那米司特(Nerandomilast) - 药物靶点：PDE4B_在研适应症：进展性肺纤维化，特发性肺纤维化，CREST综合征_专利_临床

概要

基本信息

药物类型

小分子化药

别名

A thienopyrimidine derivative that preferentially inhibits Phosphodiesterase 4B、BI 1015550、BI-1015550

+ [3]

靶点

PDE4B

作用方式

抑制剂

作用机制

PDE4B抑制剂(磷酸二酯酶4B抑制剂)

治疗领域

呼吸系统疾病其他疾病免疫系统疾病+ [7]

在研适应症

进展性肺纤维化特发性肺纤维化CREST综合征+ [5]

非在研适应症-

原研机构

Boehringer Ingelheim Pharmaceuticals, Inc.

在研机构

Boehringer Ingelheim GmbHBoehringer Ingelheim International GmbHBoehringer Ingelheim Pharma GmbH & Co., KG

+ [4]

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2025-10-07),

特发性肺纤维化

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、突破性疗法 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、孤儿药 (日本)

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结构/序列

分子式C20H25ClN6O2S

InChIKeyUHYCLWAANUGUMN-SSEXGKCCSA-N

CAS号1423719-30-5

关联

34

项与那米司特相关的临床试验

NCT07366034

/ Not yet recruiting临床3期

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.

开始日期2026-07-27

申办/合作机构

Boehringer Ingelheim GmbH

NCT07321860

/ Not yet recruiting临床2/3期

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.

开始日期2026-06-30

申办/合作机构-

NCT07497087

/ Not yet recruiting临床3期

A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)

Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression. This study is open to adults who are at least 18 years old and have systemic sclerosis (SSc). People can join the study if they have limited or diffuse cutaneous SSc with disease onset within 7 years of the first non-Raynaud's symptom. The purpose of this study is to find out whether a medicine called nerandomilast helps people with systemic sclerosis. This study also aims to find out how well nerandomilast is tolerated in people with systemic sclerosis.
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 the tablets twice a day.
Participants are in the study for 1 to about 4 years. During this time, they visit the study site regularly and get phone calls from the site staff. During study visits participants regularly have blood samples taken and doctors check changes in skin thickening, lung function, and internal organs, overall health and the safety and tolerability of study treatment in people with SSc. 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.

开始日期2026-06-09

申办/合作机构

Boehringer Ingelheim GmbH

100 项与那米司特相关的临床结果

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100 项与那米司特相关的转化医学

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100 项与那米司特相关的专利（医药）

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42

项与那米司特相关的文献（医药）

2026-04-01·British Journal of Pharmacology

Nerandomilast, a PDE4B inhibitor, alleviates silica‐induced lung inflammation and fibrosis by inhibition of NLRP3 inflammasome and TGF‐β/Smad signalling

Article

作者: Song, Yawen ; Wang, Yuanying ; Ye, Qiao ; Sun, Di ; Dilixiati, Nafeisa ; Wang, Dongmei

Background and Purpose:

Silicosis is a major cause of occupational disease‐related morbidity and mortality worldwide, yet effective pharmacological treatments remain limited. Nerandomilast, a novel inhibitor of phosphodiesterase‐4B (PDE4B), has demonstrated anti‐fibrotic potential in idiopathic pulmonary fibrosis (IPF); however, its efficacy and mechanisms in silicosis have not been investigated.

Experimental Approach:

The therapeutic effects (and their underlying mechanisms) of PDE4B inhibition was evaluated in in models of silicosis, both in vivo (male C57BL/6N mice) and in vitro (THP‐1 macrophages and MRC‐5 cells). Single‐cell RNA sequencing, using lung tissue, was first performed to identify PDE4B as a key regulatory target in the pathogenesis of silicosis. Based on this finding, the therapeutic effects and underlying mechanisms of PDE4B inhibition were assessed using nerandomilast. Pulmonary function tests, inflammatory marker analyses and fibrosis evaluations were conducted to determine treatment efficacy. In addition, bulk RNA sequencing and transcriptomic analyses were performed to explore the molecular pathways modulated by nerandomilast.

Key Results:

PDE4B inhibition effectively prevented and attenuated silica‐induced lung inflammation in the mouse model by suppressing both canonical and non‐canonical NLRP3 inflammasome pathways in lung macrophages. Furthermore, PDE4B inhibition down‐regulated TGF‐β/Smad signalling in lung fibroblasts of silicosis, leading to a significant reduction in fibrosis‐related gene expression.

Conclusions and Implications:

These findings suggest that nerandomilast, a PDE4B inhibitor, may be a promising treatment for silicosis, which currently lacks effective therapies.

2026-01-01·European Respiratory Review

Mechanistic basis for the antifibrotic actions of cAMP-based therapies

Review

作者: Fortier, Sean M ; Peters-Golden, Marc

The human and economic impact of idiopathic pulmonary fibrosis and other interstitial lung diseases is enormous, and available therapies are of limited utility. A decade after the introduction of the first antifibrotic agents, two new agents are on the horizon. Nerandomilast is an inhibitor of phosphodiesterase 4B, while treprostinil is an analogue of prostacyclin. Both agents increase intracellular cAMP. Although the smooth muscle relaxant properties of agents that increase cAMP have long been leveraged for the treatment of airway and vascular diseases, potential antifibrotic actions of cAMP elevation are much less well appreciated by clinicians and researchers. The purpose of this review is to discuss the mechanistic underpinnings for a beneficial role of cAMP in fibrotic lung diseases. We briefly review the pathogenesis of fibrotic lung disease, the anatomy of the cAMP pathway, and the myriad ways in which this pathway is disrupted in fibrotic diseases. We then focus on the pleiotropic actions by which cAMP opposes the aberrant phenotypes of immune cells, fibroblasts, and epithelial cells that characterise fibrotic diseases. Finally, we highlight some unanswered questions about, and future opportunities for optimising, therapeutic interventions that leverage the cAMP pathway.

2026-01-01·Annals of Medicine and Surgery

Jascayd (nerandomilast): a novel PDE4B inhibitor for idiopathic pulmonary fibrosis

作者: Hujjat, Syeda Fadak Zahra ; Chandani, Devya Khaim ; Khan, Muhammad Saad ; Chandani, Harshika Khaim ; Mahmoud, Abubakr

Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial pneumonia with poor prognosis and limited therapeutic options. Despite the introduction of pirfenidone and nintedanib, treatment discontinuation due to adverse effects remains common, highlighting the need for better-tolerated, mechanistically distinct agents. Jascayd (nerandomilast), a first-in-class selective phosphodiesterase-4B inhibitor developed by Boehringer Ingelheim, was approved by the FDA in October 2025 for adults with IPF. By elevating intracellular cyclic adenosine monophosphate (cAMP) in inflammatory and structural lung cells, nerandomilast suppresses pro-inflammatory cytokines and fibroblast activation, producing anti-inflammatory and antifibrotic effects with improved tolerability over nonselective PDE4 inhibitors. In phase 3 FIBRONEER-IPF and FIBRONEER-ILD trials, nerandomilast significantly reduced the annual rate of forced vital capacity decline versus placebo, regardless of concomitant antifibrotic use. Common adverse effects included mild diarrhea, nausea, and fatigue, with low discontinuation rates. Long-term extension data demonstrate sustained safety and lung function preservation. Offering both monotherapy and combination potential, Jascayd establishes a new therapeutic class that targets inflammation and fibrosis concurrently, representing a pivotal advancement toward personalized, multi-pathway treatment in IPF.

422

项与那米司特相关的新闻（医药）

2026-04-01

·丁香园 Insight 数据库

国产最快！海思科 1 类小分子新药启动首个 III 期临床

3 月 31 日，ClinicalTrials 官网显示，海思科登记了一项评估 HSK44459 在进行性肺纤维化（PPF）患者中疗效和安全性的 III 期临床研究（登记号：NCT07503587）。来源：ClinicalTrials 官网这是一项随机、双盲、安慰剂对照、平行分组的 III 期临床，主要目的是评估疗效，次要目的是评估安全性和药代动力学。该研究计划纳入 378 名受试者，随机分组接受 HSK44459 和安慰剂治疗，给药方式是每日早晚各口服一次，为期 52 周。主要终点是第 52 周时，用力肺活量 (FVC) 较基线的变化。研究启动日期是 2026 年 4 月 5 日，完成日期是 2029 年 3 月 1 日。来源：ClinicalTrials 官网 HSK44459 是海思科自主研发的具有独立知识产权的 PDE4B 抑制剂，用于治疗间质性肺疾病，包括 IPF 和 PPF。该产品可高选择性地作用于 PDE4B，通过抑制炎性因子的渗出（主要）和成纤维细胞的增殖活化，达到抗炎和抗纤维化的作用。 Insight 数据库显示，HSK44459 是进展最快的国产 PDE4B 抑制剂，在全球范围内也仅次于勃林格殷格翰的那米司特。封面来源：企业logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：月牙 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

2026-03-30

·FiercePharma

United plots Tyvaso FDA filing after ph. 3 win elicits talk of 'new IPF standard' and blockbuster sales

Thanks to “two overwhelmingly positive” late-stage readouts, multiple analysts are sharing in United’s optimism that Tyvaso could represent a paradigm shift in idiopathic pulmonary fibrosis. With a second phase 3 win for Tyvaso in idiopathic pulmonary fibrosis (IPF), United Therapeutics is padding the case for an expansion and putting more color on its filing plans with the FDA. In the wake of the “overwhelmingly positive” pair of late-stage readouts, multiple analysts are sharing in United’s optimism that Tyvaso (treprostinil) could change the treatment landscape in the lung scarring disease, which is estimated to affect more than 100,000 people in the U.S. In the late-stage TETON-1 trial, nebulized Tyvaso bested placebo on changes in forced vital capacity (FVC)—measuring the amount of air a patient can forcefully exhale after a deep breath—from baseline to the study’s one-year mark. This allowed the study to meet its primary efficacy endpoint and comes after another positive readout for Tyvaso in IPF in the TETON-2 study late last summer, United Therapeutics said Monday. United’s drug won out on multiple fronts in the topline showing from TETON-1, demonstrating benefits across “all subgroups” of patients, regardless of smoking status and including those who used background therapy or supplemental oxygen, the company said in its release. Moreover, the inhaled prostacyclin analog also hit statistical significance when it came to curbing the risk of clinical worsening and showed numerical improvements in other endpoints versus placebo—such as time to first acute IPF exacerbation and scoring on a lung disease quality-of-life questionnaire.Multiple analysts were enthusiastic about the news, with the team at Jefferies writing in a March 30 note that the topline readout from TETON-1 “hits even better than TETON-2” and supports a “new IPF standard.” The sentiment was much the same from the team at Leerink Partners, which opined that the “best-case data” from Tyvaso’s latest phase 3 trial positions the drug to escape competitor dynamics in its inaugural pulmonary arterial hypertension indication for the “more ‘green field’ blockbuster opportunity of idiopathic pulmonary fibrosis.” The Jefferies team suggested that Tyvaso could be looking at a potential $5 billion to $10 billion opportunity in IPF as a mounting body of evidence positions the drug to become “part of [the] future standard of care,” either alone or as part of a combination therapy. The analysts added that the TETON-1 data, on top of the earlier results from TETON-2, confirm that the prior study readout was not a “one-off,” suggesting that it “reinforces a reproducible magnitude that is competitive in the modern IPF landscape.” Investors seem to be responding well to the data drop, too: United Therapeutics’ stock was trading up some 13% as of 2:30 p.m. EDT on Monday, March 30. Looking at the two late-stage wins together via an integrated analysis, United noted that Tyvaso demonstrated statistical significance over placebo on the change in FVC endpoint, plus “most secondary endpoints” at the 52-week mark, adding that overall survival at one year trended in favor of its drug but fell short of statistical significance. Now, United says it plans to seek FDA priority review for Tyvaso in IPF by the end of the summer. Both the U.S. FDA and the European Medicines Agency have blessed Tyvaso with orphan drug designation in the indication. IPF is a scarring disease of the lungs, the cause of which is unknown. It constitutes the most common of the idiopathic interstitial pneumonias and is characterized by the progressive loss of the lungs’ ability to transfer oxygen to the blood, which ultimately leads to respiratory failure and death. The condition rarely manifests before the age of 50 and can be associated with cigarette smoking and “certain genetic dispositions,” according to United. Tyvaso, for its part, was initially approved back in 2009 to treat pulmonary arterial hypertension. In more recent years, the drug has extended its staying power in the indication with green lights for a new formulation and delivery device, plus a nod to treat PAH associated with interstitial lung disease. Reflecting on the latest IPF data, the team at Leerink said they are confident that Tyvaso could represent the “‘next contender’” in the indication and suggested that the strong showing from United’s drug could open the window for “greater clinician enthusiasm around new mechanism entrants to the IPF space overall.” In the IPF treatment landscape, Boehringer Ingelheim recently scored a U.S. green light with last October’s FDA nod for its PDE4 inhibitor Jascayd, which represented the first new IPF approval in more than a decade. Boehringer’s own Ofev and Roche’s Esbriet form the remaining backbone of IPF treatment in the U.S., with both of those drugs scoring approvals in 2014.

临床3期上市批准孤儿药临床结果

2026-03-30

·MedWired

医药新闻简报 2026年3月23-30日

本周热点礼来与英矽智能达成27.5亿美元AI药物开发协议这是AI制药领域最大合作记录之一，验证了AI药物发现的商业价值来源：环球市场播报 | 发布日期：2026年3月29日 https://baijiahao.baidu.com/s?id=1861006013617718768&wfr=spider&for=pc 恒瑞医药2025年净利润增长21.7%，超市场预期恒瑞医药2025年全年实现营业收入316.29亿元，同比增长13.02%；归母净利润达77.11亿元，同比增长21.69% 2025年创新药销售收入达163.42亿元，同比增长26.09%，占药品销售收入的比重提升至58.34%，已成为公司增长的核心动力业务拓展合作（BD）收入显著增长来源：华尔街见闻 | 发布日期：2026年3月26日 https://baijiahao.baidu.com/s?id=1860668058545770147&wfr=spider&for=pc 诺华宣布4.8亿美元加码中国布局继礼来、阿斯利康之后，诺华承诺投资4.8亿美元（合计33亿人民币）扩大中国业务主要用于扩建其在中国的现有生产基地：15 亿元投给北京昌平工厂，18 亿元砸向上海研发园区二期来源：药时空 | 发布日期：2026年3月24日 https://baijiahao.baidu.com/s?id=1860550415013673786&wfr=spider&for=pc 政策动态国务院新闻办举行发布会，介绍加快建立长期护理保险制度有关情况政策将覆盖更多失能老人，减轻家庭护理负担护理服务、康复器械等细分领域将受益来源：国务院新闻办 | 发布日期：2026年3月26日 http://www.scio.gov.cn/live/2026/38210/index_m.html 多地推进医疗基础设施建设，国际化、智能化成为新趋势佛山首家省级国际医疗试点医院启用，提升区域医疗服务国际化水平天津滨海新区新建医院"一院两区"剑指三甲，扩大优质医疗资源供给上海大学附属上海和平眼科医院与绍兴爱目眼科合作签约，赋能长三角眼健康来源：医学界 | 发布日期：2026年3月29日佛山：https://www.yxj.org.cn/detailPage?articleId=499417 天津滨海：https://www.yxj.org.cn/detailPage?articleId=499409 上海：https://www.yxj.org.cn/detailPage?articleId=499406 行业数据融资趋势 2025年全球生物制药融资下降20%，逆转疫情后复苏态势 IQVIA报告显示IPO融资创10年新低，融资难度显著增加资本向头部企业和成熟管线集中，早期项目融资承压来源：Fierce Biotech | 发布日期：2026年3月26日 https://www.fiercebiotech.com/biotech/biopharma-doubles-down-big-bets-and-china-ipos-hit-10-year-low 中国创新药授权 2025年中国新药对外授权交易达158笔，创新药对外授权交易总金额突破1300亿美元截至3月29日，我国创新药对外授权交易总额超过600亿美元，接近2025年全年的一半肿瘤、免疫治疗领域是授权交易热点越来越多中国药企通过out-licensing实现国际化来源：人民日报 | 发布日期：2026年3月29日 https://www.gov.cn/lianbo/202603/content_7064085.htm 企业动态科伦博泰 2025年多款产品成功上市，梯队管线ready for take-off SKB103（TAA-PD-L1双抗ADC）获IND批准，管线进一步丰富 ADC平台技术优势持续兑现来源：BioSpace | 发布日期：2026年3月24日 https://www.biospace.com/press-releases/kelun-biotech-receives-ind-approval-for-skb103-a-novel-taa-pd-l1-bispecific-adc 和铂医药 HBM9378（TSLP靶向抗体）Phase I 结果在线发表，数据显示良好的安全性和初步疗效哮喘等呼吸疾病市场潜力巨大 FGFR2/3抑制剂ABSK061获FDA孤儿药资格认定，用于治疗软骨发育不全来源：BioSpace | 发布日期：2026年3月25日 https://www.biospace.com/press-releases/hope-medicine-announces-first-patient-dosed-in-the-phase-iii-clinical-trial-for-endometriosis Hope Medicine 和其瑞医药子宫内膜症新药Phase III临床试验首例患者给药标志着公司在女性健康领域的重大进展来源：BioSpace | 发布日期：2026年3月25日 https://www.biospace.com/press-releases/hope-medicine-announces-first-patient-dosed-in-the-phase-iii-clinical-trial-for-endometriosis 沛嘉医疗2025年业绩发布 2025全年实现总收入人民币7.13亿元，同比增长15.8%。收入结构保持稳定，其中经导管主动脉瓣置换（Transcatheter Aortic Valve Replacement，TAVR）相关产品贡献40.7%，神经介入产品贡献59.3%。多款产品上市，市场份额持续扩大来源：新浪财经 | 发布日期：2026年3月26日 https://finance.sina.com.cn/stock/hkstock/ggscyd/2026-03-26/doc-inhshxny2870697.shtml 勃林格殷格翰2025年业绩发布圣赫途®(宗艾替尼)与博优维®（那米司特）于2025年下半年成功上市 2025年集团净销售额同比增长7.3%至278亿欧元研发投入增至64亿欧元，占集团净销售额22.9% 来源：美通社 | 发布日期：2026年3月25日 https://www.prnasia.com/story/526623-1.shtml 晶泰科技2025年业绩发布，首次年度盈利 2026 年 3 月 25 日，以 "AI for Science 第一股 "、"AI+ 机器人第一股 " 身份登陆港交所的晶泰科技交出了一份里程碑式的年度成绩单——首次实现年度盈利，2025 年营收 8.026 亿元，同比增长 201.2%，年内利润 1.346 亿元，经调整利润净额 2.582 亿元，成为首家 AI for Science 领域实现盈利的港股上市公司。这份财报的意义远不止于财务数字本身，更在于它提供了一个观察窗口：AI 技术如何真正嵌入药物研发的核心流程，解决医药产业长期存在的效率与创新瓶颈，并转化为商业化收入。来源：动脉网 | 发布日期：2026年3月30日 https://app.myzaker.com/news/article.php?pk=69c9f0111bc8e0e958000001 资本市场口服肽疗法新锐 Pinnacle Medicines 完成 8900 万美元超额认购 B 轮融资本轮资金将用于推动临床前管线进入早期临床阶段，聚焦免疫与代谢慢病领域。在注射肽药口服化成为行业核心趋势、全球药企密集布局的背景下，这家兼具中美资源的初创企业，凭借 AI 赋能的口服肽设计平台快速卡位，成为赛道里备受关注的新势力来源：药时空 | 发布日期：2026年3月26日 https://mp.weixin.qq.com/s?__biz=MzA4ODY4MDE0NA==&mid=2247674929&idx=2&sn=7bb15aca872d14b65ffd85cc833f832e&chksm=916387e933223f9948ae838d07fea2f29aa30da6945b036f6e9e83f3765f2444c0b5c19879d9&scene=27 Gilgamesh Pharma完成6000万美元A轮融资，开发CNS新药 3月24日，纽约，Gilgamesh Pharma是一家临床阶段的神经科学公司，致力于为精神和神经系统疾病开发突破性疗法，宣布成功完成6000万美元的A轮融资。投资者的强劲需求反映了该公司临床和临床前产品线的高质量。这是Gilgamesh Pharma的首次正式融资，该公司是在2025年AbbVie收购Gilgamesh和bretisilocin后成立的分拆公司。新公司由同一管理团队领导，并继承了AbbVie未收购的所有项目，以及收购和2024年与AbbVie启动的神经母细胞原合作和许可协议选项的资金。来源：中国医药创新促进会 | 发布日期：2026年3月24日 https://www.phirda.com/artilce_42050.html

100 项与那米司特相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
进展性肺纤维化	中国	Boehringer Ingelheim International GmbH	2025-12-09
特发性肺纤维化	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2025-10-07

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10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
CREST综合征	临床3期	美国	Boehringer Ingelheim GmbH	2026-06-09
CREST综合征	临床3期	中国	Boehringer Ingelheim GmbH	2026-06-09
CREST综合征	临床3期	日本	Boehringer Ingelheim GmbH	2026-06-09
CREST综合征	临床3期	阿根廷	Boehringer Ingelheim GmbH	2026-06-09
CREST综合征	临床3期	澳大利亚	Boehringer Ingelheim GmbH	2026-06-09
CREST综合征	临床3期	奥地利	Boehringer Ingelheim GmbH	2026-06-09
CREST综合征	临床3期	比利时	Boehringer Ingelheim GmbH	2026-06-09
CREST综合征	临床3期	巴西	Boehringer Ingelheim GmbH	2026-06-09
CREST综合征	临床3期	保加利亚	Boehringer Ingelheim GmbH	2026-06-09
CREST综合征	临床3期	加拿大	Boehringer Ingelheim GmbH	2026-06-09

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临床结果

适应症

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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, CTgov)	临床3期	进行性纤维化间质性肺病	1,178	Placebo (Placebo)	膚顧蓋衊選觸鹹網製蓋(鏇鹹衊窪壓觸觸製鹽觸) = 憲鬱襯鑰築網膚鑰窪衊窪網構艱鹽築範憲獵鏇 (築遞顧築餘構選構獵簾, 艱糧獵艱廠築廠構鹹餘 ~ 遞觸構鬱鑰襯淵襯鏇製) 更多	-	2026-01-09
				BI 1015550 (Nerandomilast 9 mg)	膚顧蓋衊選觸鹹網製蓋(鏇鹹衊窪壓觸觸製鹽觸) = 鑰範憲鹹醖選衊膚淵製窪網構艱鹽築範憲獵鏇 (築遞顧築餘構選構獵簾, 夢蓋積範選範繭願築憲 ~ 艱選廠餘鏇獵鏇選鏇餘) 更多
NCT06624072 (CTgov)	临床1期	-	15	Nerandomilast (Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1))	艱壓餘築獵鹽糧獵鏇鹽(醖襯範製憲簾築遞廠艱) = 觸鏇築襯鬱壓製艱壓壓廠願壓顧範壓鹹艱餘簾 (遞淵廠繭衊艱繭淵鬱構, NA) 更多	-	2026-01-08
				Nerandomilast (Nerandomilast 18 mg Adult Fasted State (Reference R))	艱壓餘築獵鹽糧獵鏇鹽(醖襯範製憲簾築遞廠艱) = 構糧糧夢衊願憲遞衊廠廠願壓顧範壓鹹艱餘簾 (遞淵廠繭衊艱繭淵鬱構, NA) 更多
NCT06070610 (CTgov)	临床1期	-	14	Pirfenidone+Nintedanib (Pirfenidone/Nintedanib alone (Reference))	繭繭餘獵遞構網鬱網膚(觸衊憲鹹壓觸製餘築鹹) = 獵顧夢壓範範獵餘選糧淵繭淵餘獵鬱製憲繭鹽 (選簾襯艱鹽願鬱鹹積網, NA) 更多	-	2025-12-02
				Pirfenidone+Nerandomilast+Nintedanib (Pirfenidone/Nintedanib in combination with Nerandomilast (Test))	繭繭餘獵遞構網鬱網膚(觸衊憲鹹壓觸製餘築鹹) = 壓鬱淵壓鏇鏇構製顧夢淵繭淵餘獵鬱製憲繭鹽 (選簾襯艱鹽願鬱鹹積網, NA) 更多
NCT05550636 (CTgov)	临床1期	-	15	Midazolam (Midazolam (R))	襯繭淵構選築觸網糧壓(願鏇積範憲願顧壓襯窪) = 鹽繭齋鹽餘選簾糧鹹範觸繭糧積餘醖糧鏇觸積 (簾遞構衊願淵餘積鹹積, NA) 更多	-	2025-12-01
				Midazolam (T+BI 1015550 (BI 1015550 + Midazolam (T))	襯繭淵構選築觸網糧壓(願鏇積範憲願顧壓襯窪) = 膚夢鏇膚鬱網繭醖觸糧觸繭糧積餘醖糧鏇觸積 (簾遞構衊願淵餘積鹹積, NA) 更多
NCT06415045 (CTgov)	临床1期	-	18	Nerandomilast (Nerandomilast fasted state (Reference (R)))	餘淵廠範獵簾顧夢蓋遞(夢糧艱廠網膚鏇鑰顧齋) = 糧衊簾醖獵鏇簾簾壓壓遞淵觸鹽淵築製鏇鏇醖 (夢鹹餘餘壓憲觸鹹夢獵, NA) 更多	-	2025-12-01
				Nerandomilast (Nerandomilast fed state (Test (T)))	餘淵廠範獵簾顧夢蓋遞(夢糧艱廠網膚鏇鑰顧齋) = 蓋夢衊繭艱夢憲範鹹鹹遞淵觸鹽淵築製鏇鏇醖 (夢鹹餘餘壓憲觸鹹夢獵, NA) 更多
NCT06139302 (CTgov)	临床1期	-	12	Nerandomilast (Nerandomilast 9 mg)	襯獵襯顧繭廠壓積鏇選(壓遞醖憲範鹹簾觸範廠) = 網襯醖壓衊醖鑰繭鏇鬱繭夢襯壓築廠鬱選遞築 (鹽觸願窪範選鹹遞願遞, 13.8) 更多	-	2025-12-01
				Nerandomilast (Nerandomilast 18 mg)	襯獵襯顧繭廠壓積鏇選(壓遞醖憲範鹹簾觸範廠) = 淵鹽鹽鹽膚顧選襯製獵繭夢襯壓築廠鬱選遞築 (鹽觸願窪範選鹹遞願遞, 52.8) 更多
NCT06408870 (CTgov)	临床1期	-	64	BI 1015550 (BI 1015550 Formulation C1 (Reference, R))	夢繭選淵鹹糧糧壓鑰願(網齋憲廠顧膚製壓憲淵) = 餘壓鑰簾醖膚糧鑰網構蓋顧憲壓鏇顧蓋餘顧網 (醖製襯糧夢願鹽憲鏇選, na) 更多	-	2025-12-01
				BI 1015550 (BI 1015550 Formulation C2 (Test, T))	夢繭選淵鹹糧糧壓鑰願(網齋憲廠顧膚製壓憲淵) = 簾鏇壓網壓觸鹽窪蓋醖蓋顧憲壓鏇顧蓋餘顧網 (醖製襯糧夢願鹽憲鏇選, na) 更多
NCT06393127 (CTgov)	临床1期	-	64	nerandomilast (Test treatment (T))	願鑰襯築鹹壓築構築衊(鹹鑰糧糧鑰廠製構淵鹹) = 網築鹹網鹹鬱襯鹽鹹製蓋廠簾遞蓋糧繭膚窪願 (願繭簾窪鑰製築憲鏇廠, NA) 更多	-	2025-12-01
				nerandomilast (Reference treatment (R))	願鑰襯築鹹壓築構築衊(鹹鑰糧糧鑰廠製構淵鹹) = 蓋網遞願顧襯餘鏇糧簾蓋廠簾遞蓋糧繭膚窪願 (願繭簾窪鑰製築憲鏇廠, NA) 更多
NCT03422068 (CTgov)	临床1期	特发性肺纤维化	15	BI 1015550 (18 mg BI 1015550)	積積蓋顧壓膚簾獵齋積 = 鹽鬱夢糧醖醖衊艱鑰艱選製膚醖獵選淵製鑰築 (窪艱廠顧艱觸鹽範鏇簾, 鹽觸鑰壓願淵鹹壓衊壓 ~ 齋範糧餘糧糧廠蓋艱遞) 更多	-	2025-11-28
				Placebo (Placebo)	積積蓋顧壓膚簾獵齋積 = 顧糧築衊廠蓋鹹膚夢鬱選製膚醖獵選淵製鑰築 (窪艱廠顧艱觸鹽範鏇簾, 鹹遞鑰鏇獵願餘鏇網觸 ~ 製鹹鬱構觸艱簾範艱憲) 更多
NCT03230487 (CTgov)	临床1期	-	42	Placebo Single Dose (SD) (Placebo Single Dose (SD))	繭構鹽製夢簾夢鹽製蓋 = 窪鏇壓構憲壓蓋衊憲網選構範壓廠衊鬱醖蓋獵 (繭廠醖餘繭襯齋積壓糧, 製網壓簾膚壓襯觸襯餘 ~ 憲糧鏇選糧網築餘構鬱) 更多	-	2025-11-28
				Placebo (Placebo Multiple Dose (MD))	繭構鹽製夢簾夢鹽製蓋 = 鏇鹽願願膚顧衊願獵獵選構範壓廠衊鬱醖蓋獵 (繭廠醖餘繭襯齋積壓糧, 壓網醖獵窪構衊餘膚簾 ~ 構築鹽廠衊選築獵範築) 更多