary fibrosis, both of which recently delivered positive pivotal results and are progressing towards potential launches in the second half of 2025. “At Boehringer Ingelheim, our commitment to transforming lives for generations is more than a mission — it's a responsibility we carry forward every day. Therapies like JARDIANCE® and OFEV® continue to make a real difference to patients — they exemplify what’s possible when true innovation addresses unmet medical needs,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma. “At the same time, we’re making strong progress across our pipeline — from obesity to liver and kidney health — with the goal of redefining standards of care. As we prepare for the potential launches of zongertinib and nerandomilast later this year, we remain focused on delivering meaningful solutions. We understand the urgency behind every patient’s need, and we’re acting with speed and purpose to meet it.” Frank Hübler, Member of the Board of Managing Directors responsible for Finance, added: “In a volatile environment, we are delivering according to plan, with robust sales performance across our portfolio in human and animal health. As we prepare for major launches, we are investing more than ever – focusing on speed, scale, and impact to ensure we are ready to deliver innovative therapies to change the course of serious diseases. Beyond the excitement of new launches, we also see substantial growth potential in our established products, particularly with JARDIANCE®, which continue to make a meaningful difference for patients worldwide.” Human Pharma In the first half of 2025, Boehringer Ingelheim’s Human Pharma business grew 5.7%* reaching EUR 11.3 billion in net sales. Growth was driven by solid global demand for key products, including EUR 4.3 billion in sales from JARDIANCE®, the treatment of chronic kidney diseases, type 2 diabetes and heart failure, and EUR 2.0 billion in sales from OFEV®, which is used to treat idiopathic pulmonary fibrosis and certain fibrosing interstitial lung diseases. Boehringer Ingelheim’s human pharma pipeline is strong, with over ten new Phase II and III trials starting in the next 12 to 18 months across our multiple therapeutic areas. These could lead to major product launches over the next five years, offering the potential to transform millions of lives. U.S. launches for zongertinib and nerandomilast are expected in the second half of 2025, pending FDA approval. Zongertinib, a targeted therapy for HER2-mutant advanced non-small cell lung cancer (NSCLC), showed durable response and clinically meaningful results in previously treated patients, with more than 70% of patients experiencing a tumor response. It is under regulatory review in U.S., Japan and China and being studied as a first-line treatment in a global Phase III trial. If approved, it would become the first orally administered targeted treatment for previously treated HER2-mutated lung cancer patients. Nerandomilast, a potential therapy for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), significantly slowed lung-function decline in the two FIBRONEER™ Phase III trials. It was well tolerated, with discontinuation rates comparable to placebo. Regulatory submissions have been made in the U.S., EU, China and Japan. The company also launched a Phase III trial for our DPP1/CatC inhibitor verducatib (BI 1291583) to evaluate its potential in treating bronchiectasis. Verducatib received FDA breakthrough therapy designation in 2024. In cardiovascular, renal, and metabolic (CRM) diseases, Boehringer Ingelheim started two new Phase III trials under the ongoing EASi trial program. In these trials, the company is investigating the potential benefits of an aldosterone synthase inhibitor/SGLT2i therapy in people with chronic heart failure and for cardiovascular risk reduction in people with type 2 diabetes, high blood pressure and cardiovascular disease. To support future launches and continued growth, the company is continuing to strengthen its global supply network. A key milestone is the EUR 300 million investment in its Yamagata site in Japan, with the opening of a new production unit, infrastructure measures and groundbreaking for an additional facility began in June. This expansion will position Japan as a critical production hub for the Asia and Oceania regions. At the same time Boehringer continues to strengthen its local production network in the USA, building on existing partnerships. Animal Health In the first six months of 2025, Boehringer Ingelheim’s Animal Health Business delivered strong growth, with net sales increasing by 7.6%* to EUR 2.6 billion. This performance was driven by continued momentum in the parasiticide portfolio, particularly the NEXGARD® brand, which grew by 7.9%*. A key growth driver in Europe was BULTAVO 3™, a newly launched vaccine that protects cattle and sheep against bluetongue virus serotype 3 (BTV-3). BULTAVO 3™ is the first vaccine to prevent both clinical signs and mortality from BTV-3 and has been licensed in several European countries. The company also expanded its vaccine portfolio with the launch of VAXXITEK® HVT+IBD+H5, a trivalent poultry vaccine, offering protection against Marek’s disease, Infectious Bursal Disease, and H5 avian influenza in a single shot. It was first introduced in Egypt in early 2025 and is designed for administration directly at the hatchery, providing early protection for chicks. In the companion animal segment, Boehringer Ingelheim entered a strategic digital health collaboration with Eko Health to improve early detection of heart disease in dogs. The partnership combines Boehringer’s expertise in canine cardiology with Eko’s AI-powered stethoscope technology, aiming to launch a dedicated mobile app for veterinarians in 2026. Outlook As Boehringer Ingelheim enters the second half of 2025, the company is well-positioned to build on its first-half year performance and expects a positive year-on-year increase in net sales. With major product launches, a robust pipeline, and strategic investments in R&D and manufacturing, Boehringer Ingelheim is set to expand its global impact and bring innovative health solutions to more patients and animals worldwide. Visit our half-year financial highlights page HERE. * on a comparable basis (adjusted for currency and other effects) Boehringer Ingelheim 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.   Intended Audiences Notice This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

Phase 3Breakthrough TherapyClinical ResultVaccineDrug Approval

24 Jul 2025

·www.fiercebiotech.com

\'Crossing fingers\': Boehringer awaits key FDA decisions to spearhead \'maturing\' pipeline

Boehringer Ingelheim\'s chief medical officer told Fierce that the FDA’s decision on zongertinib could come at “any moment.”\n It\'s shaping up to be a big year for Boehringer Ingelheim—at least if the FDA plays ball. The German drugmaker is awaiting the agency\'s decision on approving key therapies for lung cancer and idiopathic pulmonary fibrosis (IPF) with the aim of launching both meds before the end of 2025.The privately owned company’s top oncology prospect is zongertinib, a HER2-selective tyrosine kinase inhibitor that earlier this year was tied to an objective response rate of 71% among patients with advanced non-small cell lung cancer.If the FDA gives zongertinib the green light in the coming months, the drug would be the first orally administered targeted therapy available for patients with previously treated HER2-mutated lung cancer.“Zongertinib selectively inhibits HER2 while sparing EGFR, which is critical,” Boehringer Chief Medical Officer Lykke Hinsch Gylvin, M.D., told Fierce Biotech in an interview ahead of the company’s first-half earnings results. “So it has the potential to be the first oral and also, as far as we can see, potential to be a best-in-class treatment with a very benign safety and tolerability profile.”For now, the company is “really excited” and “crossing fingers” while it waits for the FDA’s verdict, which could come at “any moment,” Hinsch Gylvin said. Another FDA decision Boehringer is “eagerly waiting” this year is for its PDE4B inhibitor nerandomilast in IPF. Phase 3 data posted in May were considered by analysts to be a step up from Boehringer’s approved IPF drug Ofev, but not a game changer.Still, Hinsch Gylvin argued that nerandomilast has “got the potential to really revolutionize care” for the chronic lung disease.Just days after the nerandomilast readout, PureTech reaffirmed a phase 2b trial success for its own IPF candidate deupirfenidone. Hinsch Gylvin wouldn’t be drawn on whether this meant nerandomilast could soon have a tough battle on its hands, instead pointing out that the aim of Boehringer’s option is to create “a solution for patients that hopefully will change this condition, which is actually fatal.”The CMO also didn’t commit herself to a ballpark figure for sales of Boehringer’s two prospective approvals, but did point out that more than one million patients worldwide have the condition.Another late-stage asset that Hinsch Gylvin is keen to raise awareness of is a DPP1/CatC inhibitor called verducatib, which Boehringer is now evaluating in a late-stage study of non-cystic fibrosis bronchiectasis.“This is part of our maturing pipeline,” she said. “We have over 10 more late-stage trials coming within the next 12 to 18 months.”It seems like any Big Pharma worth the name has a contestant in the obesity race, and Boehringer is no exception. The company’s glucagon/GLP-1 receptor dual agonist survodutide is in late-stage development for both weight loss and metabolic dysfunction-associated steatohepatitis (MASH). Phase 2 readouts for the Zealand Pharma-partnered drug have already demonstrated a placebo-adjusted 64.8% improvement in the fatty liver disease as well as almost 19% weight loss at 46 weeks.But with everyone from Novo Nordisk’s weight loss mainstay Wegovy to up-and-comer candidates from the likes of Rivus Pharmaceuticals showing promise in both obesity and MASH, does Boehringer still think it can stand out in such a crowded space?“We expect a lot from survodutide,” said Hinsch Gylvin, who pointed to the fact that weight loss hadn’t plateaued in the phase 2 trial by the 46-week readout. “In MASH, we had very strong data in phase 2 that helped us to really accelerate.”The company’s MASH ambitions aren’t limited to survodutide, however. There’s also a SIRPα antagonist in a midstage trial that Boehringer “expects a lot from.” Another red-hot space Boehringer has been dabbling in is T-cell engagers. The DLL3/CD3 T-cell engager obrixtamig is being evaluated in midstage trials in both extrapulmonary neuroendocrine carcinoma and small-cell lung cancer.“That\'s definitely also one to look out for,” Hinsch Gylvin said.Further back in development, Boehringer has a B7-H6/CD3 T-cell engager that is tasked with “turn[ing] cold tumors hot.” Another phase 1-stage cancer drug name-checked by Hinsch Gylvin is a CD137/FAP bispecific agonist being aimed at head and neck cancer.In April, Boehringer committed more than $30 million to a new R&D facility specifically focused on antibody-drug conjugates. The site is run by the company’s Swiss subsidiary NBE Therapeutics, which Boehringer bought for $1.5 billion in 2020 in a deal centered around a ROR1-directed ADC. More recently, Boehringer has continued to seek out partners in the ADC arena, kicking off 2025 with a $1.3 billion biobucks licensing deal with Synaffix.Announcing the site in Basel in April, Boehringer said the location will “contribute to building a broad pipeline of ADCs, addressing novel tumor target space to develop next-generation cancer treatments.”Hinsch Gylvin placed this ADC work in the broader context of the company’s “very robust oncology pipeline.”“Apart from small molecule inhibitors, we\'re also exploring T cell engagers, protein degraders, ADCs, cancer vaccines [and] oncolytic viruses,” she continued. “So we really do have a robust pipeline, and we continue to look to strengthen it even further.”One disease area for which Boehringer is less well known is eye health, but the company has been working to change that in recent years—including by licensing a bispecific antibody from Surrozen and a geographic-atrophy-focused pact with RetinAI.Hinsch Glyvin said this ophthalmology work is “fairly new for Boehringer” but has already been “recognized by clinicians as something to look out for.” Boehringer’s Human Pharma business grew 5.7% in the first half of 2025, reaching 11.3 billion euros ($13.2 million) in net sales. This growth was credited to the likes of Jardiance for diabetes, heart failure and kidney disease as well as IPF drug Ofev.According to Hinsch Glyvin, Boehringer invests around 28% of this Human Pharma revenue back into its innovation pipeline—a ratio at the top end of its Big Pharma peers.So, is the company eyeing some of this cash to seek out new drugs to plug any remaining gaps in its portfolio?“About 50% of our pipeline is already anchored in partnerships, and so we continue to always look outside, whether it is for actual partnerships on our current pipeline, or anywhere else to invest,” Hinsch Glyvin said.“I would say we are very fortunate also with this maturing pipeline and the outlook we have to potentially launch up to 20 indications in the coming years,” she added.

Phase 2AcquisitionLicense out/in

17 Jun 2025

·www.einpresswire.com

Pulmonologists and Rheumatologists Struggle to Diagnose and Manage CTD-ILD, According to New Research from Spherix Global Insights

Systemic sclerosis and myositis interstitial lung disease subtypes flagged as most difficult to manage; specialists cite lack of effective treatments and diagnostic clarity EXTON, PA, June 17, 2025 (GLOBE NEWSWIRE) -- According to Spherix Global Insights’ newly published Special Topix™: Interstitial Lung Disease in Rheumatology (US) report, both rheumatologists and pulmonologists report significant challenges in diagnosing and managing connective tissue disease-associated interstitial lung disease (CTD-ILD), with systemic sclerosis (SSc) and myositis (IIM) cited as the most difficult subtypes to treat. The research, based on responses from 138 US specialists (n=68 rheumatologists and 70 pulmonologists), highlights persistent unmet needs, diagnostic ambiguity, and a call for more robust and collaborative management strategies. The findings reflect that undiagnosed and misdiagnosed patients make up a substantial portion of the CTD-ILD population, with nearly one-third of rheumatologists and over half of pulmonologists naming differential diagnosis as a key challenge. Specialists underscore a lack of specific biomarkers, logistical biopsy issues, and overlapping symptoms as primary obstacles. “The most definitive test (biopsy) is invasive. It is difficult to find the clinicians who are willing to do it in a timely manner, and to convince the patient it needs to be done.” – Rheumatologist “Ensuring the correct diagnosis to avoid misdiagnosing the type of ILD or source of ILD. I usually employ the assistance of a rheumatologist.” – Pulmonologist “Often it would be difficult to get patients biopsied for logistical reasons, and often the pathology report would not be precise enough.” – Pulmonologist Even once diagnosed, CTD-ILD patients face a treatment landscape with few options to slow or halt disease progression. When asked about the most difficult aspects of management, specialists consistently pointed to a lack of effective and targeted therapies, with SSc-ILD and myositis-ILD receiving the highest unmet need scores. For SSc-ILD specifically, not only is it associated with the most aggressive progression and worst long-term outcomes, but it also presents a uniquely complex therapeutic challenge. The clinical burden is especially pronounced in patients with diffuse cutaneous systemic sclerosis (dcSSc), where the use of corticosteroids is often limited due to the heightened risk of scleroderma renal crisis. This leaves physicians with a narrow band of anti-fibrotic and immunosuppressive options, many of which are perceived as only modestly effective in controlling ILD progression, let alone reversing it. Even therapies with regulatory approval for SSc-ILD, such as Boehringer Ingelheim’s OFEV (nintedanib), garner only measured enthusiasm from treating physicians. While rheumatologists acknowledge nintedanib’s potential to slow functional decline, they note it does little to address the underlying autoimmune pathology. Similarly, mycophenolate mofetil and rituximab remain staples of clinical practice, yet their real-world performance is viewed as inconsistent and difficult to monitor. Across the board, satisfaction ratings for currently utilized agents fall short of expectations, reinforcing a treatment landscape still dominated by trial-and-error approaches. This disconnect between disease complexity and treatment efficacy is fueling demand for dual-acting agents, therapies that can address both systemic autoimmunity and pulmonary fibrosis. Nowhere is this demand more visible than in systemic lupus erythematosus-associated ILD (SLE-ILD), where rheumatologists express growing interest in GSK’s Benlysta (belimumab). Though not currently approved for ILD, belimumab’s immunologic mechanism and expanded label for lupus nephritis have raised hopes that similar benefit may extend to pulmonary manifestations. Across interviews and survey feedback, physicians articulate a desire for treatments that reduce systemic activity while simultaneously preventing fibrotic progression—without the need for an antifibrotic add-on with limited synergy. Looking ahead, specialists are cautiously optimistic about the pipeline. While interest in agents with antifibrotic and immunomodulatory properties is rising, physicians emphasize that what’s most needed is not just another drug, but a paradigm shift—a treatment model that reflects the multifaceted nature of CTD-ILD. As one physician summarized, the goal is to "treat the patient, not just the lungs." In addition to tracking physician sentiment and practice patterns, the study includes target product profile evaluations for several pipeline therapies: Benlysta (GSK), BMS-986278 (Bristol Myers Squibb), Nerandomilast (Boehringer Ingelheim), and Treprostinil (United Therapeutics). These profiles offer manufacturers timely insights into clinical expectations, adoption potential, and differentiation opportunities in an increasingly complex ILD treatment landscape. Special Topix ™ is an independent service that includes access to a report or series of reports based on current events or topics of interest in specialty markets covered by Spherix. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix’s unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit spherixglobalinsights.com or connect through LinkedIn . For more details on Spherix’s primary market research reports and interactive dashboard offerings, visit or register here: https://clientportal.spherixglobalinsights.com NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight’s analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. Andy Stankus, Rheumatology Franchise Head Spherix Global Insights 4848794284 andy.stankus@spherixglobalinsights.com 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.

Drug Approval

100 Deals associated with Nerandomilast

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Progressive pulmonary fibrosis	NDA/BLA	China	Boehringer Ingelheim Pharma GmbH & Co., KG	15 May 2025
Progressive pulmonary fibrosis	NDA/BLA	China	Boehringer Ingelheim International GmbH	15 May 2025
Idiopathic Pulmonary Fibrosis	NDA/BLA	China	Boehringer Ingelheim International GmbH	25 Feb 2025
Idiopathic Pulmonary Fibrosis	NDA/BLA	China	Boehringer Ingelheim Pharma GmbH & Co., KG	25 Feb 2025
Rheumatic Diseases	Phase 3	United States	Boehringer Ingelheim GmbH	21 Aug 2025
Rheumatic Diseases	Phase 3	China	Boehringer Ingelheim GmbH	21 Aug 2025
Rheumatic Diseases	Phase 3	Japan	Boehringer Ingelheim GmbH	21 Aug 2025
Rheumatic Diseases	Phase 3	Australia	Boehringer Ingelheim GmbH	21 Aug 2025
Rheumatic Diseases	Phase 3	Austria	Boehringer Ingelheim GmbH	21 Aug 2025
Rheumatic Diseases	Phase 3	France	Boehringer Ingelheim GmbH	21 Aug 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05321082 (FIBRONEER-ILD, Pubmed \| N Engl J Med)	Phase 3	Progressive pulmonary fibrosis	1,176	Nerandomilast 18 mg	zhuvdsmeoo(jphhhtgcvn) = wjspsqjhel dzyglwgnpb (kdmfrenpfp, -123.7 to -73.4)	Positive	12 Jun 2025
				Nerandomilast 9 mg	zhuvdsmeoo(jphhhtgcvn) = etltwvoiob dzyglwgnpb (kdmfrenpfp, -109.6 to -59.7)
NCT05321082 (FIBRONEER-ILD, Literature \| NEWS) Manual	Phase 3	Progressive pulmonary fibrosis	1,176	Nerandomilast 18 mg twice daily	knjafhqmye(vztikqnwqo) = otyolhilgc kxgknsavqh (ysvkbecktf, -123.7 to -73.4) Met View more	Positive	19 May 2025
				Nerandomilast 9 mg twice daily	knjafhqmye(vztikqnwqo) = fnsvrajydi kxgknsavqh (ysvkbecktf, -109.6 to -59.7) Met View more
NCT05321069 (FIBRONEER-IPF, Pubmed \| NEWS) Manual	Phase 3	Idiopathic Pulmonary Fibrosis	1,177	Nerandomilast 18 mg	tzeouossnp(yrtypdycki) = rhgrqsbfvu zoepgntise (iwntfnwczc, -141.8 to -87.5) Met View more	Positive	18 May 2025
				Nerandomilast 9 mg	tzeouossnp(yrtypdycki) = oshqmkiuoz zoepgntise (iwntfnwczc, -165.6 to -111.6) Met View more
ATS2025	Phase 3	Pulmonary Atelectasis	-	Nerandomilast	zlliwamxvt(sgxwpntlfd) = The signals derived from nerandomilast were strongly localized in the bronchial epithelium, whereas nintedanib was evenly detected throughout the lung tissue muskoufjbf (rurkietcal ) View more	-	16 May 2025
				Nintedanib
NCT05321082 (FIBRONEER-ILD, NEWS) Manual	Phase 3	Fibrosis	1,178	nerandomilast 9 mg or 18 mg dose	myqamkrucn(qareotqeky) = The study hit its primary endpoint. qnaxewmqce (nswerfuqyv ) Met View more	Positive	10 Feb 2025
				placebo
NCT05321069 (FIBRONEER-IPF, Biospace) Manual	Phase 3	Idiopathic Pulmonary Fibrosis	1,177	nerandomilast	koddzopqzh(czrqpsuhgf) = Phase III trial in a decade to meet its primary endpoint. cnnynfnyaz (cshnptqnma ) Met	Positive	24 Sep 2024
				Placebo
NCT04419506 (Phase 2 \| 1305-0013, CTgov)	Phase 2	Idiopathic Pulmonary Fibrosis	147	Placebo (Placebo - Antifibrotics at Baseline)	frasruidpp(ysplhrzcot) = exerwlikha atutmllodf (wmgbvtclmk, cbjndsarhz - yuejzxxtmq) View more	-	01 Nov 2022
				prifenidone+pirfenidone+BI 1015550+nintedanib (BI 1015550 - Antifibrotics at Baseline)	frasruidpp(ysplhrzcot) = oylrtwsfqk atutmllodf (wmgbvtclmk, hfvaogcwqt - bbvmnihpio) View more
NCT01835899 (CTgov)	Phase 1	-	24	Placebo	yskjuoaxeu = oztxasjjgm rjuopjwvnp (dagkwrmpno, jntvdrvwpi - xdgwmrxwsg) View more	-	22 Jan 2016

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