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

Structure/Sequence

Molecular FormulaC20H25ClN6O2S

InChIKeyUHYCLWAANUGUMN-SSEXGKCCSA-N

CAS Registry1423719-30-5

Clinical Trials associated with Nerandomilast

NCT07789015

/ Not yet recruitingPhase 3

A Phase III, Parallel Design, Double-blind, Randomised, Placebo-controlled, Multi-centre Trial to Evaluate the Efficacy and Safety of Nerandomilast Oral Therapy Added to Standard Background Therapy Over 52 Weeks in Adult Trial Participants With Active Idiopathic Inflammatory Myopathies (VERANDA™-IIM)

This study is open to adults aged 18 and older who have a condition known as active idiopathic inflammatory myopathy (IIM) or myositis. People can participate if they have a specific type of myositis. The purpose of this study is to find out whether a medicine called nerandomilast improves IIM symptoms.
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 nerandomilast or placebo twice a day for 1 year.
Participants are in the study for about 1 year and 2 months. During this time, they visit the study site at least 16 times. During this time, doctors regularly check the participant's health, IIM symptoms, and take note of any unwanted effects. Participants fill in questionnaires about their IIM symptoms and how IIM impacts their quality of life. The results are compared between the 2 groups to see whether the treatment works.

Start Date14 Dec 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

JPRN-jRCT2071260103

/ Not yet recruitingPhase 3

A Phase III, parallel design, double-blind, randomised, placebocontrolled, multi-centre trial to evaluate the efficacy and safety of nerandomilast oral therapy added to standard background therapy over 52 weeks in adult trial participants with active idiopathic inflammatory myopathies (VERANDA.-IIM)

Start Date01 Nov 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT07540988

/ RecruitingPhase 3

A Double-blind, Randomized, Placebo-controlled Trial Investigating the Efficacy and Safety of Nerandomilast Over at Least 52 Weeks in Patients With Fibrosing Interstitial Lung Disease at Risk for Disease Progression (FIBRONEER-ACT)

This study is open to adults with fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF). People can join the study if they have been diagnosed with this condition within the last 3 years and are at risk of developing progressive pulmonary fibrosis (PPF). The purpose of this study is to find out whether a medicine called nerandomilast helps people with fibrosing interstitial lung disease who may be at risk for their disease getting worse.
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. Nerandomilast is a type of medicine that may help reduce lung function decline and slow disease progression.
Participants are in the study for up to about 2 years and 4 months. During this time, they visit the study site regularly. Doctors regularly test lung function using methods like spirometry to measure forced vital capacity (FVC, maximum amount of air a participant can blow out after taking a deep breath) and DLCO (diffusing capacity of the lungs for carbon monoxide; it estimates how well oxygen moves from the lungs into the blood). Additionally, high-resolution computed tomography (HRCT) is performed to monitor how the lung condition is changing over time. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Start Date17 Sep 2026

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 Dec 2026·Cells & Development

Macrophage-fibroblast communication driven by biomechanical stress in the pulmonary profibrotic niche: From signalling transduction to clinical translation

Review

Author: Ye, Liya ; Yang, Hong ; Tao, Xia ; He, Yuqiong ; Hou, Xingyun ; Chen, Wansheng

Pulmonary (interstitial) fibrosis, the terminal pathological stage of various interstitial lung diseases, remains a major therapeutic challenge. The three approved antifibrotic agents - pirfenidone, nintedanib, and nerandomilast - receive only moderate endorsements in current guidelines, as they decelerate rather than arrest or reverse fibrotic remodelling, and none directly engages the mechanical dysregulation of the extracellular matrix (ECM) that underlies fibrogenesis. Macrophages and fibroblasts, two highly plastic cell populations, are the principal orchestrators of the pulmonary profibrotic niche: fibroblasts undergo profibrotic activation to become the dominant extracellular matrix (ECM) producers, while macrophages acquire profibrotic states that sense and amplify microenvironmental signals. Because the lung is an inherently mechanosensitive organ, biomechanical stress within the fibrotic niche emerges as a critical - yet therapeutically underexploited - dimension of their interaction. This review consolidates recent progress in understanding how biomechanical stress drives macrophage-fibroblast communication during pulmonary fibrogenesis. We first delineate the profibrotic activation of each cell type and their biomechanical interplay within the stiffening niche; we then examine the core mechanosensitive signalling mechanisms operating in fibroblasts and macrophages individually, their shared cell-state changes, and the direct and indirect crosstalk - encompassing membrane mechanosensors, integrin-FAK and Piezo1-YAP/TAZ pathways, secreted factors and extracellular vesicles - that closes a self-reinforcing mechano-chemical loop. Finally, we discuss the clinical translation of mechanosignalling-targeted antifibrotic therapies, from the limited mechanosensing engagement of approved drugs to current pipeline advances and the preclinical and clinical hurdles ahead. By framing fibrosis as a druggable biomechanical circuit, this review aims to inform strategies that halt - and potentially reverse - pulmonary fibrosis.

01 Dec 2026·ANNALS OF PHARMACOTHERAPY

Nerandomilast for Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis: Clinical Efficacy, Safety, and Place in Therapy

Review

Author: Sotolongo-Miranda, Hanna ; Trabulsi, Tala ; Bui, Phuoc (Tyler) ; St. Onge, Erin

Objective::

To describe nerandomilast, a preferential phosphodiesterase 4B inhibitor indicated for the treatment of idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.

Data Sources::

A PubMed search was conducted from origin to mid-April 2026 using the terms nerandomilast, Jascyd, BI 1015550, idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis, and interstitial lung disease. Phase 2 and 3 clinical trials, prescribing information, pooled analyses, and relevant guideline documents were included.

Study Selection and Data Extraction::

Two phase 3 randomized controlled trials evaluating nerandomilast in IPF and progressive pulmonary fibrosis were reviewed, along with regulatory prescribing information.

Data Synthesis::

In the FIBRONEER-ILD and FIBRONEER-IPF trials, nerandomilast reduced forced vital capacity decline at 52 weeks compared with placebo. Treatment effects were observed in patients receiving background antifibrotic therapy and those treated with nerandomilast alone. Secondary time-to-event outcomes were not statistically significant. Diarrhea was the most common adverse event and occurred more frequently with nerandomilast, while serious adverse events were similar across treatment groups.

Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs::

Nerandomilast targets inflammatory and profibrotic pathways distinct from currently available antifibrotic therapies and may be used as monotherapy or in combination with existing agents. Its role is best understood as disease stabilization rather than reversal of established fibrosis.

Conclusion and Relevance::

Nerandomilast represents an additional therapeutic option for patients with IPF and progressive pulmonary fibrosis. Ongoing long-term and real-world data will further clarify its place in clinical practice.

01 Nov 2026·GENES TO CELLS

Nerandomilast is Associated With Altered Alveolar Epithelial Cell State Dynamics While Attenuating Fibrotic Remodeling in Pulmonary Fibrosis

Article

Author: Motooka, Daisuke ; Akira, Shizuo ; Kuwahara, Atsushi ; Hamada, Nanako ; Hayashi, Yoshiaki ; Fukushima, Kiyoharu

ABSTRACT:

Pulmonary fibrosis is a progressive and life‐threatening lung disorder characterized by excessive fibrogenesis and impaired respiratory function. Nerandomilast, a preferential phosphodiesterase 4B inhibitor, is currently approved for the treatment of idiopathic pulmonary fibrosis and progressive pulmonary fibrosis in several countries following its demonstrated clinical efficacy in Phase III trials. However, its cellular mechanisms of action remain incompletely understood. In this study, we investigated the effects of nerandomilast on a bleomycin‐induced mouse model of lung fibrosis. Nerandomilast treatment attenuates fibrotic remodeling and preserves alveolar epithelial architecture. Single‐cell transcriptomic analyses revealed altered alveolar epithelial cell state dynamics accompanied by increased cell cycle‐associated pathways in alveolar type 2 cells and an increased relative abundance of alveolar type 2 cells. Consistent with the single‐cell findings, nerandomilast was associated with an increased SFTPC‐positive area and the preservation of alveolar epithelial architecture in vivo. Collectively, our findings suggest that nerandomilast attenuates fibrotic remodeling while modulating alveolar epithelial cell state dynamics, which may provide a possible cellular explanation for its clinical efficacy in patients with pulmonary fibrosis.

114

News (Medical) associated with Nerandomilast

23 Oct 2026

·www.biospace.com

Vicore’s Phase 2b ASPIRE Trial of Buloxibutid in IPF Passes Pre-Planned Futility Analysis and Remains on Track for Mid-2027 Topline Results

Independent Data Monitoring Committee recommends ASPIRE continue without modification; no safety concerns identified Fully enrolled 378-patient trial advances toward 52-week readout STOCKHOLM, SE AND CAMBRIDGE, MA / ACCESS Newswire / October 22, 2026 / Vicore Pharma Holding AB (Nasdaq Stockholm:VICO)(Nasdaq US:VCRE), a biopharmaceutical company unlocking the potential of angiotensin II type 2 receptor agonists, today announced that the independent Data Monitoring Committee (iDMC) for the Phase 2b ASPIRE trial of buloxibutid in idiopathic pulmonary fibrosis (IPF) recommended that the trial continue without modification following a pre-planned futility analysis. In parallel, the iDMC conducted its regular safety and benefit-risk review of all available data and raised no concerns. ASPIRE continues as planned and remains on track to report 52-week topline results in mid-2027. "Passing this futility analysis is an important milestone that allows ASPIRE to continue as designed. With 378 patients enrolled and a 52-week FVC primary endpoint, ASPIRE was built to generate a high-quality dataset, and our focus remains on disciplined execution through database lock and expected topline results in mid-2027," said Ahmed Mousa, Chief Executive Officer of Vicore Pharma. "Our cash runway into the second half of 2028 takes us beyond the readout and allows us to plan the next steps for the program and the company." "The futility analysis was designed to protect patients and allow us to preserve the integrity of the trial, and we thank the iDMC for its independent review," said Bernt van den Blink, MD, PhD, Chief Medical Officer of Vicore Pharma. "We look forward to the final assessment of the efficacy and safety of buloxibutid next year. We are grateful to the patients, investigators and site staff whose commitment makes this trial possible." The futility analysis assessed whether the trial should stop early for futility. The futility criteria were not met, and the iDMC recommended that the trial continue without modification. The analysis was conducted by an external statistician and reviewed by the iDMC, based on efficacy data from approximately the first 100 randomized patients who had completed 52 weeks of treatment or discontinued from the trial, representing around 27% of the enrolled patients. The analysis assessed the primary endpoint, the change from baseline in forced vital capacity (FVC) at Week 52, for the high dose of buloxibutid (100 mg twice daily) versus placebo. It used a conditional power approach, with a pre-specified threshold to consider stopping the trial for futility if conditional power was below 20%. Vicore remains blinded to the trial data. To preserve trial integrity, no quantitative results, such as treatment effect estimates or conditional power values, were disclosed to the company. For further information, please contact: Hans Jeppsson, Chief Financial Officer, +46 (0)70 553 14 65, hans.jeppsson@vicorepharma.com About Idiopathic Pulmonary Fibrosis (IPF) IPF is a progressive and lethal fibrotic lung disease impacting approximately 250,000 people across the United States and Europe. The average life expectancy following diagnosis is 3-5 years, and currently approved therapies only slow the decline of lung function. While there are three antifibrotic therapies available today, a large proportion of patients do not initiate treatment, and those who do often discontinue due to limited efficacy and significant tolerability issues. With a growing patient population, there is a clear need for new disease-modifying treatments. About the Phase 2b ASPIRE Trial ASPIRE is an ongoing global 52-week Phase 2b, randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy and safety of buloxibutid in IPF patients who are either not currently on treatment or are receiving standard of care (nintedanib or nerandomilast). Participants are randomized to receive one of two doses of buloxibutid (50 mg or 100 mg taken orally twice daily) or placebo. The primary endpoint is change from baseline in forced vital capacity (FVC) at 52 weeks, the registrational endpoint for IPF. Secondary endpoints include safety, tolerability, and the proportion of patients with disease progression over the trial period. The trial completed enrollment in April 2026, with 378 patients randomized across over 100 sites in 14 countries, including the United States. Recruitment was completed ahead of schedule, positioning the company to report topline results in mid-2027. About Vicore Pharma Holding AB Vicore Pharma is a clinical-stage biopharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential in respiratory and fibrotic diseases, including idiopathic pulmonary fibrosis (IPF). The company's lead program, buloxibutid, is an oral small-molecule angiotensin II type 2 receptor agonist, which received Orphan Drug and Fast Track designations from the United States Food and Drug Administration and is currently being investigated in the global 52-week Phase 2b ASPIRE trial in IPF. Vicore Pharma is publicly listed on Nasdaq Stockholm (VICO) and Nasdaq US (VCRE). Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the ongoing Phase 2b ASPIRE clinical trial; the potential clinical benefits, safety, and efficacy of buloxibutid; clinical development timelines, including expected timing of topline data from the ASPIRE trial and continued development plans for buloxibutid, strategic and business plans, financial position and the anticipated cash runway. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties inherent in clinical development (including that interim or early data may not be predictive of later or final results and data from a small sample size may not be indicative of results that may be observed in a larger group), clinical trial execution risks, the occurrence of adverse safety events, and references to those risks identified in the section entitled "Risk Factors" in Vicore Pharma's filings with the U.S. Securities and Exchange Commission and discussed in Vicore Pharma's Swedish filings and its press releases. Vicore Pharma cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Vicore Pharma disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Vicore Pharma's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This information is information that Vicore Pharma Holding is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-10-22 18:50 CEST. Attachments Vicore’s Phase 2b ASPIRE Trial of Buloxibutid in IPF Passes Pre-Planned Futility Analysis and Remains on Track for Mid-2027 Topline Results SOURCE: Vicore Pharma Holding View the original press release on ACCESS Newswire

Phase 2Orphan DrugFast Track

14 Oct 2026

·www.biospace.com

JASCAYD™ receives Health Canada authorization for a new, well-tolerated oral treatment for adults with IPF and PPF

This marks the first new treatment approved for IPF in Canada in over a decade and for PPF in more than five years. 1 , 2 BURLINGTON, ON , Oct. 13, 2026 /CNW/ -- Boehringer Ingelheim Canada announced that JASCAYD ™ (nerandomilast) has received authorization from Health Canada for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF). JASCAYD™ is the first phosphodiesterase 4B (PDE4B) inhibitor authorized in Canada for these indications and represents an important new treatment option for Canadians living with these progressive and life-limiting fibrosing lung diseases. 3 JASCAYD™ is the first treatment in over a decade to demonstrate efficacy in IPF and the first alternative treatment option for PPF in more than five years. 1 , 2 It also shows a favorable tolerability and safety pro low discontinuation rates across both conditions in the phase III clinical trials. 1 , 2 The authorization is supported by results from the Phase III FIBRONEER™-IPF and FIBRONEER™-ILD trials, the largest Phase III clinical program conducted across IPF and PPF to date. 1 , 2 In both the FIBRONEER™-IPF and FIBRONEER™-ILD trials, the primary endpoint was met: nerandomilast successfully slowed lung function decline, measured by absolute change in forced vital capacity (FVC) from baseline to week 52 compared to placebo. 1 , 2 While the key secondary endpoint was not met in either trial, a numerical reduction in mortality was observed across both trials, reaching nominal significance in FIBRONEER™-ILD. 1 , 2 Nerandomilast demonstrated a favorable safety and tolerability pro no requirement for liver monitoring. As monotherapy, it showed similar discontinuation rates to placebo. 1 , 2 Canadian prevalence estimates suggest that more than 17,000 people may be living with IPF. 4 IPF and PPF are rare, progressive lung diseases, causing irreversible lung scarring that severely restricts breathing. 5 , 6 Despite the life-threatening nature of these conditions that have a prognosis worse than many cancers, 7 , 8 , 9 many people delay initiating therapy or discontinue therapy due to gastrointestinal side effects and/or photosensitivity. 10 , 11 , 13 In IPF specifically, approximately half of those who stop therapy do so within six months. 12 Dr. Martin Kolb, MD, PhD, Professor of Medicine, Division of Respirology, McMaster University "Idiopathic pulmonary fibrosis and progressive pulmonary fibrosis are rare, progressive diseases with limited treatment options. In IPF, we have seen little clinical trial success over the past decade. The authorization of JASCAYD™ is welcome news and provides an important new and better tolerated treatment option for patients living with IPF and PPF." Sharon Lee, CEO, Canadian Pulmonary Fibrosis Foundation (CPFF) "People living with pulmonary fibrosis have waited more than a decade for a new treatment option. During that time, patients and families have faced the daily challenges of a disease that affects their independence, quality of life and plans for the future. The authorization of JASCAYD™ brings renewed hope to our community. We are grateful to the researchers and clinical trial participants who made this advancement possible, and we will continue working toward equitable access for Canadians who need it." Dr. Rasha Eldesouky Abouelabbas, Vice President, Medical and Regulatory Affairs, Boehringer Ingelheim (Canada) Ltd . "The authorization of JASCAYD™ marks an important milestone for patients, caregivers and healthcare professionals. We are proud to bring a new treatment option to Canadians living with IPF and PPF and remain committed to advancing lung health innovation for people affected by serious lung diseases." About nerandomilast JASCAYD ™ (nerandomilast) is an oral PDE4B inhibitor with antifibrotic and immunomodulatory effects authorized in multiple countries worldwide for the treatment of adults with IPF and adults with PPF. Boehringer Ingelheim is also exploring the potential of nerandomilast in two rheumatic diseases: systemic sclerosis (SSc) and myositis (IIM). About IPF and PPF Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) are both conditions with irreversible build-up of scar tissue in the lungs, affecting the lungs' ability to take in and transfer oxygen into the bloodstream. 6 , 7 , 13 Signs and symptoms of IPF and PPF include a persistent dry cough and shortness of breath on exertion. 7 , 14 In IPF, the root cause of pulmonary fibrosis is not known. 14 In PPF, the scarring of the lungs may be linked to an existing condition (e.g. rheumatoid arthritis or systemic sclerosis), result from exposure to inhaled substances (e.g. asbestos or mold), or due to an unknown cause (idiopathic). 6 About Boehringer Ingelheim (Canada) Ltd. 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 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 500 people across Canada. Learn more at . References ___________________________________ 1 Maher T et al. Nerandomilast in Patients with Progressive Pulmonary Fibrosis. N Engl J Med. 2025;392(22):2203-2214. 2 Richeldi L, et al. Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis. N Engl J Med . 2025;392(22):2193-2202. 3 JASCAYD™ (nerandomilast) Product Monograph. Canada. (Last updated: Oct 2026). 4 Hopkins, Robert & Burke, Natasha & Fell, Charlene & Dion, Genevieve & Kolb, Martin. (2016). Epidemiology and survival of idiopathic pulmonary fibrosis from national data in Canada. European Respiratory Journal. 48. ERJ-01504. 10.1183/13993003.01504-2015. 5 Kondoh Y, Inoue Y. Progressive Pulmonary Fibrosis: Current Status in Terminology and Future Directions. Adv Ther . 2025;42(7):2988–3001. 6 van Cleemput, J, et al. Idiopathic Pulmonary Fibrosis for Cardiologists: Differential Diagnosis, Cardiovascular Comorbidities, and Patient Management. Adv Ther . 2019;36, 298–317. 7 Cen Z, et al . Ann Med . 2024;56(1):2406439. 8 Siegel RL, et al. A Cancer Journal for Clinicians . 2024;74(1):12–49. 9 Vancheri C, et al. Eur Respir J . 2010;35(3):496–504. 10 Esbriet SmPC -- Roche, 2014. 11 Ofev SmPC -- Boehringer Ingelheim, 2025 (Last updated: Oct 2025). 12 Levra S et al. Biomedicine s. 2022;10(12):3229. 13 Upagupta C, et al. Eur Respir Rev . 2018;27:180033. 14 Grant-Orser A, et al. BMJ Open Respir Res. 2024;11:e002333. SOURCE Boehringer Ingelheim Canada Ltd.

Phase 3Drug ApprovalClinical Result

12 Oct 2026

·www.biopharmadive.com

Bristol Myers dips on ‘confounding’ lung drug results

Dive Brief:Bristol Myers Squibb said Monday that its experimental lung disease drug admilparant succeeded in a Phase 3 trial in idiopathic pulmonary fibrosis, significantly slowing the decline of study participants breathing capacity when compared to a placebo over the course of a year.However, trial investigators only found a clear benefit among those who received a 60 milligram dose of admilparant. A 120 milligram dose was associated with an impact on disease progression, but the difference didnt meet the threshold for statistical significance, the company said.The failure of the high-dose arm is confounding and requires further explanation, RBC Capital Markets analyst Trung Huynh wrote in a client note. Bristol Myers previously made certain trial revisions that sparked liver-related safety concerns about admilparant, too, although the company said Monday that the drug demonstrated a well-tolerated safety profile and treatment-related study discontinuations were similar between study groups.Dive Insight:Admilparant is the furthest along among a class of idiopathic pulmonary fibrosis, or IPF, drugs called LPA1 receptor antagonists. These treatments work by blocking a signaling molecule that plays an important role in lung scarring. They could emerge as alternatives to marketed drugs like Esbriet, Ofev and Jascayd, each of which has limitations.These admilparant results represent an important advancement as there remains a need for therapies that are both effective and tolerable for patients living with IPF, Fernando Martinez, the trial steering committee chair and a medical professor at the University of Massachusetts, in a statement from Bristol Myers.Earlier LPA1 drugs struggled in clinical testing. Bristol Myers scrapped one because of liver toxicity and Amgen canceled work on another after it fell short in a Phase 2 trial. News last month that Bristol Myers changed safety monitoring protocols in Europe for admilparants trial fueled additional consternation among Wall Street analysts and investors and heightened anticipation for the coming study readout.The announcement Monday that a 60 mg dose helped meaningfully improve forced vital capacity, or the amount of air people can exhale from their lungs at once, when compared to a placebo would ordinarily be taken as positive. However, physicians and drug reviewers frequently look to see whether higher doses perform better than lower ones. The lack of this kind of dose response sparked debate about admilparants prospects.The results could be sufficient to support admilparant regulatory approval, but the lack of dose response raises questions about [admilparants] profile, Leerink Partners analyst David Risinger wrote in a Monday client note. We await detailed results to better understand the drugs efficacy.Others were more positive. While there will be some lingering questions on dose response and the magnitude of benefit for admilparant, the success of the lower dose is likely to open a blockbuster opportunity, William Blair analyst Matt Phipps wrote in a separate note.Bristol Myers shares initially climbed more than 6% in pre-market trading before reversing course and settling into a roughly 4% loss. The data were also taken as bad news by investors of Contineum Therapeutics, which has a different LPA1 drug in Phase 2 testing. Contineums stock price fell about 30% in Monday morning trading.Bristol Myers separately claimed success in a different late-stage study testing a radiopharmaceutical called RYZ-101 against certain neuroendocrine tumors. The drugmaker gained control of RYZ-101 in a $4.1 billion buyout of RayzeBio. '

Phase 2AcquisitionPhase 3Clinical ResultClinical Trial Failure

100 Deals associated with Nerandomilast

External Link

KEGG	Wiki	ATC	Drug Bank
D12975	-	L04AA61	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Progressive fibrotic interstitial lung disease	European Union	Boehringer Ingelheim GmbH	15 Jul 2026
Progressive fibrotic interstitial lung disease	Iceland	Boehringer Ingelheim GmbH	15 Jul 2026
Progressive fibrotic interstitial lung disease	Liechtenstein	Boehringer Ingelheim GmbH	15 Jul 2026
Progressive fibrotic interstitial lung disease	Norway	Boehringer Ingelheim GmbH	15 Jul 2026
Progressive pulmonary fibrosis	China	Boehringer Ingelheim International GmbH	09 Dec 2025
Idiopathic Pulmonary Fibrosis	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	07 Oct 2025

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Dermatomyositis	Phase 3	United States	Boehringer Ingelheim GmbH	01 Nov 2026
Dermatomyositis	Phase 3	China	Boehringer Ingelheim GmbH	01 Nov 2026
Dermatomyositis	Phase 3	Japan	Boehringer Ingelheim GmbH	01 Nov 2026
Dermatomyositis	Phase 3	Argentina	Boehringer Ingelheim GmbH	01 Nov 2026
Dermatomyositis	Phase 3	Australia	Boehringer Ingelheim GmbH	01 Nov 2026
Dermatomyositis	Phase 3	Belgium	Boehringer Ingelheim GmbH	01 Nov 2026
Dermatomyositis	Phase 3	Brazil	Boehringer Ingelheim GmbH	01 Nov 2026
Dermatomyositis	Phase 3	Bulgaria	Boehringer Ingelheim GmbH	01 Nov 2026
Dermatomyositis	Phase 3	Canada	Boehringer Ingelheim GmbH	01 Nov 2026
Dermatomyositis	Phase 3	France	Boehringer Ingelheim GmbH	01 Nov 2026

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


FIBRONEER-ILD (ACR2026)	Phase 3	Progressive pulmonary fibrosis \| COPA syndrome	325	Nerandomilast 9 mg bid	xemttzzaev(bgkotozntr) = asbkqbhbpw gnotcbxqic (nparmwgbxd ) View more	Positive	06 Nov 2026
				Nerandomilast 18 mg bid	xemttzzaev(bgkotozntr) = bnuixblwny gnotcbxqic (nparmwgbxd ) View more
FIBRONEER-ILD (ACR2026)	Phase 3	Progressive pulmonary fibrosis \| COPA syndrome	325	Nerandomilast 9 mg bid	behooobkug(mqeoiwzkgd) = wvpzptqkdy bkgykdhcxt (xjebfycody ) View more	Negative	06 Nov 2026
				Nerandomilast 18 mg bid	behooobkug(mqeoiwzkgd) = lcgyzkkqxz bkgykdhcxt (xjebfycody ) View more
FIBRONEER-ILD (ACR2026)	Phase 3	Lung Diseases, Interstitial	33	Nerandomilast 9 mg BID	qaawdjiedy(xnhwitydee) = Diarrhea and upper respiratory tract infection were the most common adverse events reported in the subgroup. zfevvdlnct (zvhbmptesk )	Positive	06 Nov 2026
				Nerandomilast 18 mg BID
NCT01835899 \| NCT04771286 \| NCT01594515 (Pubmed \| Eur J Drug Metab Pharmacokinet)	Phase 1	-	75	Nerandomilast	zgdapnktte(cknlibtinm) = cyqasbrmdr xsggbouzwp (qagwqxkazd ) View more	Positive	01 Sep 2026
NCT06195072 (CONQUEST, EULAR2026)	Phase 2	Interstitial lung disease due to systemic disease	127	Amlitelimab	srygvojwvp(wrmsycprye) = movqrsnflv pqeznwlmdj (txycoctjvc ) View more	Positive	11 Jun 2026
ATS2026	Not Applicable	Lung Diseases, Interstitial	1,715	Nerandomilast 18 mg	ewklsdrrtg(ldzsqbtvwv): MD = 72.64 (95.0% CI, 49.79 - 95.48), P-Value = < 0.01 View more	Positive	15 May 2026
				Placebo
FIBRONEER-IPF (ATS2026)	Phase 3	Idiopathic Pulmonary Fibrosis \| Progressive fibrotic interstitial lung disease	2,353	Nerandomilast 9 mg bid	ihotheelie(yytxzlldhx) = lower with nerandomilast versus placebo tkzapbdekc (sinwzkddjm ) View more	Positive	15 May 2026
				Nerandomilast 18 mg bid
FIBRONEER-ILD (ATS2026)	Phase 3	Idiopathic Pulmonary Fibrosis \| Progressive pulmonary fibrosis	2,353	Nerandomilast 9 mg bid	ppdkyopnhe(jcmxsjsyrw): P-Value = 0.88	Positive	15 May 2026
				Nerandomilast 18 mg bid
NCT05321082 (FIBRONEER-ILD, CTgov)	Phase 3	Progressive fibrotic interstitial lung disease	1,178	Placebo (Placebo)	ibvzqwcujo(bcndutdjhb) = qnhhzuvepx fyiydmnaeu (fgaojskpqy, bnumhwsnpq - bebjnxwwja) View more	-	09 Jan 2026
				BI 1015550 (Nerandomilast 9 mg)	ibvzqwcujo(bcndutdjhb) = xfqxnevlim fyiydmnaeu (fgaojskpqy, vmqdadsvdo - qjyjcmcbco) View more
NCT06624072 (CTgov)	Phase 1	-	15	Nerandomilast (Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1))	wqwyjmndvm(cxvmyqmppa) = hcxabmoxdw pngxfpvcha (pudxkbvhlb, NA) View more	-	08 Jan 2026
				Nerandomilast (Nerandomilast 18 mg Adult Fasted State (Reference R))	wqwyjmndvm(cxvmyqmppa) = dldzdgmcll pngxfpvcha (pudxkbvhlb, NA) View more

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