度普利尤单抗(Dupilumab) - 药物靶点：IL-4Rα_在研适应症：慢性阻塞性肺疾病，慢性荨麻疹，嗜酸粒细胞性食管炎_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Dupilumab (Genetical Recombination)、Dupilumab (genetical recombination) (JAN)、Dupilumab (USAN)

+ [10]

靶点

IL-4Rα

作用机制

IL-4Rα抑制剂(白细胞介素-4受体α亚基抑制剂)

治疗领域

免疫系统疾病感染遗传病与畸形+ [6]

在研适应症

慢性阻塞性肺疾病慢性荨麻疹嗜酸粒细胞性食管炎+ [24]

非在研适应症

阿尔茨海默症血管性水肿嗜酸性粒细胞性哮喘+ [7]

原研机构

Sanofi

在研机构

Sanofi Winthrop Industrie SA

Regeneron Pharmaceuticals, Inc.

Sanofi

+ [8]

非在研机构

Aimmune Therapeutics, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2017-03-28),

特应性皮炎

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、突破性疗法 (美国)、孤儿药 (美国)、优先审评 (中国)、临床急需境外新药 (中国)、优先审评 (澳大利亚)

登录后查看首次获批时间轴

序列信息

Sequence Code 9909199H

来源: *****

Sequence Code 9931072L

来源: *****

关联

256

项与度普利尤单抗相关的临床试验

NCT06465732 / Not yet recruiting临床4期IIT

A Randomized Controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Combination With Short-term Low-dose Tofacitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

Atopic dermatitis (AD) is a common chronic inflammatory skin disease characterized by intense pruritus and sleep disturbances. The clinical manifestations of AD are varied, with the most basic features being dry skin, chronic eczema-like dermatitis, and intense pruritus. The prevalence in children and adults is about 30% and 10%, respectively. Most patients respond well to topical anti-inflammatory drugs, but approximately 10 percent of patients with moderate-to-severe AD require one or more systemic therapies to achieve good disease control. Although nonspecific immunosuppressive drugs (including glucocorticoids, cyclosporine A, methotrexate, azathioprine, or mycophenolate mofetil) are effective in alleviating or controlling these disorders to some extent, their overall efficacy in patients is limited and associated with significant side effects with long-term use.
The main hallmarks of systemic type II inflammation are eosinophilia and elevated serum immunoglobulin E (IgE) levels. Type II inflammatory response is not only associated with allergic reactions, but is also a driver of such diseases. The release of cytokines (interleukins 4, 5, and 13) in the response to type II inflammation can trigger a lymphocyte-mediated type II inflammatory response, inducing the onset and progression of allergic diseases. Reducing the inflammatory response by inhibiting the above-mentioned inflammatory factors is a potential therapeutic means for the treatment of allergic diseases represented by AD.
Investigational drug Dupilumab injection, an interleukin-4 receptor α (IL-4Rα) antagonist, is a human monoclonal antibody that binds IL-4Rα and inhibits IL-4 and IL-13 signaling. With a molecular weight of about 147 kDa, it inhibits the signaling of interleukin 4 and interleukin 13 and blocks its signaling pathway through the atopic binding of the interleukin 4Ra subunit shared with the interleukin 4 and interleukin 13 receptor complex, and blocks their signaling pathways, which can achieve continuous, efficient and safe improvement of skin lesions, itching and other symptoms and alleviate the condition.
Tofacitinib is a Janus kinase (JAK) inhibitor. JAK is an intracellular enzyme that conducts signals generated by cytokine or growth factor-receptor interactions on cell membranes, thereby affecting cell hematopoiesis and cellular immune function.

开始日期2025-01-01

申办/合作机构

浙江大学医学院附属第二医院

NCT06477653 / Not yet recruiting临床2期IIT

A Pilot Phase 2 Study of the Safety and Efficacy of Dupilumab as Add-on Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents

Background:
Hypereosinophilic syndrome (HES) is a blood disorder that causes high levels of white blood cells called eosinophils. HES can damage the lungs and airways, intestines, skin, and other organs. The current primary treatment for HES can cause serious side effects. Secondary treatments do not work in all people.
Objective:
To test an approved drug (dupilumab), combined with other drugs, in people with HES.
Eligibility:
People aged 18 years and older who take drugs (mepolizumab, reslizumab, or benralizumab) to treat HES.
Design:
Participants will have up to 6 clinic visits and 7 remote visits in up to 48 weeks.
Participants will be screened. They will have blood and urine tests. They will have a test of their heart function. They will take surveys about how HES affects their daily life. Some participants may have a bone marrow biopsy: A sample of tissue and fluid from inside a bone will be removed with a large needle.
Participants will have other tests specific to their symptoms. For example, those with symptoms affecting their lungs will have breathing tests. Others may have tests that target symptoms in their sinuses, gastrointestinal tract, or skin.
Dupilumab is injected under the skin once every 1 or 2 weeks. Dose and timing will vary among participants. They will be taught how to inject themselves at home between clinic visits. They will take dupilumab plus their current medications for 24 weeks. If the drug is helping them, they will continue taking it for another 24 weeks.
Participants will have a final visit 12 weeks after their last dose.

开始日期2024-10-08

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT06572228 / Not yet recruiting临床4期

AIM4: Next Step - Asthma Uncontrolled With ICS in Medium Dose (GINA 4): Next Step; Efficacy of Dupilumab Added to Medium Dose ICS/LABA in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Patients With Uncontrolled Asthma

This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication.
The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA.
The study is also looking at:
• What side effects may happen from taking dupilumab

开始日期2024-09-17

申办/合作机构

Regeneron Pharmaceuticals, Inc.

[+1]

100 项与度普利尤单抗相关的临床结果

登录后查看更多信息

100 项与度普利尤单抗相关的转化医学

登录后查看更多信息

100 项与度普利尤单抗相关的专利（医药）

登录后查看更多信息

3,108

项与度普利尤单抗相关的文献（医药）

2024-12-31·The Journal of dermatological treatment

Mandated step therapy for dupilumab delays the inevitable

Letter

作者: Smith, Aaron D ; Flowers, R Hal ; Bryer, Bridget ; Florenzo, Brian ; Lyons, Catherine E ; Remington, Courtney

The article quantify treatment delay associated with dupilumab mandated step therapy in adults with atopic dermatitis.Patients with moderate-to-severe atopic dermatitis refractory to topical treatments (defined as lack of improvement >6 mo after treatment initiation) who were prescribed dupilumab between Jan. 1, 2018 and Jan. 1, 2023 were identified.Of 446 patients meeting inclusion criteria, 114 were subject to MSt. While there was no statistical difference between the two cohorts regarding sex, race, or ethnicity, the MSt group was younger by 7.2 years (31.9 ± 21.7, (1-72) vs 39.1 ± 26.3, (1-92); p < .008) compared to their counterparts.MSt caused an average therapeutic delay of 4.6 ± 4.99 mo and 1.4 ± 1.96 appointments (p < .001) before treatment could be initiated.Most patients ended up receiving dupilumab regardless of MSt, so MSt simply delays definitive therapy.

2024-12-31·The Journal of dermatological treatment

The changes of leukocytes and T lymphocytes in atopic dermatitis patients with and without dupilumab therapy and in control group in pollen season compared to out of pollen season

Article

作者: Krejsek, Jan ; Boudkova, Petra ; Čelakovská, Jarmila ; Čermáková, Eva

A review.This study investigates the variations in leukocytes and T lymphocytes among atopic dermatitis patients undergoing dupilumab therapy, those without the therapy, and a control group during pollen season compared to non-pollen season.The aim is to discern any differential responses in immune cell profiles in the context of seasonal allergen exposure and dupilumab treatment.

2024-12-31·The Journal of dermatological treatment

The expression of CD200 and CD23 on B lymphocytes in the pollen season and outside the pollen season in atopic dermatitis patients with and without dupilumab therapy

Letter

作者: Krejsek, Jan ; Čelakovská, Jarmila ; Boudkova, Petra ; Andrýs, Ctirad ; Čermáková, Eva

The aim of the study is to measure the expression of these mols. on B lymphocytes and on their subsets (memory, naive, non-switched, total B lymphocytes) in patients suffering from moderate and severe form of Ad (with and without dupilumab therapy) in pollen season (June-August) and out of pollen season (Oct.- Feb.) and compare it with these counts in healthy subjects.Complete dermatol. examination was performed in all patients included in the study.Inclusion criteria: (1) age 14 years and over, (2) Ad as defined by the criteria of hanifin and rajka.Patients with moderate and severe form of Ad without dupilumab and patients with dupilumab therapy lasting at least 18 mo were included. exclusion criteria: pregnancy, breastfeeding, and systemic therapy (cyclosporin, systemic corticoids).We show the count of absolute leukocytes and absolute lymphocytes; Cd23 B lymphocytes with their subsets; Cd200 B lymphocytes with their subsets.The results of our study suggest that dupilumab affects the expression of Cd200 and Cd23 on B lymphocytes.

1,465

项与度普利尤单抗相关的新闻（医药）

2024-10-02

·药智网

当国产自免药物，撕开了一个口

2024年，可谓是国产自免药物的爆发之年。尤其最近两个月，有3款国产自免创新药获批上市，包括两款同日获批的IL-17A单抗（智翔金泰的赛立奇单抗、恒瑞医药的夫那奇珠单抗），以及康诺亚的IL-4R单抗司普奇拜单抗。国产自免新药的闪亮登场，犹如破冰之船，成功击碎了外资药企的垄断坚冰。此外，其他国内药企正在各个自免细分赛道全力冲刺，宛如一场风暴席卷而来。两款国产问世，上演激烈比拼在国产IL-17A单抗上市前，国内这一领域仅有进口产品获批。截至目前，国内已有6款IL-17靶向药物获批上市，包括诺华的司库奇尤单抗、礼来的依奇珠单抗、协和麒麟的布罗利尤单抗、优时比的比吉利珠单抗，以及智翔金泰的赛立奇单抗、恒瑞医药的夫那奇珠单抗。其中，司库奇尤单抗、依奇珠单抗是IL-17单抗领域的头部产品，2023年销售额分别高达49.8亿美元、27.6亿美元。这两款产品在中国市场也是迅速放量。数据显示，司库奇尤单抗、依奇珠单抗在2023年的销售额分别为37.64亿元、3.34亿元，合计销售额达40.98亿元。图片来源：国投证券研报如今，国内药企已经在IL-17A单抗市场占据了两个席位，获批的适应症均为患者数量庞大的中重度斑块状银屑病。而且，夫那奇珠单抗针对成人活动性强直性脊柱炎已进入上市申报阶段，赛立奇单抗针对强直性脊柱炎也已处于NDA阶段。特别是，目前还有不少国产IL-17A单抗已处于Ⅲ期临床，包括康方生物AK111（古莫奇单抗）、三生国健SSGJ-608、君实生物JS005、丽珠医药/鑫康合XKH004、荃信生物QX002N等。此外，石药集团、甘李药业和百奥泰还布局了司库奇尤单抗生物类似药。市场参与者的不断增加，无疑推动了国内IL-17单抗市场的快速发展。但面对日益激烈的市场竞争，差异化策略成为药企赢得市场份额的关键。围猎新一代自免“药王” 相较于IL-17A单抗领域，当下的IL-4R药物领域市场竞争较为缓和。目前，全球仅有2款IL-4Rα单抗获批上市，分别是赛诺菲/再生元的度普利尤单抗、康诺亚的司普奇拜单抗（CM310）。其中，司普奇拜单抗在9月12日获NMPA批准上市，用于治疗成人中重度特应性皮炎，成为国产首款、全球第二个IL-4Rα抗体药物。值得一提的是，度普利尤单抗是新一代自免“药王”，继2023年迈入“百亿美元俱乐部”后，今年上半年销售额实现同比增长25.8%至66.3亿美元，超越强生的乌司奴单抗、艾伯维的阿达木单抗，拿下了自免药物销售额TOP1。 2024H1自免药物销售额TOP10 数据来源：公开数据整理度普利尤单抗能成为自免新“药王”，除了具有市场独占优势外，还在于目前已在全球范围内获批包括特应性皮炎、哮喘、慢性阻塞性肺疾病（COPD）等在内的7个适应症。不过，康诺亚也在针对司普奇拜单抗拓展广泛的适应症，其中治疗季节性过敏性鼻炎及慢性鼻窦炎伴鼻息肉的新药上市申请已获NMPA受理。在商业化策略上，康诺亚不仅自建商业化核心团队（预计今年底规模有望突破250人）、打造了18600升的产能，还与石药集团达成部分合作：将司普奇拜单抗的中国地区（不包括港澳台）针对中重度哮喘和COPD等呼吸系统疾病进行开发和商业化的权益授予后者。另一边，其他国内药企正在开展针对度普利尤单抗的“围猎行动”。据不完全统计，目前已有8款国产IL-4R单抗处于临床Ⅲ期阶段，包括康方生物的曼多奇单抗、恒瑞医药SHR-1819、智翔金泰GR1802、三生国健SSGJ-611、康乃德生物CBP-201等。不难预见，未来几年IL-4R药物领域也将展开激烈的厮杀。 IL-12/IL-23药物赛道：新旧“药王”更替说到激烈厮杀，靶向IL-12/IL-23药物领域已经到了新旧“药王”交替的时刻。这一领域的两大头部产品：强生的IL-12/23抑制剂乌司奴单抗、艾伯维IL-23抑制剂利生奇珠单抗（曾用名：瑞莎珠单抗），正上演着激烈的较量。 2023年，乌司奴单抗销售额突破百亿美元大关，但面临专利悬崖的挑战，今年上半年仅同比微增1.8%至53.36亿美元，环比增速已经开始下滑。反过来，在头对头研究中打败乌司奴单抗、阿达木单抗的瑞莎珠单抗，可谓风头正盛，2023年销售额同比增长50.3%至77.63亿美元，今年上半年再以46%的同比增速实现47.35亿美元。另外，强生也有一款IL-23抑制剂古塞奇尤单抗，2023年销售额同比增长17.9%至31.47亿美元，今年上半年实现同比增长27%至17.14亿美元，销售增速不及瑞莎珠单抗；礼来的Mirikizumab于2023年10月获FDA批准上市，成为首个获批用于治疗成人中至重度溃疡性结肠炎（UC）的IL-23抗体。图片来源：浙商证券研报相比厮杀激烈的IL-17A单抗、IL-4R单抗，当前国内药企较少布局IL-12/IL-23药物，尚且算得上“风景这边独好”。 IL-12药物方面，已进入临床阶段的国产药物，包括翰森制药/荃信生物QX004N（目前针对银屑病、克罗恩病分别处于Ⅱ期、Ⅰa期临床），艾博生物ABO2011（主要针对实体瘤）、嘉晨西海JCXH-211（主要针对实体瘤）。 IL-23抑制剂方面，康哲药业从印度太阳制药引进的替瑞奇珠单抗（Tildrakizumab），已于2023年5月获批用于治疗中重度斑块状银屑病，信达生物的匹康奇拜单抗（IBI112）也已申报上市申请。另外，康方生物IL-12/23单抗AK101（依若奇单抗），已于2023年8月向NMPA递交治疗中重度斑块型银屑病的上市申请。相较之下，竞争较为激烈的是乌司奴单抗生物类似药，目前百奥泰、华东医药/荃信生物均已申报上市，石药集团SYSA-1902也已处于Ⅲ期临床。恒瑞、泽璟发力JAK抑制剂除白介素（IL）抑制剂外，国内药企也在发力小分子JAK抑制剂。这是由于，JAK抑制剂的应用范围相当广泛，不仅可应用于血液系统疾病、肿瘤，还在自免疾病的治疗中得到了进一步拓展。目前，全球已有近20款JAK抑制剂获批上市，其中诺华/Incyte的芦可替尼、艾伯维的乌帕替尼是这一领域的头部产品，2023年销售额分别高达43亿美元、39.7亿美元。今年上半年，乌帕替尼实现同比增长57.3%至25.23亿美元，超越芦可替尼成为JAK抑制剂领域的新任“药王”。如此巨额的市场蛋糕，必然少不了激烈的厮杀。据统计，目前国内已有10款JAK抑制剂获批上市，4款处于NDA阶段，另外还有超过50款在研，适应症主要集中在自免疾病。从进度上看，迪哲医药的戈利昔替尼已获批用于治疗血液瘤，其他在研适应症主要集中在肿瘤领域，自免适应症尚未进入临床阶段。另外，恒瑞医药的艾玛昔替尼（SHR0302）、泽璟制药的吉卡昔替尼（杰克替尼）均已申报上市，尤其艾玛昔替尼已提交4项适应症的上市申请（强直性脊柱炎、特应性皮炎、类风湿关节炎和斑秃），在自免领域是国产JAK抑制剂中进展最快的。紧随其后的其他国产JAK抑制剂，还包括科伦药业KL130008、先声药业/凌科药业的LNK01001、信达生物的伊他替尼（Itacitinib）等。抢占自免新靶点自免赛道是个“群像戏”，“主角”有很多，除了IL、JAK，还有许多潜力新靶点。例如，武田制药的α4β7整合素抑制剂Entyvio（维得利珠单抗），已于2014年获FDA批准用于治疗溃疡性结肠炎（UC）和克罗恩病（CD），其中在针对UC的头对头研究中击败了前任全球“药王”阿达木单抗。 UC和CD是炎症性肠病（IBD）的重要类型，具有反复发作、难以治愈的特点，且患者数量庞大、获批药物较少。由此，Entyvio在2023年实现销售额超过50亿美元。 IBD赛道巨大的市场潜力，吸引了默沙东、罗氏、艾伯维等众多MNC巨头频频重金布局，靶点集中在整合素α4β7和TL1A。其中，艾伯维在今年6月以超17亿美元引进了明济生物的临床前TL1A单抗FG-M701（其中首付款达1.5亿美元）。图片来源：东方证券研报另外，罗氏研发的第二代CD20单抗奥瑞珠单抗，凭借可超长效治疗多发性硬化症（MS）以及可减少患者给药时间的皮下注射剂型，2023年全球销售额超过70亿美元，今年上半年也达到约40亿美元。诺华的奥法妥木单抗也是获批了MS的第二代CD20单抗，今年上半年实现同比增长64%至13亿美元。可见，针对自免疾病的CD20单抗也将是药企竞逐的“香饽饽”。除此以外，还有一些自免药物靶点已验证了成药性，包括BMS的抗CD80/86融合蛋白阿巴西普，靶向BAFF的泰它西普（BAFF/APRIL）、贝利尤单抗，靶向PDE-4的罗氟司特、阿普米司特等。其中，泰它西普是荣昌生物研发的全新双靶点全人源TACI-Fc融合蛋白，已获批治疗系统性红斑狼疮、类风湿关节炎，目前还有多个自免疾病已处于III期临床，包括重症肌无力、免疫球蛋白A肾病（IgAN）、原发性干燥综合征和视神经脊髓炎频谱系疾病。 PDE-4靶向药物方面，济川药业引进了恒翼生物的HPP737，海南海灵的Hemay005也已处于III期临床。结语自免市场是医药行业的又一高地，无疑成为众多药企竞相追逐的焦点。当前，随着国内药企全力冲刺自免领域，不仅在多个细分赛道上成功突围，更实现了从跟跑到并跑的转变。参考资料： 1.各家公司的财报、公告、官微 2.国投证券、浙商证券、东方证券研报声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

上市批准临床3期生物类似药

2024-10-02

·EndPoints

Triveni to take experimental eczema drug to the clinic, backed by new $115M financing round

On Wednesday, Triveni Bio became the latest immunology and inflammation startup this year to announce a $100 million-plus financing round. Money has come thick and fast to I&I companies this year, and Triveni’s Series B comes less than a year after it announced a $92 million Series A. The new round was led by Goldman Sachs and included Fidelity, Deep Track Capital and other previous investors in the company, like Atlas Venture and OrbiMed. With the raise, Triveni will fund its lead experimental eczema antibody drug, TRIV-509, and plans to ask the FDA to let it start clinical trials of its lead program in the first quarter of 2025. That study will be in healthy volunteers, medical chief Bhaskar Srivastava told Endpoints News , and the company is seeking to develop the asset for atopic dermatitis, or eczema. Srivastava joined the company in June, leaving his post as SVP of clinical development at Nimbus Therapeutics. TRIV-509 targets kallikreins 5 and 7, and is involved in what’s called barrier dysfunction — when the skin can’t act as a proper protector from allergens and other irritants in people with atopic dermatitis. Triveni CEO Vishal Patel described barrier dysfunction as a hallmark feature of atopic dermatitis, as well as inflammation. “The barrier part, in particular, is novel because that is a unique part of that atopic dermatitis vicious cycle that really hasn’t been prosecuted in the past,” Patel told Endpoints. The company is also working on a follow-on compound called TRIV-573 that combines kallikrein 5/7 inhibition with IL-13, a well-known target (one of Dupixent’s targets). Triveni’s third program is an antibody treatment for hereditary pancreatitis.

高管变更

2024-10-02

·PMLiVE

Sanofi/Regeneron’s Dupixent approved by FDA to treat uncontrolled COPD

Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the US Food and Drug Administration (FDA) as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD). The regulator’s decision, which makes Dupixent the first biologic medicines approved in the US for COPD, specifically applies to adults with inadequately controlled cases of the condition and an eosinophilic phenotype. COPD is a chronic respiratory disease that causes progressive lung function decline and results in symptoms such as persistent cough, excessive mucus production and a shortness of breath. Sanofi and Regeneron have outlined that there are approximately 300,000 patients in the US who will be eligible for treatment with Dupixent, a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways shown to be central drivers of the type 2 inflammation that plays a major role in multiple related diseases. The approval was based on positive results from the late-stage BOREAS and NOTUS trials of the therapy in adults with uncontrolled COPD and blood eosinophils of at least 300 cells per μL. All patients were on maximal standard-of-care inhaled therapy and nearly all were receiving triple therapy. The primary endpoint was met in both studies, with Dupixent demonstrating a 30% and 34% reduction in annualised moderate or severe COPD exacerbations compared to placebo over 52 weeks in BOREAS and NOTUS, respectively. Improvements in lung function in Dupixent-treated patients were sustained at 52 weeks, and the therapy was also associated with greater improvements in health-related quality of life compared to placebo at one year, as assessed by a four-point improvement on the St George’s Respiratory Questionnaire. Dupixent was recently approved in the UK, EU and China for uncontrolled COPD, with submissions currently under review with other regulatory authorities globally. Rippon Ubhi, country lead, Sanofi UK and Ireland, said: “This approval represents a significant shift in the longstanding treatment landscape for COPD patients. It marks the first time in more than a decade that we’ve seen a meaningful change in the treatments available to physicians to combat this devastating disease. Respiratory illnesses are the third biggest cause of death in the UK behind cancer and cardiovascular disease. Over 20,000 people with COPD die every year in the UK. “[Dupixent] has been clinically shown to reduce COPD exacerbations and improve lung function, and it is our priority to work with regulatory bodies to ensure patients in the UK can access this important treatment option as soon as possible.”

上市批准临床结果

100 项与度普利尤单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D10354	度普利尤单抗	D11AH05	DB12159

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
慢性阻塞性肺疾病	欧盟	Sanofi Winthrop Industrie SA	2024-07-03
慢性阻塞性肺疾病	冰岛	Sanofi Winthrop Industrie SA	2024-07-03
慢性阻塞性肺疾病	列支敦士登	Sanofi Winthrop Industrie SA	2024-07-03
慢性阻塞性肺疾病	挪威	Sanofi Winthrop Industrie SA	2024-07-03
慢性荨麻疹	日本	Regeneron Pharmaceuticals, Inc.	2024-02-09
嗜酸粒细胞性食管炎	加拿大	Sanofi	2018-02-06
结节性痒疹	澳大利亚	Sanofi	2018-01-24
哮喘	欧盟	Sanofi Winthrop Industrie SA	2017-09-26
哮喘	冰岛	Sanofi Winthrop Industrie SA	2017-09-26
哮喘	列支敦士登	Sanofi Winthrop Industrie SA	2017-09-26
哮喘	挪威	Sanofi Winthrop Industrie SA	2017-09-26
慢性鼻窦炎伴鼻息肉	欧盟	Sanofi Winthrop Industrie SA	2017-09-26
慢性鼻窦炎伴鼻息肉	冰岛	Sanofi Winthrop Industrie SA	2017-09-26
慢性鼻窦炎伴鼻息肉	列支敦士登	Sanofi Winthrop Industrie SA	2017-09-26
慢性鼻窦炎伴鼻息肉	挪威	Sanofi Winthrop Industrie SA	2017-09-26
特应性皮炎	美国	Regeneron Pharmaceuticals, Inc.	2017-03-28

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
嗜酸性粒细胞性十二指肠炎	临床3期	美国	Sanofi	2023-05-03
嗜酸性粒细胞性十二指肠炎	临床3期	美国	Regeneron Pharmaceuticals, Inc.	2023-05-03
嗜酸性粒细胞性十二指肠炎	临床3期	日本	Sanofi	2023-05-03
嗜酸性粒细胞性十二指肠炎	临床3期	日本	Regeneron Pharmaceuticals, Inc.	2023-05-03
嗜酸性粒细胞性十二指肠炎	临床3期	澳大利亚	Sanofi	2023-05-03
嗜酸性粒细胞性十二指肠炎	临床3期	澳大利亚	Regeneron Pharmaceuticals, Inc.	2023-05-03
嗜酸性粒细胞性十二指肠炎	临床3期	意大利	Sanofi	2023-05-03
嗜酸性粒细胞性十二指肠炎	临床3期	意大利	Regeneron Pharmaceuticals, Inc.	2023-05-03
嗜酸性粒细胞性十二指肠炎	临床3期	波兰	Sanofi	2023-05-03
嗜酸性粒细胞性十二指肠炎	临床3期	波兰	Regeneron Pharmaceuticals, Inc.	2023-05-03

登录后查看更多信息

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


NEWS 人工标引	N/A	大疱性类天疱疮	106	Dupixent	觸廠鹽獵齋糧築餘壓淵(廠積鑰壓廠蓋廠簾衊簾) = 憲淵繭糧齋窪窪鏇繭築築製衊願廠願選醖糧壓 (顧廠餘獵鏇築糧蓋鏇鑰 ) 达到	积极	2024-09-11
				Placebo	觸廠鹽獵齋糧築餘壓淵(廠積鑰壓廠蓋廠簾衊簾) = 鹹夢窪築鬱衊構廠廠積築製衊願廠願選醖糧壓 (顧廠餘獵鏇築糧蓋鏇鑰 ) 达到
NCT04180488 (LIBERTY-CUPID, GlobeNewswire) 人工标引	临床3期	慢性荨麻疹	151	Dupixent (dupilumab) (Study C)	簾淵壓範鏇鑰願鬱憲窪(壓觸膚窪夢鏇衊齋積鹽) = 觸襯壓鹹餘醖範艱遞積繭蓋窪鹽鹽蓋衊繭蓋憲 (鑰顧夢淵鏇壓膚製夢膚 ) 达到更多	积极	2024-09-11
				Placebo (Study C)	簾淵壓範鏇鑰願鬱憲窪(壓觸膚窪夢鏇衊齋積鹽) = 簾齋齋鹽觸壓顧襯廠選繭蓋窪鹽鹽蓋衊繭蓋憲 (鑰顧夢淵鏇壓膚製夢膚 ) 达到更多
NCT04456673 \| NCT03930732 (NOTUS, NEWS) 人工标引	N/A	慢性阻塞性肺疾病	-	Dupixent	遞憲廠遞壓襯糧廠築糧(遞製壓選網網窪鹽鑰繭) = 淵壓夢淵構簾遞衊齋窪製襯簾壓繭築願廠繭製 (壓觸廠網憲窪簾鏇憲繭 )	积极	2024-08-27
				Placebo	-
NCT04394351 (EoE KIDS, CTgov)	临床3期	嗜酸粒细胞性食管炎	102	placebo+dupilumab (Part A: Pooled Placebo)	膚鹹壓願簾艱廠鏇壓襯(窪齋壓鑰製淵築齋襯顧) = 蓋網憲窪鏇糧選襯顧蓋鬱醖網顧鏇衊鹹範鏇壓 (廠簾淵簾觸簾鹽壓艱願, 廠選衊鹽遞網淵選壓網 ~ 蓋構遞蓋鬱製網衊廠鏇) 更多	-	2024-08-27
				Dupilumab (Part A: Dupilumab High Dose)	膚鹹壓願簾艱廠鏇壓襯(窪齋壓鑰製淵築齋襯顧) = 鏇製願齋鑰壓鏇顧壓襯鬱醖網顧鏇衊鹹範鏇壓 (廠簾淵簾觸簾鹽壓艱願, 選廠膚蓋築積觸齋餘選 ~ 襯構糧夢艱製淵鏇衊餘) 更多
NCT04442269 (CTgov)	临床2期	变应性支气管肺曲霉菌病	62	Placebo	選觸構餘憲鬱築積衊淵(膚廠鏇壓網鹹淵憲繭鑰) = 廠糧簾齋襯衊構壓壓齋醖衊窪構襯憲獵膚範網 (襯繭艱簾鹽憲繭範膚鑰, 繭繭襯積齋範鬱襯願顧 ~ 鏇壓顧鏇遞獵餘觸製積) 更多	-	2024-08-21
Literature 人工标引	N/A	特应性皮炎	1,286	Dupilumab	鏇壓醖鏇壓範鑰遞廠顧(廠醖襯憲繭遞遞衊壓餘) = 醖繭積網糧築鹽艱糧鹹蓋襯鏇壓範簾積衊獵網 (齋鹹襯網積鹽鹽餘簾築 ) 更多	积极	2024-08-07
NCT02898454 (SINUS-52, Pubmed \| J Allergy Clin Immunol)	临床3期	慢性鼻窦炎伴鼻息肉	303	Dupilumab 300 mg	選齋構廠鑰衊構壓醖廠(夢觸齋齋襯窪膚構夢憲) = 鹹製構鹽繭淵簾鏇鏇顧艱鑰齋鏇構壓鬱壓鹽網 (糧範顧壓築廠繭簾鹽築 ) 更多	积极	2024-08-01
				Placebo	選齋構廠鑰衊構壓醖廠(夢觸齋齋襯窪膚構夢憲) = 憲襯夢憲醖夢醖鑰獵積艱鑰齋鏇構壓鬱壓鹽網 (糧範顧壓築廠繭簾鹽築 ) 更多
NCT04180488 (LIBERTY-CSU CUPID, Pubmed) 人工标引	临床3期	慢性荨麻疹 serum total IgE levels	138	Dupilumab	遞窪廠鏇膚獵選憲簾襯(範遞鑰簾艱選選鑰鏇鏇) = 糧網顧構網廠遞壓糧憲鏇範廠鏇積糧鹹蓋簾鑰 (糧壓憲顧簾製憲襯壓網, -41.9 ~ -22.6) 更多	积极	2024-07-27
				Placebo	遞窪廠鏇膚獵選憲簾襯(範遞鑰簾艱選選鑰鏇鏇) = 構遞蓋鹹窪築築觸遞糧鏇範廠鏇積糧鹹蓋簾鑰 (糧壓憲顧簾製憲襯壓網, -21.3 ~ 14.9) 更多
NCT04400318 (VESTIGE, CTgov)	临床4期	哮喘 \| 气道病变 \| 肺炎	109	Placebo	製夢壓鹹淵願繭蓋鹽簾(淵鏇醖齋鹽構製鏇壓鏇) = 夢膚築齋憲觸顧艱衊鏇廠醖簾築製遞衊網遞選 (獵積齋窪積選蓋鏇憲範, 夢網繭夢獵積積獵積鬱 ~ 夢願蓋蓋醖膚膚簾築範) 更多	-	2024-07-10
NCT02612454 \| NCT03346434 (LIBERTY AD PED-OLE, Pubmed)	临床3期	特应性皮炎	142	Dupilumab	糧獵廠鏇蓋鏇網獵窪構(廠膚憲艱糧觸醖壓壓鏇) = One TEAE led to treatment discontinuation (severe urticaria, which resolved in 1 day) 選獵鬱鹽願積製淵夢積 (膚憲鹹艱餘夢簾網廠衊 )	积极	2024-07-01