维得利珠单抗(Vedolizumab) - 药物靶点：α4β7_在研适应症：回肠疾病，活动性中度克罗恩病，活动性重度克罗恩病_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Kynteles、Vedolizumab (Genetical Recombination)、Vedolizumab (genetical recombination) (JAN)

+ [14]

靶点

α4β7

作用方式

拮抗剂

作用机制

α4β7拮抗剂(整合素α-4/β-7复合体拮抗剂)

治疗领域

免疫系统疾病消化系统疾病其他疾病+ [2]

在研适应症

回肠疾病活动性中度克罗恩病活动性重度克罗恩病+ [9]

非在研适应症

急性移植物抗宿主病乳糜泻原发性硬化性胆管炎+ [8]

原研机构

Millennium Pharmaceuticals, Inc.

在研机构

Takeda Pharmaceutical Co., Ltd.

Hospira, Inc.Takeda Development Center Americas, Inc.

+ [8]

非在研机构

Millennium Pharmaceuticals, Inc.

权益机构

Royalty Pharma PlcThe General Hospital Corp.

最高研发阶段批准上市

首次获批日期

美国 (2014-05-20),

溃疡性结肠炎克罗恩病

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、临床急需境外新药 (中国)、孤儿药 (澳大利亚)

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结构/序列

Sequence Code 9976148H

来源: *****

Sequence Code 13007748L

来源: *****

关联

144

项与维得利珠单抗相关的临床试验

NCT06405087

/ Not yet recruiting临床3期

A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC.
In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 [NCT06100289]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study.
During the study, participants will visit their study clinic several times.

开始日期2025-10-22

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT07123350

/ Not yet recruitingN/AIIT

Evolving Biologic Administration: Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease

The goal of this retrospective study is to learn about dosing patterns in patients starting subcutaneous vedolizumab administration and patient outcomes after starting subcutaneous administration.
Patients with IBD who are starting subcutaneous vedolizumab administration between September 1, 2023, and December 31, 2024, as part of normal patient care, will be retrospectively reviewed and analyzed.

开始日期2025-10-01

申办/合作机构

Vanderbilt University Medical Center

[+1]

NCT06788340

/ Not yet recruiting临床4期IIT

MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - An Independent Randomized Controlled Trial

The goal of this clinical trial is to investigate if dosage of Ustekinumab (UST) and Vedolizumab (VDZ) based on Model-Informed Precision Dosing (MIPD) is equally as efficient in keeping adults with Inflammatory Bowel Disease (IBD) in remission as management based on what the treating physician deems best. The main question is:
Is using pharmacokinetic-pharmacodynamic (PK-PD) models to predict the appropriate dose and dosing interval for VDZ and UST at least as effective as current practices in maintaining IBD remission.
As above mentioned the comparison-group is adults with IBD, treated with UST or VDZ, managed as the physician deems best.
Participants will:
Have blood and stool tests done, as well as answer a questionnaire 4th weekly Have their dosage frequency decided on either by the PK-model or as the physician deems best visit the clinic once every 24 weeks for checkups. Have an endoscopy done at completion of the study (if the disease is primarily located in the small intestine, MRI or capsule endoscopy will be used instead)

开始日期2025-09-01

申办/合作机构

Odense University Hospital

100 项与维得利珠单抗相关的临床结果

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100 项与维得利珠单抗相关的转化医学

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100 项与维得利珠单抗相关的专利（医药）

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2,156

项与维得利珠单抗相关的文献（医药）

2025-12-01·JOURNAL OF CLINICAL IMMUNOLOGY

X-linked Deficiency in ELF4 in Females with Skewed X Chromosome Inactivation

Article

作者: Zhou, Lina ; Du, Hongqiang ; Liu, Zhifeng ; Sun, Gan ; Zhang, Zhuo ; An, Yunfei ; Zhang, Qianlu ; Zhao, Rongtao ; Mei, Shiyue ; Zhao, Xiaodong ; Tang, Xuemei ; Lv, Qianying ; Sun, Li ; Zhou, Fang

Deficiency in ELF4, X-linked (DEX) is a newly identified monogenic autoinflammatory disease. Most reported cases are male, leading to the recognition of DEX being primarily limited to male patients. Here we described 3 pediatric female patients with DEX from 3 unrelated families, who are all heterozygous for ELF4 mutations (c.320_c.321insA, c.329delA and c.685 A > G). Similar to reported male DEX patients, the main clinical features include recurring oral ulcers, abdominal pain and diarrhea with colonoscopy showing ulcers in the colon. Meanwhile, novel and effective treatment strategies, such as the use of the biologic vedolizumab and exclusive enteral nutrition (EEN), have provided additional options for the treatment of DEX. Finally, we observed skewed X chromosome inactivation patterns in all three female patients, with over-inactivation of the X chromosome carrying the wild-type allele confirmed in two of them.

2025-10-01·IMMUNOLOGY LETTERS

Identification of S100A9 as a target for diagnosis and treatment of Crohn’s Disease after Vedolizumab treatment failure

Article

作者: Lv, Wen ; He, Yijia ; Zhang, Zhe ; Ning, Shiyang ; Xia, Yimeng ; Feng, Baisui ; Liu, Ruixian ; Sun, Qiankun ; Zhang, Yanru ; Li, Yilong ; Yu, Junzhi ; Pang, Xinji ; Liu, Lu ; Liu, Yan ; Wang, Zhihong

The vedolizumab medication is the treatment that precisely targets the gut for Crohn's Disease (CD). It can inhibit the migration of lymphocytes to the intestinal site despite the fact that a significant portion of the population continues to be ineffectively treated. In this study, peripheral blood leukocytes sampled from the CD patients who are nonresponsive or responsive to vedolizumab treatment were used for transcriptome sequencing. Intersected differentially expressed mRNA obtained from transcriptome sequencing and GSE191328 were utilized to predict key therapeutic targets. Bioinformatics analyses were used to explore potential biological mechanisms and to screen pivotal genes. Inhibitor of S100A9 increased the body weight and colon length of mice with colitis, and decreased the DAI score. Our study also demonstrated that the combination of anti-α4β7 integrin antibody with inhibitor of S100A9 further alleviates colitis. Through flow cytometry, changes in the composition of immune cell populations in colon tissues were found after intragastric administration of paquinimod, an inhibitor of S100A9. It is important that blocking S100A9 inhibited the recruitment of neutrophils in the mice's colon. Our findings lay a foundation for the further exploration of the new targets for non-responders to vedolizumab in CD patients.

2025-09-01·Lancet Gastroenterology & Hepatology

Development and validation of peripheral blood DNA methylation signatures to predict response to biological therapy in adults with Crohn's disease (EPIC-CD): an epigenome-wide association study

Article

作者: Chapman, Thomas P ; Levin, Evgeni ; McGregor, Colleen G C ; de Waard, Tristan ; Joustra, Vincent W ; de Jonge, Wouter J ; Henneman, Peter ; Li Yim, Andrew Y F ; Satsangi, Jack J ; Noble, Alexandra J ; Hageman, Ishtu ; Hulshoff, Melanie S ; Lee, Donghyeok ; van Zon, Sarah ; D'Haens, Geert R ; Mol, Femke

BACKGROUND:

Biological therapeutics are widely used in Crohn's disease, with evidence of efficacy from randomised trials and real-world experience. Primary non-response is a common, poorly understood problem. We aimed to assess blood methylation as a predictor of response to adalimumab, vedolizumab, or ustekinumab in patients with Crohn's disease.

METHODS:

This epigenome-wide association study used data from two ongoing biobanks (one from the Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands [discovery cohort] and the other from the John Radcliffe Hospital, Oxford, UK [validation cohort]) that recruited patients between Oct 1, 2009, and June 17, 2022. Adult participants (age ≥18 years) with active symptomatic and endoscopic Crohn's disease who were scheduled to start adalimumab, vedolizumab, or ustekinumab treatment were included. Patients with ongoing malignancy or serious concomitant inflammatory diseases were excluded. Treatment response was assessed after a median of 28 weeks of treatment (IQR 18-36). Response was defined as a combination of endoscopic criteria (50% or more reduction in the Simple Endoscopic Score for Crohn's Disease) with either clinical or biochemical criteria (corticosteroid-free clinical response: ≥3 point decrease in Harvey-Bradshaw Index [HBI] score or remission [HBI ≤4] and no systemic steroids at follow up; biochemical response: C-reactive protein reduction ≥50% or ≤5 mg/L and faecal calprotectin reduction ≥50% or ≤250 μg/g) compared with baseline. Epigenome-wide DNA methylation and transcriptome-wide gene expression analyses were done on whole peripheral blood leukocyte samples that were collected before the start of treatment. To identify baseline DNA methylation markers associated with response or non-response to treatment, we performed supervised machine learning through stability selected gradient boosting. In a post-hoc analysis, we compared our DNA methylation-based prediction model with clinical decision support tools (CDSTs).

FINDINGS:

We profiled the peripheral blood DNA methylome of 273 adults with Crohn's disease scheduled to start adalimumab, vedolizumab, or ustekinumab in the discovery (Amsterdam, n=183; 108 [59·0%] female and 75 [41·0%] male) and the validation cohort (Oxford, n=90; 46 [51·1%] female and 44 [48·9%] male). In the discovery cohort, we defined a panel of DNA methylation biomarkers that were associated with combined endoscopic and clinical or biochemical response to adalimumab (18 markers), vedolizumab (25 markers), or ustekinumab (68 markers), with an area under the curve (AUC) of 0·86 (95% CI 0·58-0·97) for adalimumab, 0·87 (0·67-0·98) for vedolizumab, and 0·89 (0·76-1·00) for ustekinumab. Validation in the Oxford cohort yielded an AUC of 0·25 (0·10-0·35) for adalimumab, 0·75 (0·65-0·85) for vedolizumab, and 0·75 (0·65-0·87) for ustekinumab. In comparison, implementing the CDSTs in the validation cohort yielded an AUC of 0·56 (0·44-0·68) for vedolizumab and 0·66 (0·54-0·77) for ustekinumab. Previous anti-TNF exposure was associated with a reduction in accuracy of the methylation models for vedolizumab (0·66 [0·55-0·73]) and ustekinumab (0·63 [0·52-0·70]) when analysed in the validation cohort.

INTERPRETATION:

Our findings provide evidence for the potential use of DNA methylation as a modality for personalised medicine for Crohn's disease by predicting response to vedolizumab and ustekinumab. The models were more accurate in biologically naive patients and outperform available vedolizumab and ustekinumab CDSTs. We were unable to predict response to adalimumab. The vedolizumab and ustekinumab prediction models are currently being tested in a multicentre randomised clinical trial.

FUNDING:

The Leona M and Harry B Helmsley Charitable Trust.

331

项与维得利珠单抗相关的新闻（医药）

2025-08-12

·GBIHealth

武田FY2025Q1财报：营收下降3.7%，全年业绩展望保持不变

近日，武田发布2025财年（FY2025）第一季度（Q1，2025年4月1日~6月30日）业绩报告。报告期内，公司营收按固定汇率计算（CER，下同）同比下降3.7%至1,106,685百万日元（约合74.63亿美元，GBI计算，下同）；核心营业利润同比下降11.9%至3218亿日元（21.70亿美元）。与上一财年的同期相比，此次业绩下滑的主要原因在于汇率影响以及仿制药冲击。武田表示，尽管部分产品因仿制药竞争对营收和核心营业利润造成了显著影响，但整体业绩表现仍符合公司对本季度的预期。公司预计，这些影响将在未来几个季度逐步减弱；其在5月发布的全年业绩展望保持不变。按业务划分，武田六大核心业务中，胃肠与炎症（GI）业务收入达3393亿日元，同比增长2.6%。其中，用于治疗溃疡性结肠炎（UC）和克罗恩病（CD）的维得利珠单抗（安吉优/Entyvio）销售额达2325亿日元（+4.9%），是GI业务增长的主要驱动力。罕见病业务收入同比增长3.0%至1964亿日元，其中拉那利尤单抗（达泽优/Takhzyro）销售额达551亿日元（+3.7%）。血浆衍生疗法（PDT）业务收入小幅增长1.7%至2609亿日元，其中免疫球蛋白产品总销售额达1940亿日元（+2.0%）。肿瘤业务收入1388亿日元，同比增长1.8%；与辉瑞合作开发的CD30 ADC维布妥昔单抗（安适利/Adcetris）销售额增长13.2%。疫苗业务收入下降6.2%至115亿日元，主要由于四价登革热疫苗Qdenga销售额缩水。神经科学业务收入同比大跌32.6%，主要归因于注意缺陷多动障碍（ADHD）治疗药Vyvanse/Elvanse持续受到仿制药竞争影响（销售额下降46.9%）。报告期内，武田的全球研发等线也取得了多顶里程碑式进展，进一步巩固了其长期增长轨迹。其中，在研新药oveporexton（TAK-861）治疗1型发作性睡病的两项关键III期研究取得积极成果，两项研究均成功达成所有主要和次要终点。全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ olivia.xu@generalbiologic.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

财报疫苗临床3期抗体药物偶联物

2025-08-07

·氨基观察

下一个修美乐藏不住了

氨基观察-创新药组原创出品作者 | 武月一款超级大单品向来是可遇而不可求，想要找到下一个修美乐绝非易事。但艾伯维是幸运的。修美乐留下的200亿美元巨坑，眼看就要被自家的自免双星Skyrizi和Rinvoq填上了。二季度，Skyrizi全球销售额44亿美元，Rinvoq 20亿美元，继续增长强劲，两者今年合计销售额有望超过250亿美元，远高于艾伯维年初的预期。基于此，艾伯维将Skyrizi的2025年销售预期上调至171亿美，同比增长46%，相较此前的指引上调了6亿美元。按照这个势头，2026年Skyrizi就将超过200亿美元，基本锁定下个自免药王之位。药王权杖的交接背后，是巨头走出专利悬崖的教科书级示范，更是创新效率的颠覆性跃迁。修美乐用了10年才解锁100亿美元，Skyrizi只用了不到6年；并且还在加速度，从100亿美元到200亿美元，修美乐又用了10年，Skyrizi大概率只用2年。恐怖如斯。自免盛宴之下，内卷暗涌。当放量曲线越来越陡，后来者越跑越快，谁又能保证自己不是下一个“悬崖边的舞者”？ / 01 / 剑指200亿美元就在两年前，市场还在担心，Skyrizi能否挑起大梁，毕竟修美乐给艾伯维留下了一个200多亿美元的巨坑。但随着适应症的扩充，Skyrizi一步步证明自己。 2024年得益于其在炎症性肠病和皮肤病治疗等领域广泛的应用前景，Skyrizi全球销售额首次突破100亿美元，同比增长50.9%，与Rinvoq（59.7亿美元）一同拉动艾伯维免疫业务重回增长。此时，距离Skyrizi首适应症银屑病获批，仅过去不到6年时间。进入2025年，Skyrizi更是进一步超预期。二季度，Skyrizi全球销售额44亿美元，同比增长61.8%。就连海外分析师都直言远远超过预期。基于增长的强劲势头，艾伯维提高了Skyrizi的全年指引，预计2025年全球销售额将达171亿美元，同比增长46%。这一指引，相较此前的指引上调了6亿美元，其中4亿美元来自IBD适应症、2亿美元来自银屑病适应症。事实上，按照这个增长趋势，2026年Skyrizi的全球销售额就将突破200亿美元。这也让自免药王有了新悬念。 2024年，在多适应症推动下，度普利尤单抗以140亿美元销售额，稳坐全球自免药物市场头把交椅。赛诺菲预计度普利尤今年销售额有望达到170亿美元，预计2026年-2027年将突破200亿美元。谁能先一步突破200亿美元？还需要时间的验证。能够确定的则是，艾伯维来到了一个新阶段，新药王已经养成，并且增长十分强势，十年内没有重大专利到期，其有了更多选择。 / 02 / 乐观与谨慎 Skyrizi的光芒之下，Rinvoq同样不容小觑。艾伯维为其规划了清晰的“三波战略”：第一波：类风湿关节炎等大适应症；第二波：特应性皮炎、IBD；第三波：巨细胞动脉炎（GCA）、系统性红斑狼疮、斑秃等。第三波的新适应症成为增量引擎。Rinvoq的斑秃三期数据亮眼，潜在患者规模近200万；GCA适应症已经获批，艾伯维表示初步处方趋势以及风湿病医生的反馈都很积极，预计在美国的医保覆盖将在今年下半年快速提升。此前其预估新增适应症将为Rinvoq带来20亿美元增量，但在电话会上，其表示需要进一步研究能否超预期。艾伯维将Skyrizi与Rinvoq增长核心动力，归结为在于“卓越临床数据、广泛适应症及医生认可的价值主张”。的确如此，以Skyrizi为例，作为一款靶向IL-23的单抗，Skyrizi通过阻断IL-23信号通路，抑制与炎症相关的T细胞激活，从而有效减少炎症反应和皮肤症状。目前，Skyrizi正处于狂揽自免适应症阶段，斑块状银屑病、银屑病关节炎、克罗恩病和溃疡性结肠炎已先后被其拿下，未来有望在更多大品种自免适应症方面发力。 Skyrizi已经也通过头对头研究证明其疗效，比如在银屑病领域头对头打败乌司奴单抗；而与其他IL-23抑制剂相比，Skyrizi也具备差异化优势，比如相比古塞奇尤单抗给药频率更低（每12周一次），依从性更高。并且，Skyrizi与Rinvoq正在协同作战。艾伯维表示，其在胃肠病学领域拥有强大的市场领导地位，Rinvoq与Skyrizi合计在美国克罗恩病市场上覆盖了每两名在治患者中的一人，在溃疡性结肠炎市场上覆盖了每三名在治患者中的一人。基于此，艾伯维提高了全年指引，并对未来增长保持乐观期待。但市场疑虑未消，分析师在财报电话会上反复追问：增长持续性：高基数下能否维持双位数增长？竞争压力：IL-23靶点已成“最卷战场”，强生、礼来等巨头虎视眈眈，以及乌司奴单抗类似药的冲击。对此，艾伯维的回应充满信心：Skyrizi在治患者份额仍在不断增长，这对一个百亿美元体量的创新药来说，非常罕见的。在银屑病相关疾病领域，持续赢得大量在治患者份额。在美国市场，Skyrizi在所有治疗线中相较于其他生物制剂和口服药物均保持领先地位；IBD领域，今年有望销售额翻倍。至于类似药竞争及关税风险，艾伯维也表示不必担心，IBD市场的天花板还远未触及。银屑病和IBD领域的全面增长，正是其上调全年指引，甚至长期指引的底气。 / 03 / 持续刷新想象艾伯维的财报印证了医药行业的铁律——没有永恒的药王，只有永恒的创新。Skyrizi与Rinvoq的成功接棒，展现了巨头转型的决断力，但修美乐的极速坠落也警示着创新的紧迫性。自免市场越来越火热，市场空间巨大是一个不争的事实，与之相比，更值得关注的是，这场新老药王交接的背后，揭示了一个趋势：自免重磅炸弹的放量曲线正越来越陡峭。修美乐用了10年解锁100亿美元，类似的还有乌司奴单抗，而Skyrizi只用了6年；并且还在加速度，从100亿美元到200亿美元，修美乐又用了10年，Skyrizi大概率只用2年。也就是说，修美乐的20年自免传奇，Skyrizi可能只需8年便将其超越。这个速度，也超过了此前自免新药王头号种子选手度普利尤单抗。这种效率跃迁的背后，是生物技术从分子设计到临床开发的全面进化。基于此，自免超级重磅炸弹在持续刷新我们的想象同时，另一个事实同样残酷：后来者的窗口期正在被急剧压缩。问世时间早、竞争格局好、专利布局强，从2012年算起，修美乐做了10年药王，爬坡放量战线十分长。但眼下，内卷与迭代同步，后来者越跑越快，如果自身优势不够突出，注定被超越，更无缘进入百亿美金阵营。比如武田制药的Entyvio，获批时间较早，竞争格局好，单独IBD适应症也爬过了50亿美元。但眼下，面临IL-23单抗和JAK抑制剂的强劲攻势，已是强弩之末。技术是第一生产力，但时间从不等人。当后来者的爬坡时间被压缩至5-7年，立项眼光与临床差异化将成为生死线。要么足够强，头对头击败老药，要么足够差异化。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

专利到期免疫疗法

2025-08-07

·EndPoints

J&J gets CRL over manufacturing issues; Charles River stays afloat

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Johnson & Johnson was handed a complete response letter for a potential label expansion of Darzalex Faspro over issues found after a facility inspection, the company said Friday. Darzalex Faspro is being reviewed in a quadruplet regimen in newly diagnosed, transplant-ineligible multiple myeloma. No safety or efficacy concerns were raised and no new clinical data are needed. Charles River Laboratories said during its second-quarter earnings call Wednesday that overall demand from its pharma clients appears to be stabilizing, but smaller biotechs are still constrained over a lack of funding. The company is not yet seeing any “meaningful impact on client spending patterns” due to tariffs or drug pricing issues, CEO James Foster said. Charles River has been slightly affected by NIH funding cuts, but this only a “small impact,” Foster added. Overall, the company reported a revenue of $1.03 billion for Q2, up 0.6% from the $1.02 billion reported in the same period last year. CDMO Esteve is acquiring Chicago-headquartered CDMO Regis Technologies, in a move that would see it expand to the US for the first time, the company said July 31. This deal expands Esteve’s services to include manufacturing of small molecule APIs for preclinical to commercial purposes. Indian API maker Garonit Pharmaceutical is building a $46.1 million facility in New Windsor, Orange County, according to a Monday release. The 200,00-square-meter site will manufacture antiseptic products. New York State is investing $3.8 million to aid the project. Bora Pharmaceuticals is expanding its facility in Maple Grove, MN, the company said Tuesday. The first step of the expansion is to be operational in Q3. Fresenius Kabi and Polpharma Biologics have entered into a new licensing agreement, according to a Tuesday release. Fresenius Kabi will exclusively commercialize Polpharma’s biosimilar to the biologic vedolizumab, sold by Takeda under the brand name Entyvio, which is used to treat Crohn’s disease and ulcerative colitis. API maker Axplora is investing €6.5 million to expand a site in India, the company said Tuesday.

引进/卖出并购

100 项与维得利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08083	维得利珠单抗	L04AA33	DB09033

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
回肠疾病	韩国	Takeda Pharmaceuticals Korea Co., Ltd.	2015-06-19
活动性中度克罗恩病	欧盟	Takeda Pharma A/S	2014-05-22
活动性中度克罗恩病	冰岛	Takeda Pharma A/S	2014-05-22
活动性中度克罗恩病	列支敦士登	Takeda Pharma A/S	2014-05-22
活动性中度克罗恩病	挪威	Takeda Pharma A/S	2014-05-22
活动性重度克罗恩病	欧盟	Takeda Pharma A/S	2014-05-22
活动性重度克罗恩病	冰岛	Takeda Pharma A/S	2014-05-22
活动性重度克罗恩病	列支敦士登	Takeda Pharma A/S	2014-05-22
活动性重度克罗恩病	挪威	Takeda Pharma A/S	2014-05-22
隐窝炎	欧盟	Takeda Pharma A/S	2014-05-22
隐窝炎	冰岛	Takeda Pharma A/S	2014-05-22
隐窝炎	列支敦士登	Takeda Pharma A/S	2014-05-22
隐窝炎	挪威	Takeda Pharma A/S	2014-05-22
活动性中度溃疡性结肠炎	欧盟	Takeda Pharma A/S	2014-05-22
活动性中度溃疡性结肠炎	冰岛	Takeda Pharma A/S	2014-05-22
活动性中度溃疡性结肠炎	列支敦士登	Takeda Pharma A/S	2014-05-22
活动性中度溃疡性结肠炎	挪威	Takeda Pharma A/S	2014-05-22
活动性重度溃疡性结肠炎	欧盟	Takeda Pharma A/S	2014-05-22
活动性重度溃疡性结肠炎	冰岛	Takeda Pharma A/S	2014-05-22
活动性重度溃疡性结肠炎	列支敦士登	Takeda Pharma A/S	2014-05-22

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
小儿克罗恩病	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2022-04-30
小儿克罗恩病	临床3期	中国	Takeda Pharmaceutical Co., Ltd.	2022-04-30
小儿克罗恩病	临床3期	日本	Takeda Pharmaceutical Co., Ltd.	2022-04-30
小儿克罗恩病	临床3期	澳大利亚	Takeda Pharmaceutical Co., Ltd.	2022-04-30
小儿克罗恩病	临床3期	比利时	Takeda Pharmaceutical Co., Ltd.	2022-04-30
小儿克罗恩病	临床3期	加拿大	Takeda Pharmaceutical Co., Ltd.	2022-04-30
小儿克罗恩病	临床3期	克罗地亚	Takeda Pharmaceutical Co., Ltd.	2022-04-30
小儿克罗恩病	临床3期	捷克	Takeda Pharmaceutical Co., Ltd.	2022-04-30
小儿克罗恩病	临床3期	希腊	Takeda Pharmaceutical Co., Ltd.	2022-04-30
小儿克罗恩病	临床3期	匈牙利	Takeda Pharmaceutical Co., Ltd.	2022-04-30

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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


NCT02620046 (CTgov)	临床3期	克罗恩病 \| 溃疡性结肠炎	746	Vedolizumab SC (Ulcerative Colitis: Vedolizumab 108 mg)	壓膚選衊衊蓋積憲艱遞 = 製遞襯築觸鏇齋蓋憲願鑰糧餘鑰獵製遞簾糧鏇 (衊範廠網憲襯蓋觸餘齋, 製窪觸艱願窪構憲憲鑰 ~ 網醖範製膚鹽獵遞襯鬱) 更多	-	2025-04-03
				Vedolizumab SC (Crohn's Disease: Vedolizumab 108 mg)	壓膚選衊衊蓋積憲艱遞 = 憲簾製製範淵遞顧衊鑰鑰糧餘鑰獵製遞簾糧鏇 (衊範廠網憲襯蓋觸餘齋, 鹹憲淵齋範觸積範醖積 ~ 鑰膚鬱鏇艱獵積構鑰鏇) 更多
NCT02862132 (VEDOKIDS, Pubmed \| Lancet Gastroenterol Hepatol)	N/A	炎症性肠病维持	137	Vedolizumab	餘觸艱製獵積艱襯簾網(製構願遞網淵糧觸鑰鹹) = 壓糧遞窪選廠憲膚窪觸願選構構憲餘鹹遞積襯 (鏇艱遞廠夢夢顧繭範夢 ) 更多	积极	2025-03-01
ChiCTR2200063233 (Early CD, PRNewswire) 人工标引	临床4期	克罗恩病	172	维得利珠单抗	齋壓構獵範壓糧觸積鬱(繭遞繭積構醖淵鏇蓋簾) = 積獵襯餘齋艱積築網構顧顧獵構壓壓蓋鑰鏇醖 (餘窪遞網艱鏇衊繭壓艱 ) 更多	积极	2025-02-21
NCT04804540 (CTgov)	临床4期	克罗恩病 \| 溃疡性结肠炎	150	Vedolizumab (UC Participants: Vedolizumab 300 mg)	範獵壓醖鏇獵膚窪觸鏇 = 憲鏇築壓醖憲蓋構齋蓋獵願製簾簾糧顧製餘憲 (襯鑰簾鹽衊醖壓餘夢觸, 壓觸廠選淵夢鏇糧淵鹹 ~ 積鏇選夢艱願鏇衊衊襯) 更多	-	2025-02-12
				Vedolizumab (CD Participants: Vedolizumab 300 mg)	範獵壓醖鏇獵膚窪觸鏇 = 膚齋積鹹積鏇鏇範憲齋獵願製簾簾糧顧製餘憲 (襯鑰簾鹽衊醖壓餘夢觸, 鑰願憲窪選廠憲繭夢鏇 ~ 齋鹽鹽積鹽鏇餘鑰艱蓋) 更多
UEGW2024	N/A	-	-	Vedolizumab	範壓糧鑰鏇築衊蓋選構(膚願繭積夢鹽願艱窪廠): OR = 1.74 (95% CI, 1.12 ~ 2.7), P-Value = 0.014 更多	-	2024-10-13
				Ustekinumab
UEGW2024	N/A	溃疡性结肠炎	-	Vedolizumab	積醖壓糧鬱繭積蓋廠艱(願顧餘鬱遞鹽選齋襯構) = 膚範淵繭鹽遞獵鹹鏇選觸範簾選觸廠襯鬱夢餘 (簾齋選製齋壓淵襯構鏇, 37.0–48.3)	-	2024-10-13
UEGW2024	N/A	溃疡性结肠炎	-	Anti-TNFs	襯膚壓觸襯構鹽淵鬱鹽(獵觸獵鹹構構積鬱鏇廠) = 1/16 (6.3%) with no cases of herpes zoster or thrombo-embolic events 艱膚遞選顧繭糧鹹觸鏇 (窪蓋齋鑰衊構醖齋繭夢 ) 更多	-	2024-10-13
				Ustekinumab
UEGW2024	N/A	克罗恩病	-	Vedolizumab (Low probability group)	糧築觸構夢積鹹醖繭廠(鑰鬱廠廠網觸蓋壓鑰鏇) = 願製網膚鑰網鏇憲憲願膚製範夢膚觸壓鑰築鹹 (齋鹹襯積憲鬱範膚鏇膚 ) 更多	-	2024-10-13
				Vedolizumab (Intermediate probability group)	糧築觸構夢積鹹醖繭廠(鑰鬱廠廠網觸蓋壓鑰鏇) = 齋膚觸鑰積範遞壓觸淵膚製範夢膚觸壓鑰築鹹 (齋鹹襯積憲鬱範膚鏇膚 ) 更多
VEDOPREDIRESP (UEGW2024)	临床4期	炎症性肠病	115	Vedolizumab 300mg	醖壓鏇範壓壓憲鑰鹽範(鑰艱遞齋獵廠鹽淵製壓) = 鹽選衊鹽壓範醖鹹蓋顧醖糧繭衊襯構範壓鹽衊 (簾壓淵淵糧艱衊齋襯襯 ) 更多	不佳	2024-10-13
UEGW2024	N/A	炎症性肠病	-	Subcutaneous Vedolizumab (SC VDZ)	艱醖選艱衊獵衊憲蓋糧(齋製淵遞願糧糧膚築衊) = Overall, 29.7 % of patients ceased SC VDZ treatment after a median of 20 (IQR 6-26) weeks. Cessation was due to secondary response losing in 3/6 and 4/5 patients in CD and UC group. In case of 2 and one patients, SC treatment was terminated due to local reactions. One patient was fear of needle. Severe adverse event did not occur. 範簾繭製獵壓衊繭簾窪 (齋襯醖壓艱鹽鹹網觸廠 )	-	2024-10-13
				Intravenous Vedolizumab (IV VDZ)