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

NCT07201922

/ Not yet recruitingPhase 3

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

This study is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe. People can join if a lung scan shows early changes in the lung, called interstitial lung abnormalities, which may lead to lung scarring. People with family members who have pulmonary fibrosis are more likely to develop it themselves. That is why it is important to check early for lung changes and find ways to prevent the condition from getting worse. The purpose of this study is to find out whether a medicine called nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis.
Participants are put into one of 2 groups randomly, which means the group is chosen by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet twice a day for about 2 to 3 years. There is a 3 out of 5 chance that participants will receive nerandomilast instead of the placebo.
Participants are in the study for about 2 to 3 years. Participants visit the study site multiple times: more frequently during the first 2 years (about every 3 months), and then every 6 months thereafter. In the 3rd year, participants also have phone calls with the site staff every 3 months.
Doctors regularly test lung function and take chest scans to see if the treatment works. The results are compared between the 2 groups to see if nerandomilast helps. The doctors also check participants' health and take note of any unwanted effects.

Start Date23 Jan 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06241560

/ Not yet recruitingPhase 2

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

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

Start Date20 Oct 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06806592

/ RecruitingPhase 3

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

Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease.
Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease.
Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Start Date13 Sep 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Nerandomilast

100 Translational Medicine associated with Nerandomilast

100 Patents (Medical) associated with Nerandomilast

Literatures (Medical) associated with Nerandomilast

01 Nov 2025·AUTOIMMUNITY REVIEWS

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

Review

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

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

01 Aug 2025·Nature Reviews Rheumatology

Nerandomilast slows progression of pulmonary fibrosis

Article

Author: Papatriantafyllou, Maria

12 Jun 2025·NEW ENGLAND JOURNAL OF MEDICINE

Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis

Article

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

BACKGROUND:

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

METHODS:

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

RESULTS:

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

CONCLUSIONS:

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

News (Medical) associated with Nerandomilast

29 Sep 2025

·www.globenewswire.com

Pooled data presented at ERS: nerandomilast monotherapy linked to nominally significant reduction in risk of death in IPF and PPF

A new pooled analysis of the FIBRONEER™-IPF and FIBRONEER™-ILD trials resulted in a nominally significant reduction in the risk of death by 59% in patients who received 18mg nerandomilast without background therapy versus placebo.1 Both FIBRONEER™ phase III trials, had met their primary endpoint (reduction of lung function decline measured in forced vital capacity) but did not meet their key secondary endpoint (risk of acute exacerbation, hospitalization for respiratory cause, or death).1-3 Nerandomilast had a favorable safety and tolerability profile, with a similar rate of discontinuation due to adverse events as placebo.1-3 Findings presented at ERS support previous clinical trial data on the safety and efficacy of nerandomilast in IPF and PPF as monotherapy and in combination with currently approved medications.1 Boehringer Ingelheim today announced new data from the global Phase III FIBRONEER™ program on nerandomilast, an investigational oral preferential PDE4B inhibitor, which is currently not approved for use. The new pooled analyses, the first to demonstrate a nominally significant reduction in risk of death across IPF and PPF, was presented in a poster at the European Respiratory Society (ERS) International Congress 2025 in Amsterdam. Nominal significance means that the trial results showed a clear trend that suggests a possible benefit; however, the evidence does not meet the strict criteria to declare it statistically significant. Both phase III trials, FIBRONEER™-IPF and FIBRONEER™-ILD, had met their primary endpoint, demonstrating that nerandomilast slowed lung function decline in IPF and PPF, with similar discontinuation rates to placebo.2,3 Although both trials did not meet the key secondary endpoint (time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death over duration of trial),2,3 the pooled analysis resulted in a nominally significant reduction in risk of death across IPF and PPF for the 18mg nerandomilast dose vs placebo in monotherapy and with background nintedanib.1 The trend was more pronounced in monotherapy.1 “The new pooled data zoom in on nerandomilast’s potential as monotherapy, pairing efficacy with a nominally significant reduction in the risk of death. While the findings are exploratory, they add to the growing body of evidence and may impact future research directions in pulmonary fibrosis,” said Marlies Wijsenbeek, Erasmus MC University Medical Centre. “The new findings go hand-in-hand with nerandomilast’s favorable safety and tolerability profile in previous studies. In a disease area with many patients discontinuing treatment,4 mostly related to limited tolerability of current therapies, this could really improve outcomes for patients.” Findings of the pooled analysis In both FIBRONEER™ trials, patients (FIBRONEER™-IPF, n=1177; FIBRONEER™-ILD, n=1176) were randomized to receive nerandomilast 9mg twice per day, 18mg twice per day, or placebo.2,3 The data was pooled and changes in FVC over 76 weeks and clinically relevant outcomes (acute exacerbations, respiratory hospitalization, and death) were analyzed. The analyses included the overall population and subgroups of patients by use of background therapy at baseline.1 In the overall trial population, a nominally significant reduction in the risk of death by 43% was observed in patients who received 18mg (HR 0.57 [CI: 0.41-0.78)].1 A nominally significant reduction in the risk of death, by 59%, was observed in patients who received 18mg nerandomilast without background therapy (HR 0.41 [CI: 0.24-0.70)].1 This downward trend was also seen in patients taking background nintedanib with a nominally significant reduction in the risk of death by 41% (HR 0.59 [CI: 0.37-0.94)].1 “For people living with pulmonary fibrosis, mortality remains unacceptably high, with every second person dying within 5 years of diagnosis,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “As the first Phase III trial program to demonstrate a nominally significant reduction in the risk of death in progressive pulmonary fibrosis, FIBRONEER heralds a significant advance for this group of patients, who face a devastating diagnosis and very limited treatment options.” In the pooled analysis, nerandomilast showed a favorable safety and tolerability profile, with a similar rate of discontinuation due to adverse events as placebo, consistent with the prior phase III results.1 The most frequent adverse event in the nerandomilast group without background therapy was diarrhea, reported in 14.6% in the placebo group, 17.5% in the nerandomilast 9 mg group, and 27.4% in the nerandomilast 18 mg group.1 Patients receiving either background nintedanib or pirfenidone reported diarrhea in 27.1% in the placebo group, in 41.9% in the 9mg nerandomilast group and in 47.7% in the 18mg nerandomilast group. In all patients, serious adverse events occurred in 44.7%, 39%, and 40.5% of patients treated with placebo, nerandomilast 9 mg, and nerandomilast 18 mg, respectively.1 These latest FIBRONEER™ findings reinforce nerandomilast’s potential as a new treatment for IPF and PPF.1 About nerandomilastNerandomilast (BI 1015550) is an investigational orally administered preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being studied as a potential treatment for IPF and PPF.2,3 Its efficacy and safety has not been established. Nerandomilast was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of IPF in February 2022 and for the treatment of PPF in April 2025.7,8 The FDA recently granted priority review to the New Drug Application (NDA) for nerandomilast in IPF, with an anticipated action date in Q4 2025. An NDA for nerandomilast in PPF has also been filed. Regulatory submissions are under review in China, the UK, and the EU, with filings in other geographies to follow.8 About IPF and PPFIdiopathic pulmonary fibrosis (IPF) is one of the more common progressive fibrosing interstitial lung diseases (ILDs), primarily affecting people over 50 and more men than women.9 It is associated with breathlessness, persistent cough, fatigue, and reduced survival. With approximately half of patients dying within five years of diagnosis,5,6 IPF is deadlier than many forms of cancer.10,11 Patients with other types of fibrosing ILD can also develop a progressive phenotype, termed progressive pulmonary fibrosis (PPF). PPF is defined by worsening respiratory symptoms, physiological and radiological progression, despite management of the underlying cause.12 Globally, up to 3.6 million people may be affected by IPF and up to 5.6 million by PPF.12,13About Boehringer IngelheimBoehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at http://www.boehringer-ingelheim.com/uk (UK) or www.boehringer-ingelheim.com (rest of world). References Oldham J, et al. (2025) Efficacy, safety and tolerability of nerandomilast in patients with pulmonary fibrosis: pooled data from the FIBRONEER-IPF and FIBRONEER-ILD trials. Poster, ERS 2025.Maher T et al. (2025) Nerandomilast in Patients with Progressive Pulmonary Fibrosis. N Engl J Med. 2025 Jun 12;392(22):2203-2214. DOI: 10.1056/NEJMoa2503643.Richeldi L, et al. Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis. N Engl J Med. 2025 Jun 12;392(22):2193-2202. DOI: 10.1056/NEJMoa2414108.Levra S et al. Long-term safety of antifibrotic drugs in IPF: a real-world experience. Biomedicines. 2022;10(12):3229. doi:10.3390/biomedicines10123229.Zheng Q et al. The global burden and temporal trends of interstitial lung disease: a systematic analysis from the Global Burden of Disease Study 2019. ERJ Open Res. 2022;8(1):00591-2021. DOI: 10.1183/23120541.00591‑2021.Cen Z et al. Outcomes and predictors of progression in progressive pulmonary fibrosis. Ann Med. 2024;56(1):2382949. DOI: 10.1080/07853890.2024.2406439.Boehringer Ingelheim (2022) FDA Grants BI 1015550 Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis. Accessed September 2025. Available at: https://www.boehringer-ingelheim.com/us/human-health/lung-diseases/pulmonary-fibrosis/fda-grants-bi-1015550-breakthrough-therapy.Boehringer Ingelheim (2025) Global phase III trials demonstrate that nerandomilast slowed lung function decline in IPF and PPF, with similar discontinuation rates to placebo. Accessed September 2025. Available at: https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/phase-3-trials-nerandomilast-slowed-lung-function-decline-ipf-and-ppf. European Lung Foundation (2023) IPF - Idiopathic Pulmonary Fibrosis. Accessed April 2025. Available at: https://europeanlung.org/en/information-hub/factsheets/ipf-idiopathic-pulmonary-fibrosis/.Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA: A Cancer Journal for Clinicians. 2024;74(1):12–49. DOI: 10.3322/caac.21820.Vancheri C, Failla M, Crimi N, et al. Idiopathic pulmonary fibrosis: a disease with similarities and links to cancer biology. Eur Respir J. 2010;35(3):496–504. DOI: 10.1183/09031936.00077309.Cottin V, Teague R, Nicholson L, Langham S, Baldwin M. The Burden of Progressive-Fibrosing Interstitial Lung Diseases. Front Med (Lausanne). 2022 Feb 1;9:799912. Doi: 10.3389/fmed.2022.799912. DOI: 10.3389/fmed.2022.799912.Podolanczuk AJ et al. Idiopathic pulmonary fibrosis: state of the art for 2023. Eur Respir J. 2023;61(4):2200957. DOI: 10.1183/13993003.00957‑2022.

Phase 3Clinical ResultBreakthrough TherapyNDAPriority Review

02 Sep 2025

·endpoints.news

United's lung disease drug Tyvaso succeeds in Phase 3 IPF trial

United Therapeutics’ stock price soared Tuesday after the company reported a Phase 3 win in a lung disease that’s had a spate of failures. Tyvaso hit the primary goal in the TETON-2 trial in idiopathic pulmonary fibrosis (IPF). Patients who took Tyvaso for one year were able to more forcefully expel air from their lungs compared to those on placebo by a highly statistically significant margin. Tyvaso also achieved most of the study’s secondary endpoints. United’s shares $UTHR were up about 35% by midday Tuesday, hitting an all-time high at one point. There has been a recent string of clinical trial failures for IPF drugs from both large and small biopharma companies. Novartis ended a Phase 2 IPF study last October, and Pliant Therapeutics discontinued a Phase 2b study for its experimental IPF drug in March. Novartis did not disclose a reason for its discontinuation, while Pliant cited “an imbalance in unadjudicated IPF-related adverse events” between the two trial arms. Meanwhile, Boehringer Ingelheim last year touted multiple Phase 3 successes for its IPF drug nerandomilast. But that drug’s efficacy underwhelmed analysts once they saw the full data and began asking questions about the drug’s potential as a combination treatment and in the real world. Then in December, PureTech reported a successful Phase 2b readout showing that deupirfenidone appeared to stack up better against nerandomilast in cross-trial comparisons. Tyvaso’s latest results garnered no such pessimism. The magnitude of the United drug’s efficacy compared to other standard-of-care treatments is “unprecedented,” Leerink analyst Roanna Ruiz wrote in a note to investors. Tyvaso was also able to provide such a benefit for patients still taking other drugs, “positioning it uniquely in the IPF treatment landscape,” Ruiz added. The FDA usually requires two Phase 3 studies to succeed for this disease, and United is running another trial called TETON-1 that should read out in the first half of next year. While TETON-2 was a global study, TETON-1 enrolled patients in the US and Canada. Tuesday’s data significantly increase the likelihood that both studies end up being positive, according to TD Cowen analyst Joseph Thome. If TETON-1 ends up as another win and Tyvaso is approved, its peak global sales in IPF could reach $2.3 billion, Thome estimates. Tyvaso has been approved for another lung condition called pulmonary arterial hypertension since 2009. But in 2022, United got a separate formulation approved using an inhalation powder, compared to the original inhaled solution. The TETON-2 trial in IPF tested the original solution formulation.

Drug ApprovalPhase 3Phase 2Clinical Result

12 Aug 2025

·www.fiercebiotech.com

PureTech launches Celea Therapeutics to develop highly touted lung disease candidate

PureTech has launched another of its hub-and-spoke subsidiaries, Celea Therapeutics, with a “mission to transform the treatment of respiratory diseases.\"\n Using its hub-and-spoke business model, PureTech is launching a new company to develop deupirfenidone (LYT-100), its promising candidate for idiopathic pulmonary fibrosis (IPF) and other fibrotic and inflammatory lung conditions.PureTech has established Celea Therapeutics with a “mission to transform the treatment of respiratory diseases,” the Boston-based company said in an Aug. 12 release.Running the London-listed subsidiary is former Teva North America CEO Sven Dethlefs, Ph.D., who has orchestrated the development of deupirfenidone for PureTech for the last year-plus.“I believe deupirfenidone has the potential to be a true turning point in the treatment of IPF,” Dethlefs said in the release. “Our phase 2b data demonstrated the potential for best-in-class efficacy with a favorable safety and tolerability profile—addressing two of the most critical limitations of current therapies.”Among the reasons he was entrusted with the job was the role he played at Teva in the launch of another deuterated product, Austedo, a blockbuster drug for Huntington’s disease and tardive dyskinesia.Deuteration is a process in which hydrogen atoms in a compound are replaced with a heavier isotope of hydrogen. It can improve the pharmacokinetic properties of existing drugs, increasing their efficacy and safety. Deupirfenidone is a deuterated version of Roche’s former IPF blockbuster Esbriet (pirfenidone), which became subject to generic competition in 2022.Boehringer Ingelheim’s Ofev is the only other drug on the market for IPF. A year ago, the German company reported success in a phase 3 trial of its Ofev follow-on, nerandomilast. The PDE4B inhibitor is up for an FDA decision in the fourth quarter of this year. PureTech says it hopes to meet with the FDA by the end of the third quarter to discuss the results of its phase 2b trial of deupirfenidone and its phase 3 trial plan.Results from the 2b trial showed the potential of deupirfenidone to stabilize lung function decline over 26 weeks, while maintaining a favorable safety profile. Open-label extension data have indicated the effect continues for at least 52 weeks.The launch of Celea is another example of PureTech’s approach, in which the company acquires promising assets and establishes subsidiaries to advance them individually. As an asset matures, it can draw new investments. With that comes an evolution of ownership, allowing PureTech to gain capital and the subsidiary to become more independent. Using this model, 20-year-old PureTech, which is listed on the London Stock Exchange, has not had to raise money since 2018, CEO Bharatt Chowrira, Ph.D., explained to Fierce Pharma in an interview last year centered on the approval of Bristol Myers Squibb’s schizophrenia treatment, Cobenfy (KarXT).PureTech spawned Karuna Therapeutics, which developed the treatment and was bought out by BMS in late 2023 for $14 billion.

Phase 2Clinical ResultAcquisitionPhase 3

100 Deals associated with Nerandomilast

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Progressive pulmonary fibrosis	NDA/BLA	China	Boehringer Ingelheim Pharma GmbH & Co., KG	15 May 2025
Progressive pulmonary fibrosis	NDA/BLA	China	Boehringer Ingelheim International GmbH	15 May 2025
Idiopathic Pulmonary Fibrosis	NDA/BLA	China	Boehringer Ingelheim Pharma GmbH & Co., KG	25 Feb 2025
Idiopathic Pulmonary Fibrosis	NDA/BLA	China	Boehringer Ingelheim International GmbH	25 Feb 2025
Idiopathic Interstitial Pneumonias	Phase 3	United States	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	Japan	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	Argentina	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	Belgium	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	France	Boehringer Ingelheim GmbH	23 Jan 2026
Idiopathic Interstitial Pneumonias	Phase 3	Germany	Boehringer Ingelheim GmbH	23 Jan 2026

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05321082 \| NCT05321069 (FIBRONEER-ILD, Company_Website) Manual	Phase 3	Idiopathic Pulmonary Fibrosis \| Progressive pulmonary fibrosis	2,353	Placebo	rqhrjxotzg(kxibxyzgix) = Both FIBRONEER™ phase III trials, had met their primary endpoint (reduction of lung function decline measured in forced vital capacity). fnjorfbpmn (fxoskwmqdl ) Met View more	Positive	29 Sep 2025
				Nerandomilast 9 mg
NCT05321069 (FIBRONEER-IPF, CTgov)	Phase 3	Idiopathic Pulmonary Fibrosis	1,177	Placebo (Placebo)	rbjlbiucto(bvzatyifet) = gdbivrkwav uyeyiohhmc (ydylgowxkr, kawjjcafeq - pwlkcaivxu) View more	-	12 Sep 2025
				BI 1015550 (Nerandomilast 9 mg BID)	rbjlbiucto(bvzatyifet) = xzutvsqqos uyeyiohhmc (ydylgowxkr, iutngxexcy - lztmrohilu) View more
NCT05321082 (FIBRONEER-ILD, Pubmed \| N Engl J Med)	Phase 3	Progressive pulmonary fibrosis	1,176	Nerandomilast 18 mg	jopvlsxzoa(qmbteumxza) = olxtwrtvnp skhxvlconn (ogerzgnvih, -123.7 to -73.4)	Positive	12 Jun 2025
				Nerandomilast 9 mg	jopvlsxzoa(qmbteumxza) = dxplionrzy skhxvlconn (ogerzgnvih, -109.6 to -59.7)
NCT05321082 (FIBRONEER-ILD, Literature \| NEWS) Manual	Phase 3	Progressive pulmonary fibrosis	1,176	Nerandomilast 18 mg twice daily	uxvtswlowq(hnlqczkfyd) = leklhkbtwc bcqlantplm (mbvgnzfxgt, -123.7 to -73.4) Met View more	Positive	19 May 2025
				Nerandomilast 9 mg twice daily	uxvtswlowq(hnlqczkfyd) = nyhqqbrryz bcqlantplm (mbvgnzfxgt, -109.6 to -59.7) Met View more
NCT05321069 (FIBRONEER-IPF, Pubmed \| NEWS) Manual	Phase 3	Idiopathic Pulmonary Fibrosis	1,177	Nerandomilast 18 mg	rofyklricu(txoaimxyab) = lylrdzmzdm amatcbsflk (cskosjaggc, -141.8 to -87.5) Met View more	Positive	18 May 2025
				Nerandomilast 9 mg	rofyklricu(txoaimxyab) = dmwkwmmaes amatcbsflk (cskosjaggc, -165.6 to -111.6) Met View more
ATS2025	Phase 3	Pulmonary Atelectasis	-	Nerandomilast	babgplaizj(qprwckzvij) = The signals derived from nerandomilast were strongly localized in the bronchial epithelium, whereas nintedanib was evenly detected throughout the lung tissue xnnqtmmssn (fjciijcacw ) View more	-	16 May 2025
				Nintedanib
NCT05321082 (FIBRONEER-ILD, NEWS) Manual	Phase 3	Fibrosis	1,178	nerandomilast 9 mg or 18 mg dose	dfrzunamjn(tcapnturzn) = The study hit its primary endpoint. zvngldsjdq (ksrghwewfk ) Met View more	Positive	10 Feb 2025
				placebo
NCT05321069 (FIBRONEER-IPF, Biospace) Manual	Phase 3	Idiopathic Pulmonary Fibrosis	1,177	nerandomilast	esgtxefcmp(fnvfedxlhg) = Phase III trial in a decade to meet its primary endpoint. kqzgvtzbgm (oubkmoezck ) Met	Positive	24 Sep 2024
				Placebo
NCT04419506 (Phase 2 \| 1305-0013, CTgov)	Phase 2	Idiopathic Pulmonary Fibrosis	147	Placebo (Placebo - Antifibrotics at Baseline)	evmxtzyzya(xqnatznnie) = bjiysidrhc nvjsmzbvgl (umzffsekln, owozvminzv - bgrogecmav) View more	-	01 Nov 2022
				prifenidone+pirfenidone+BI 1015550+nintedanib (BI 1015550 - Antifibrotics at Baseline)	evmxtzyzya(xqnatznnie) = ysskfqaxne nvjsmzbvgl (umzffsekln, ykrsotkuie - hxcprjfrju) View more
NCT01835899 (CTgov)	Phase 1	-	24	Placebo	iiujyxsjke = rybcorcsgg muonnlbozw (hqjytofizh, spmtlyzjkt - ctxrfqobbe) View more	-	22 Jan 2016

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