Open Label, Single Dose, Parallel-group Study to Evaluate the PK and the Safety and Tolerability of Single Oral Doses of BI 1291583 in Trial Participants With Mild, Moderate and Severe Hepatic Impairment as Compared to Matched, Hepatically Healthy Trial Participants.

This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 18.5 to 42 kg/m². People with or without liver problems can take part in the study. The purpose of this study is to find out how much of a medicine called BI 1291583 gets into the blood of people with and without liver problems. BI 1291583 is being developed to treat people with bronchiectasis, a chronic disease of the lungs. People living with this condition often also have liver problems. Therefore, it is important to find out whether liver problems influence the amount of BI 1291583 that gets into the blood.
Study participants receive a single dose of BI 1291583 as a tablet taken by mouth. Participants are divided into 4 groups based on how well their liver works: 1 group without liver problems, and 3 groups with mild, moderate, and severe liver problems. Each participant without liver problems is matched with participants from the other groups based on factors such as age, sex, smoking habits, and body weight to ensure accurate comparisons.
Participants are in the study for about 3 months. They stay for 3 days at the study site and also visit the study site up to 9 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The doctors regularly check participants' health and take note of any unwanted effects.

开始日期2025-07-17

申办/合作机构

Boehringer Ingelheim GmbH

NCT06872892

/ Recruiting临床3期

A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of BI 1291583 2.5 mg Administered Once Daily for up to 76 Weeks in Patients With Bronchiectasis (The AIRTIVITY™ Study)

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations).
The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months.
Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.

开始日期2025-06-09

申办/合作机构

Boehringer Ingelheim GmbH

NCT06917872

/ Completed临床1期

An Open-label, Fixed-sequence, Two-period Phase I Trial to Evaluate the Effect of Multiple Oral Doses of Erythromycin, a Moderate CYP3A4 Inhibitor, on the Pharmacokinetics of BI 1291583 at Steady State in Healthy Male and Female Subjects

The main objective of this trial is to investigate the effect of erythromycin, a moderate CYP3A4 inhibitor on the pharmacokinetics of BI 1291583 at steady state.

开始日期2025-04-29

申办/合作机构

Boehringer Ingelheim GmbH

100 项与 Verducatib 相关的临床结果

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100 项与 Verducatib 相关的转化医学

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100 项与 Verducatib 相关的专利（医药）

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项与 Verducatib 相关的文献（医药）

2025-07-01·Journal of Thoracic Disease

Dipeptidyl peptidase 1 inhibitors and neutrophilic inflammation in bronchiectasis: a narrative review

Review

作者: Tang, Rui-Di ; Guan, Wei-Jie ; Yue, Jun-Qing ; Chalmers, James D

Background and Objective:

Bronchiectasis is a chronic respiratory disease characterized by predominantly neutrophilic inflammation, recurrent infection and pathological dilatation of the airways. Current therapeutic strategies primarily target infections and improving mucus clearance. However, no current treatment can directly ameliorate neutrophilic inflammation. Recently, dipeptidyl peptidase 1 (DPP-1) inhibitors effectively abrogated neutrophilic inflammation in bronchiectasis. This narrative review aimed to analyze the structural characteristics and functional effects of DPP-1, explore the mechanism of DPP-1 inhibitors in bronchiectasis, and highlight major clinical trial findings.

Methods:

We performed an online electronic search for relevant English literature on PubMed and Web of Science databases, with the keywords of "dipeptidyl peptidase 1", "cathepsin C", "cathepsin C structure", "cathepsin C maturation", "cathepsin C loss-of-function", "neutrophil serine proteases and bronchiectasis", "neutrophil serine proteases and cathepsin C", "neutrophil serine proteases and DPP-1", "DPP-1 inhibitors", "cathepsin C inhibitors", "DPP-1 inhibitors and bronchiectasis", "cathepsin C inhibitors and bronchiectasis". Two authors (R.D.T. and J.Q.Y.) independently searched and reviewed the articles.

Key Content and Findings:

Excessive and uncontrolled release of neutrophil serine proteases (NSPs) can lead to airway inflammatory responses and structural damage in bronchiectasis. Elevated levels of neutrophil elastase (NE) and other neutrophil markers in the airway are associated with exacerbations and lung function decline. In light of the pivotal role of DPP-1 in eliciting neutrophilic inflammation, several DPP-1 inhibitors have been developed and entered clinical trials for safety and efficacy assessment in bronchiectasis. Of these, brensocatib markedly prolonged the time to the first exacerbation and decreased the exacerbation frequency via decreasing the activity of NSPs. The phase III ASPEN trial has been completed and confirms reduced exacerbations and slower lung function decline with DPP-1 inhibitor treatment. Treatment with BI 1291583 reduced the risk of bronchiectasis exacerbations in the phase II Airleaf^® trial. HSK31858 significantly decreased the exacerbation frequency and prolonged the time to the first exacerbation in the latest phase II trial among the Chinese population.

Conclusions:

DPP-1 inhibitors have exhibited promising effects in improving several major clinical outcomes in bronchiectasis via suppressing the activity of NSPs.

2025-01-01·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

A randomized phase I study of the safety and pharmacokinetics of BI 1291583 in healthy Japanese male subjects

Article

作者: Tadayasu, Yusuke ; Sauter, Wiebke ; Furuichi, Takumi ; Eleftheraki, Anastasia ; Nakamura, Shuhei ; Sarubbi, Donald ; Hanada, Ryuzo

Aims:

Bronchiectasis patients face an unmet need for treatment options that reduce inflammation. Cathepsin C inhibition is expected to achieve this by reducing the activation of neutrophil‐derived serine proteases. Here, we present safety and pharmacokinetic (PK) data from a Phase I trial evaluating the novel cathepsin C inhibitor BI 1291583 in healthy Japanese male subjects.

Methods:

This randomized, double‐blind, placebo‐controlled, parallel‐group study investigated BI 1291583 in healthy Japanese male subjects (jRCT2071210111) and consisted of a single‐rising‐dose (SRD) part and a multiple‐dose (MD) part. The primary endpoint was the percentage of subjects with drug‐related treatment‐emergent adverse events (AEs). Secondary PK endpoints (SRD: AUC0‐∞ and Cmax; MD: AUCτ,1 and Cmax,1 after first dose and AUCτ,ss and Cmax,ss after last dose), as well as further safety and PK endpoints, were also assessed.

Results:

Overall, 36 subjects (n = 24 for SRD part; n = 12 for MD part) entered this Phase I trial. BI 1291583 was safe and well tolerated across the doses tested. All AEs were of mild intensity, with no drug‐related treatment‐emergent AEs, deaths, serious AEs or AEs of special interest reported in either part of the trial. Following both SRD and MD administration, BI 1291583 was readily absorbed, and PK was supraproportional over the doses assessed.

Conclusion:

The results show that BI 1291583 has an appropriate benefit–risk ratio for Japanese patients, with no safety or exposure concerns at the doses studied. Japanese patients with bronchiectasis can be safely integrated into future global clinical trials of BI 1291583, with no dose adjustment required.

2025-01-01·EUROPEAN RESPIRATORY JOURNAL

Cathepsin C (dipeptidyl peptidase 1) inhibition in adults with bronchiectasis: AIRLEAF, a phase II randomised, double-blind, placebo-controlled, dose-finding study

Article

作者: Armstrong, April W ; Shteinberg, Michal ; Chotirmall, Sanjay H ; McShane, Pamela J ; Chalmers, James D ; Mall, Marcus A ; O'Donnell, Anne E ; Gupta, Abhya ; Eleftheraki, Anastasia ; Watz, Henrik ; Sauter, Wiebke ; Hasegawa, Naoki ; Eickholz, Peter ; Frahm, Edith ; Rauch, Johanna

Background:

Bronchiectasis is characterised by uncontrolled neutrophil serine protease (NSP) activity. Cathepsin C (CatC; dipeptidyl peptidase 1) activates NSPs during neutrophil maturation. CatC inhibitors can potentially reduce neutrophil-mediated lung damage. This phase II, randomised, double-blind, placebo-controlled trial (AIRLEAF®; clinicaltrials.gov identifierNCT05238675) evaluated efficacy, safety and optimal dosing of BI 1291583, a novel, reversible CatC inhibitor, in adults with bronchiectasis.

Methods:

In total, 322 participants were randomised (2:1:1:2) to receive one of three oral doses of BI 1291583 (1 mg/2.5 mg/5 mg) or placebo for 24–48 weeks. A multiple comparison procedure and modelling approach was used to demonstrate a nonflat dose–response curve based on the time to first pulmonary exacerbation up to week 48. In addition, efficacy of individual BI 1291583 doses was evaluated based on the frequency of exacerbations, severe exacerbations (fatal or leading to hospitalisation and/or intravenous antibiotic administration), lung function and quality of life.

Results:

A significant dose-dependent benefit of BI 1291583 over placebo was established based on time to first exacerbation (shape: maximum effect curve 1; adjusted p=0.0448). Treatment with BI 1291583 5 mg and 2.5 mg numerically reduced the risk of an exacerbation compared with placebo (hazard ratio (95% CI) 0.71 (0.48 to 1.05) and 0.66 (0.40 to 1.08), respectively; both p>0.05). BI 1291583 2.5 mg showed numerically better efficacy compared with 5 mg across several end-points; 1 mg was similar to placebo. The safety profile of BI 1291583 was similar to placebo.

Conclusion:

Treatment with BI 1291583 resulted in a reduction in the risk of experiencing an exacerbation in adults with bronchiectasis.

项与 Verducatib 相关的新闻（医药）

2026-01-20

·百度百家

慢性气道里的“过度清洁工”：中性粒细胞如何加重支气管扩张？一种新疗法带来希望

如果你或你身边的人长期咳嗽、痰多，反复出现肺部感染，那么可能对“支气管扩张症”这个病名并不陌生。这是一种被称为“新兴全球流行病”的慢性气道疾病，其患病率在全球范围内不断上升，严重影响患者的生活质量。简单来说，它就像是我们肺部深处的支气管（气道）因为反复的损伤和炎症，像被吹胀的气球一样发生了永久或持久的扩张、变形，从而失去了正常清除黏液和细菌的能力。长期以来，支气管扩张症的治疗主要集中在控制症状、清除痰液和抗感染上，缺乏针对疾病核心机制的“治本”之药。为什么会这样？一个关键原因在于我们一直未能找到一个普遍、可靠的“生物标志物”——一个能像血糖反映糖尿病一样，精准反映支气管扩张症活动性和严重程度，并能用来评估治疗效果的指标。近期，一篇发表在《欧洲呼吸杂志》上的重磅综述为我们指明了方向。文章指出，在各种复杂病因的背后，几乎所有的支气管扩张症都有一个共同的“幕后推手”：中性粒细胞介导的慢性炎症。而中性粒细胞释放的一类“破坏性剪刀”——中性粒细胞丝氨酸蛋白酶（NSPs），正是连接疾病发生、发展和恶化的核心生物标志物和潜在治疗靶点。好心办坏事的“过度清洁工”：中性粒细胞想象一下，我们的气道像一条需要时刻保持清洁的管道，依靠表面的纤毛和适量的黏液（痰）将灰尘、细菌等“垃圾”运出体外。中性粒细胞是人体免疫系统的“先锋部队”，当气道有细菌感染时，它们会迅速聚集，通过吞噬、释放抗菌物质等方式消灭入侵者。这本是好事。但在支气管扩张症患者的气道里，情况失控了。中性粒细胞不仅数量激增，而且“赖着不走”（凋亡延迟），功能也发生紊乱。它们持续处于激活状态，大量释放三种NSPs：中性粒细胞弹性蛋白酶（NE）、蛋白酶3（PR3）和组织蛋白酶G（CatG）。这些蛋白酶本意是帮助杀菌，但当其数量远超体内抑制物（抗蛋白酶）时，就变成了一把把“破坏性剪刀”，从多个方面推动疾病的“恶性循环”：破坏黏液平衡：NE能刺激气道产生过多、过黏的黏液（主要成分是MUC5AC），导致痰液难以咳出，堵塞气道。损伤纤毛与气道壁：它们能直接损伤气道表面的纤毛，削弱其摆动清除能力；还能降解气道壁的结构蛋白（如弹性蛋白），导致气道永久性扩张和结构破坏。削弱自身防御：NSPs会破坏气道内天然的抗菌肽和抗蛋白酶（如SLPI），使肺部更容易发生持续感染。火上浇油，加剧炎症：它们还能激活其他炎症信号（如IL-1β），招募更多中性粒细胞前来，形成一个越演越烈的“炎症漩涡”。这个由“慢性感染/炎症 → 黏液清除障碍 → 更多感染/炎症 → 气道结构破坏”构成的“恶性循环”，正是支气管扩张症不断进展、急性加重反复发作的核心机制。而NSPs的活性，尤其是NE的活性，已被多项研究证实与疾病严重程度、急性加重频率和肺功能下降速度直接相关，使其成为目前最被验证的、有希望指导治疗的生物标志物。旧思路遇挫，新策略曙光：擒贼先擒王既然NSPs如此“罪大恶极”，直接抑制它们（尤其是NE）不就行了？事实上，多年来科学家们确实尝试研发直接抑制NE的药物，但在临床试验中效果不一，未能取得普遍成功。这可能是因为只抑制一种蛋白酶，其他蛋白酶（PR3、CatG）仍可继续“搞破坏”，无法真正打破平衡。于是，一种“擒贼先擒王”的间接抑制策略应运而生，并展现出巨大潜力。研究发现，中性粒细胞在骨髓中发育成熟时，需要一种名为组织蛋白酶C（CatC，也称DPP1）的“激活酶”来将NE、PR3和CatG这三种蛋白酶从无活性的前体“修剪”成有活性的形态。如果能在骨髓中抑制CatC，就能从源头上减少活性NSPs的产生，让中性粒细胞“带枪少、火力弱”地进入肺部，从而恢复蛋白酶与抗蛋白酶的平衡。 CatC抑制剂的安全性如何？这曾是人们最大的担忧。因为一种名为Papillon-Lefèvre综合征的罕见遗传病，正是由CatC基因突变导致功能完全丧失引起的。但研究发现，这类患者虽然会有掌跖角化等皮肤问题，却并未表现出严重的免疫缺陷或感染易感性增加。这说明，完全或部分抑制CatC，可能不会严重影响机体对抗日常感染的核心防御能力。这一发现为药物研发扫清了关键的理论障碍。新药突破：从临床试验到未来希望目前，已有多种CatC抑制剂进入了临床研究阶段，其中进展最快的brensocatib 已完成了III期临床试验（ASPEN研究），并取得了积极成果：显著减少急性加重：在II期（WILLOW研究）和III期（ASPEN研究）中，与安慰剂相比，brensocatib能显著延长患者首次发生急性加重的时间，并将年急性加重率降低约20-60%。改善多重指标：治疗不仅降低了痰液中三种NSPs的活性，还观察到黏液核心蛋白MUC5AC的减少和抗蛋白酶SLPI的增加，证实其能从多个环节打断“恶性循环”。安全性可接受：主要不良反应是轻微、可逆的皮肤相关事件（如角化过度），严重感染风险并未增加。此外，其他CatC抑制剂如BI 1291583和HSK31858也在II期研究中显示出类似的降低NSP活性和减少急性加重的趋势。这些成功共同印证了“从源头集体抑制NSPs”这一策略的有效性。总结与展望这篇综述为我们清晰地勾勒出支气管扩张症治疗领域的重大转变：从症状管理到靶向核心：治疗焦点正从单纯的抗感染、排痰，转向靶向驱动疾病进展的共同核心通路——中性粒细胞炎症及NSPs失衡。生物标志物驱动的精准医疗：以NE为代表的NSPs，作为经过验证的生物标志物，未来不仅可用于评估疾病活动度，更能用于筛选最适合CatC抑制剂治疗的患者，并精准监测疗效。 “擒王”策略的成功：CatC抑制剂（如brensocatib）的研发成功，标志着通过间接、上游抑制来恢复肺部免疫平衡的新策略获得验证，为患者带来了首个有望改变疾病进程的靶向治疗希望。尽管疾病具有高度异质性，但找到像NSPs这样的“共同靶点”，意味着我们有可能用一种药物惠及更广泛的患者群体。随着CatC抑制剂等新型疗法走向临床，我们有理由期待，支气管扩张症患者将迎来一个急性加重更少、生活质量更高、肺功能衰退更慢的新时代。参考文献：Chalmers JD, Mall MA, Nielsen KG, et al. Neutrophil-derived biomarkers in bronchiectasis: identifying a common therapeutic target. Eur Respir J 2025; 66: 2500081.

2026-01-18

·信狐药迅

3个1类国产新药：上海光声华卟啉钠、怡道生物带状疱疹疫苗和中山康方古莫奇单抗提交上市申请|新受理（1.12-1.18）

本周药品注册受理数据，分门别类呈现，一目了然。(1.12-1.18）新药上市申请药品名称企业注册分类受理号注射用华卟啉钠上海光声制药有限公司 1 CXHS2600017 重组带状疱疹疫苗(CHO细胞) 怡道生物科技(苏州)有限公司 1.3 CXSS2600011 古莫奇单抗注射液中山康方生物医药有限公司 1 CXSS2600010 古莫奇单抗注射液中山康方生物医药有限公司 1 CXSS2600009 新药临床申请药品名称企业注册分类受理号 SST001注射液思努赛生物科技(上海)有限责任公司 1 CXHL2600082 PAM-194软膏潘普洛纳生物科技(深圳)有限公司 1 CXHL2600080 PAM-194软膏潘普洛纳生物科技(深圳)有限公司 1 CXHL2600079 PAM-194软膏潘普洛纳生物科技(深圳)有限公司 1 CXHL2600078 MY008211A片武汉朗来科技发展有限公司 1 CXHL2600083 QR059349片武汉朗来科技发展有限公司 1 CXHL2600081 JKN2404吸入混悬液健康元药业集团股份有限公司 1 CXHL2600074 JKN2404吸入混悬液健康元药业集团股份有限公司 1 CXHL2600073 JKN2404吸入混悬液健康元药业集团股份有限公司 1 CXHL2600072 BSA204注射液倍臻生物技术(苏州)有限公司 1 CXHL2600071 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600068 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600067 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600066 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600065 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600064 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600063 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600062 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600061 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600060 HRS-5765片成都盛迪医药有限公司 1 CXHL2600059 HRS-5765片成都盛迪医药有限公司 1 CXHL2600058 GK001片杭州港康医药有限公司 1 CXHL2600069 ZYG24004 江苏知原药业股份有限公司 2.2 CXHL2600085 ZYG24004 江苏知原药业股份有限公司 2.2 CXHL2600084 烟酰胺腺嘌呤二核苷酸片康诺生物制药股份有限公司 2.2;2.4 CXHL2600070 MI226注射液南京迈诺威医药科技有限公司 2.4 CXHL2600077 MI226注射液南京迈诺威医药科技有限公司 2.4 CXHL2600076 MI226注射液南京迈诺威医药科技有限公司 2.4 CXHL2600075 RG004注射液仁景(苏州)生物科技有限公司 1.2 CXSL2600078 HLXTE-HAase02重组人透明质酸酶注射液复星汉霖(成都)生物技术有限公司 1 CXSL2600095 人脐带间充质干细胞注射液长春拓华医药有限公司 1 CXSL2600094 注射用QLS5132 齐鲁制药有限公司 1 CXSL2600093 注射用BL-B01D1 成都百利多特生物药业有限责任公司 1 CXSL2600091 BY002 杭州百懿生物药业有限公司 1 CXSL2600090 EMB-15注射液上海岸迈生物科技有限公司 1 CXSL2600089 PRO-203 北京MEDPACE医药科技有限公司 1 CXSL2600085 SPX-303注射液科霸生物(江苏)有限公司 1 CXSL2600088 GLR1062注射液甘李药业股份有限公司 1 CXSL2600087 Pumitamig注射液百时美施贵宝(中国)投资有限公司 1 CXSL2600081 FKC289注射液复星凯瑞(上海)生物科技有限公司 1 CXSL2600079 注射用KHN922 成都康弘生物科技有限公司 1 CXSL2600077 SCTB41注射液神州细胞工程有限公司 1 CXSL2600076 注射用LY4170156 礼来苏州制药有限公司 1 CXSL2600075 注射用HDM2024 杭州中美华东制药有限公司 1 CXSL2600084 注射用BL-B01D1 成都百利多特生物药业有限责任公司 1 CXSL2600072 FKC289注射液复星凯瑞(上海)生物科技有限公司 1 CXSL2600071 重组人源化抗HER2双特异性抗体注射液上海津曼特生物科技有限公司 1 CXSL2600073 VG801 德康明基医疗科技(上海)有限公司 1 CXSL2600074 注射用SKB103 四川科伦博泰生物医药股份有限公司 1 CXSL2600069 BG-A3004注射液广州百济神州生物制药有限公司 1 CXSL2600068 QL2107注射液齐鲁制药有限公司 2.2 CXSL2600092 仿制药申请药品名称企业注册分类受理号醋酸钠林格注射液辰欣药业股份有限公司 3 CYHS2600203 头孢呋辛酯干混悬剂华北制药河北华民药业有限责任公司 3 CYHS2600200 头孢呋辛酯干混悬剂华北制药河北华民药业有限责任公司 3 CYHS2600199 地拉罗司片湖南欧亚药业有限公司 3 CYHS2600193 地拉罗司片湖南欧亚药业有限公司 3 CYHS2600192 普罗布考片山西华夏泰康医药集团有限公司 3 CYHS2600190 薁磺酸钠片华益药业科技(安徽)有限公司 3 CYHS2600188 铝镁匹林片(II) 海南海灵化学制药有限公司 3 CYHS2600174 盐酸普萘洛尔注射液北京华素制药股份有限公司 3 CYHS2600173 维生素K1注射液重庆世森医药科技有限公司 3 CYHS2600155 葡萄糖酸钙氯化钠注射液河南双鹤华利药业有限公司 3 CYHS2600153 葡萄糖酸钙氯化钠注射液河南双鹤华利药业有限公司 3 CYHS2600152 乙酰半胱氨酸片长春澜江医药科技有限公司 3 CYHS2600151 布立西坦片成都奥邦药业有限公司 3 CYHS2600146 布立西坦片成都奥邦药业有限公司 3 CYHS2600145 复方电解质醋酸钠葡萄糖注射液四川奇裕医药科技有限公司 3 CYHS2600163 复方电解质醋酸钠葡萄糖注射液四川奇裕医药科技有限公司 3 CYHS2600162 达格列净片新乡市常乐制药有限责任公司 4 CYHS2600211 达格列净片新乡市常乐制药有限责任公司 4 CYHS2600210 盐酸头孢卡品酯颗粒广州艾奇西医药科技有限公司 4 CYHS2600208 奥美沙坦酯氨氯地平片云鹏医药集团有限公司 4 CYHS2600207 阿立哌唑片海南日中天制药有限公司 4 CYHS2600206 阿立哌唑片海南日中天制药有限公司 4 CYHS2600205 恩他卡朋双多巴片(II) 宁波美诺华天康药业有限公司 4 CYHS2600204 依折麦布阿托伐他汀钙片(I) 昆明积大制药股份有限公司 4 CYHS2600202 依折麦布阿托伐他汀钙片(II) 昆明积大制药股份有限公司 4 CYHS2600201 苯磺酸美洛加巴林片江苏联环药业股份有限公司 4 CYHS2600198 孟鲁司特钠片苏州俞氏药业有限公司 4 CYHS2600197 苯磺酸美洛加巴林片江苏联环药业股份有限公司 4 CYHS2600196 苯磺酸美洛加巴林片江苏联环药业股份有限公司 4 CYHS2600195 脂肪乳(10)/氨基酸(15)/葡萄糖(20)注射液四川太平洋药业有限责任公司 4 CYHS2600194 丁二磺酸腺苷蛋氨酸肠溶片浙江皓格药业有限公司 4 CYHS2600191 依达拉奉右莰醇注射用浓溶液石药集团欧意药业有限公司 4 CYHS2600189 艾普拉唑肠溶片湖南华纳大药厂股份有限公司 4 CYHS2600187 依非米替片(I) 浙江华海药业股份有限公司 4 CYHS2600209 艾拉莫德片安徽贝克生物制药有限公司 4 CYHS2600186 糠酸莫米松乳膏浙江高跖医药科技股份有限公司 4 CYHS2600184 洛索洛芬钠贴剂重庆希尔安药业有限公司 4 CYHS2600183 洛索洛芬钠贴剂重庆希尔安药业有限公司 4 CYHS2600182 美沙拉秦灌肠液杭州和泽坤元药业有限公司 4 CYHS2600181 盐酸曲唑酮缓释片重庆世森医药科技有限公司 4 CYHS2600176 缬沙坦氨氯地平片(I) 苏州俞氏药业有限公司 4 CYHS2600179 达沙替尼片广州科锐特药业有限公司 4 CYHS2600178 达沙替尼片广州科锐特药业有限公司 4 CYHS2600177 盐酸伊托必利片安徽杰玺医药有限公司 4 CYHS2600175 洛索洛芬钠贴剂湖南迪诺制药股份有限公司 4 CYHS2600172 洛索洛芬钠贴剂湖南迪诺制药股份有限公司 4 CYHS2600171 培哚普利氨氯地平片(III) 湖南先施制药有限公司 4 CYHS2600170 替米沙坦片太康海恩药业有限公司 4 CYHS2600169 替米沙坦片太康海恩药业有限公司 4 CYHS2600168 克立硼罗软膏海南海灵化学制药有限公司 4 CYHS2600180 脂肪乳氨基酸(17)葡萄糖(11%)注射液山东齐都药业有限公司 4 CYHS2600185 阿达帕林过氧苯甲酰凝胶北京诚济制药股份有限公司 4 CYHS2600160 酒石酸溴莫尼定滴眼液复星医药(徐州)有限公司 4 CYHS2600159 多替诺雷片山西泽辰医药科技有限公司 4 CYHS2600158 瑞舒伐他汀依折麦布片(Ι) 宁波美诺华天康药业有限公司 4 CYHS2600157 多替诺雷片山西泽辰医药科技有限公司 4 CYHS2600156 莫匹罗星软膏北京诚济制药股份有限公司 4 CYHS2600154 蛋白琥珀酸铁口服溶液健民药业集团股份有限公司 4 CYHS2600149 比拉斯汀片江西施美药业股份有限公司 4 CYHS2600148 甲磺酸多沙唑嗪缓释片上海信谊百路达药业有限公司 4 CYHS2600147 洛索洛芬钠贴剂北京百奥药业有限责任公司 4 CYHS2600167 洛索洛芬钠贴剂北京百奥药业有限责任公司 4 CYHS2600166 盐酸米诺环素胶囊福安药业集团宁波天衡制药有限公司 4 CYHS2600165 盐酸米诺环素胶囊福安药业集团宁波天衡制药有限公司 4 CYHS2600164 阿达帕林过氧苯甲酰凝胶德全药品(江苏)股份有限公司 4 CYHS2600161 阿达帕林凝胶浙江华海药业股份有限公司 4 CYHS2600150 磷酸奥司他韦胶囊河北龙海药业股份有限公司 4 CYHS2600144 盐酸莫西沙星片北大医药股份有限公司 4 CYHS2600143 人干扰素α2b注射液长春生物制品研究所有限责任公司 3.4 CXSS2600008 盐酸羟甲唑啉滴眼液南京正科医药股份有限公司 3 CYHL2600011 6-[18F]氟-L-多巴注射液江苏万高药业股份有限公司 3 CYHL2600010 酒石酸溴莫尼定滴眼液北京汇恩兰德制药股份有限公司 3 CYHL2600008 醋酸乌利司他片杭州天晟泰丰药业有限公司 3 CYHL2600007 酒石酸溴莫尼定滴眼液北京汇恩兰德制药股份有限公司 3 CYHL2600009 冻干人用狂犬病疫苗(人二倍体细胞) 北京吉诺卫生物科技有限公司 3.3 CXSL2600080 9MW4113注射液迈威(上海)生物科技股份有限公司 3.3 CXSL2600086 IBI3027 信达生物制药(苏州)有限公司 3.3 CXSL2600083 IBI3027 信达生物制药(苏州)有限公司 3.3 CXSL2600082 度普利尤单抗注射液华润生物医药有限公司 3.3 CXSL2600070 进口申请药品名称企业注册分类受理号奥博雷通片 Takeda Pharmaceuticals U.S.A., Inc. 1 JXHS2600017 奥博雷通片 Takeda Pharmaceuticals U.S.A., Inc. 1 JXHS2600016 奥博雷通片 Takeda Pharmaceuticals U.S.A., Inc. 1 JXHS2600015 依柯胰岛素司美格鲁肽注射液 Novo Nordisk A/S 2.2 JXSS2600004 依柯胰岛素司美格鲁肽注射液 Novo Nordisk A/S 2.2 JXSS2600003 依柯胰岛素司美格鲁肽注射液 Novo Nordisk A/S 2.2 JXSS2600002 Enpatoran Merck Healthcare KGaA 1 JXHL2600015 RO7771950肠溶片 F. Hoffmann-La Roche Ltd. 1 JXHL2600014 RO7771950片 F. Hoffmann-La Roche Ltd. 1 JXHL2600013 verducatib 片 Boehringer Ingelheim International GmbH 1 JXHL2600012 BI764198 片 Boehringer Ingelheim International GmbH 1 JXHL2600016 司来帕格片 Actelion Pharmaceuticals Ltd. 2.4 JXHL2600011 司来帕格片 Actelion Pharmaceuticals Ltd. 2.4 JXHL2600010 司来帕格片 Actelion Pharmaceuticals Ltd. 2.4 JXHL2600009 FXB0871 Fosun Industrial Co., Limited 1 JXSL2600005 Budoprutug注射液 Climb Bio, Inc. 1 JXSL2600004 可伐利单抗注射液 F.Hoffmann-La Roche Ltd. 2.2 JXSL2600003 重酒石酸氢可酮缓释片 Humanwell Pharmaceutical US, Inc. 5.2 JYHL2600002 重酒石酸氢可酮缓释片 Humanwell Pharmaceutical US, Inc. 5.2 JYHL2600001 中药相关申请药品名称企业注册分类受理号轻身调脂消渴片江苏九旭药业有限公司 1.1 CXZL2600006 双苓止泻颗粒太极集团重庆涪陵制药厂有限公司 2.2 CXZL2600005 温胆汤颗粒北京同仁堂股份有限公司同仁堂制药厂 3.1 CXZS2600003 注：绿色字体部分为潜在首仿品种；微信关键词回复 ” 每月药讯：回复年+月，如202512” 获得最新药迅！不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

疫苗申请上市临床申请核酸药物

2026-01-09

·FiercePharma

Insmed's 'blowout' Brinsupri sales beat fuels multi-blockbuster outlook

The “blowout sales performance” has increased the confidence of William Blair analysts in Brinsupri’s “multi-blockbuster sales potential longer term,” according to a Jan. 9 note. Early launch numbers of Brinsupri are so strong that Insmed couldn’t wait for the J.P. Morgan Healthcare Conference to share them. The first-in-class inflammatory drug shattered Wall Street estimates in its first full quarter on the market, fueling fresh confidence in its blockbuster potential.Friday, Insmed announced preliminary Brinsupri total revenues of about $144.6 million in the fourth quarter of 2025. That sum beat Wall Street’s consensus projections by more than 150% in what Mizuho analysts called “a ginormous result.”Insmed’s share price jumped about 10% in premarket trading Jan. 9, although the stock has not fully recovered from the damage dealt by Brinsupri’s phase 2 trial flop in chronic rhinosinusitis without nasal polyps (CRwNP) in December.Approved by the FDA in August—and by the European Commission in November—to treat the chronic lung disease bronchiectasis, Brinsupri is the first DPP-1 inhibitor to reach the market and the first drug specifically cleared for the condition. The drug’s fourth quarter sales marked a significant acceleration from the $28.1 million it collected in the third quarter following its U.S. launch.Insmed plans to debut the drug in the European Union in the first half of 2026, with additional approvals anticipated in the U.K. and Japan this year.The “blowout sales performance,” meanwhile, has increased the confidence of William Blair analysts in Brinsupri’s “multi-blockbuster sales potential longer term,” according to a Jan. 9 note. The team expects the drug to reach blockbuster status in 2027 and has put its 2029 sales at nearly $3.3 billion. The Brinsupri sales beat was aided by a roughly 9% benefit from inventory build, according to an Insmed presentation. But this level was in line with the company’s expectations and was meaningfully lower than the 40% reported for the third quarter, the William Blair team noted.“[T]his is undoubtedly a clean beat,” Evercore ISI analysts wrote in a separate note Friday. The drug’s haul topped even the highest estimates of around $120 million to $125 million previously floated by investors, which accounted for inventory benefits, the analysts pointed out.Brinsupri added about 9,000 new patients in the fourth quarter, bringing its cumulative total to 11,550 as of the end of last year, according to Insmed. The number of prescribers also reached about 4,000, up from 1,700 in September. Despite the upbeat performance, Insmed, in a Jan. 9 presentation, tried to rein in expectations for 2026 with a few reasons for caution. These include routine patient out-of-pocket cost resets at the beginning of a year, as well as potential higher rebates and access criteria as payer contracts are finalized. While the CRwNP failure last year dented Insmed’s share price, analysts mostly remained bullish on Brinsupri’s potential. Even after the setback, TD Cowen analysts maintained modeled peak sales of $4.3 billion for the drug, according to a Dec. 17 note.Insmed expects a topline readout from another phase 2b study, called Cedar, of Brinsupri in hidradenitis suppurativa in the second quarter of 2026. DPP-1 has drawn increased interest from biopharma companies as a novel target for inflammatory diseases. Right before Brinsupri’s anticipated FDA go-ahead, inflammatory disease-focused startup Expedition Therapeutics licensed a DPP-1 candidate from Fosun Pharma in a potential $645 million deal. Back in 2023, Chiesi obtained a license to a DPP-1 inhibitor from China’s Haisco Pharmaceutical.Boehringer Ingelheim, too, has a potential rival DPP-1/CatC inhibitor, verducatib (BI 1291583), which was pushed into phase 3 testing in bronchiectasis last year.For its part, Insmed is also developing a next-generation DPP-1 drug, INS1033, and is moving toward the clinic in two large immunology indications—rheumatoid arthritis and inflammatory bowel disease—as the company expects to file an investigational new drug application with the FDA in 2026.

上市批准临床3期临床2期临床结果

100 项与 Verducatib 相关的药物交易

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研发状态

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
支气管扩张	临床3期	美国	Boehringer Ingelheim GmbH	2025-06-09
支气管扩张	临床3期	中国	Boehringer Ingelheim GmbH	2025-06-09
支气管扩张	临床3期	日本	Boehringer Ingelheim GmbH	2025-06-09
支气管扩张	临床3期	阿根廷	Boehringer Ingelheim GmbH	2025-06-09
支气管扩张	临床3期	澳大利亚	Boehringer Ingelheim GmbH	2025-06-09
支气管扩张	临床3期	奥地利	Boehringer Ingelheim GmbH	2025-06-09
支气管扩张	临床3期	比利时	Boehringer Ingelheim GmbH	2025-06-09
支气管扩张	临床3期	巴西	Boehringer Ingelheim GmbH	2025-06-09
支气管扩张	临床3期	保加利亚	Boehringer Ingelheim GmbH	2025-06-09
支气管扩张	临床3期	加拿大	Boehringer Ingelheim GmbH	2025-06-09

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临床结果

适应症

分期

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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


NCT05833035 (CTgov)	临床1期	-	8	BI 1291583 mixed with [C-14] BI 1291583	鹹遞築餘構觸齋鹹醖醖(製願壓齋築壓選鑰齋蓋) = 鑰醖鹹餘鏇鬱願醖憲壓築膚蓋淵獵積蓋遞簾蓋 (範艱壓範鬱網蓋壓簾夢, 12.9) 更多	-	2026-01-21
NCT05865886 (CTgov)	临床2期	非囊性支气管扩张 \| 囊性纤维化	22	Placebo to BI 1291583 (Placebo)	獵襯製衊艱衊鹽觸選獵 = 窪鹽窪窪夢糧艱遞鬱範構鹹餘築範膚膚淵夢壓 (窪築簾選淵憲範窪構鹽, 糧獵鹽醖簾鏇餘壓繭糧 ~ 醖襯鏇製製觸獵淵蓋網) 更多	-	2025-11-18
				BI 1291583 (5 mg BI 1291583)	糧選願憲構艱夢齋鑰襯(築願壓壓築觸鏇鹹廠鬱) = 選繭鏇鹹襯廠衊淵蓋範憲艱鹹廠鹽糧蓋壓鏇簾 (憲醖憲齋鏇醖壓顧襯壓, 49.37) 更多
NCT05238675 (AIRLEAF, Pubmed \| Eur Respir J)	临床2期	支气管扩张 neutrophil serine protease (NSP) activity	322	BI 1291583 2.5mg	-	积极	2025-01-01
				BI 1291583 5mg