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

Structure/Sequence

Molecular FormulaC20H25ClN6O2S

InChIKeyUHYCLWAANUGUMN-SSEXGKCCSA-N

CAS Registry1423719-30-5

Clinical Trials associated with Nerandomilast

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

NCT07366034

/ Not yet recruitingPhase 3

A Study to Evaluate the Dose-exposure, Safety, and Exploratory Efficacy of Nerandomilast in Children and Adolescents From 2 Years to Less Than 18 Years of Age With Fibrosing Interstitial Lung Disease (Part A: Double-blind, Placebo-controlled in Children From 6 to Less Than 18 Years of Age and Open-label Active Treatment in Children From 2 to Less Than 6 Years of Age), Followed by an Open-label Phase With Active Treatment (Part B)

This study is open to children and adolescents aged 2 to 17 years with interstitial lung disease (ILD). Nerandomilast has just been approved in some countries to help adults with a lung condition called idiopathic pulmonary fibrosis. The purpose of this study is to understand how nerandomilast is tolerated and handled by the body and whether nerandomilast also helps children and adolescents with ILD.
For participants aged 6 to 17 years when joining, the study has 2 parts. In the first part, participants are put into 1 of 2 groups randomly, which means by chance. One group gets nerandomilast and the other group placebo. Placebo looks like nerandomilast but does not contain any medicine.
Participants are twice as likely to be in the nerandomilast group. They take tablets twice a day for 6 months. After these 6 months, in the second part of this study, they get nerandomilast for at least 2 years regardless of what they got in the first part.
Young participants aged 2 to 5 years when joining get nerandomilast from the start. They receive tablets twice a day for at least 2 and a half years.
Depending on when a person joins, the study lasts between 2 and a half years and up to 5 years. During this time, participants may visit the study site about 18 to 30 times. Study doctors collect blood samples to check participants' health and to find out how their body handles the study medicine. Doctors also check the function of the lungs, body growth, and how participants feel. The study doctors also regularly check participants' health and take note of any changes. For participants aged 6 to 17 years, the results are compared between the groups to see whether nerandomilast treatment helps children and adolescents.

Start Date27 Jul 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT07321860

/ Not yet recruitingPhase 2/3

Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Partial TGF-βR1 (ALK5) Inhibition With Galunisertib Combined With PDE4 Inhibition With Nerandomilast in GREM2-Positive ALS

Amyotrophic lateral sclerosis (ALS) is a relentlessly progressive neurodegenerative disorder characterized by loss of upper and lower motor neurons, leading to muscle weakness, respiratory decline, and eventual mortality. A growing body of translational and clinical evidence implicates neuroinflammation, reactive astrocytosis, and maladaptive TGF-β signaling as central contributors to disease progression. Elevated levels of Gremlin-2 (GREM2) have been identified as a marker of dysregulated TGF-β-linked astrocytic activity and fibrotic gene programs in some ALS patients, and preclinical data suggest that attenuating these pathways may mitigate glial toxicity and improve neuronal survival.
Galunisertib, a selective ATP-competitive TGF-β receptor type I (TGF-βR1/ALK5) inhibitor, has been developed to block SMAD2/3 phosphorylation and TGF-β-mediated transcriptional programs. Meanwhile, nerandomilast, a selective PDE4B inhibitor, elevates intracellular cAMP in immune and glial cells, shifting pro-inflammatory signaling toward resolution and antagonizing secondary fibrotic and inflammatory cascades. Preclinical models show that PDE4 inhibition and TGF-β pathway blockade concurrently reduce maladaptive glial phenotypes and fibrotic mediators.
This study investigates the combination of galunisertib + nerandomilast in ALS patients with elevated GREM2, hypothesizing that dual targeting of TGF-β-mediated astrocytic reactivity and PDE4B-regulated inflammatory signaling will translate into slowing of disease progression and favorable pharmacodynamic effects on central biomarkers of neuroinflammation and neurodegeneration.

Start Date30 Jun 2026

Sponsor / Collaborator-

100 Clinical Results associated with Nerandomilast

100 Translational Medicine associated with Nerandomilast

100 Patents (Medical) associated with Nerandomilast

Literatures (Medical) associated with Nerandomilast

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.

01 May 2026·AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE

Will the anti-fibrotic effects of nerandomi-last? FIBRONEER-IPF part 2

Article

Author: Khor, Yet H ; Jenkins, R Gisli

01 May 2026·AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE

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

Article

Abstract:

Rationale:

In the randomized placebo-controlled FIBRONEER-IPF trial in patients with idiopathic pulmonary fibrosis, both nerandomilast 9 mg bid and 18 mg bid met the primary endpoint of reducing decline in forced vital capacity at week 52. Patients continued to receive randomized treatment after week 52, until the last patient had completed an end-of-treatment visit.

Objectives:

To assess the effects of nerandomilast over the full duration of follow-up in the FIBRONEER-IPF trial.

Methods:

Time to first acute exacerbation of IPF, hospitalization for respiratory cause, or death (key secondary endpoint) and other time-to-event endpoints were assessed at final database lock.

Measurements and main results:

1177 patients were treated. Mean (SD) exposure to trial medication was 14.8 (5.0), 14.9 (5.0) and 14.7 (5.3) months in the placebo, nerandomilast 9 mg bid and nerandomilast 18 mg bid groups, respectively. Compared with placebo, the hazard ratio (95% CI) for the key secondary endpoint was 0.92 (0.69, 1.22) for nerandomilast 9 mg bid and 0.99 (0.75, 1.31) for nerandomilast 18 mg bid and the hazard ratio (95% CI) for death was 0.95 (0.61, 1.49) for nerandomilast 9 mg bid and 0.66 (0.41, 1.08) for nerandomilast 18 mg bid. Adverse events led to treatment discontinuation in 13.0%, 13.5% and 16.1% of the placebo, nerandomilast 9 mg bid and nerandomilast 18 mg bid groups, respectively.

Conclusions:

In the FIBRONEER-IPF trial, nerandomilast had no effect on the composite endpoint of time to first acute exacerbation of IPF, hospitalization for respiratory cause, or death, but nerandomilast 18 mg bid was associated with a numerically lower risk of death. Nerandomilast had a favorable safety profile, with a low rate of discontinuation due to adverse events.

100

News (Medical) associated with Nerandomilast

18 Jun 2026

·www.globenewswire.com

New analyses from FIBRONEER™ trials suggest survival benefit with nerandomilast in IPF and PPF

Not intended for UK and US audiences Nerandomilast long-term survival modeling presented at American Thoracic Society (ATS) 2026 and European Alliance of Associations for Rheumatology (EULAR) 2026 international congresses.Based on the modeling, nerandomilast consistently increased median survival in both idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).1,2Modeling predicts meaningful extensions in survival with nerandomilast, including a multi-year increase in median survival when used as monotherapy, and additional gains when added to standard treatment.1,2 Ingelheim, Germany - Long-term survival modeling of Boehringer Ingelheim’s oral preferential PDE4B inhibitor, nerandomilast, predicts the therapy could extend survival by up to 5.4 years in adults with idiopathic pulmonary fibrosis (IPF) and up to 3.3 years in adults with progressive pulmonary fibrosis (PPF), compared with no therapy.1,2 These findings are based on data from the Phase III FIBRONEER™ trials and were recently presented at the ATS and EULAR 2026 international congresses. "I expect that nerandomilast will offer a transformative survival benefit for patients with either IPF or PPF,” said Toby Maher, M.D., Ph.D., Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles. “In clinical practice, we believe that slowing FVC decline is one important precursor to improving survival in people with IPF and PPF. Data from the FIBRONEER™ trials, plus the survival modeling, are showing us improvements that are truly meaningful, suggesting nerandomilast may have an effect on survival beyond that mediated by reducing decline in FVC." In patients with IPF, it is estimated that nerandomilast 18 mg monotherapy could more than double median survival to 9.1 years, extending it from 3.7 years with no therapy. For those receiving standard background therapy with nintedanib, adding nerandomilast 18 mg is predicted to increase median survival from 4.6 years to 6.0 years.1 In patients with PPF, it is predicted that nerandomilast 18 mg monotherapy could extend median survival to 7.2 years compared to 3.9 years with no therapy. When added to background nintedanib, predicted median survival is extended from 3.4 years to 4.4 years.2 "IPF and PPF are devastating, life-threatening diseases that ruthlessly steal time from patients. Historically, burdensome side effects have forced many to abandon therapy limiting the potential for a sustained treatment effect,” said Dr. Lykke Hinsch Gylvin, Chief Medical Officer and Head of Global Medicine at Boehringer Ingelheim. “Nerandomilast represents a meaningful step forward. By offering an effective and safe therapy that patients can actually tolerate, it supports sustained, long-term treatment. If patients are able to stay on therapy longer, nerandomilast may have the potential to translate its predicted survival benefit into what really matters: more precious time with family and loved ones.” In FIBRONEER™-IPF and FIBRONEER™-ILD nerandomilast met its primary endpoint, demonstrating slowed lung function decline compared to placebo as measured by the absolute change in Forced Vital Capacity (FVC) from baseline to week 52 in IPF and PPF, respectively. While the key secondary endpoint* was not met in either FIBRONEER™-trial, in a pooled analysis of FIBRONEER™-trials, a 59% nominally significant reduction in the risk of death was observed in participants treated with nerandomilast 18 mg as monotherapy compared with placebo.3 *The key secondary endpoint was time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death over the duration of trial About the survival modeling analysis The survival benefits were estimated using a statistical model based on data from the FIBRONEER™-IPF and FIBRONEER™-ILD trials. Researchers used a standard method (Weibull distribution modeling) to estimate long-term survival outcomes over a 30-year period, assuming consistent treatment effects and discontinuation rates similar to those seen during the respective trials.1,2 It is important to note that these figures represent modeled projections, not observed patient outcomes from the clinical trials. Data from the open-label extension of the FIBRONEER™ trials, FIBRONEER™-ON, and real-world evidence will provide further evidence into the long-term effect of nerandomilast. About nerandomilast JASCAYD® (nerandomilast) is an oral preferential PDE4B inhibitor with antifibrotic, immunomodulatory and vascular effects approved in the US, China, the UAE, and Japan for the treatment of adults with IPF and adults with PPF. Regulatory submissions for nerandomilast in IPF and PPF are also under review in the European Union - having received a positive CHMP opinion in May 2026 - the UK, and 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). 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.4,5,6 Signs and symptoms of IPF and PPF include a persistent dry cough and shortness of breath on exertion.6,7 In IPF, the root cause of pulmonary fibrosis is not known.4 The disease primarily affects people over the age of 50 and affects more men than women.8 In PPF, the scarring of the lungs may be linked to an existing condition (e.g. rheumatoid arthritis or systemic sclerosis), which causes inflammation of the lung tissue repeatedly and leads to fibrosis. PPF can also 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.5 Together, IPF and PPF may affect up to 9.2 million people worldwide.9,10 Approximately half of people with IPF or PPF die within 5 years of diagnosis11,12,13 – a higher mortality rate than many cancers.14,15 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 Pimple et al. Predicting long-term survival benefit of nerandomilast in patients with idiopathic pulmonary fibrosis (IPF). (Poster presented at ATS 2026)Maher et al. Predicting long-term survival benefit of nerandomilast in patients with progressive pulmonary fibrosis (PPF). (Poster presented at EULAR 2026Oldham J et al. (Pooled analysis from the FIBRONEER IPF and FIBRONEER ILD trials- ERS 2025) 2025;392(22):2203-2214.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.Kondoh Y, et al. Respir Investig. 2021;59(6):709-740.Wang J, et al. MedComm (2020). 2024;5(10):e744.Podolanczuk AJ, et al. Eur Respir J. 2023;61(4)2200957.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. CA Cancer J Clin. 2024;74(1):12–49.Vancheri C, et al. Eur Respir J. 2010;35(3):496–504.

Clinical ResultPhase 3Drug Approval

22 May 2026

·www.fiercepharma.com

Europe's CHMP gives thumbs up to AZ's breast cancer drug after thumbs down from FDA adcomm

A CHMP recommendation for AstraZeneca’s novel cancer drug Etcamah was one of several positive decisions for drugmakers at this week's meeting. Less than a month after an FDA advisory committee voted 6-3 to reject AstraZeneca’s camizestrant, Europe’s Committee for Medicinal Products for Human Use (CHMP) has blessed it with a positive opinion. The European experts have recommended that the oral SERD treatment can be used in combination with a CDK4/6 inhibitor for patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer if they have ESRI mutations.Last month, the FDA’s Oncologic Drugs Advisory Committee (ODAC) raised questions about the design of the pivotal SERENA-6 study, which showed a 56% improvement in progression-free survival (PFS) for switching to camizestrant, used on top of a CDK4/6 inhibitor, compared with continuing treatment with an aromatase inhibitor (AI) and a CDK4/6 drug.The FDA took issue with AZ’s study, arguing it did not address whether this first-line switch approach provides long-term benefit to patients compared with the standard practice of waiting until disease progression to use a new therapy. Although camizestrant extended median PFS by 6.8 months in the trial design, the FDA was unsure of its clinical meaningfulness.The FDA has not yet issued its decision on the drug, though it usually sides with the recommendations provided by their expert committees. In Europe, the drug will carry the brand name Etcamah. Europe signs off on Novo’s Wegovy pill The CHMP also endorsed Novo Nordisk’s Wegovy pill, clearing it for approval to become the first oral GLP-1 treatment for obesity in Europe. The arrival of the Wegovy pill comes as other drugmakers are developing their investigational oral weight-loss treatments. Last month, Eli Lilly gained approval in the United States for its obesity pill Foundayo. The Indianapolis company has yet to submit for approval of its pill in Europe. The FDA signed off on oral Wegovy in January and the company reported its first quarter sales at $355 million.While injected Wegovy can be used by patients age 12 and older, the European recommendation for the oral version covers adults only. The daily pill must be taken on an empty stomach, after an eight hour fast, followed by 30 more minutes without food, drink or any other medications. The nod was backed by a trial of 307 adults who were obese or overweight, with participants losing an average of 14% of their body weight compared to a 2% figure for those on placebo. The CHMP also signed off on two versions of Novo-developed GLP-1 liraglutide, which are now sold by German generics specialist Stada. The positive opinions were issued for obesity treatment Ablymico, which is a hybrid version of Novo’s Saxenda, and for Liraglutide Stada, which contains the same active substance of Novo’s Victoza. New drugs gain CHMP nods The CHMP has put its stamp of approval on Boehringer Ingelheim’s Jascayd for two lung disorders—idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The nod comes two months after Boehringer Chairman Shashank Deshpande expressed frustration over the regulatory timelines in Europe.“Why is that possible in one jurisdiction or territory and why does it take six months, nine months in Europe?" Deshpande asked. Jascayd is the first new treatment in more than a decade for IPF, a potentially fatal disorder that causes a buildup of scar tissue in the lungs and limits oxygen intake. As a selective phosphodiesterase-4B (PDE4B) inhibitor, Jascayd brings a new mechanism of action to the market. The FDA approved Jascayd for IPF in October of last year and two months later followed with an expansion to treat PPF.Meanwhile, Novartis has scored a CHMP nod for Vijoice, an oral drug that treats the rare disorder PIK3CA-related overgrowth spectrum (PROS). The endorsement comes four years after the FDA approved the treatment, which is the first of its kind to address the underlying cause of the condition. The CHMP green light covers patients age 2 and older. Additionally, a month after the FDA rejected a novel aesthetic product from AbbVie, the CHMP has signed off on it for glabellar frown lines following local muscular paralysis. The U.S. regulator gave the fast-acting follow-on to its blockbuster Botox a thumbs down because of a manufacturing snafu. The injected treatment works for two to three weeks, often giving patients confidence to move onto longer-acting Botox. NICE does a 180 on Genmab’s Tivdak Over in the United Kingdom, the National Institute for Health and Care Excellence (NICE) has reversed its opinion on Genmab’s cancer treatment Tivdak, now recommending (PDF) its use by the National Health Service (NHS) for those with recurrent or metastatic cervical cancer who have had disease progression despite earlier systemic therapy.England’s Medicines and Healthcare Products Regulatory Agency (MHRA) approved Tivdak in the indication December of last year. But two months ago, in its initial guidance, NICE questioned its cost-effectiveness, saying it was “higher than the range normally considered acceptable.”

Drug ApprovalAccelerated ApprovalClinical Result

22 May 2026

·endpoints.news

AstraZeneca wins EU backing for breast cancer drug, splitting with FDA panel

An AstraZeneca breast cancer drug received a positive opinion from European regulators, despite an FDA advisory committee voting against the drug last month. Novo Nordisk’s Wegovy pill also got the EU go-ahead. The European Medicines Agency’s human medicines committee on Friday recommended approving the AstraZeneca oral selective estrogen receptor degrader called camizestrant, which is to be marketed as Etcamah. CHMP gives its opinions on drug approvals to the European Commission, which then has the final say but normally follows the committee’s advice. The EU regulators said camizestrant should be approved as a treatment for adults with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1‑mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor. The decision stands in stark contrast to the April 30 vote by the FDA’s Oncology Drugs Advisory Committee, or ODAC, which voted 6-3 that the Phase 3 study’s design didn’t show a “clinically meaningful” benefit. CHMP gave its positive recommendation based on data from the same Phase 3 study, known as SERENA-6. As for Novo’s Wegovy pill, it won CHMP approval for use as a treatment for adults with obesity, becoming the first weight loss tablet to get the green light from European regulators. CHMP said the tablet should be available as an alternative to semaglutide injections and follows Novo’s launch in the US earlier this year, after receiving FDA approval in December 2025. Novo’s main rival, Eli Lilly, is following closely after winning US approval last month for its weight loss pill, orforglipron. Also on Friday, CHMP recommended approving: CHMP further recommended expanding the labels for 13 other drugs.

Phase 3Clinical ResultDrug Approval

100 Deals associated with Nerandomilast

R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
CREST Syndrome	Phase 3	United States	Boehringer Ingelheim GmbH	22 Jun 2026
CREST Syndrome	Phase 3	China	Boehringer Ingelheim GmbH	22 Jun 2026
CREST Syndrome	Phase 3	Japan	Boehringer Ingelheim GmbH	22 Jun 2026
CREST Syndrome	Phase 3	Argentina	Boehringer Ingelheim GmbH	22 Jun 2026
CREST Syndrome	Phase 3	Australia	Boehringer Ingelheim GmbH	22 Jun 2026
CREST Syndrome	Phase 3	Austria	Boehringer Ingelheim GmbH	22 Jun 2026
CREST Syndrome	Phase 3	Belgium	Boehringer Ingelheim GmbH	22 Jun 2026
CREST Syndrome	Phase 3	Brazil	Boehringer Ingelheim GmbH	22 Jun 2026
CREST Syndrome	Phase 3	Bulgaria	Boehringer Ingelheim GmbH	22 Jun 2026
CREST Syndrome	Phase 3	Canada	Boehringer Ingelheim GmbH	22 Jun 2026

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06195072 (CONQUEST, EULAR2026)	Phase 2	Interstitial lung disease due to systemic disease	127	Amlitelimab	twvsqynrjj(vktcpdsddy) = wglylqrjrq izoxllbjta (fmvwbhfqpu ) View more	Positive	11 Jun 2026
NCT05321082 (FIBRONEER-ILD, CTgov)	Phase 3	Progressive fibrotic interstitial lung disease	1,178	Placebo (Placebo)	brwcptyaiw(skvpqtuwks) = zknysuqkos juqvnwsvrp (rkjrjelnoo, qjyfxwejib - yzsdxealkn) View more	-	09 Jan 2026
				BI 1015550 (Nerandomilast 9 mg)	brwcptyaiw(skvpqtuwks) = tiqieoehph juqvnwsvrp (rkjrjelnoo, xyahtxzufr - vhqdicrcsx) View more
NCT06624072 (CTgov)	Phase 1	-	15	Nerandomilast (Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1))	frxptffotn(ertppridtx) = tvnrggjipg carouendwz (aaovzvkiqv, NA) View more	-	08 Jan 2026
				Nerandomilast (Nerandomilast 18 mg Adult Fasted State (Reference R))	frxptffotn(ertppridtx) = aualivysgq carouendwz (aaovzvkiqv, NA) View more
NCT06070610 (CTgov)	Phase 1	-	14	Pirfenidone+Nintedanib (Pirfenidone/Nintedanib alone (Reference))	bboudjxkra(zpgrfwzcrs) = chpuylaqqa hfvjfouovw (ejgbvghcky, NA) View more	-	02 Dec 2025
				Pirfenidone+Nerandomilast+Nintedanib (Pirfenidone/Nintedanib in combination with Nerandomilast (Test))	bboudjxkra(zpgrfwzcrs) = rdawsfbdwm hfvjfouovw (ejgbvghcky, NA) View more
NCT06408870 (CTgov)	Phase 1	-	64	BI 1015550 (BI 1015550 Formulation C1 (Reference, R))	xzeyzjxusb(wdlawnopta) = itpbuxrhxv whypjrzpoj (omedcyfrpv, na) View more	-	01 Dec 2025
				BI 1015550 (BI 1015550 Formulation C2 (Test, T))	xzeyzjxusb(wdlawnopta) = kmblodvlck whypjrzpoj (omedcyfrpv, na) View more
NCT06415045 (CTgov)	Phase 1	-	18	Nerandomilast (Nerandomilast fasted state (Reference (R)))	wxberjevtw(tibdbwzzvb) = yivtrctnai dukgtzgvqs (bjkccunreo, NA) View more	-	01 Dec 2025
				Nerandomilast (Nerandomilast fed state (Test (T)))	wxberjevtw(tibdbwzzvb) = euppznksiu dukgtzgvqs (bjkccunreo, NA) View more
NCT06393127 (CTgov)	Phase 1	-	64	nerandomilast (Test treatment (T))	ipbevhlrgr(rmmsdlfxtc) = nhbmbtaipg ybphbzrwwk (lviiscwfge, NA) View more	-	01 Dec 2025
				nerandomilast (Reference treatment (R))	ipbevhlrgr(rmmsdlfxtc) = djtrbojjme ybphbzrwwk (lviiscwfge, NA) View more
NCT06139302 (CTgov)	Phase 1	-	12	Nerandomilast (Nerandomilast 9 mg)	xcupsmhqky(esfgbwnasc) = fsvjbmllno svxgqmlcls (ttaosrhuhv, 13.8) View more	-	01 Dec 2025
				Nerandomilast (Nerandomilast 18 mg)	xcupsmhqky(esfgbwnasc) = wpnjnoelnu svxgqmlcls (ttaosrhuhv, 52.8) View more
NCT05550636 (CTgov)	Phase 1	-	15	Midazolam (Midazolam (R))	pdikybbffz(dllapkfhnv) = klfetfiryr wpsykmdcgo (coizbosebp, NA) View more	-	01 Dec 2025
				Midazolam (T+BI 1015550 (BI 1015550 + Midazolam (T))	pdikybbffz(dllapkfhnv) = bdnhpczgki wpsykmdcgo (coizbosebp, NA) View more
NCT05633862 (CTgov)	Phase 1	-	24	BI 1015550 (BI 1015550 9 mg)	aydtsrpwor(qvuzoibnjx) = jgijfwqakr oljmixzelc (nskydwzkqj, 19.1) View more	-	28 Nov 2025
				BI 1015550 (BI 1015550 18 mg)	aydtsrpwor(qvuzoibnjx) = isfspevafs oljmixzelc (nskydwzkqj, 32.6) View more

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