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.

开始日期2025-09-01

申办/合作机构

Boehringer Ingelheim GmbH

NCT07081932

/ Not yet recruiting临床1期

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

The main objective of this trial is to investigate the effect of bosentan, a moderate Cytochrome P450 (CYP) 3A inducer on the single dose pharmacokinetics of nerandomilast.

开始日期2025-08-26

申办/合作机构

Boehringer Ingelheim GmbH

NCT06806592

/ Not yet recruiting临床3期

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.

开始日期2025-08-21

申办/合作机构

Boehringer Ingelheim GmbH

100 项与那米司特相关的临床结果

登录后查看更多信息

100 项与那米司特相关的转化医学

登录后查看更多信息

100 项与那米司特相关的专利（医药）

登录后查看更多信息

项与那米司特相关的文献（医药）

2025-08-01·Nature Reviews Rheumatology

Nerandomilast slows progression of pulmonary fibrosis.

Article

作者: Papatriantafyllou, Maria

2025-06-12·NEW ENGLAND JOURNAL OF MEDICINE

Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis

Article

作者: Schlecker, Christina ; Valenzuela, Claudia ; Clerisme-Beaty, Emmanuelle ; Kreuter, Michael ; Gordat, Maud ; Zoz, Donald F. ; Stowasser, Susanne ; Oldham, Justin M. ; 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.).

2025-06-12·NEW ENGLAND JOURNAL OF MEDICINE

Nerandomilast in Patients with Progressive Pulmonary Fibrosis

Article

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

BACKGROUND:

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

METHODS:

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

RESULTS:

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

CONCLUSIONS:

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

136

项与那米司特相关的新闻（医药）

2025-08-12

·FierceBiotech

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.

临床2期临床结果并购临床3期

2025-08-08

·FiercePharma

Boehringer Ingelheim breaks into oncology with FDA approval for lung cancer med Hernexeos

Boehringer Ingelheim's Hernexeos is one of two new drug approvals the company is expecting this year. With the FDA approval of its zongertinib in certain non-small cell lung cancer (NSCLC) patients, 175-year-old Boehringer Ingelheim is entering the oncology market.Zongertinib, which will be sold as Hernexeos, was specifically cleared to treat previously treated NSCLC patients who have the relatively rare HER2 activating mutations in the tyrosine kinase domain (TKD).It’s a patient population that has a “huge unmet need” and is estimated to be comprised of about 40,000 people across the globe, Boehringer’s senior vice president of oncology, Itziar Canamasas, Ph.D., told Fierce Pharma in a recent interview. The mutated cancer type occurs in approximately 2% to 4% of NSCLC cases. Hernexeos is now the first FDA-approved oral treatment that can specifically target the disease. It marks a welcome chemo-free treatment option for patients as well as a “big entry” for Boehringer into the oncology space, Canamasas said. The drug's benefits were supported by the Beamion Lung-1 phase 1b trial, in which Hernexeos proved an objective response rate of 75% among 71 patients who had received prior platinum-based chemotherapy but not a HER2-targeted tyrosine kinase inhibitor or antibody-drug conjugate, according to the FDA. Within this cohort, 58% of patient had their responses lasting for at least six months.Among 34 patients previously treated with platinum-based chemotherapy and a HER2-targeted ADC, the objective response rate was 44%, with 27% having a duration of response of at least six months.Additional data published in April showed that the drug may help patients in the first cohort live without their disease getting worse for a median of 12.4 months, although the data were immature. The results signaled Hernexeos' potential to "impact clinical practice," Boehringer said at the time. All in all, “nearly every patient” benefited from treatment in the study, Canamasas said, referring to a 96% disease control rate revealed in April.Fewer than 3 in 10 patients are alive five years after a diagnosis of HER2-mutant advanced NSCLC, according to Boehringer, with advanced disease causing a “physical, psychological, and emotional impact” in patients' daily lives. The mutation is linked with a high incidence of brain metastasis.As it stands, AstraZeneca and Daiichi Sankyo’s Enhertu is the only FDA-approved regimen cleared to treat the HER2-mutant NSCLC population, but that option comes with “chemotherapy-like side effects,” thoracic medical oncologist and lead study investigator Joshua Sabari, M.D., told Fierce Pharma over email. Hernexeos’ data, meanwhile, prove the drug as “truly a targeted therapy” with low dose reduction rates, “very low” discontinuation and very low-grade rash rate, he said.“To me, it's a game changer—a truly targeted agent for our patients with optimal activity, selectivity as well as quality of life and side effect profile,” Sabari said, adding that “most patients on this therapy do extremely well for prolonged periods of time with excellent quality of life.”The lung disease nod is just the start of Boehringer’s journey with Hernexeos, which Canamasas called a “pipeline in a product.” Next, the company hopes to be able to position the drug as a first-line treatment in its NSCLC indication and is currently studying the potential in a phase 3 trial, while additional explorations in pan tumors, breast cancer and gastric cancer are ongoing. The drug's current indication is granted under the FDA accelerated approval pathway, and Boehringer is on the hook to provide confirmatory evidence to further verify the drug's profile. Hernexeos headlines Boehringer’s cancer care ambitions, and more is on the horizon. The company’s oncology pipeline includes a T-cell engager that’s currently being evaluated in mid-stage trials in extrapulmonary neuroendocrine carcinoma and small-cell lung cancer. Oncology is certainly an area that Boehringer is putting its chips behind, as it recently opened a 27 million Swiss franc ($33.6 million) ADC R&D spot in Basel, Switzerland.Outside of oncology and Hernexeos, the company is awaiting another new drug approval this year for its PDE4B inhibitor nerandomilast in idiopathic pulmonary fibrosis. Boehringer expects to launch both treatments this year and, further ahead, is plotting 15 launches through 2030.

临床结果上市批准抗体药物偶联物临床3期临床1期

2025-07-31

·E药经理人

独家｜专访勃林格殷格翰全球CEO：如何带领全球最大家族药企，持续打胜仗？

超140年历史全球大药厂勃林格殷格翰持续基业长青的密码，内化于“创新”二字之中。上海静安寺越洋国际广场办公室里，一场热情洋溢的员工见面会如期举行。于2025年7月1日接任勃林格殷格翰（以下简称“勃林格”）全球执行董事会主席并继续兼任人用药品业务负责人的Shashank Deshpande，将上任后全球业务巡访的第一站落脚在中国。被员工围聚在中间的Shashank，逐一回应了中国区员工对公司未来发展及中国区战略的各类问题。事实上，这也是外界对这家拥有超140年历史、全球最大家族药企的核心关注点。2023年，勃林格殷格翰以稳健的业绩增速成为德国最大制药企业，并在近两年稳居全球制药企业前20强。与所有跨国药企一样，这家去年全球营收达268亿欧元的制药巨擘，需在地缘因素频现的当下锚定技术赛道与疾病领域，进一步探索多元化商业经营模式，确保后续稳健可持续发展。这也恰是包括Shashank在内、所有跨国药企掌舵人必须在实践中回答的问题。在勃林格中国区员工见面会当天的专访中，Shashank告诉E药经理人，勃林格正通过提升组织能力、拓展疾病领域版图、深耕创新生态、激活全球人才等关键举措，开启“迈向2035”战略。其中，中国市场扮演重要角色——在勃林格全球规划中，中国有望打造成为其全球第二大市场。勃林格殷格翰全球执行董事会主席兼人用药品业务负责人Shashank Deshpande01新产品组合格局已现评估一家跨国药企竞争力的核心指标，是现有产品组合的持续性、未来产品组合的潜力，以及两者能否实现无缝衔接，以规避“专利悬崖”带来的业绩下滑风险。Shashank用“激动人心”描述现阶段勃林格的创新布局：“我们正处在新增长阶段的起点，预计将在多个治疗领域推出新产品。”众所周知，勃林格同时拥有人用药品和动物保健两大业务板块，前者营收占比超80%。在人用药品领域，勃林格在呼吸系统疾病领域有百年积淀，是其传统优势领域；本世纪初，随着欧唐宁®（利格列汀）、欧唐静®（恩格列净）获批上市，其优势领域进一步拓展至心血管、肾脏和代谢领域。截至2025年上半年，勃林格已上市产品组合中，代谢领域的恩格列净系列与呼吸领域的维加特®（尼达尼布）分别位列全球年营收第一和第二，占人用药品板块总营收的55%，与2024年持平。如今，在深耕原有两大疾病领域的基础上，勃林格将关注点拓展至肿瘤和免疫领域，同时推进精神健康和视网膜疾病疗法开发。2025年半年报显示，勃林格未来12至18个月内，将启动超过10项新的II期和III期临床试验，覆盖多个治疗领域，有望在未来五年内将一系列重要产品推向市场。“从全球范围看，恩格列净系列的生命周期还将延续，但产品组合更新确实是我们的首要任务。”Shashank在专访中着重提及3个新产品，分别来自肿瘤、代谢和呼吸领域——与勃林格一贯秉持的“解决临床痛点”研发理念一致，这些产品均具备“同类最佳（BIC）”或“同类首创（FIC）”特质。严格来说，勃林格殷格翰是“重回”肿瘤领域。其肿瘤布局始于本世纪初，2013年上市首款肿瘤药阿法替尼（Giotrif）——这是全球首个不可逆ErbB家族抑制剂，属于第二代口服小分子EGFR TKI。此次回归，Shashank寄予厚望的产品是zongertinib。Zongertinib是一款用于治疗人表皮生长因子受体2（HER2）突变阳性晚期非小细胞肺癌（NSCLC）的靶向疗法，在经治患者中展现出持久且具有临床意义的疗效，超过70%的患者实现肿瘤缓解。据悉，该药目前正在美国、日本和中国药监机构的注册审批中，其作为一线疗法的全球III期临床试验正在进行中，预计2025年下半年将在美国获批上市。Shashank特别强调其剂型优势：“Zongertinib为口服剂型，这种创新将极大便利患者使用。”另一款勃林格殷格翰寄予厚望，且有望在2025年下半年获批上市的新产品是nerandomilast，来自其有着长期积淀的呼吸系统疾病领域。作为特发性肺纤维化（IPF）和进展性肺纤维化（PPF）领域首个PDE4B抑制剂类分子，它是近10年来首个在IPF和PPF领域III期临床达到主要终点的新药。目前，该药已向美国、欧盟、中国及日本的药监机构递交上市申请，并获得FDA和CDE的优先审评资格。此外，备受产业界关注、也是Shashank常被问及的在研新药是survodutide。作为新型胰高血糖素受体/胰高血糖素样肽-1受体（GCGR/GLP-1R）双重激动剂，由勃林格殷格翰与丹麦创新药企Zealand Pharma联合研发，其II期临床试验数据显示，有望成为治疗代谢功能障碍相关脂肪性肝炎（MASH）的最佳疗法。作为当前爆火的GLP-1技术赛道中的差异化选手，产业界聚焦其III期临床试验结果能否延续II期的惊艳表现。Shashank表示：“Survodutide的III期临床正在进行中，我们同样期待看到结果。”据悉，该药已获美国和中国的突破性疗法认定。新产品组合的逐步清晰为Shashank推动勃林格进入新增长阶段带来底气，但他也坦言，这对“此前专注于一两个疾病领域的勃林格殷格翰”而言，是种挑战。他列举了很多正在思考的问题，比如：“如何为增长提供资源？如何保持速度？如何在3-4个治疗领域同时保持竞争力？如何从战略和执行层面获取人才？”医药行业的通识认知是：新药是基础，而借新药实现增长的路径是市场塑造——尤其对FIC和勃林格殷格翰C而言，本质上是对医生、患者、医疗标准与规范固有理念的挑战。于是，Shashank将中国市场视为验证未来10年战略可行性的“灵感之地”。采访中，他多次提及中国药审改革10年来在医药创新生态构建上的巨大成就，以及伴随生态完善积淀的人才与创新技术优势。02中国力量融入全球创新“想想未来十年将会发生什么，以及中国将在创新领域做出多大贡献，是一件令人欣喜的事。”这或许是Shashank仅仅时隔3个月，便以全球执行董事会主席新身份再次到访中国的原因。若为Shashank此次中国行制定“任务清单”，核心包括以下4项：如何更快地将全球创新惠及中国患者；如何让中国创新更好地融入勃林格全球创新体系；如何激发中国人才潜能服务全球战略目标；如何将中国市场打造为勃林格全球第二大医药市场。Shashank表示，这些是他履新以来时刻思考的问题。事实上，第一项任务已阶段性完成。受益于中国药审改革的有力推进，2018年勃林格殷格翰启动“中国纳入”计划，默认中国加入所有全球注册临床试验，实现中美欧同步申报；一年后，该计划升级为“中国关键”，将中国全面纳入全球早期临床开发（Ⅰ/Ⅱ期），打破“欧美为先”模式。此后，勃林格持续深化本土创新生态建设，与32家医疗机构签署临床研究框架协议，加速临床试验启动。2024年，勃林格殷格翰旗下一款用于罕见皮肤病治疗药物的新适应症在中国首发，早于欧美市场；未来，其在肿瘤、代谢、呼吸领域的新产品组合也将基本实现中国与全球同步。“未来五年，我们计划在中国投入50亿元用于研发，其中人用药品领域的研发投入占到35亿元，目标是在人用药品领域获得25项以上新的注册获批成果。”Shashank说。“让中国创新嵌入勃林格全球创新体系”也有了实质性动作。勃林格殷格翰正与苏州瑞博生物合作开发基于小核酸的非酒精性脂肪性肝炎（NASH）/代谢相关脂肪性肝炎（MASH）疗法；此外，已在上海、北京、深圳设立联合外部创新孵化器，并与北京大学等学术机构建立合作。“激发中国人才潜能服务全球战略目标”也已启动。Shashank认为，一切业务的基础是人才，而让勃林格全球员工的经验流动，是激活人才、更有力推进战略目标的有效工具。2024年，勃林格中国启动“Think China”计划，目标是将中国打造成为全球人才枢纽，推动人才培养与交流。“我们希望将全球化融入中国市场，赋能本土人才不仅在中国，更在全球舞台发挥领导作用。”以“迈向2035”战略为引导，勃林格殷格翰全球开启新增长阶段，这也将带动中国市场增长。“勃林格中国区战略既在演进又保持一致性”，战略重点始终聚焦于“能产生重大影响、为患者创造最大价值的领域”。在此理念支撑下，勃林格殷格翰资源配置的底层逻辑是“集中资源于核心专长与创新领域”。过去一两年，其在华的战略调整（包括肿瘤管线及部分成熟产品的外部合作）均基于此。“我们持续适应动态变化的中国市场，寻求新合作，探索创新解决方案以应对未被满足的医疗需求。”Shashank表示。创新成果持续涌现，人才潜能不断激发，叠加勃林格过去30年在华构建的从研发到生产、从动物保健全球创新到数字创新的独特全价值链，让Shashank“将中国打造为勃林格殷格翰全球第二大医药市场”的目标，不仅是战略蓝图上的规划，更成为看得见、可触及的未来。一审| 黄佳二审| 李芳晨三审| 李静芝

高管变更财报

100 项与那米司特相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
进展性肺纤维化	申请上市	中国	Boehringer Ingelheim International GmbH	2025-05-15
进展性肺纤维化	申请上市	中国	Boehringer Ingelheim Pharma GmbH & Co., KG	2025-05-15
特发性肺纤维化	申请上市	中国	Boehringer Ingelheim Pharma GmbH & Co., KG	2025-02-25
特发性肺纤维化	申请上市	中国	Boehringer Ingelheim International GmbH	2025-02-25
风湿性疾病	临床3期	美国	Boehringer Ingelheim GmbH	2025-08-21
风湿性疾病	临床3期	中国	Boehringer Ingelheim GmbH	2025-08-21
风湿性疾病	临床3期	日本	Boehringer Ingelheim GmbH	2025-08-21
风湿性疾病	临床3期	澳大利亚	Boehringer Ingelheim GmbH	2025-08-21
风湿性疾病	临床3期	奥地利	Boehringer Ingelheim GmbH	2025-08-21
风湿性疾病	临床3期	法国	Boehringer Ingelheim GmbH	2025-08-21

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05321082 (FIBRONEER-ILD, Literature \| NEWS) 人工标引	临床3期	进展性肺纤维化	1,176	Nerandomilast 18 mg twice daily	顧顧遞夢衊廠顧艱鑰廠(簾膚獵餘鏇衊網願艱醖) = 選選鹽觸範網糧齋網鹽廠艱鏇夢襯獵淵鹽構憲 (顧鏇餘蓋蓋繭鬱膚艱鑰, -123.7 ~ -73.4) 达到更多	积极	2025-05-19
				Nerandomilast 9 mg twice daily	顧顧遞夢衊廠顧艱鑰廠(簾膚獵餘鏇衊網願艱醖) = 製餘觸範選鹹獵鹹淵襯廠艱鏇夢襯獵淵鹽構憲 (顧鏇餘蓋蓋繭鬱膚艱鑰, -109.6 ~ -59.7) 达到更多
NCT05321069 (FIBRONEER-IPF, Pubmed \| NEWS) 人工标引	临床3期	特发性肺纤维化	1,177	Nerandomilast 18 mg	製膚襯觸鬱鑰選襯醖醖(鹹願築積艱選衊廠網觸) = 選鹽觸醖憲餘鑰壓顧構襯衊齋範窪窪蓋憲鏇鬱 (遞鬱鏇獵範廠鹽廠衊範, -141.8 ~ -87.5) 达到更多	积极	2025-05-18
				Nerandomilast 9 mg	製膚襯觸鬱鑰選襯醖醖(鹹願築積艱選衊廠網觸) = 鏇鏇夢獵蓋獵鬱網簾衊襯衊齋範窪窪蓋憲鏇鬱 (遞鬱鏇獵範廠鹽廠衊範, -165.6 ~ -111.6) 达到更多
ATS2025	临床3期	肺不张	-	Nerandomilast	膚壓艱壓鹽製糧餘觸積(衊鏇壓齋鹹鬱餘醖築壓) = The signals derived from nerandomilast were strongly localized in the bronchial epithelium, whereas nintedanib was evenly detected throughout the lung tissue 製鑰鏇網蓋鏇範獵鏇獵 (廠膚齋廠繭遞艱鹹淵艱 ) 更多	-	2025-05-16
				Nintedanib
NCT05321082 (FIBRONEER-ILD, NEWS) 人工标引	临床3期	纤维化	1,178	nerandomilast 9 mg or 18 mg dose	網襯齋遞遞憲憲構選鏇(廠齋餘鏇窪鹹願憲鏇膚) = The study hit its primary endpoint. 獵窪顧淵壓遞願鹹糧構 (鏇餘衊壓構築鏇簾構積 ) 达到更多	积极	2025-02-10
				placebo
NCT05321069 (FIBRONEER-IPF, Biospace) 人工标引	临床3期	特发性肺纤维化	1,177	nerandomilast	製獵糧築窪齋鹹範鑰鏇(網襯鏇廠範選齋選壓壓) = Phase III trial in a decade to meet its primary endpoint. 衊鏇顧鏇積衊遞餘繭糧 (繭齋簾鬱觸廠鏇壓齋鏇 ) 达到	积极	2024-09-24
				Placebo
NCT04419506 (Phase 2 \| 1305-0013, CTgov)	临床2期	特发性肺纤维化	147	Placebo (Placebo - Antifibrotics at Baseline)	鏇遞壓鬱醖簾鏇餘壓選(繭觸顧鏇觸遞窪餘衊襯) = 窪壓鏇顧糧淵鏇壓製遞廠餘餘範鑰襯壓餘壓簾 (鹹構範餘壓鬱壓獵餘醖, 齋鬱襯艱憲鬱鹽憲膚願 ~ 鹽齋壓糧淵壓範餘鹹衊) 更多	-	2022-11-01
				prifenidone+pirfenidone+BI 1015550+nintedanib (BI 1015550 - Antifibrotics at Baseline)	鏇遞壓鬱醖簾鏇餘壓選(繭觸顧鏇觸遞窪餘衊襯) = 衊壓製淵醖齋積齋淵顧廠餘餘範鑰襯壓餘壓簾 (鹹構範餘壓鬱壓獵餘醖, 淵壓齋獵蓋觸艱積積醖 ~ 襯簾窪糧鏇顧構積蓋夢) 更多
NCT01835899 (CTgov)	临床1期	-	24	Placebo	網膚衊願廠鹹膚構觸壓 = 襯壓顧廠築糧構窪蓋簾艱網憲衊觸網夢製蓋簾 (憲淵鹹築襯糧鹹窪醖顧, 網憲窪鏇顧網窪憲遞築 ~ 鏇鑰憲顧蓋遞鹽顧憲鏇) 更多	-	2016-01-22