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 Date09 Nov 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

JPRN-jRCT2030260406

/ Not yet 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)

Start Date01 Sep 2026

Sponsor / Collaborator

Nippon Boehringer Ingelheim Co., Ltd.

NCT07540988

/ Not yet 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 Date28 Aug 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 Jul 2026·European Respiratory Review

Selective phosphodiesterase 4B inhibition in fibrotic lung disease: a scoping review of vascular–immune mechanisms and extrapulmonary implications

Article

Author: Pagliaro, Raffaella ; Mariniello, Domenica Francesca ; Perrotta, Fabio ; Bianco, Andrea

Background:

Preferential phosphodiesterase 4B (PDE4B) inhibition with nerandomilast has demonstrated attenuation of forced vital capacity decline in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. Because PDE4 enzymes regulate cAMP-dependent inflammatory and endothelial signalling, class-level PDE4 inhibition has been consistently linked to vascular–immune pathways. Whether preferential PDE4B inhibition reproduces these effects remains uncertain.

Objectives:

To map the available mechanistic and translational literature on extrapulmonary or systemic biological effects of PDE4/PDE4B inhibition and to place nerandomilast trial findings within that framework without inferring clinical efficacy outside pre-specified trial outcomes.

Methods:

We performed a the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews informed scoping review of PubMed/MEDLINE from database inception to 1 March 2026. Eligible studies included pre-clinical, translational and clinical reports addressing endothelial, immune, microvascular or organ-level effects of PDE4/PDE4B modulation. Evidence was charted and narratively synthesised rather than quantitatively pooled.

Results:

71 studies were included. Experimental data (primarily derived from class-level PDE4 inhibition) consistently link these pathways to modulation of endothelial permeability, leukocyte–endothelial adhesion, thromboinflammatory signalling, and macrophage resolution programmes across pulmonary and extrapulmonary models. However, most extrapulmonary evidence derives from class-level PDE4 biology rather than nerandomilast-specific investigations, and clinical evidence for extrapulmonary benefit in fibrotic lung disease remains indirect.

Conclusions:

Because PDE4 enzymes regulate cAMP-dependent inflammatory and endothelial signalling, class-level PDE4 inhibition has been consistently linked to modulation of vascular–immune pathways. Whether preferential PDE4B inhibition reproduces these effects in humans remains to be established. While at present, extrapulmonary clinical benefit in fibrotic lung disease remains unproven, future studies should prospectively evaluate systemic biomarkers and organ-level outcomes rather than relying on post hoc interpretation of numerical signals.

01 Jul 2026·EUROPEAN RESPIRATORY JOURNAL

Nerandomilast in progressive pulmonary fibrosis: data from the whole follow-up period of the FIBRONEER-ILD trial

Article

Author: Richeldi, Luca ; Gu, Hui ; Hoffmann-Vold, Anna-Maria ; Valenzuela, Claudia ; Maher, Toby M ; Oldham, Justin M ; Stowasser, Susanne ; Assassi, Shervin ; Martinez, Fernando J ; Ritter, Ivana ; Wijsenbeek, Marlies S ; Azuma, Arata ; Kreuter, Michael ; Cottin, Vincent

Background:

In the FIBRONEER-ILD trial in patients with progressive pulmonary fibrosis (PPF), nerandomilast 9 mg twice daily and 18 mg twice daily (hereafter nerandomilast 9 mg and 18 mg, respectively) reduced the decline in forced vital capacity at week 52 compared with placebo (primary end-point). We assessed the effects of nerandomilast up to the final database lock.

Methods:

Time to first acute exacerbation of interstitial lung disease, hospitalisation for respiratory cause or death (key secondary end-point) and other time-to-event end-points were assessed.

Results:

1176 patients, of whom 512 were taking background nintedanib, received nerandomilast or placebo. At the final database lock, the mean± sd exposure to trial medication was 15.1±5.7 months and the mean± sd observation period was 17.0±4.1 months. Compared with placebo, the hazard ratio for the key secondary end-point was 0.78 (95% CI 0.61–1.00) for nerandomilast 9 mg and 0.77 (95% CI 0.60–0.99) for nerandomilast 18 mg; hazard ratios were lower among patients not taking nintedanib (0.69 (95% CI 0.49–0.97) and 0.65 (95% CI 0.46–0.92), respectively) than among those taking background nintedanib (0.90 (95% CI 0.63–1.30) and 0.93 (95% CI 0.65–1.34), respectively). For death, the hazard ratio versus placebo was 0.51 (95% CI 0.34–0.78) for both nerandomilast doses. Adverse events led to discontinuation of trial medication in 12.5%, 12.0% and 12.3% of the placebo, nerandomilast 9 mg and nerandomilast 18 mg groups, respectively.

Conclusions:

In the FIBRONEER-ILD trial in patients with PPF, nerandomilast reduced the risk of clinically important outcomes, including death, over the whole trial. Nerandomilast had a favourable safety and tolerability profile.

01 Jun 2026·BMJ medicine

Pulmonary fibrosis: evolving therapeutic pipeline

Review

Author: Rooney, Rebecca ; Hilary, Benjamin ; Shannon, Laura ; Murphy, Gary ; Chaudhuri, Nazia ; Islam, Sabria ; Bailey, Simon

Current treatment for pulmonary fibrosis is limited to nintedanib and pirfenidone, which slow but do not halt or reverse the progression of the disease. These treatments are widely used globally. Emerging agents, such as nerandomilast, showed positive results in phase 3 trials and was approved in the US in 2025 for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, but is not yet licensed for clinical use in the UK. As our understanding of the pathogenesis of pulmonary fibrosis advances, so does the potential to develop treatments that more effectively target underlying mechanisms while being safe and well tolerated. Insights into key pathogenic pathways, including epithelial injury, fibroblast activation, extracellular matrix deposition, B and T cell involvement, and dysregulated cytokine signalling pathways, have enabled various therapeutic targets to be explored. Despite the extensive efforts behind each study, many questions remain unanswered. Negative trials are equally important, in providing insights into how future clinical trials can be better designed and targeted. Meanwhile, positive studies show encouraging results and identify potential treatments, all contributing to the overarching goal of not just slowing, but ultimately reversing, fibrosis.

109

News (Medical) associated with Nerandomilast

24 Aug 2026

·www.biospace.com

Vicore Pharma to Present at the European Respiratory Society Congress 2026

STOCKHOLM, SE / ACCESS Newswire / August 24, 2026 / Vicore Pharma Holding AB (NASDAQ Stockholm:VICO)(NASDAQ:VCRE), a clinical-stage biopharmaceutical company unlocking the potential of a novel class of drugs, angiotensin II type 2 receptor agonists, today announced that the company will participate in the European Respiratory Society (ERS) Congress 2026, taking place in Barcelona, Spain and online September 5-9, 2026. Vicore will present new data on the design and baseline characteristics of patients enrolled in the global Phase 2b ASPIRE trial in buloxibutid, the company's lead program in idiopathic pulmonary fibrosis (IPF), along with translational findings on AT2 receptor activation in alveolar epithelial type II cells and its association with MMP-13, a collagenase linked to fibrosis resolution. Oral presentation: ASPIRE-IPF, a global, double-blind, randomized, placebo-controlled Phase 2b trial of buloxibutid, an angiotensin II type 2 receptor agonist, in idiopathic pulmonary fibrosis: trial design and patient characteristics Presenter: Toby Maher (Los Angeles, California, United States) Presented within the session: Moving forward in interstitial lung disease: new data on novel therapies Date: Monday, September 7, 2026 Presentation Time: 11:35 CEST Poster: Buloxibutid (C21) activates the angiotensin II type 2 receptor in alveolar epithelial type II cells, increasing MMP-13 associated with fibrosis resolution in idiopathic pulmonary fibrosis First author: Johan Raud (Stockholm, Sweden) Presented within the Poster session: Metabolic pathways in pulmonary fibrosis Date: Sunday, September 6, 2026 Presentation Time: 12:30 CEST Following the presentations, the materials will be made available on the Publications page of Vicore's website. For further information, please contact: Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com About Vicore Pharma 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 has received Orphan Drug and Fast Track designation 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). 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 anti-fibrotic 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 (100 mg or 50 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 more than 360 patients enrolled 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. Cautionary Note Regarding 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 concerning Vicore Pharma, its leadership, its pipeline, and the development of buloxibutid. 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, 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, its press releases, and the Registration Statements. Forward-looking statements include, among others, anticipated presentations at the upcoming ERS Congress, the timing of topline results from the Phase 2b ASPIRE clinical trial, and the treatment potential of buloxibutid in IPF. 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. Attachments Vicore Pharma to Present at the European Respiratory Society Congress 2026 SOURCE: Vicore Pharma Holding View the original press release on ACCESS Newswire

Phase 2Fast TrackOrphan Drug

30 Jul 2026

·www.globenewswire.com

European Commission approves JASCAYD®, bringing well-tolerated, novel oral treatment for IPF and PPF to the EU

Not intended for UK and US audiences JASCAYD® (nerandomilast) is the first oral, preferential PDE4B inhibitor approved in the European Union, delivering a novel mechanism of action with antifibrotic and immunomodulatory effectsPhase III FIBRONEER™️trials demonstrated that nerandomilast effectively slows lung function decline in adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF), two life-threatening, progressive lung conditions1,2,3,4Nerandomilast demonstrated a favorable safety and tolerability profile in clinical trials, notably, with monotherapy discontinuation rates similar to placebo Ingelheim, Germany - Boehringer Ingelheim today announced that the European Commission (EC) has granted marketing authorization for JASCAYD® (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF). This marks the first new treatment approved in IPF in the EU in over a decade and for PPF in more than five years. As a first-in-class oral preferential phosphodiesterase 4B (PDE4B) inhibitor, nerandomilast addresses a critical unmet need by successfully slowing disease progression while remaining tolerable. “With JASCAYD®, physicians across the EU gain a long-awaited, new treatment option for people living with IPF and PPF that is effective, has a well-characterized safety profile and may support long-term adherence,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “This milestone is a major advancement, but it must also be a catalyst for broader recognition that lungs can’t wait. Earlier recognition and diagnosis of pulmonary fibrosis are crucial because for people living with a progressive disease, every moment matters.” The EC approval follows the positive CHMP opinion received in May and is based on results from the FIBRONEER™ Phase III program, the largest clinical trial program conducted in 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 profile with no requirement for liver monitoring. As monotherapy, it showed similar discontinuation rates to placebo.1,2 “One of the challenges of managing IPF and PPF is seeing patients needing to stop treatment early because the side effects are too much to tolerate,” said Prof Marlies Wijsenbeek, Pulmonary Physician at the Erasmus MC University Medical Centre. “The FIBRONEER™ trials showed us that nerandomilast preserves lung function with a tolerability profile that allows patients to stay on their medication, which is a major clinical advancement that patients across the EU have been waiting for. Also, removing the burden of ongoing liver monitoring is an additional improvement for patients.” IPF and PPF affect more than 500,000 people across Europe,5 causing irreversible lung scarring that severely restricts breathing. Despite the life-threatening nature of these conditions, where approximately half of those diagnosed lose their lives within five years6,7,8 – a prognosis worse than many cancers.7,9,10 – many people delay or stop existing therapies due to side effects such as nausea, photosensitivity, and diarrhea.11,12,13 In IPF specifically, approximately half of those who stop therapy do so within six months.13 “When diagnosed with a progressive and irreversible lung condition like IPF or PPF, your greatest fear is running out of treatment options,” said Sue Farrington, President of the Federation of European Scleroderma Associations (FESCA). “Today’s authorization is a long-awaited breakthrough for the IPF and PPF community in the EU and offers renewed hope for people living with systemic sclerosis and other diseases that can lead to progressive lung fibrosis. Having a therapy that patients can reliably stay on to preserve their lung health brings real stability and hope to families.” About IPF and PPF Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) are both conditions characterized by irreversible build-up of scar tissue in the lungs, affecting the lungs’ ability to take in and transfer oxygen into the bloodstream.14,15,16 Once lung function is lost, it’s lost forever. Signs and symptoms of IPF and PPF include a persistent dry cough, shortness of breath, fatigue and finger/toe clubbing (widening and rounding of the tips of fingers/toes).4,16 In IPF, the root cause of pulmonary fibrosis is not known.14 The disease primarily affects people over the age of 50 and affects more men than women.17 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 be due to an unknown cause (idiopathic) and worsens despite treatment of the condition.15 Together, IPF and PPF may affect up to 9.2 million people worldwide.5,18 Approximately half of people with IPF or PPF die within 5 years of diagnosis6,7,8 – a higher mortality than many cancers.7,9,10 About nerandomilast JASCAYD® (nerandomilast) is a twice daily oral, preferential PDE4B inhibitor with antifibrotic and immunomodulatory effects approved in the United States, China, the United Arab Emirates, Japan, Thailand, the United Kingdom, Brazil and the European Union for the treatment of adults with IPF and for the treatment of adults with PPF. Regulatory submissions for nerandomilast in IPF and PPF are also under review in other countries with additional approvals anticipated in 2026. Boehringer Ingelheim is also exploring the potential of nerandomilast in two rheumatic diseases: systemic sclerosis (SSc) and myositis (IIM). 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 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com. References *FVC is a measure of lung function, measured in mL. **The key secondary endpoint was time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death over the duration of trial Richeldi, et al. NEJM. 2025;392:2193-2202.Maher, et al. NEJM. 2025. doi:10.1056/NEJMoa2503643Hoyer N, et al. Respir Res. 2019;20(1).Grant-Orser A, et al. BMJ Open Respir Res. 2024;11:e002333.Cottin V, et al. Front Med (Lausanne). 2022;9:799912.Zheng Q et al. ERJ Open Res. 2022;8(1):00591-2021.Cen Z, et al. Ann Med. 2024;56(1):2406439.Nasser M, et al. Respir Res 2021;22:162.Siegel RL, et al. A Cancer Journal for Clinicians. 2024;74(1):12–49.Vancheri C, et al. Eur Respir J. 2010;35(3):496–504.Esbriet SmPC — Roche, 2014.Ofev SmPC — Boehringer Ingelheim, 2025 (Last updated: Oct 2025).Levra S et al. Biomedicines. 2022;10(12):3229.Upagupta C, et al. Eur Respir Rev. 2018;27:180033.Kondoh Y, Inoue Y. Adv Ther. 2025;42(7):2988–3001.van Cleemput, J, et al. Adv Ther. 2019;36, 298–317.Wang J, et al. MedComm (2020). 2024;5(10):e744.Podolanczuk A, et al. Eur Respir J. 2023;61(4). Attachment Boehringer headquarters

Clinical ResultDrug ApprovalPhase 3

15 Jul 2026

·pmlive.com

Boehringer Ingelheim’s Jascayd approved by MHRA for idiopathic pulmonary fibrosis

Boehringer Ingelheim’s Jascayd (nerandomilast) tablets have been granted marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF). Jascayd is the first treatment of its kind licensed for use in IPF and PPF in adults. The MHRA authorisation is based on the results of the pivotal phase 3 clinical trials involving 1,177 and 1,176 patients with IPF and PPF respectively. Currently, there is a high unmet need for patients, as there are few treatment options that slow the disease progression, with IPF being described as having a five-year survival rate of just 45.6%, comparable with many cancers. Over 5,000 people in the UK die each year from IPF, which represents around 1 in 100 deaths nationwide. “The MHRA authorisation of nerandomilast is a meaningful advancement in the management of this condition, where there is high mortality and a substantial impact on quality of life,” commented Douglas Clark, Medical Director of Boehringer Ingelheim UK & Ireland. “We are now working closely with NICE, aiming to bring nerandomilast to eligible patients on the NHS as soon as possible.” Pulmonary fibrosis is a chronic and ultimately fatal condition characterised by irreversible lung scarring and a continuous decline in lung function. Symptoms include worsening breathlessness, a persistent dry cough and fatigue. Antifibrotics have been the mainstay of treatment for the past decade, with no effective treatment innovations licensed since then. “A diagnosis of progressive pulmonary fibrosis means that life expectancy is reduced while day-to-day quality of life can often deteriorate, as breathlessness and fatigue worsen,” commented Professor Philip Molyneaux, Consultant Respiratory Physician and Professor of Interstitial Lung Disease at Imperial College London. “With the authorisation of nerandomilast by the MHRA, clinicians have a new treatment option that can slow the decline in lung function, expanding the choices available for eligible patients.” NICE is evaluating Jascayd to treat adults with IPF or PPF, with guidance expected in September 2026. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalClinical Result

100 Deals associated with Nerandomilast

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
Idiopathic Inflammatory Myopathies	Phase 3	United States	Boehringer Ingelheim GmbH	09 Nov 2026
Idiopathic Inflammatory Myopathies	Phase 3	China	Boehringer Ingelheim GmbH	09 Nov 2026
Idiopathic Inflammatory Myopathies	Phase 3	Japan	Boehringer Ingelheim GmbH	09 Nov 2026
Idiopathic Inflammatory Myopathies	Phase 3	Argentina	Boehringer Ingelheim GmbH	09 Nov 2026
Idiopathic Inflammatory Myopathies	Phase 3	Australia	Boehringer Ingelheim GmbH	09 Nov 2026
Idiopathic Inflammatory Myopathies	Phase 3	Belgium	Boehringer Ingelheim GmbH	09 Nov 2026
Idiopathic Inflammatory Myopathies	Phase 3	Brazil	Boehringer Ingelheim GmbH	09 Nov 2026
Idiopathic Inflammatory Myopathies	Phase 3	Bulgaria	Boehringer Ingelheim GmbH	09 Nov 2026
Idiopathic Inflammatory Myopathies	Phase 3	Canada	Boehringer Ingelheim GmbH	09 Nov 2026
Idiopathic Inflammatory Myopathies	Phase 3	France	Boehringer Ingelheim GmbH	09 Nov 2026

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06195072 (CONQUEST, EULAR2026)	Phase 2	Interstitial lung disease due to systemic disease	127	Amlitelimab	pfigpoiycm(rnosqtnlgf) = bgsdyhdbhp kvkukksqoz (aqssmkmtnf ) View more	Positive	11 Jun 2026
FIBRONEER-IPF (ATS2026)	Phase 3	Idiopathic Pulmonary Fibrosis \| Progressive fibrotic interstitial lung disease	2,353	Nerandomilast 9 mg bid	jifzuvhauq(zkyqwbtjzz) = lower with nerandomilast versus placebo evyugxdkza (qldbmldhga ) View more	Positive	15 May 2026
				Nerandomilast 18 mg bid
ATS2026	Not Applicable	Lung Diseases, Interstitial	1,715	Nerandomilast 18 mg	zkxsmzmppg(vinivspntz): MD = 72.64 (95.0% CI, 49.79 - 95.48), P-Value = < 0.01 View more	Positive	15 May 2026
				Placebo
FIBRONEER-ILD (ATS2026)	Phase 3	Idiopathic Pulmonary Fibrosis \| Progressive pulmonary fibrosis	2,353	Nerandomilast 9 mg bid	boyoalbayg(dxjmbmbepw): 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)	iioobgmlzm(gphqoiqhla) = qeyytxjdrr cawlblztjw (aacyeiylvr, osdikfxzvb - kjblfrdccq) View more	-	09 Jan 2026
				BI 1015550 (Nerandomilast 9 mg)	iioobgmlzm(gphqoiqhla) = phzgagoiqr cawlblztjw (aacyeiylvr, bxqfkbxitp - kfxklpqzdf) View more
NCT06624072 (CTgov)	Phase 1	-	15	Nerandomilast (Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1))	lpamxzfqpb(kjviekakgz) = pohgpvplpe zokqfkppac (rraulpvdzt, NA) View more	-	08 Jan 2026
				Nerandomilast (Nerandomilast 18 mg Adult Fasted State (Reference R))	lpamxzfqpb(kjviekakgz) = loblwvauso zokqfkppac (rraulpvdzt, NA) View more
NCT06070610 (CTgov)	Phase 1	-	14	Pirfenidone+Nintedanib (Pirfenidone/Nintedanib alone (Reference))	tktmyosmiw(yxveecgloz) = eyoqqwofin fdnldwarlm (twwcutsvsu, NA) View more	-	02 Dec 2025
				Pirfenidone+Nerandomilast+Nintedanib (Pirfenidone/Nintedanib in combination with Nerandomilast (Test))	tktmyosmiw(yxveecgloz) = rovejrbyxc fdnldwarlm (twwcutsvsu, NA) View more
NCT06139302 (CTgov)	Phase 1	-	12	Nerandomilast (Nerandomilast 9 mg)	emjxwttpmi(owhsdjunqr) = vprftdtciy nhkkxufnou (idbzokueqz, 13.8) View more	-	01 Dec 2025
				Nerandomilast (Nerandomilast 18 mg)	emjxwttpmi(owhsdjunqr) = ugukzadhmz nhkkxufnou (idbzokueqz, 52.8) View more
NCT06393127 (CTgov)	Phase 1	-	64	nerandomilast (Test treatment (T))	xcohiidejo(pflhnjspke) = rswdlmcrao sctletnjfx (tnsfjrugks, NA) View more	-	01 Dec 2025
				nerandomilast (Reference treatment (R))	xcohiidejo(pflhnjspke) = sxlneqejvo sctletnjfx (tnsfjrugks, NA) View more
NCT06408870 (CTgov)	Phase 1	-	64	BI 1015550 (BI 1015550 Formulation C1 (Reference, R))	lcihvvyehp(qebtprhadm) = ygzyeelwve nmlntfsobl (bjoosnbcjf, na) View more	-	01 Dec 2025
				BI 1015550 (BI 1015550 Formulation C2 (Test, T))	lcihvvyehp(qebtprhadm) = kergdmunfx nmlntfsobl (bjoosnbcjf, na) View more

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