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.

NCT06880744

/ Recruiting临床3期

Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Naïve to Targeted Therapies

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs).
Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide.
For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study.
The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.

开始日期2025-06-17

申办/合作机构

AbbVie, Inc.

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2025-05-01

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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2,116

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 ; An, Yunfei ; Zhang, Zhuo ; 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.

2025-08-04·JOURNAL OF EXPERIMENTAL MEDICINE

Immunopathological and microbial signatures of inflammatory bowel disease in partial RAG deficiency

Article

作者: Pasic, Srdjan ; Villa, Anna ; Yilmaz, Melis ; Riley, Deanna ; Smith, Grace ; Corsino, Cristina ; Lim, Ai Ing ; Lionakis, Michail S. ; Oguz, Cihan ; Dimitrova, Dimana ; Segre, Julia A. ; Belkaid, Yasmine ; Pala, Francesca ; Licciardi, Francesco ; Freeman, Alexandra F. ; Delmonte, Ottavia M. ; Brigatti, Karlla W. ; Bohrnsen, Eric ; Holland, Steven M. ; Alva-Lozada, Guisela ; Subramanian, Poorani ; Brett, Ana ; Potts, David E. ; Kimzey, Cole D. ; Pittaluga, Stefania ; Vujkovic-Cvijin, Ivan ; Bergerson, Jenna R.E. ; Ale, Hanadys ; Daley, Stephen R. ; Sharapova, Svetlana O. ; Marseglia, Gian Luigi ; Burns, Andrew S. ; Ward, Brant R. ; Strauss, Kevin A. ; Fontana, Elena ; Poskitt, Laura E. ; Dos Santos Dias, Lucas ; Ott de Bruin, Lisa ; Fink, Danielle ; Kuhns, Douglas B. ; Schwarz, Benjamin ; Dasso, Joseph F. ; Kong, Heidi H. ; Bosticardo, Marita ; Dutmer, Cullen M. ; Castagnoli, Riccardo ; Walter, Jolan E. ; Notarangelo, Luigi D. ; Oikonomou, Vasileios ; Angelova, Angelina ; Kenney, Heather

Partial RAG deficiency (pRD) can manifest with systemic and tissue-specific immune dysregulation, with inflammatory bowel disease (IBD) in 15% of the patients. We aimed at identifying the immunopathological and microbial signatures associated with IBD in patients with pRD and in a mouse model of pRD (Rag1w/w) with spontaneous development of colitis. pRD patients with IBD and Rag1w/w mice showed a systemic and colonic Th1/Th17 inflammatory signature. Restriction of fecal microbial diversity, abundance of pathogenic bacteria, and depletion of microbial species producing short-chain fatty acid were observed, which were associated with impaired induction of lamina propria peripheral Treg cells in Rag1w/w mice. The use of vedolizumab in Rag1w/w mice and of ustekinumab in a pRD patient were ineffective. Antibiotics ameliorated gut inflammation in Rag1w/w mice, but only bone marrow transplantation (BMT) rescued the immunopathological and microbial signatures. Our findings shed new light in the pathophysiology of gut inflammation in pRD and establish a curative role for BMT to resolve the disease phenotype.

323

项与维得利珠单抗相关的新闻（医药）

2025-06-17

·小药说药

自身免疫和炎症性疾病的新治疗策略

-01-引言免疫介导的炎症性疾病(IMID)是一组常见的、临床多样化的疾病，包括类风湿性关节炎(RA)、脊柱关节炎(SpA)、结缔组织疾病、皮肤炎症性疾病（包括银屑病和特应性皮炎）、炎症性肠病(IBD)、哮喘和自身免疫性神经系统疾病如多发性硬化症。1948年首次使用可的松治疗RA是IMID治疗史上最重要的进展之一。在20世纪下半叶，迅速发展的制药工业使几种常规免疫抑制剂得以实现化学合成，如环磷酰胺、甲氨蝶呤、硫唑嘌呤、环孢菌素、他克莫司和霉酚酸酯。随后的研究证实了几种免疫靶点的临床相关性，如IL-1、IL-6、IL-17、IL-23、B淋巴细胞刺激因子（BLyS）和IFN-α受体、细胞表面标记物如CD20和CD52、共刺激分子如细CTLA-4和PD-1，以及信号通路分子如Janus激酶（JAK）和酪氨酸激酶2（Tyk2），一系列不同的靶向治疗和免疫治疗获得了监管部门的批准。然而，并非所有IMID患者对靶向治疗都有反应，许多患者在治疗后有复发。因此，迫切需要在IMID领域积极开发新的治疗策略，如双特异性抗体（BsAbs）、纳米抗体和纳米颗粒、治疗性疫苗、siRNA干扰、自体造血干细胞移植（aHSCT）和CAR-T细胞。尽管这些新的治疗策略中的大多数仍在临床前和临床中进行评估，但它们已经在未来改善IMID患者方面展现出良好的前景。-02-一、靶向治疗的联合应用两个或多个互补途径可以同时或依次靶向，首先诱导自身免疫性疾病缓解，然后恢复免疫耐受状态，防止疾病过程的再激活。例如B细胞活化因子（BAFF）在利妥昔单抗诱导的B细胞清除后表达上调，导致B细胞活化和存活，基于这种机制，一些联合应用已经在不同适应症中进行测试，如系统性红斑狼疮（SLE）、干燥综合征或系统性硬化症。2021年公布的两项III期试验结果表明，在干燥综合征中，belimumab和利妥昔单抗的联合治疗显示，随着时间的推移，EULAR干燥综合征疾病活动指数（ESSDAI）和刺激唾液流有改善的趋势，这一趋势在治疗后持续存在。而在另一项SLE的临床实验中，belimumab和利妥昔单抗的联合应用没有显著提高SLE患者的疾病控制率。此外，在这两项研究中，与单独的belimumab和利妥昔单抗相比，没有发现额外的安全问题。最近，法国发表了一项大型前瞻性多中心队列研究的结果，该研究调查了143名IMID患者的150种靶向治疗组合。患者主要患有炎症性肠病（77.6%）、脊椎关节炎（44%）和RA（9.1%），其中一半患者患有两种或两种以上联合IMID。最常见的靶向治疗组合是TNFi联合Vedolizumab（30%）或Ustekinumab（28.7%）。从结果来看，50%的患者报告的结果得到了显著改善，27%的患者获得了轻度至中度改善。联合治疗期间的严重感染估计为4.51/100每患者年，1年后未中断治疗的维持率估计为74.9%。-03- 二、双特异性抗体在自身免疫性疾病中，BsAbs的治疗作用主要涉及通过靶向表面标记物或中和炎性细胞因子来预防幼稚T细胞与抗原呈递细胞（APC）或B淋巴细胞之间的免疫相互作用。这些靶点集中于B细胞（CD19、FcγRIIb、BAFF、B7RP1、CD32B和CD79B）或APC（CD86）上的表面受体，以及促炎T细胞调节因子（IL-1、IL-4、TNF-α、IL-13和IL-17）。关于IMID，到目前为止，已有十几种BsAb在临床试验中进行了评估。第一种被批准用于治疗IMID的双特异性单克隆抗体是bimekizumab，它于2021年被美国食品药品监督管理局（FDA）批准用于治疗成人中重度斑块状银屑病。Bimekizumab靶向两种细胞因子，IL17A和IL17F，它们参与银屑病的炎症过程。通过阻断IL17A和IL17F，与以前仅针对IL17A的治疗相比更有效。Tibulizumab (LY3090106)是礼来开发的四价双特异性抗体，包含两种独立作用的二价抗体，靶向BAFF和IL17A；AMG570靶向诱导型T细胞共刺激配体（ICOSL）和BAFF；bsHexAb是一种六价双特异性抗体，靶向CD20和CD22；MT-6194是一种同时靶向IL17A和IL6R的BsAb。-04-三、纳米抗体纳米抗体相比单克隆抗体在生产、结构、溶解度以及对pH和温度范围的耐受性方面具有额外的优势，很可能成为IMID靶向治疗的下一个重要领域。到目前为止，已经在临床试验中评估了十多个纳米抗体。Ozoralizumab（ATN-103/TS-152）是一种三价双特异性纳米抗体，可有效中和TNFα并与人血清白蛋白结合以增加其体内半衰期。它包括两个抗TNFα纳米抗体和一个白蛋白结合纳米抗体。最近公布了其在RA中的II/III期和III期临床试验（OHZORA和NATSUZORA研究）的结果。结果显示，与安慰剂组相比，Ozoralizumab达到主要终点（第16周ACR20改善）的患者比例显著增高（79.6% vs 37.3%）。2022年9月，日本批准了Ozoralizumab用于治疗对现有治疗反应不充分的RA患者。 -05-四、造血干细胞移植aHSCT在自身免疫性疾病中的应用在于自身反应性免疫细胞清除后，从aHSC产生新的自我耐受免疫系统。这一程序有可能通过重置免疫系统来改变自身免疫性疾病的进程，建立一个具有恢复免疫检查点的新免疫库。aHSCT在20世纪90年代末首次用于SSc。三项随机对照临床试验的结果显示，aHSCT与第一年治疗相关死亡率的增加有关。然而，aHSCT具有显著的长期无事件生存益处，并显著改善了SSc中的几个器官受累。此外，在最近的研究中，aHSCT在治疗难治性狼疮肾炎（LN）方面似乎是有效和安全的。在该研究中，22名难治性LN患者接受了aHSCT治疗，随访期间没有患者死亡，10年无病生存率为35%，10年后只有10%的患者需要肾脏支持。在另一项研究中，8名难治性SLE患者接受了aHSCT治疗，5例为LN，3例为中枢神经系统受累。八名患者中有五名获得了完全缓解，包括系统性红斑狼疮疾病活动指数（SLEDAI）降至零，四名患者的缓解持续时间中位数为165个月；一名患者在18个月后出现部分缓解，随后复发。此外，两名患有肾炎和潜在合并症的患者因感染和多器官衰竭死亡。-06-五、CAR-T细胞治疗在IMID的治疗应用中，与单克隆抗体相比，CAR-T细胞有特别的优势：因为它们是长寿命细胞，可以增殖、运输到淋巴组织或靶器官，并发展成记忆群体，可以防止致病淋巴细胞的再次出现。因此，CAR-T细胞治疗可能只需要单一剂量就能达到持久的治疗效果。此外，T细胞的其他嵌合修饰也在自身免疫性疾病中进行研究。嵌合自身抗体受体T细胞（CAAR-T）针对细胞表面的抗体，CAR-Treg针对靶细胞中的特异性抗原，利用Tregs的免疫调节功能。最近，CAR-T细胞已被应用于RA、结肠炎、SLE、寻常型天疱疮（PV）、自身免疫性脑脊髓炎和1型糖尿病的临床前和临床研究，为自身免疫性疾病的治疗选择带来了新的希望。2019年，CAR-T细胞在IMID中得到首次临床应用。一名20岁的严重活动性和难治性SLE患者接受了CD19 CAR-T细胞治疗，疾病迅速完全缓解。另一项由五名难治性SLE患者参与的小型研究中，在CD19 CAR-T细胞给药3个月后，SLE得到缓解。即使在B细胞再次出现后，在更长的随访期间仍保持缓解。该治疗耐受性良好，仅出现中度的细胞因子释放综合征。目前，CAR-T细胞治疗正在各种IMID进行11项研究，如SLE、干燥综合征、SSc和自身免疫性溶血性贫血。-07-六、治疗性疫苗另一种针对促炎细胞因子的治疗方法是使用疫苗来产生针对这些细胞因子的内源性自然免疫反应。目前，最领先的策略是基于肽的针对促炎细胞因子的主动疫苗接种，旨在直接中和致病细胞因子。与高免疫原性蛋白，如KLH偶联的靶向细胞因子复合物可以产生靶向该细胞因子的多克隆中和抗体。使用灭活的IFNα2b合成K-IFNα，在28名轻度至中度SLE女性的I/II期剂量递增研究中，K-IFNα显著降低了IFN诱导基因的表达，在另一项I/II期研究也发现了类似的结果。然而，一在项针对活动性SLE和IFNGS阳性患者的IIb期研究，尽管更多的患者达到了狼疮低疾病活动状态（LLDAS），但没有达到其主要终点。目前，K-IFNα在SLE中的开发已经暂停。IMID的治疗性疫苗策略是替代传统治疗的一种有趣的方案，但仍在很大程度上处于早期开发阶段，需要更好地了解IMID的发病机制。克服目前限制的一种方法可能是根据患者个人疾病转录特征选择个性化疫苗。-08-七、RNA干扰RNA干扰（RNAi）的原理是小RNA结合互补mRNA并诱导基因沉默。过去十年来，治疗人类疾病的RNAi药物开发一直在进行中，Patisiran是第一种上市的RNAi药物，靶向肝细胞中甲状腺素运载蛋白（TTR）mRNA的3′-非翻译区，用于治疗成人hATTR淀粉样变的多发性神经病。在自身免疫疾病中，研究人员一直在临床前疾病模型中积极开发RNAi策略。在RA中，几个团队已经证明，靶向TNFα或NF-κB的RNAi改善了关节炎动物模型中的关节炎和结构损伤。另一项研究表明，在红斑狼疮小鼠的NZB/NZW F1模型中，靶向BLyS或IFN调节因子5（IRF5）的siRNA改善了疾病的进程。尽管目前还没有正在进行的研究RNAi在自身免疫性疾病中的临床试验，但在不久的将来，在自身免疫中使用RNAi靶向“不可成药”的分子途径可能会展现出其巨大的潜力。-09-结语新型策略通过精准靶向或多通路干预，有望解决传统治疗应答不足与复发问题，推动IMID进入"异病同治"时代。随着医疗健康领域步入了大数据时代，国家级大型数据库（如中国的CRDC数据库）中的“云病例”和大型生物样本库的关联组装，可使得跨学科的IMID病例能够更加精细的被比较和归类。同时，基于组织活检样本RNA单细胞测序等新兴技术也将进一步揭开IMID背后的复杂炎症机制，促使更多治疗靶点和靶向联合治疗方案的产生，推动临床管理思路的迭代更新，使更多IMID患者受益。参考资料：1.Novel therapeutic strategies for autoimmune and inflammatory rheumatic diseases. Drug Discov Today.2023 May 8;28(7):103612.公众号内回复“ADC”或扫描下方图片中的二维码免费下载《抗体偶联药物：从基础到临床》的PDF格式电子书！公众号已建立“小药说药专业交流群”微信行业交流群以及读者交流群，扫描下方小编二维码加入，入行业群请主动告知姓名、工作单位和职务。

免疫疗法临床3期临床结果疫苗细胞疗法

2025-06-10

·FierceBiotech

Odyssey abandons IPO plans in latest sign of tough environment for biotech listings

Odyssey Therapeutics announced its IPO ambitions in January around the same time as Sionna Therapeutics.\n Odyssey Therapeutics has bailed on its long-awaited public listing, providing further evidence that the IPO window remains firmly shut for now.The autoimmune- and inflammatory-disease-focused biotech first announced an ambition in January to go public as part of a mini-wave of like-minded drug developers. But the company informed the Securities and Exchange Commission on Monday that it is withdrawing its registration statement because the drug developer “has determined that it is not in the best interests of the company to conduct the proposed offering at this time.”Odyssey’s decision shouldn’t come as a surprise; capital markets experts have already predicted to Fierce that the market turbulence unleashed by President Donald Trump’s tariff policies would likely evaporate the trickle of biotech IPOs that were expected in 2025.Odyssey had been eyeing an IPO as way to access fresh funding for a pipeline led by an RIPK2 inhibitor that was being readied for phase 2 trials for ulcerative colitis as a monotherapy and in combination with Takeda’s Entyvio.The biotech has previously struck deals to add to its assets and capabilities, buying Rahko for its machine learning prowess and acquiring IFM Discovery for MDA5 and NLRP1 discovery programs. IFM was a subsidiary of IFM Therapeutics, a biotech founded by Odyssey CEO Gary Glick, Ph.D. Glick previously set up and ran Scorpion Therapeutics, which Eli Lilly recently bought for up to $2.5 billion.Odyssey has also bagged Big Pharma partnerships, included receiving $6.5 million from Johnson & Johnson to jointly discover and optimize small molecules using Odyssey’s artificial intelligence and machine learning capabilities. Meanwhile, Pfizer paid $1 million as part of a collaboration intended to identify novel hits using Odyssey’s natural product platform. The biotech announced its IPO ambitions in January around the same time as Sionna Therapeutics—which did follow through with its plans to go public. Sionna raised $219.2 million via its listing in February, and the cystic fibrosis-focused biotech’s shares closed trading Monday at $16.46, slightly below their $18 debut price.Other biotechs that squeezed in through the short-lived IPO window at the start of the year include Maze Therapeutics and Metsera Therapeutics. Metsera’s stock has soared 66% from a January debut of $18 to a Monday closing price of $30 thanks in part to some impressive weight loss data yesterday.Kidney-disease-focused Maze has been less successful, with its shares trading down 20% at $12.81 yesterday compared to a debut price of $16.

IPO并购临床2期

2025-06-10

·Pharmaceutical Technology

Odyssey bails on public listing as US IPO landscape stutters

Nasdaq’s trading boards will not parade Odyssey Therapeutics’ name for the time being. Credit: Goran Vrhovac via Shutterstock. Odyssey Therapeutics is unlikely to join the 2025 class of biotechs hitting the stock exchanges after the company withdrew its registration statement for an initial public offering (IPO). The autoimmune and inflammatory disease specialist was one in a wave of biotechs to reveal IPO ambitions in January 2025. While Sionna Therapeutics, a biopharma that filed IPO paperwork at the same time, went on to close a nearly $220m IPO in February, Odyssey has bailed on a public listing. Odyssey did not disclose the number of its common stock shares it was offering, nor the price at which the IPO would conduct on each share. The Form S-1, a registration form with the US Securities and Exchange Commission (SEC) for companies carrying out public offerings, only mentioned that the listing would have occurred on the Nasdaq. Odyssey was eyeing an IPO as a way to fund its pipeline, headed by RIPK2 inhibitor OD-07656 that was set for Phase II trials for ulcerative colitis treatment, both as a monotherapy and in combination with Takeda’s blockbuster Entyvio (vedolizumab). As per its IPO prospectus in January, the monotherapy trial was set to commence in Q1 2025, with the combo trial slated for the same quarter in 2026. Two pre-clinical programmes also stood to benefit from cash generated from the IPO. In its notice to the SEC outlining the withdrawal of the registration statement, Odyssey stated it is because it is “not in the best interests of the company to conduct the proposed offering at this time”. The IPO U-turn is the first sign that the health of the IPO landscape could be suffering in the wake of economic fallout from US President Donald Trump’s policies. Indeed, it consolidates predictions made by one GlobalData analyst earlier this year. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence In April, GlobalData business fundamentals analyst Alison Labya said: “The Trump administration has introduced uncertainty to the biopharmaceutical industry across healthcare policies, drug pricing reforms, and regulatory frameworks, all of which could impact investor confidence. “Additionally, Trump’s recent tariff announcement on imports from Canada, Mexico, and China has led to increased market volatility, potentially delaying IPOs as investors await the countries’ responses to the tariffs.” Biotech IPOs saw a strong recovery in 2024 , with a total raise of $8.52bn, up 68.4% from $5.06bn raised in 2023. It was the highest total IPO value raised since 2021, with the rebound driven by US Federal Reserve interest rate cuts. The uptick continued into 2025, with Sionna joined by Maze Therapeutics and Metsera Therapeutics. U-turning on IPOs is rare, but Odyssey is not the only biotech to bail on a public listing in the past year. Australian biotech Telix Pharmaceuticals withdrew its US public listing at the last minute in June 2024, also citing unfavourable market conditions at the time. Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

IPO

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

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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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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


NCT02620046 (CTgov)	临床3期	克罗恩病 \| 溃疡性结肠炎	746	Vedolizumab SC (Ulcerative Colitis: Vedolizumab 108 mg)	壓積壓蓋遞構糧鹹觸觸 = 艱繭願壓構膚觸簾蓋糧蓋憲範衊廠鑰選築築糧 (獵簾觸夢築網鏇廠襯衊, 廠鹹糧鏇願製淵製鑰衊 ~ 觸築願獵鏇窪鬱願積繭) 更多	-	2025-04-03
				Vedolizumab SC (Crohn's Disease: Vedolizumab 108 mg)	壓積壓蓋遞構糧鹹觸觸 = 襯糧鏇艱廠構鹽廠網獵蓋憲範衊廠鑰選築築糧 (獵簾觸夢築網鏇廠襯衊, 觸願憲膚糧蓋鹹鑰構蓋 ~ 醖蓋製觸糧鹽鑰壓艱鬱) 更多
NCT02862132 (VEDOKIDS, Pubmed \| Lancet Gastroenterol Hepatol)	N/A	炎症性肠病维持	137	Vedolizumab	獵獵艱糧蓋鑰膚夢餘獵(顧鑰範襯膚範齋淵餘繭) = 鏇齋積簾醖鏇鹽醖襯膚繭膚衊膚鹽選糧憲憲選 (憲糧觸繭衊餘製壓壓選 ) 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	選蓋構窪築鏇範網齋鬱(餘廠鹹鬱網襯糧艱構遞) = 衊觸憲構觸餘繭範憲構積積願蓋鏇獵願醖鏇選 (範鬱鑰膚憲鏇餘積餘獵 ) 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)	艱網膚遞窪憲積範選繭 = 構簾壓獵觸獵艱顧遞鑰繭積襯艱壓鬱鹽齋鏇壓 (齋糧顧積廠顧憲鹽鹽願, 淵蓋構艱齋遞齋構遞蓋 ~ 衊醖網繭淵鑰艱淵顧膚) 更多	-	2025-02-12
				Vedolizumab (CD Participants: Vedolizumab 300 mg)	艱網膚遞窪憲積範選繭 = 範廠衊衊鏇憲積壓窪觸繭積襯艱壓鬱鹽齋鏇壓 (齋糧顧積廠顧憲鹽鹽願, 構襯齋範鹽鹹齋淵獵積 ~ 艱觸蓋壓製鏇製獵觸選) 更多
ESMO_IO2024	N/A	结肠炎	74	Vedolizumab	遞鑰衊糧鹹願餘齋構鏇(簾憲壓蓋淵鹹繭觸襯窪) = 構築鑰醖網鹽築遞餘築觸鹹繭醖鏇願鏇糧簾鏇 (廠餘鬱繭簾繭憲糧獵選 )	-	2024-12-12
UEGW2024	N/A	炎症性肠病	-	Subcutaneous Vedolizumab	鏇願餘鹽構鑰範選鬱餘(廠齋壓鏇繭鏇壓醖構廠) = 遞膚齋壓糧餘鏇衊遞艱夢鬱餘醖蓋網繭繭遞廠 (製壓衊顧壓觸範選獵餘 )	-	2024-10-13
				Intravenous Vedolizumab	鏇願餘鹽構鑰範選鬱餘(廠齋壓鏇繭鏇壓醖構廠) = 遞範願鬱鹹鏇窪鑰窪淵夢鬱餘醖蓋網繭繭遞廠 (製壓衊顧壓觸範選獵餘 )
UEGW2024	N/A	溃疡性结肠炎	-	Vedolizumab	餘鹹鹽鹹鹹願積鹽鑰獵(齋鑰衊廠鏇憲積衊鹽淵) = 構範夢鑰簾衊廠蓋觸衊願壓鬱醖遞蓋遞衊顧鹽 (遞鏇構蓋構廠壓願鹽艱 )	-	2024-10-13
UEGW2024	N/A	克罗恩病	-	Vedolizumab (Low probability group)	壓衊壓鹹顧遞廠壓遞選(簾餘蓋製簾獵窪願鬱膚) = 衊繭襯觸齋鹹簾願獵壓網衊選膚簾製簾窪膚範 (網選淵齋築遞選網鏇窪 ) 更多	-	2024-10-13
				Vedolizumab (Intermediate probability group)	壓衊壓鹹顧遞廠壓遞選(簾餘蓋製簾獵窪願鬱膚) = 鬱壓網願遞築壓淵醖積網衊選膚簾製簾窪膚範 (網選淵齋築遞選網鏇窪 ) 更多
UEGW2024	N/A	-	-	Vedolizumab	餘獵願蓋蓋艱範淵餘繭(繭糧襯醖網憲餘網淵夢): 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	夢艱鬱鑰築淵壓顧遞襯(選醖網網顧壓鹽憲鹽獵) = 範鹹艱廠餘憲齋網壓壓淵襯顧願壓鏇觸製衊築 (獵構選鹽積艱鹽艱範餘, 37.0–48.3)	-	2024-10-13