Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Triple-blinded, Placebo-controlled, Exploratory, Phase 2, Pilot Trial

The development of coronary atherosclerosis is closely related to inflammation, and CD147 may play an important role in its process. The present study was designed to evaluate the effects of long-term administration of mepolizumab (humanized anti-CD147 antibody) on lipid deposition and inflammation in coronary atherosclerotic plaques in patients with high-risk coronary artery disease, and to preliminarily explore the efficacy, safety, and dosage of long-term administration of mepolizumab in this population.

开始日期2024-10-16

申办/合作机构

西京医院第四军医大学

NCT06501807

/ Not yet recruitingN/AIIT

Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps

With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.
During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).

开始日期2024-09-02

申办/合作机构-

100 项与美泊利珠单抗相关的临床结果

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100 项与美泊利珠单抗相关的转化医学

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100 项与美泊利珠单抗相关的专利（医药）

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1,631

项与美泊利珠单抗相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Rapid improvement of kimura disease with dupilumab in a patient with suboptimal response to mepolizumab: a case report

Article

作者: Tao, Meiying ; Liu, Haotian ; Cao, Naiqing ; Gao, Tingting ; Zhi, Lili

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of mepolizumab vs anti-interleukin-5/5r biologic therapies for the treatment of adults with severe asthma with an eosinophilic phenotype: a Chilean healthcare system perspective

Article

作者: Romero, Jose ; Giovini, Vanina ; Espinoza, Manuel Antonio ; Balmaceda, Carlos ; Moraes dos Santos, Felipe ; Rodríguez Martínez, Consuelo

AIM:

Asthma is a heterogeneous respiratory condition often classified into distinct phenotypes. Severe asthma, characterized by uncontrolled symptoms despite optimal treatment, imposes a significant burden on healthcare systems, particularly in low- and middle-income countries. This study evaluates the cost-effectiveness of mepolizumab compared with other interleukin (IL)-5 pathway inhibitors, benralizumab and reslizumab, in treating severe asthma with an eosinophilic phenotype in Chile.

MATERIALS AND METHODS:

A Markov cohort model was developed to compare mepolizumab (100 mg subcutaneously every four weeks) with benralizumab (30 mg subcutaneously every four weeks for the first three doses, every eight weeks subsequently) and reslizumab (3 mg/kg intravenously every four weeks), both as add-on therapies to standard care. Data from the Mepolizumab as Adjunctive Therapy in Patients with Severe Asthma (MENSA) clinical trial and a network meta-analysis were used. Utility values were extracted using the EuroQoL 5-Dimension questionnaire (EQ-5D-5L) questionnaire. Probabilistic and one-way sensitivity analyses assessed model robustness.

RESULTS:

Mepolizumab demonstrated dominance with probability over 95% when compared with benralizumab and reslizumab. Cost savings ranged from 37,000 United States dollars (USD) to 104,000 USD, with an increase of 0.52 to 0.55 quality-adjusted life years. Mepolizumab was also associated with a lower incidence of exacerbations and asthma-related deaths. Sensitivity analyses confirmed the stability of the model outcomes across key parameters.

LIMITATIONS:

Limitations of the economic model are related to the lack of direct comparisons between mepolizumab and other biologics. Additionally, the absence of data on continuation criteria required estimating relative risks for the overall population.

CONCLUSIONS:

Mepolizumab offers greater efficacy and cost savings compared to benralizumab and reslizumab for eosinophilic asthma, providing essential insights for improving asthma management and informing healthcare policies in Chile.

2025-12-01·Current Cardiology Reports

Eosinophilic Myocarditis: A Concise Review

Review

作者: Kahwash, Rami ; Trovato, Vincenzo ; Asada, Ashlee M

Abstract:

Purpose of Review:

Eosinophilic myocarditis (EM) is a rare and heterogeneous form of inflammatory heart disease that can present with a wide range of severity. Current literature is limited to case reports or small case series that outline the evaluation process, disease course, and the nonstandardized treatments trialed. This review aims to concisely summarize the current literature on EM including an update on maintenance therapy for refractory or recurrent disease.

Recent Findings:

In the last several years, several observational studies have reported the clinical benefit of mepolizumab and benralizumab in refractory EM.

Summary:

EM is a complex and heterogenous cause of inflammatory heart disease with a wide range of etiologies and presentations. Treatment of this disease has not been standardized as there are no large scale trials quantifying benefit of any specific therapy regimen. Targeted biologics show promise in observational studies; therefore, prospective studies are needed to quantify this benefit in EM.

311

项与美泊利珠单抗相关的新闻（医药）

2025-08-20

·Keymed Biosciences

JAMA社论力荐！司普奇拜单抗III期研究改写慢性鼻窦炎治疗格局

2025年8月18日，司普奇拜单抗治疗严重未控制的慢性鼻窦炎伴鼻息肉（CRSwNP）Ⅲ期临床研究（CROWNS-2）结果于国际顶级期刊《美国医学会杂志》（JAMA，影响因子55.0）发表，同日，JAMA配发专题社论Phenotype to Endotype—The Future of Chronic Rhinosinusitis，由波士顿大学Michael P. Platt教授、哈佛医学院Stacey T. Gray教授等国际专家联合撰写。该社论深度解析司普奇拜单抗治疗慢性鼻窦炎伴鼻息肉的突破性研究成果，力证其改写慢性鼻窦炎伴鼻息肉治疗格局，为全球难治性患者带来新希望。原文链接：https://jamanetwork.com/journals/jama/article-abstract/2837785 核心亮点一鼻息肉缩小应答率显著领先同类产品 CROWNS-2为中国多中心、随机、双盲、安慰剂对照Ⅲ期临床试验，纳入180例经规范治疗仍未控制的慢性鼻窦炎伴鼻息肉患者，实际179例完成给药。患者按随机分配进入司普奇拜单抗组（300mg每2周+鼻用糠酸莫米松）或安慰剂组（+鼻用糠酸莫米松），治疗24周后全队列进入开放标签阶段（司普奇拜单抗持续治疗28周，总疗程52周）。社论重点强调其疗效突破：治疗24周时，主要终点鼻息肉评分（NPS）最小二乘均值变化组间差异达-2.3，司普奇拜单抗组鼻息肉缩小幅度显著优于安慰剂组（+鼻用糠酸莫米松）；治疗52周时，96.5%患者鼻息肉显著缩小（NPS 下降≥1分），89.5%患者鼻息肉体积缩小至少50%（NPS下降≥2分），较同类生物制剂（度普利尤单抗、美泊利珠单抗及奥马珠单抗）关键III期研究结果（NPS较基线改善≥1分应答率仅31%～65%）[1-3] ，长程疗效显著领先，刷新慢性鼻窦炎伴鼻息肉生物治疗应答纪录。核心亮点二全球首创“组织学嗜酸标准” 推动从“表型”到“内型”的治疗革命传统“表型分类”（如是否伴鼻息肉）无法区分病理机制：同一“伴鼻息肉”表型可能源自变应性真菌性鼻窦炎、阿司匹林加重性呼吸道疾病等异质病因，治疗策略差异悬殊；“不伴鼻息肉”也可能隐藏早期慢性鼻窦炎伴鼻息肉或感染、免疫异常等复杂机制。社论明确指出，这种分类“在表征潜在疾病病理生理学方面敏感性和特异性均有限”，难以指导精准治疗。本研究的突破性贡献在于：全球首个在III期临床试验中采用“外周血嗜酸性粒细胞 + 鼻息肉组织嗜酸性粒细胞双维度标准”（鼻息肉组织嗜酸粒细胞计数≥55个/高倍镜视野或占比≥27%），精准锚定T2型CRSwNP（以鼻息肉组织嗜酸性粒细胞浸润、IL-4/IL-13主导为核心特征）。这一标准既契合社论强调的“T2型炎症分子本质”，又通过可及性检测打破传统分类的模糊性——社论特别提到，生物疗法时代亟需“易于获取且可行的内型分类方法”，而该双维度标准恰好搭建了“病理机制-治疗靶点”的精准桥梁，为司普奇拜单抗的靶向应用提供了科学依据。核心亮点三双维度标准破局地域异质性解锁中国T2型患者的精准治疗社论明确慢性鼻窦炎伴鼻息肉内型存在地域分野：欧美以T2型炎症为主，亚洲（含中国）T1/T3型占比更高，传统分类下中国T2型患者常被漏诊。本研究的关键突破在于“精准筛选”，纳入研究的患者有78%符合T2型特征。接受司普奇拜单抗治疗后：胸腺活化调节趋化因子（TARC）、IgE、嗜酸粒细胞趋化因子及组织嗜酸计数同步下降，证实T2炎症通路被高效阻断；本研究纳入的中国受试者多为T2型且对靶向治疗响应良好，息肉与症状持续改善。同时研究也发现司普奇拜单抗可能对非T2型通路有作用。核心亮点四司普奇拜单抗耐受性与安全性优异突破同类药物局限在同类IL-4Rα单抗（如度普利尤单抗）的已知不良反应中，关节痛与结膜炎属常见类型，且嗜酸性粒细胞增多亦属其特征性不良反应。但本研究未观察到嗜酸性粒细胞增多的不良反应，仅出现1例结膜炎（研究判定与药物无关）。综合研究数据，可初步呈现出与同类产品的安全性数据差异。 JAMA以专题社论，再次解析和证实司普奇拜单抗治疗慢性鼻窦炎伴鼻息肉的卓越疗效，为其临床价值提供权威背书，以国际前沿的突破性成果，引领慢性鼻窦炎伴鼻息肉治疗进入精准化新时代。参考文献： 1. Bachert C, Han JK, Desrosiers M, et al. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind,placebo-controlled, parallel-group phase 3 trials.Lancet. 2019;394(10209):1638-1650. doi:10.1016/S0140-6736(19)31881-1 2. Han JK, Bachert C, Fokkens W, et al; SYNAPSE Study Investigators. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled,phase 3 trial. Lancet Respir Med. 2021;9(10): 1141-1153.doi:10.1016/S2213-2600(21)00097-7 3.Gevaert P, Omachi TA, Corren J, et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol.2020;146(3):595-605. doi: 10.1016/j.jaci.2020.05.032

临床3期临床结果

2025-08-18

·E药经理人

罗氏、辉瑞急刹车，AZ、GSK逆势加码，全球营收TOP20 H1钱都砸哪儿了？

2025年年中，MNC从“豪赌时代”骤然换挡到保守投入：有人紧急止损、并购改走“小单多点”，也有人在减法周期里坚持做加法。GSK把增量压向ADC，再生元把研投/营收拉到近四成，阿斯利康在多赛道临门冲刺。下一轮版图，已进入洗牌局。撰文| Erin 还会MNC 押注新一轮“大BD/并购”吗？如果只看2025年上半年的BD热潮，答案似乎是肯定的；但进入中报季后，来自全球巨头们的信号又多了几分不确定。整体来看，2025年H1财报，全球药企研发投入占营收比普遍“收缩”，TOP20中逾半数下调研投占比，BMS大幅削减，罗氏连续三年下行，吉利德密集裁撤管线止损。行业的隐形共识正在从押注增长切换向守住效率，并购似乎也由动辄百亿的大单，转向更可控的多笔小单。但收缩并非停摆。GSK、再生元与阿斯利康仍在减法周期中做加法：GSK成为研发增量第一，再生元研投占营收比领跑，AZ以约24%高位投入依旧交出双位数增长。三者共同特点是把有限增量集中到明确里程碑上，追求更高的研发效率，增厚护城河。可以预见的是，当营收增速放缓，研投占比走向分水岭，2025年下半年也将走到MNC格局洗牌的临界点。（数据来源：Wind）回撤潮时间来到2025年年中，跨国药企的研发策略发生了近乎180°的转向。两年前，无论是凭借抗病毒药/疫苗“躺赢”的阵营，还是寄望以大手笔研发投入扭转基本面的阵营，虽也会“砍管线”，但总体是边砍边加、持续抬高研发强度。到了今年中报，保守、收缩成了更高频的关键词：研发/营收占比超过30%的MNC从两三家锐减到几乎仅剩再生元坚守；TOP20里有8家下调研发投入，BMS削减幅度最大，约7.6亿美元。最具代表性的是辉瑞。2025年H1营收283.67亿美元、研发投入46.85亿美元，占比17.77%。更具象的“回撤”出现在赛道选择上：在2023年与2025年相继叫停两款，口服GLP-1接连受挫后，辉瑞在发布H1财报同期，宣布终止了最后一款GLP-1管线PF-06954522。代谢领域的另一核心项目——GIPR拮抗剂PF-07976016也因联用伙伴Danuglipron被叫停而前景受挫。多轮打击后，管理层在Q2电话会上释放出更保守的信号：代谢、肿瘤、疫苗仍是重点，但将以多笔小型交易构建管线，肥胖领域并购“会非常谨慎，不会付出过高溢价，只为资产应得的价值”。同样典型回撤的还有罗氏，伴随其在7月底发布H1财报，两项大消息几乎“带崩”全球研发界。一则是，其TIGIT管线RG6058（tiragolumab）仅存的两项III期试验正式终止——在被视为“下一个PD-1”的靶点上，这意味着，最能抗、坚守最久的玩家也撤退了。另一则是，罗氏旗下基因泰克与Bicycle Therapeutics基于双环肽平台的17亿美元级合作亦告终止。Bicycle随后宣布裁员约25%，配合总费用下调30%，以将现金流续至2028年。此外，由于罗氏大手笔的“砍项目”，其今年上半年研发费用率为19.63%，这也是罗氏的H1研发费用率连续三年下滑。在适应证层面宣告“阶段性终结”的还有吉利德。2019年，吉利德布局NASH的核心管线 selonsertib的研发遭遇滑铁卢，由于关键临床试验未达预期，让本在全球NASH药物开发上领先的吉利德，倒退了一大截，也让吉利德与全球NASH领导者的目标失之交臂。不过，之后与诺和诺德司美格鲁肽的合作，让吉利德再次燃起希望。其两款药物cilofexor、firsocostat与司美格鲁肽初步合作的积极数据，让两家公司不断加深合作。然而，当时间来到2025年，这个梦想再次破碎，伴随吉利德发布H1财报，上述两款药物被列入了终止名单，这不仅意味着吉利德与诺和诺德的分手，也预示着吉利德想要在MASH领域分一杯羹，也宣告中场暂停。不过，吉利德并未因MASH适应证研发折戟，就削减研发投入，2025年H1，仍然高达28.7亿美元，占137.49亿美元营收比例高达20.87%，在营收TOP20的MNC中仍然是佼佼者。总而言之，从狂增研发转向保守投入，从重仓大项目到多笔小型投入的组合拳，或许会在2025年年中成为MNC管线布局未来的新常态。推荐阅读 * 罗氏血亏，百济叫停，MNC全员撤退！明星赛道沦为“天坑”，发生了啥？ * 礼来狂飙，诺华爆发，百济首进，全球畅销药TOP50变天！谁在“减法周期”做加法即使“收缩”成了跨国药企研发投入的高频词，但也可以看到，仍有少数玩家逆势加码，把有限的资源精确投向有明确里程碑的管线上。GSK、再生元与AZ正是这波加码的主角。即使在2025年H1，GSK的营收依然未能回归TOP10阵营，但在抗肿瘤领域的持续增长，还是给这家公司带来了进一步深耕的信心。营收层面来看，GSK上半年总收入约为155.02亿英镑，同比增长达5%。增长的两极非常明确：呼吸、免疫与炎症（RI&I）收入17.67亿英镑，同比+18%；肿瘤收入8.99亿英镑，同比+47%。也正因如此，可以明显看到，GSK也将研发火力集中于这两大业务上，全管线60余项在研临床资产、16项处后期，年内已拿下3项FDA批准，还将再点火4个关键研究。 RI&I端，一边是Nucala获得COPD适应证，另一边是超长效IL-5抗体depemokimab治疗哮喘/鼻息肉即将在12月16日迎来PDUFA；肿瘤端，则以ADC为核心，B7-H3 ADC就是年内关键研究之一，B7-H4 ADC预计明年初启动。GSK的逻辑很清晰：用稳定的RI&I构筑“底盘”，用肿瘤ADC带来“弹性”，研发节奏围绕“后期兑现+平台复用”展开，从而解释了为何它在TOP20中呈现出最明显的研发增量。 GSK是研发投入增长最多的公司，再生元则是研投/总营收比增长最快的公司。再生元2025年H1总收入67.04亿美元，研发投入总额27.71亿美元，研投率攀至41.34%；其中，Q2单季研发费用同比增加19%，直接对应中后期项目的密集节点。不过，也能看出，再生元在急于寻找阿柏西普的继任者。一方面，公司加速“肿瘤双引擎”：巩固Lynozyfic（linvoseltamab）在复发难治多发性骨髓瘤上的地位，推动Libtayo术后CSCC的潜在获批；另一方面，在炎症与呼吸领域持续扩展Dupixent适应证，同时评估Itepekimab在COPD赛道的差异化位点。第三条主线落在代谢赛道：在引进双GLP-1/GIP之后，叠加自家“肌肉维持”抗体开展组合研究，把“减重质量”（在降低脂肪的同时保住瘦体重）作为下一代竞争点。另一大看点其实是阿斯利康，作为TOP10中还能保持10%左右增长少数几家公司之一，AZ其实面临的专利悬崖风险也相对较远，但其仍然选择保持高研发投入来押注新管线。其H1财报显示，AZ上半年总营收约280.45亿美元，研发投入67.07亿美元，同比增加16%，研投占比约24%。拉动这波投入的，是肿瘤、呼吸免疫与CVRM三条战线几乎同步的“临门冲刺”：肿瘤方面，Tagrisso 、Imfinzi、Datroway与Enhertu的新适应证与里程碑密集推进；呼吸免疫方面，Breztri两项哮喘适应证进展喜人，Fasenra与Saphnelo取得积极信号；CVRM方面，baxdrostat在临床研究达到主要终点。更关键的是，AZ把增量押在最接近商业兑现的中后期资产，同时前置布局自体细胞疗法、口服代谢组合与核药等新疗法上，力争新增长点。把三家“逆行者”放在同一维度里，能看到共性与差异化：共性在于都把研发增量具有明确里程碑的管线上，并以BD补齐短板；分歧在于路径选择，GSK押注两极驱动，用RI&I稳住基本盘、靠ADC提升弹性；再生元保持高研投加速多赛道新引擎，试图对冲单品更替；AZ则以密集里程碑+平台押注的打通中短期与中长期增长。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册一审| 黄佳二审| 李芳晨三审| 李静芝

财报并购疫苗临床3期抗体药物偶联物

2025-08-13

·EINPresswire

Family Allergy & Asthma Research Institute Contributes to Groundbreaking Global Study on Severe Asthma Treatment

FAA Research Institute contributes to global study proving mepolizumab's effectiveness in reducing severe asthma exacerbations Our team’s commitment to advancing asthma care through research is unwavering, showcasing how collaboration and innovation improve patient outcomes.” — Dr. Stephen Pollard LOUISVILLE, KY, UNITED STATES, August 13, 2025 / EINPresswire.com / -- Family Allergy & Asthma (FAA) is proud to announce that Dr. Stephen Pollard, Principal Investigator at the FAA Research Institute, has been published as a co-author in the prestigious Annals of Allergy, Asthma & Immunology. The study, titled “ Mepolizumab Real-World Effectiveness in Severe Asthma with an Eosinophilic Phenotype and Overlapping Severe Allergic Asthma,” represents a significant advancement in the understanding and treatment of severe asthma. This large-scale, real-world study highlights the effectiveness of mepolizumab, a biologic therapy targeting eosinophilic inflammation, in reducing asthma exacerbations in patients with overlapping allergic and eosinophilic phenotypes. The findings provide critical insights for clinicians managing complex asthma cases, where multiple biologic treatment options may be considered. A Team Effort in Research Excellence The success of this study is a testament to the dedication and expertise of the FAA Research Institute team. Research coordinators Becky Whitehead and Amber Noe played a pivotal role in patient recruitment, retention, and data management, ensuring the study’s success. While not listed as authors, their behind-the-scenes contributions were instrumental and reflect the high standards of FAA’s clinical research staff. “Our team’s commitment to advancing asthma care through research is unwavering,” said Dr. Stephen Pollard. “This study is a prime example of how collaboration and innovation can lead to meaningful improvements in patient outcomes.” Join the FAA Research Institute’s Mission Since 1991, the FAA Research Institute has been at the forefront of clinical research, contributing to the development of groundbreaking treatments like Zyrtec, Allegra, Claritin, Flonase, and Nasonex. Located at the Goss Avenue location in Louisville, KY, the institute boasts state-of-the-art technology and a computerized database of over 15,000 patients. The institute collaborates with leading national pharmaceutical and clinical research organizations, ensuring that all studies are closely monitored by the FDA and Institutional Review Boards to prioritize participant safety and rights. Why Participate in Clinical Research? Participants in FAA’s clinical trials benefit from: Personalized care with close monitoring of health conditions. Access to study-related office visits, physician exams, and medications. Reimbursement for time and travel. The opportunity to contribute to advancements in treatments for asthma, allergies, and other conditions. “Our research is fueled by a shared goal to enhance lives through evidence-based findings and innovations,” said Becky Whitehead, Director of Clinical Research. “By joining our studies, participants not only gain access to cutting-edge treatments but also play a vital role in shaping the future of care.” Current Research Opportunities The FAA Research Institute is currently recruiting participants for studies on asthma, food allergies, COPD, dermatitis, and more. To learn more about ongoing trials or to participate, contact the FAA Research Institute at 502.368.0732 or visit familyallergy.com. Advancing Asthma Care Through Cutting-Edge Research Family Allergy & Asthma’s participation in this peer-reviewed publication underscores its dedication to leading-edge research and evidence-based treatment. By contributing to the evolving landscape of biologic therapies for severe asthma, FAA continues to support clinicians and patients in making informed treatment decisions. About Family Allergy & Asthma Research Institute Family Allergy & Asthma is a leading provider of allergy and asthma care, offering comprehensive services to patients across Louisville, KY. With a strong focus on clinical research, FAA is committed to improving the lives of individuals with asthma and allergies through innovative treatments and personalized care. For more information about this study or Family Allergy & Asthma’s research initiatives, please contact Research Department Director Becky White at bwhite@familyallergy.com Becky Whitehead Family Allergy & Asthma +1 502-368-0732 bwhite@familyallergy.com Visit us on social media: LinkedIn Instagram Facebook YouTube X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床研究

100 项与美泊利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04923	美泊利珠单抗	R03DX09	DB06612

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
慢性阻塞性肺疾病	美国	GSK Plc	2025-05-22
哮喘	日本	GlaxoSmithKline KK	2020-03-25
慢性鼻窦炎伴鼻息肉	欧盟	GlaxoSmithKline Trading Services Ltd.	2015-12-01
慢性鼻窦炎伴鼻息肉	冰岛	GlaxoSmithKline Trading Services Ltd.	2015-12-01
慢性鼻窦炎伴鼻息肉	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2015-12-01
慢性鼻窦炎伴鼻息肉	挪威	GlaxoSmithKline Trading Services Ltd.	2015-12-01
Churg-Strauss综合征	欧盟	GlaxoSmithKline Trading Services Ltd.	2015-12-01
Churg-Strauss综合征	冰岛	GlaxoSmithKline Trading Services Ltd.	2015-12-01
Churg-Strauss综合征	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2015-12-01
Churg-Strauss综合征	挪威	GlaxoSmithKline Trading Services Ltd.	2015-12-01
嗜酸性粒细胞性哮喘	欧盟	GlaxoSmithKline Trading Services Ltd.	2015-12-01
嗜酸性粒细胞性哮喘	冰岛	GlaxoSmithKline Trading Services Ltd.	2015-12-01
嗜酸性粒细胞性哮喘	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2015-12-01
嗜酸性粒细胞性哮喘	挪威	GlaxoSmithKline Trading Services Ltd.	2015-12-01
高嗜酸性粒细胞综合征	欧盟	GlaxoSmithKline Trading Services Ltd.	2015-12-01
高嗜酸性粒细胞综合征	冰岛	GlaxoSmithKline Trading Services Ltd.	2015-12-01
高嗜酸性粒细胞综合征	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2015-12-01
高嗜酸性粒细胞综合征	挪威	GlaxoSmithKline Trading Services Ltd.	2015-12-01
重度哮喘	美国	GlaxoSmithKline LLC	2015-11-04

未上市

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
肺嗜酸性粒细胞增多	申请上市	中国	葛兰素史克（中国）投资有限公司	2023-03-14
哮喘，鼻息肉和阿司匹林不耐受	临床3期	中国	GSK Plc	2021-04-22
哮喘，鼻息肉和阿司匹林不耐受	临床3期	日本	GSK Plc	2021-04-22
哮喘，鼻息肉和阿司匹林不耐受	临床3期	俄罗斯	GSK Plc	2021-04-22
嗜酸粒细胞增多症	临床3期	英国	GSK Plc	2020-09-07
鼻息肉	临床3期	美国	GSK Plc	2017-05-25
鼻息肉	临床3期	阿根廷	GSK Plc	2017-05-25
鼻息肉	临床3期	澳大利亚	GSK Plc	2017-05-25
鼻息肉	临床3期	加拿大	GSK Plc	2017-05-25
鼻息肉	临床3期	德国	GSK Plc	2017-05-25

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临床结果

适应症

分期

评价

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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


NCT04133909 (MATINEE, CTgov)	临床3期	慢性阻塞性肺疾病	806	Mepolizumab (Mepolizumab 100 mg)	鏇醖齋糧鹹憲觸蓋願齋(襯願範鏇壓齋憲範鬱廠) = 鏇膚鹹壓築窪繭鏇觸遞製願鹽鏇餘衊鏇鹽鏇觸 (齋醖糧夢構願鹽簾廠製, 憲遞壓築積壓選窪壓憲 ~ 顧襯遞夢襯築築鹽顧憲) 更多	-	2025-08-15
				Placebo (Placebo)	鏇醖齋糧鹹憲觸蓋願齋(襯願範鏇壓齋憲範鬱廠) = 夢積餘積膚蓋淵繭簾衊製願鹽鏇餘衊鏇鹽鏇觸 (齋醖糧夢構願鹽簾廠製, 鏇淵淵網餘繭遞鬱構膚 ~ 鑰衊艱鹹壓範夢繭廠製) 更多
NEST (ATS2025)	N/A	重度哮喘 eosinophilic phenotype	174	Mepolizumab	網壓鹽繭鬱獵製窪鬱襯(窪鏇鬱夢願選憲構鏇製): incident rate ratio = 0.26 (95% CI, 0.18 ~ 0.36)	积极	2025-05-16
				Previous Biologic Treatments
JPRN-UMIN000045021 (J-Real-Mepo Study, ATS2025)	N/A	Galectin-10 (Gal10) \| TARC \| peripheral blood eosinophil counts	78	Mepolizumab	觸廠鑰壓製構衊製憲遞(鑰廠繭憲糧顧願築選範) = 鹹範範齋衊選齋範選襯衊鹹範衊顧襯憲糧鑰構 (壓觸廠鬱窪網觸廠衊廠 ) 更多	积极	2025-05-16
ATS2025	N/A	重度哮喘	308	Mepolizumab	製鬱壓構艱衊醖齋蓋鹹(鑰廠構築餘範餘蓋繭憲) = 觸憲餘繭積糧窪鏇鏇鹹鑰壓鹽範範積蓋餘選願 (膚鏇淵觸構鹽簾餘顧鹹 ) 更多	积极	2025-05-16
NEST (ATS2025)	N/A	重度哮喘 eosinophilic phenotype	306	Mepolizumab 100 mg	製製繭製鬱積鹽鑰襯壓(鹽廠鑰醖鏇餘獵繭構構) = 蓋襯夢壓襯觸簾糧膚鬱窪願壓醖範積淵積鹽網 (淵蓋選遞鑰範鏇鬱鬱醖 ) 更多	积极	2025-05-16
				Maintenance OCS (mOCS)	製製繭製鬱積鹽鑰襯壓(鹽廠鑰醖鏇餘獵繭構構) = 齋觸簾鹹糧構鹽蓋壓選窪願壓醖範積淵積鹽網 (淵蓋選遞鑰範鏇鬱鬱醖 ) 更多
NCT04765722 (MUCOSA, ATS2025)	临床4期	难治性慢性咳嗽 sputum eosinophilia	30	Mepolizumab 100 mg	齋鑰遞淵鹽鹹艱鏇鹽壓(築選選鏇膚壓醖窪鹹簾): % = 18.6 (95% CI, -23 ~ 82), P-Value = 0.44	不佳	2025-05-16
				Placebo
NCT03562195 (Pubmed \| Allergy Asthma Immunol Res)	临床3期	重度哮喘	300	Mepolizumab	蓋網簾築齋餘糧壓繭獵(製襯繭憲鏇構壓顧鏇獵) = 餘選獵構鬱製鹽淵襯鹹鹽襯獵鬱襯艱製願糧鏇 (繭簾醖顧廠夢憲艱憲襯 ) 更多	积极	2025-01-01
				Placebo	蓋網簾築齋餘糧壓繭獵(製襯繭憲鏇構壓顧鏇獵) = 餘獵鏇淵獵繭觸築顧積鹽襯獵鬱襯艱製願糧鏇 (繭簾醖顧廠夢憲艱憲襯 ) 更多
NCT04276233 (PRISM, CTgov)	临床4期	哮喘 \| 嗜酸性粒细胞性哮喘	100	Mepolizumab	鹽窪糧壓淵獵築襯製齋 = 顧積憲壓繭齋選鬱窪膚廠網鹹糧衊鹽鏇夢願積 (憲壓製窪網艱選鏇獵衊, 夢襯壓廠築鑰積窪膚願 ~ 鏇願壓鹽鹹鬱觸觸夢積) 更多	-	2024-12-10
NCT04607005 (MERIT, CTgov)	临床3期	哮喘，鼻息肉和阿司匹林不耐受 \| 鼻息肉 \| 慢性鼻窦炎伴鼻息肉	169	Mepolizumab (Mepolizumab)	鑰淵鬱獵廠衊築積鑰憲(築膚顧鑰齋夢顧製顧衊) = 願壓醖襯簾壓壓觸鑰積鏇築鹹鹹淵蓋鹽鹹窪艱 (觸蓋齋鬱壓膚窪醖網廠, 0.164) 更多	-	2024-11-25
				placebo (Placebo)	鑰淵鬱獵廠衊築積鑰憲(築膚顧鑰齋夢顧製顧衊) = 窪鏇範簾鬱繭觸構願顧鏇築鹹鹹淵蓋鹽鹹窪艱 (觸蓋齋鬱壓膚窪醖網廠, 0.164) 更多
NCT00244686 (Pubmed) 人工标引	临床3期	重度哮喘	514	Mepolizumab 100 mg SC (Adults/adolescents (≥12 years of age))	糧鬱窪獵鹽顧齋淵窪窪(製鏇築製餘餘獵製鹹製) = 鹹簾夢範範選鏇蓋齋顧壓選憲構蓋襯遞蓋鏇糧 (獵鹽鏇醖獵襯積壓遞顧 )	积极	2024-10-28
				Mepolizumab 40 mg or 100 mg SC (bodyweight <40 or ≥40 kg, respectively) (Pediatric patients (6-11 years of age))	-