度普利尤单抗(Dupilumab) - 药物靶点：IL-4Rα_在研适应症：大疱性类天疱疮，慢性阻塞性肺疾病，慢性荨麻疹_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

作用方式

抑制剂

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

大疱性类天疱疮慢性阻塞性肺疾病慢性荨麻疹+ [26]

非在研适应症

血管性水肿慢性湿疹嗜酸性粒细胞性哮喘+ [9]

原研机构

Sanofi

在研机构

Sanofi

Sanofi Winthrop Industrie SA

Regeneron Pharmaceuticals, Inc.

+ [5]

非在研机构

Sanofi SA

Aimmune Therapeutics, Inc.

Genzyme Corp.

权益机构

Regeneron Pharmaceuticals, Inc.

Sanofi

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)、孤儿药 (澳大利亚)、临床急需境外新药 (中国)、优先审评 (澳大利亚)、孤儿药 (日本)

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结构/序列

Sequence Code 9909199H

来源: *****

Sequence Code 9931072L

来源: *****

关联

252

项与度普利尤单抗相关的临床试验

NCT07112378

/ Recruiting临床3期

A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis

This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment.
The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

开始日期2026-01-13

申办/合作机构

Regeneron Pharmaceuticals, Inc.

[+1]

NCT07187089

/ Not yet recruiting临床4期

An Open-Label, Single-Arm Study to Assess Growth and Bone Mineral Density in Children ≥6 to <12 Years of Age With Severe Atopic Dermatitis Treated With Dupilumab

This study is researching an approved drug called dupilumab (called "study drug"). Dupilumab is approved in the United States for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (also commonly known as eczema).
The aim of the study is to see if dupilumab treatment of children with severe atopic dermatitis, which cannot be adequately controlled with topical atopic dermatitis medication, improves growth and bone strength.
The study is looking at other research questions, including:
• What side effects may happen from taking dupilumab

开始日期2025-11-11

申办/合作机构

Regeneron Pharmaceuticals, Inc.

[+1]

NCT07053423

/ Not yet recruiting临床4期

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease.

LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive).
Study details include:
The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.

开始日期2025-09-15

申办/合作机构

Sanofi

[+1]

100 项与度普利尤单抗相关的临床结果

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100 项与度普利尤单抗相关的转化医学

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100 项与度普利尤单抗相关的专利（医药）

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4,008

项与度普利尤单抗相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Frequency and clinical features of disease flares in patients with atopic dermatitis treated with dupilumab

Article

作者: Parodi, Aurora ; Salvi, Ilaria ; Battaglia, Giorgio ; Vischi, Alice ; Trave, Ilaria ; Cozzani, Emanuele

BACKGROUND:

Dupilumab, an interleukin 4 (IL-4) receptor α-antagonist approved for the treatment of atopic dermatitis, is considered effective in preventing disease recurrences. However, the incidence and characteristics od atopic dermatitis flares during treatment with dupilumab in a real-life setting have not been described in the literature.

OBJECTIVE:

This study aims to evaluate the prevalence of disease flares in patients in treatment with dupilumab and to describe the features of flares in our study population.

METHODS:

We conducted a retrospective observational study in which we collected demographic and clinical data on adult patients with a diagnosis of severe atopic dermatitis in treatment with dupilumab for a minimum of six months, who reached EASI75 within six months of treatment initiation.

RESULTS:

Ninety-nine patients were enrolled. Recurrences were recorded for 38.4% of patients and 7.1% developed a second recurrence. The EASI at recurrence was always lower than the EASI before treatment initiation. The localization of disease at head and neck before treatment was associated to the same localization of disease at the first recurrence (p = 0.011). The risk of recurrence was associated to the baseline EASI score (p = 0.005). The presence of dupilumab-related conjunctivitis was significantly associated to recurrences (p = 0.02).

CONCLUSIONS:

Treatment with dupilumab does not exclude the risk of a relapse, which can be estimated around 50% within a timespan of three years. In the most cases, flares should not be regarded as treatment failures, and can be easily managed with additional treatment.

2025-12-31·Journal of Immunotoxicology

The interaction between the expression of CD23 molecule on B- lymphocytes and the level of specific IgE against molecular components of pollen in atopic dermatitis patients with and without dupilumab therapy

Article

作者: Čelakovská, J. ; Boudková, P. ; Čermáková, E.

The aim of the study here was to evaluate the association between expression of CD23 molecule on B-lymphocytes and the level of specific IgE to molecular components of birch, Bermuda grass, hazel pollen, timothy, and rye grass in atopic dermatitis (AD) patients (with and without dupilumab therapy). A total of 46 patients suffering from AD were included: 26 without dupilumab treatment and 20 with dupilumab treatment. Serum levels of specific IgE were measured by the components resolved diagnostic assay ALEX2 Allergy Xplorer, the expression of CD23 molecule on B-lymphocytes was evaluated with flow cytometry. For the statistical analysis, the Spearman's rank correlation coefficient was used. In patients treated with dupilumab, the higher association was observed between the expression of CD23 on B-lymphocytes and specific IgE to molecular components Bet v 1, Cor a 1.0103, Cor a 1.0401, and Phl p 1. This study demonstrated that the relationship between CD23 expression on B-lymphocytes and specific IgE to pollen molecular components varies depending on whether the patient was treated with dupilumab and the type of molecular component involved.

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Dupilumab monotherapy in super-elderly patients with bullous pemphigoid: a retrospective study on long-term efficacy and safety in mild to moderate cases

Article

作者: Zhang, Qiuli ; Lv, Haozhen ; Yang, Kun ; Zhou, Yuxi ; Bao, Yingqiu ; Han, Zhenxin ; Fang, Xing ; Gong, Qi ; Fu, Yu

BACKGROUND:

Bullous pemphigoid (BP) is a common autoimmune subepidermal bullous disease. Dupilumab, an IL-4/IL-13 inhibitor, represents a novel therapeutic approach for BP, but real-world long-term data in super-elderly patients are limited.

METHODS:

This retrospective, single-center observational study included super-elderly BP patients (≥80 years) receiving dupilumab monotherapy from September 2022 to September 2024. Disease severity was assessed using BPDAI and NRSP, and BP180 antibody, total IgE, and eosinophil count were monitored over 52 weeks.

RESULTS:

Thirteen patients with mild to moderate BP were enrolled. Ten (76.9%) achieved Complete remission (CR) within a mean of 7.4 weeks. BPDAI and NRSP significantly improved, with BPDAI scores decreased from 16.08 ± 9.00 at baseline to 1.23 ± 1.64 at week 16 and 0.23 ± 0.44 at week 52 (both p < 0.001). BP180 and total IgE also showed significant improvement. Two patients experienced relapse after discontinuing treatment. Comorbidities were generally well managed, though three patients passed away due to worsening comorbidities. One patient experienced mild drowsiness and erythema; no other dupilumab-related adverse events were observed.

CONCLUSION:

Dupilumab demonstrates significant long-term efficacy and safety in super-elderly BP patients (≥80 years) with mild to moderate disease and multiple comorbidities, offering a promising alternative to traditional therapies.

2,072

项与度普利尤单抗相关的新闻（医药）

2025-10-01

·BioDialectics

特应性皮炎的多面驱动因子—IL-18

特应性皮炎（AD）作为一种常见的慢性炎症性皮肤病，以剧烈瘙痒、皮肤屏障功能障碍及免疫细胞浸润为核心特征，其发病机制复杂且尚未完全阐明。近期发表的文章《IL-18 in atopic dermatitis-A multifaceted driver of skin inflammation》，系统揭示白细胞介素-18（IL-18）在AD病理生理过程中的关键作用，为理解AD炎症调控机制及开发新型治疗策略提供了重要理论依据。一、IL-18的生物学特性：激活、调控与功能多样性 IL-18作为IL-1细胞因子家族成员，其生物学活性的发挥依赖精准的激活调控与信号传导，且功能具有显著的组织和语境依赖性。 1.产生与激活：多途径调控的“炎症开关” 1）细胞来源与储备：生理状态下，IL-18以无活性前体（pro-IL-18）形式组成表达于上皮细胞（尤其是皮肤基底及棘层角质形成细胞）、巨噬细胞、树突状细胞（DCs）等，皮肤是其最主要的储备组织；炎症刺激（如病原体入侵、组织损伤）可进一步诱导其表达上调。 2）pro-IL-18的激活途径需经蛋白酶切割方可激活，主要途径包括：经典焦亡途径：模式识别受体（PRR）激活后组装炎症小体（如NLRP1、NLRP3、AIM2等），激活胱天蛋白酶-1（caspase-1），切割pro-IL-18生成成熟IL-18，同时释放的N端GasderminD（N-GSDMD）形成膜孔，介导IL-18选择性释放；非经典途径：胞内脂多糖（LPS）直接激活人caspase-4/5，不依赖炎症小体即可切割pro-IL-18；其他途径：Fas诱导的caspase-8激活、细菌蛋白酶（如链球菌致热外毒素B）、NK细胞/CD8⁺T细胞衍生颗粒酶等，也可在炎症小体非依赖模式下激活pro-IL-18。 2.信号传导与调控：精准平衡的“分子网络” 1）受体与信号通路：成熟IL-18需与异二聚体受体（IL-18Rα/IL-18RAP）结合，通过招募MyD88、TRAM等适配器分子，激活IRAK1/4-TRAF6信号轴，进而调控NF-κB、AP-1等转录因子，同时激活MAPK（ERK、JNK）、PI3K/Akt及STAT3通路，参与炎症反应、细胞存活及应激应答。 2）内源性抑制机制：IL-18活性受双重调控以维持免疫稳态： IL-18结合蛋白（IL-18BP）：作为可溶性诱饵受体，与IL-18高亲和力结合使其失活，血清中IL-18BP浓度远超IL-18，约95%循环IL-18处于结合抑制状态，且IL-18诱导的IFN-γ可反向上调IL-18BP，形成负反馈； IL-37：通过竞争结合IL-18Rα并招募IL-1R8/SIGIRR，阻断IL-18信号传导，同时触发抗炎反应，其表达可由LPS、TNF-α等炎症刺激诱导。 3.功能多样性：语境依赖的“炎症调节器” IL-18的功能并非固定不变，而是受组织微环境、协同细胞因子及细胞类型影响： 1）经典功能：传统认知中，IL-18主要促进NK细胞、Th1细胞分泌IFN-γ，参与Th1型免疫应答； 2）AD中的特殊作用：在AD等过敏性疾病中，IL-18可转向促进Th2型炎症，通过激活致病性Th2（pTh2）细胞、2型固有淋巴细胞（ILC2）等，诱导IL-4、IL-5、IL-13等Th2细胞因子分泌； 3) 组织特异性：在胃肠道中，IL-18支持黏膜免疫与屏障完整性，而在皮肤中则主要加剧allergic炎症，这种差异反映了其功能的语境依赖性。二、IL-18在AD中的作用机制：从屏障破坏到炎症放大在AD病理过程中，IL-18通过多维度调控，贯穿“屏障损伤-炎症激活-炎症放大”的全链条，成为连接皮肤屏障功能障碍与免疫紊乱的关键分子。 1.破坏皮肤屏障：形成“恶性循环” 直接抑制屏障相关蛋白：体外实验证实，IL-18可下调角质形成细胞中丝聚蛋白（FLG）、兜甲蛋白（LOR）的表达，这两种蛋白是皮肤角质层的核心结构成分，其表达降低直接导致经表皮水分流失（TEWL）增加、天然保湿因子（NMF）减少，加剧屏障功能障碍；反向促进自身释放：FLG或LOR敲低的角质形成细胞会进一步增加IL-18分泌，形成“IL-18破坏屏障→屏障受损促进IL-18释放”的恶性循环。临床研究显示，AD患者（尤其是携带FLG突变者）皮肤角质层IL-18水平显著升高，且与TEWL呈正相关，印证了这一机制的临床相关性。 2.驱动微生物相关炎症：链接菌群失调与免疫激活 AD皮肤常伴随金黄色葡萄球菌（S.aureus）定植增加，而IL-18是介导微生物刺激与炎症反应的关键桥梁： S.aureus的直接诱导：S.aureus的毒力因子（如肠毒素B、蛋白A）可激活角质形成细胞NLRP1炎症小体，促进caspase-1依赖的IL-18释放；同时，S.aureus感染还可激活巨噬细胞炎症小体，进一步放大IL-18介导的炎症；共生菌的间接影响：皮肤共生菌表皮葡萄球菌分泌的酚溶性调节蛋白，也可触发角质形成细胞caspase-1激活与IL-18释放，且FLG缺陷会增强这一响应，提示IL-18可能是结构屏障缺陷与菌群紊乱交互作用的“分子枢纽”。 3.调控免疫细胞：放大Th2型炎症 IL-18通过靶向多种免疫细胞，精准放大AD中的Th2型炎症反应，其作用具有细胞特异性：致病性Th2（pTh2）细胞：pTh2细胞是AD中Th2炎症的核心效应细胞，与常规Th2细胞不同，其持续表达IL-18受体（IL-18R），IL-18可显著增强其IL-13、IL-22分泌；且IL-9可进一步上调pTh2细胞IL-18R表达，形成“IL-9-IL-18-pTh2”的正向放大环路； 2型固有淋巴细胞（ILC2）：皮肤ILC2高表达IL-18R，IL-18可直接激活其分泌IL-5、IL-13，且与IL-3协同作用时激活效应更强；IL-18敲除小鼠的AD模型中，ILC2浸润与细胞因子分泌显著减少，证实其对ILC2的调控作用； NK细胞：AD患者存在NK细胞数量减少、细胞毒性受损的现象，IL-18通过激活诱导细胞死亡（AICD）、NK细胞fratricide（自相残杀）及TNF-α介导的细胞死亡，导致NK细胞耗竭；同时，IL-18还可使NK细胞从分泌IFN-γ转向分泌TNF-α，削弱其抑制Th2炎症的能力，进一步加剧免疫失衡。三、IL-18与AD的临床关联：从生物标志物到治疗靶点 IL-18不仅是AD病理机制中的关键分子，还具有重要的临床转化价值，可作为AD的生物标志物及潜在治疗靶点。 1.AD生物标志物：评估病情与治疗响应诊断与严重度评估：AD患者血清及皮肤IL-18水平均显著升高，且与疾病严重度评分（EASI/SCORAD）呈中等程度正相关（r≈0.35-0.60），其相关性优于胸腺基质淋巴细胞生成素（TSLP）。预测与监测价值：非病变皮肤IL-18升高可在AD临床症状出现前预测疾病发生，提示其潜在的早期诊断价值；此外，皮肤IL-18水平可随局部治疗（如外用药物）正常化，血清IL-18则对系统性治疗（如度普利尤单抗）响应敏感，可用于监测治疗效果；亚型区分：IL-18在外源性AD（高IgE、Th2主导）中水平显著高于内源性AD（正常IgE、Th1/Th17主导），为AD亚型分型提供了分子依据。 2.治疗靶点：新型干预策略的开发基于IL-18在AD中的核心作用，多种靶向IL-18的治疗策略已进入临床开发阶段，主要包括：抗IL-18抗体：AVTX007（IIa期）、GSK1070806（IIb期）、CMK389（II期已完成）等药物均显示出良好的短期安全性，且GSK1070806在早期临床试验中呈现剂量依赖性的EASI评分改善及瘙痒缓解，提示其临床潜力。重组IL-18BP：IL-18BP作为内源性抑制剂，已在巨噬细胞活化综合征等疾病中验证疗效，其白蛋白结合修饰形式可延长半衰期，在小鼠AD模型中，该修饰形式的抗炎效果优于抗IL-18单克隆抗体。上游炎症小体/焦亡抑制剂：抑制炎症小体组装（如NLRP1抑制剂）或焦亡关键分子（如GSDMD抑制剂），可减少IL-18激活释放，小鼠模型显示此类干预可缓解AD样皮炎。四、总结思考：治疗机遇与挑战 IL-18作为AD炎症的多面驱动因子，其研究为AD病理机制解析及治疗突破提供了重要视角，但从基础研究到临床应用仍需解决多重关键问题。 1.安全性平衡：规避长期抑制的潜在风险 IL-18在正常免疫防御（如抗菌、抗肿瘤）中具有重要作用，长期抑制可能带来免疫功能受损风险：短期安全性验证：目前临床研究显示抗IL-18药物短期安全性良好，但需长期随访评估其对感染（如皮肤细菌/病毒感染）、肿瘤发生的影响；局部治疗优先：鉴于皮肤是IL-18的主要作用部位，开发局部IL-18抑制剂（如外用IL-18BP、局部炎症小体抑制剂）可能在增强疗效的同时降低全身毒性。 3.联合治疗：协同改善AD多维度病理 AD的复杂性决定了单一靶点治疗难以完全控制疾病，联合治疗具有广阔潜力：与Th2细胞因子抑制剂联用：IL-18主要作用于pTh2细胞上游激活环节，与IL-4/IL-13抑制剂（如度普利尤单抗）联用，可从“上游激活-下游效应”双重阻断Th2炎症，增强疗效；与JAK抑制剂联用：JAK抑制剂可抑制IL-18下游信号通路（如STAT3、NF-κB），与IL-18抑制剂联用可能产生协同抗炎效应，同时覆盖AD中的多种炎症通路；与屏障修复剂联用：针对IL-18介导的屏障破坏，联合使用皮肤屏障修复剂（如神经酰胺、胆固醇），可打破“屏障受损-IL-18释放”的恶性循环，提升长期治疗效果。 IL-18作为AD病理中的关键分子，IL-18靶向疗法有望成为AD治疗的重要补充，为更多难治性AD患者带来新的治疗选择。但同时也需认识到，AD的异质性及IL-18功能的复杂性仍需进一步研究，只有通过多学科协作、基础与临床转化结合，才能真正实现IL-18靶向治疗的临床价值。《IL-18 in atopic dermatitis - A multifaceted driver of skin inflammation》，The Journal of Allergy and Clinical Immunology，2025

临床结果

2025-10-01

·药番茄Pharmato

诺华：全球首款治疗慢性自发性荨麻疹的口服BTK抑制剂获FDA批准

9月30，诺华（Novartis）宣布，FDA已批准其新药Rhapsido®（remibrutinib）上市。该药物是一种每日两次的口服BTK抑制剂，用于治疗在使用H1抗组胺药后仍有症状的成年慢性自发性荨麻疹（CSU）患者。此次批准标志着CSU治疗领域的一个重要里程碑，为患者提供了首个无需注射、无需常规实验室监测的靶向口服治疗新选择。路透社报道，Rhapsido在美国的标价约为4521美元/30天，III期数据在瘙痒、风团计数和总体疾病活动度方面显示显著改善，约三分之一患者在第12周时达到症状完全缓解。慢性自发性荨麻疹（CSU）是一种令人痛苦且难以预测的皮肤疾病，其特征是突发的、持续超过六周的瘙痒性风团和/或血管性水肿。据统计，美国有超过170万人受到该疾病困扰，超过半数的CSU患者对H1抗组胺药治疗反应不佳，生活质量受到严重影响。Rhapsido®通过靶向BTK这一关键炎症通路，有效抑制组胺等炎症介质的释放，从而快速、持续地缓解患者的瘙痒和风团症状。· Rhapsido®作为CSU领域的首个BTK抑制剂上市药物，预计将对皮肤科和免疫学药物市场产生深远影响。对CSU治疗市场格局对生物制剂格局的冲击。Xolair（Omalizumab，奥马珠单抗）2024年全球销售额约44亿美元，长期占据CSU与哮喘等适应症的核心地位。随着诺华的Dupixent扩展至CSU以及Rhapsido的加入，CSU用药结构或从“单一生物制剂为主”转向“生物制剂 + 口服小分子”的双线格局，预计将对Xolair在CSU份额带来结构性压力，同时推动生物制剂向更难治或特殊人群聚焦。 BTK抑制剂应用领域的拓展 BTK抑制剂最初主要用于治疗血液肿瘤，Rhapsido®的获批成功地将其适应症拓展到了自身免疫性疾病领域，为这一靶点在如慢性诱导性荨麻疹、化脓性汗腺炎和食物过敏等其他疾病的治疗探索开辟了新的可能性。下面表格总结了BTK针对CSU研发的竞争格局，根据智慧芽新药情报数据，BTK在研药物超过373个新药，其中在研适应症包括CSU的包含12款如下，未来可能会有更多BTK药物转战CSU市场。总结诺华Rhapsido®的获批是CSU患者的福音，它以其差异化的口服优势和确切的疗效，预示着CSU治疗将进入一个由口服靶向药物引领的新时代，并极大地丰富了诺华在免疫学领域的产品组合。 Reference： https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-rhapsido-remibrutinib-only-oral-targeted-btki-treatment-chronic-spontaneous-urticaria-csu https://www.centerforbiosimilars.com/view/omalizumab-biosimilar-matches-reference-product-in-chronic-spontaneous-urticaria?utm_source=chatgpt.com https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-novartis-drug-skin-disease-2025-09-30/?utm_source=chatgpt.com 关于药番茄科技我们一支致力于医药企业数智化解决方案的团队，在医药数据智能与大语言模型应用方面具有多年经验与落地的项目案例。药企AI解决方案，医药竞争格局调研咨询与解决方案业务，欢迎联系助理进一步沟通。声明：本文内容供业内同行交流学习，不代表药番茄表平台立场，不构成任何投资意见和建议。药番茄不对任何主体因使用本文内容而导致的任何损失承担责任。内容如有疏漏，欢迎沟通指出！

上市批准临床3期申请上市

2025-10-01

·BioSpace

Novartis Secures First FDA Approval of Oral BTK Inhibitor for Chronic Hives

iStock, TBE The first oral BTK blocker for chronic spontaneous urticaria, Rhapsido offers a more convenient treatment option for patients who still show symptoms after antihistamine treatment. The FDA has approved Novartis’ remibrutinib for the treatment of chronic spontaneous urticaria. The drug will be marketed under the brand name Rhapsido . In particular, Rhapsido is indicated for adult patients who continue to suffer from the symptoms of hives even after antihistamine treatment. In the U.S., that means a market of more than half of the 1.7 million people with the condition, according to a company press release on Wednesday. Rhapsido will have a wholesale acquisition cost of $4,521 per 30-day supply, and will be available “in the coming days,” a Novartis spokesperson told BioSpace in an email. Rhapsido is the first oral and targeted BTK inhibitor for chronic spontaneous urticaria (CSU). Before its approval, patients who do not respond completely to antihistamines were given injectable therapies, such as Roche’s Xolair. In April this year, the FDA expanded treatment options for CSU when it approved Sanofi and Regeneron’s Dupixent for the indication. Unlike Xolair and Dupixent, which are monoclonal antibodies, Rhapsido is an orally available blocker of the BTK enzyme. This mechanism disrupts a signaling cascade and prevents the secretion of histamine, which causes the itching and swelling typical of CSU. Phase III data from the REMIX program, published in March in the New England Journal of Medicine , showed treatment with Rhapsido resulted in improvements in urticaria activity scores versus placebo, a benefit that was sustained through 24 weeks of follow-up. In a prepared statement alongside Novartis’ press announcement on Tuesday, Giselle Mosnaim, University of Chicago immunologist and investigator on the REMIX trial, called Rhapsido’s approval “significant,” noting that it provides an alternative “beyond existing injectable treatments and gives patients an oral option that can easily be incorporated into their daily lives.” Besides CSU, Novartis is also testing remibrutinib—Rhapsido’s active ingredient—in other immune indications. In March last year, the pharma reported findings from a small Phase IIb study, demonstrating that a 25-mg dose of the drug achieved a 50% reduction in abscesses and inflammatory nodules in 73% of treated patients with hidradenitis suppurativa, compared with 34.7% of placebo comparators. At the time of that mid-stage readout, Novartis said it had plans to approval in this indication before the end of 2024, but it is unclear if the company pushed through with those plans. In its latest earnings presentation , remibrutinib’s hidradenitis suppurativa program was listed as a late-stage project. Beyond immunology, Novartis is also testing remibrutinib as a therapy for multiple sclerosis, for which it is running two Phase III studies. Primary completion for both trials is expected in 2026 .

临床结果临床3期上市批准临床2期并购

100 项与度普利尤单抗相关的药物交易

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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,

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适应症	国家/地区	公司	日期
大疱性类天疱疮	美国	Regeneron Pharmaceuticals, Inc.	2025-06-18
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	Sanofi KK	2024-02-09
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,

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适应症	最高研发状态	国家/地区	公司	日期
瘙痒	临床3期	美国	Sanofi	2022-02-15
瘙痒	临床3期	中国	Sanofi	2022-02-15
瘙痒	临床3期	日本	Sanofi	2022-02-15
瘙痒	临床3期	阿根廷	Sanofi	2022-02-15
瘙痒	临床3期	澳大利亚	Sanofi	2022-02-15
瘙痒	临床3期	加拿大	Sanofi	2022-02-15
瘙痒	临床3期	克罗地亚	Sanofi	2022-02-15
瘙痒	临床3期	德国	Sanofi	2022-02-15
瘙痒	临床3期	希腊	Sanofi	2022-02-15
瘙痒	临床3期	匈牙利	Sanofi	2022-02-15

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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


NCT05878093 (CTgov)	临床3期	慢性鼻窦炎伴鼻息肉	63	Placebo+Budesonide	餘醖遞構鑰鹽選構淵襯(鏇醖範範壓範窪遞壓蓋) = 醖遞選鬱餘糧襯夢顧繭廠鏇糧醖淵夢願網艱範 (淵餘鏇獵衊醖夢遞鹹襯, 0.30) 更多	-	2025-09-25
NCT03054428 \| NCT02260986 \| NCT03345914 \| NCT02277769 \| NCT02277743 \| NCT03346434 (Pubmed \| Am J Clin Dermatol)	临床3期	中度特应性皮炎	7,000	Dupilumab + Dupilumab	齋窪簾鹹鬱製網衊鹽積(遞鏇觸襯鑰壓夢構齋窪) = 鬱顧獵積襯艱遞構願艱鏇簾蓋簾餘範艱夢憲願 (鑰鏇鑰艱願醖鬱鹹範蓋 )	积极	2025-09-24
	临床3期	中度特应性皮炎	7,000	Placebo + TCS	齋窪簾鹹鬱製網衊鹽積(遞鏇觸襯鑰壓夢構齋窪) = 簾簾築築構窪觸鬱網遞鏇簾蓋簾餘範艱夢憲願 (鑰鏇鑰艱願醖鬱鹹範蓋 )	积极	2025-09-24
NCT02260986 (LIBERTY AD CHRONOS, Pubmed \| Dermatol Ther (Heidelb))	临床3期	中度特应性皮炎	90	Dupilumab	鹹鑰鹹夢願製餘襯鑰窪(選鬱艱築鹽艱蓋遞餘鏇) = 壓鏇衊憲構壓醖壓鑰顧糧選衊憲齋構積遞獵範 (衊鹽積範衊製夢顧膚鑰 ) 更多	积极	2025-09-19
NCT05049122 (LIBERTY SINUS-24, Pubmed \| Laryngoscope)	临床4期	慢性鼻窦炎伴鼻息肉	25	Dupilumab 300 mg	製鹽艱製淵遞糧襯壓鏇(簾醖製鬱膚憲鑰蓋齋淵) = 築廠製繭憲艱鏇膚鏇簾構繭願衊夢遞築夢築築 (繭構築鬱餘鑰願範醖繭 )	积极	2025-08-30
NCT04180488 (LIBERTY-CSU CUPID Study C \| LIBERTY-CSU CUPID \| LIBERTY-CUPID-Study A \| LIBERTY-CUPID-Study B \| LIBERTY-CSU CUPID Study A \| LIBERTY-CUPID \| Liberty-Cupid C \| CUPID, CTgov)	临床3期	慢性荨麻疹	397	placebo+dupilumab+omalizumab (Study A: Placebo)	選餘鬱製遞艱顧築構簾(膚憲襯醖選積繭餘獵夢) = 範遞餘觸鹹鏇餘範簾製獵鬱蓋糧窪壓鬱膚醖襯 (獵廠選顧膚醖繭餘範範, 0.94) 更多	-	2025-08-20
	临床3期	慢性荨麻疹	397	Dupilumab (Study A: Dupilumab)	選餘鬱製遞艱顧築構簾(膚憲襯醖選積繭餘獵夢) = 鬱鑰選鹽憲淵範鹽窪鏇獵鬱蓋糧窪壓鬱膚醖襯 (獵廠選顧膚醖繭餘範範, 0.91) 更多	-	2025-08-20
NCT06369467 (NEWS)	临床1期	食物过敏	1	Linvoseltamab+Dupilumab	膚齋鏇獵糧鏇願壓觸鹹(廠膚艱獵夢鏇獵鬱選獵) = 夢鏇廠衊艱糧廠鬱獵築壓鹹壓蓋鹽積餘壓遞衊 (憲壓遞構壓鬱網簾遞膚 )	积极	2025-08-01
NCT04206553 (ADEPT, FDA_CDER) 人工标引	临床2/3期	大疱性类天疱疮	106	DUPIXENT 300 mg Q2W + OCS	簾觸鬱積蓋鹽醖憲壓齋(築觸繭積夢鏇艱選鹹願) = 廠遞選鹹醖繭鬱蓋鏇築膚願積網廠蓋顧衊齋鑰 (製鬱製廠蓋廠鏇顧積衊 ) 更多	积极	2025-06-18
NCT04206553 (ADEPT, FDA_CDER) 人工标引	临床2/3期	大疱性类天疱疮	106	Placebo + OCS	簾觸鬱積蓋鹽醖憲壓齋(築觸繭積夢鏇艱選鹹願) = 觸襯範繭鑰壓鑰選獵獵膚願積網廠蓋顧衊齋鑰 (製鬱製廠蓋廠鏇顧積衊 ) 更多	积极	2025-06-18
NCT04998604 (EVEREST, Company_Website) 人工标引	临床4期	哮喘 \| 慢性鼻窦炎伴鼻息肉	360	Dupixent 300 mg every two weeks	積製製糧製鬱願築艱醖(夢觸壓衊壓窪構蓋鹹鬱) = 廠艱衊簾醖艱醖範鹽夢獵網選範積積願糧夢衊 (製鏇構觸選願願顧憲廠 ) 更多	积极	2025-06-15
NCT04998604 (EVEREST, Company_Website) 人工标引	临床4期	哮喘 \| 慢性鼻窦炎伴鼻息肉	360	Xolair	-	积极	2025-06-15
NCT05590585 (DISCOVER, NEWS) 人工标引	临床4期	特应性皮炎	120	Dupixent	鑰觸壓遞鬱觸鏇糧觸範(憲繭餘衊齋醖構鏇憲襯) = 76% of patients achieved at least a 75% improvement 構鏇衊廠鬱夢襯艱鏇願 (窪繭糧壓壓淵襯鑰壓襯 ) 更多	积极	2025-06-12
ASCO2025	N/A	大疱性类天疱疮	17	Dupilumab	遞壓淵顧構蓋憲築鹽製(鑰顧繭鏇鏇構繭構壓蓋) = 糧膚獵鬱鑰糧艱醖積積鹽選鑰鏇觸壓糧鬱醖淵 (願糧鑰簾範觸廠鏇範積 ) 更多	积极	2025-05-30