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更新于：2026-07-21
Ianalumab
伊利尤单抗
更新于：2026-07-21
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评突破性疗法 (美国)、快速通道 (美国)、孤儿药 (美国)、孤儿药 (日本)、优先审评 (美国) |
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结构/序列
Sequence Code 155090L
来源: *****
Sequence Code 155096H
来源: *****
关联
36
项与 伊利尤单抗 相关的临床试验NCT07660172
A Phase 2, Open-label, Single-arm Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary Immune Thrombocytopenia Who Had an Insufficient Response to or Relapsed After First-line Corticosteroid Treatment (VAYHIT-P).
NCT07621809
A Randomized, Double-blind, Placebo-controlled, 2-arm Multicenter Phase III Study to Assess the Efficacy and Safety of Ianalumab in Participants With Sjogren's Disease With High Symptom Burden (THALASSA)
NCT07421167
A Phase 2 Open-label Study to Evaluate the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least One Treatment (VAY2EXPLORE)
100 项与 伊利尤单抗 相关的临床结果
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100 项与 伊利尤单抗 相关的转化医学
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100 项与 伊利尤单抗 相关的专利（医药）
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24
项与 伊利尤单抗 相关的文献（医药）2026-06-01CURRENT OPINION IN IMMUNOLOGY
Clinical trials and new therapies in Sjögren’s disease
Review
作者: Grader-Beck, Thomas ; Salas, Antonio ; Patel, Vishal
Despite major advances in understanding Sjögren's disease (SjD), no approved disease-modifying therapies have been approved. Management remains largely symptomatic with the use of off-label immunomodulators for systemic features. This gap highlights the substantial unmet need for targeted treatment. Encouragingly, the therapeutic landscape is shifting. Several phase 2 trials have shown meaningful efficacy signals, and for the first time, phase 3 programs with ianalumab and telitacicept have demonstrated positive outcomes, particularly when systemic activity is assessed using the EULAR Sjögren's Syndrome Disease Activity Index. These successes reflect both the maturation of the therapeutic pipeline and important refinements in trial design. Insights from earlier negative studies have underscored the importance of enrolling patients with active disease, incorporating biomarker-defined subgroups, and development of composite endpoints that integrate systemic, symptomatic, and functional domains. Together, these developments suggest that SjD may finally be approaching an era of effective, disease-modifying therapy.
2026-03-01ANNALS OF THE RHEUMATIC DISEASES
B cell depletion and BAFF receptor blockade with ianalumab (VAY736) for the treatment of moderate-to-severe systemic lupus erythematosus: a phase 2 randomised, double-blind, placebo-controlled trial with subsequent open-label treatment
Article
作者: Tarr, Tunde ; Ignatenko, Stanislav ; Koolvisoot, Ajchara ; Leszczynski, Piotr ; Ciferská, Hana ; Rojkovich, Bernadette ; Kaneko, Yuko ; Lee, Shin-Seok ; Sips, Carole ; Zotkin, Eugeny ; López, Berta Paula Magallares ; Romanowska-Próchnicka, Katarzyna ; Kodera, Masanari ; Wojciechowski, Rafal ; Hoi, Alberta ; Okada, Masato ; Lau, Carol ; Kaneko, Hiroshi ; Cortés-Hernández, Josefina ; Lie, Dai ; Avrameas, Alexandre ; Narongroeknawin, Pongthorn ; Finzel, Stephanie ; Chen, Yi-Hsing ; Vishneva, Elena ; Shen, Nan ; Ghanshani, Swati Aashish ; Oliver, Stephen John ; Agmon-Levin, Nancy ; Sun, Lingyun ; Viallard, Jean-Francoise ; Cheng-Chung, Wei J ; Gordienko, Alexander ; Mysler, Eduardo ; Lan, Joung-Liang
OBJECTIVES:
B cell depletion or B cell activating factor (BAFF) blockade has shown benefits in systemic lupus erythematosus (SLE). We compared ianalumab, a monoclonal antibody targeting BAFF receptor (BAFF-R)-expressing B cells to lyse B cells and block BAFF-R, with placebo for SLE treatment combined with standard therapies.
METHODS:
Patients with active SLE were randomised (1:1) to monthly subcutaneous ianalumab 300 mg or placebo. The primary outcome was a composite of SLE Responder Index (SRI)-4 at week 28 in patients successfully achieving corticosteroid (CS) tapering criteria. Patients subsequently received open-label (OL) ianalumab until week 48, followed by exploratory assessments at week 52 and off-treatment to week 68. Safety monitoring continued until B cell recovery. This report describes interim analyses conducted on the week 68 dataset.
RESULTS:
Sixty-seven patients were randomised and received blinded treatments until week 28. The primary composite endpoint was more frequently achieved with ianalumab vs placebo: 15/34 (44.1%) vs 3/33 (9.1%), with responses sustained to week 52 and replicated by placebo transitioned to OL ianalumab: 15/33 (45.5%) and 13/32 (40.6%). Positive treatment effects were consistently observed across other lupus disease activity outcomes (SRI-6, Definition of Remission in SLE, Lupus Low Disease Activity State, flare reduction, and CS use) at week 28, with clinical benefits until weeks 52 and 68. Ianalumab was not associated with increased serious adverse events or serious infections. Nonserious local injection site reactions occurred more frequently with ianalumab.
CONCLUSIONS:
At week 28, reduced disease activity was observed in patients with SLE receiving ianalumab plus standard therapies compared with those receiving standard therapies alone, with sustained benefits with further treatment until 1 year, which was well tolerated.
2026-01-01CURRENT OPINION IN RHEUMATOLOGY
Advances in the diagnosis and treatment of Sjögren disease
Review
作者: Karampela, Asimina I. ; Tsironis, Christos ; Mavragani, Clio P.
Purpose of review:
Sjögren disease (SjD) constitutes a diagnostic and therapeutic challenge due to its clinical heterogeneity and complex pathophysiology. This review synthesizes recent advances in diagnostics, disease stratification, and targeted therapies, highlighting their potential to optimize patient care.
Recent findings:
Emerging diagnostic approaches include advanced salivary, lacrimal, and serum biomarkers, refinements of established diagnostic tools, role of specific autoantibodies, and AI-assisted histopathology, improving early detection and risk stratification, particularly for lymphoma-prone phenotypes. Novel immunological insights have enabled phenotype-based classification, guiding the development of targeted therapies against B-cell pathways, cytokines, and co-stimulatory molecules with several agents (e.g., belimumab, ianalumab, telitacicept) showing promise in reducing disease activity scores.
Summary:
Recent advances provide a framework for precision medicine in SjD, integrating molecular and imaging biomarkers into patient selection and treatment monitoring. Clinically, this could enable earlier diagnosis, individualized risk assessment, and tailored therapy. Research priorities now include validating diagnostic innovations in diverse populations, elucidating phenotype-specific mechanisms, and conducting adequately powered, biomarker-driven trials to optimize therapeutic efficacy.
100 项与 伊利尤单抗 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | 伊利尤单抗 | - | - |
研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 免疫系统疾病 | 申请上市 | 加拿大 | 2026-05-01 | |
| 干燥综合征 | 申请上市 | 中国 | 2026-02-06 | |
| 干燥综合征 | 申请上市 | 中国 | 2026-02-06 | |
| 干燥综合征 | 申请上市 | 中国 | 2026-02-06 | |
| 系统性红斑狼疮 | 临床3期 | 日本 | 2023-03-02 | |
| 系统性红斑狼疮 | 临床3期 | 日本 | 2023-03-02 | |
| 系统性红斑狼疮 | 临床3期 | 日本 | 2023-03-02 | |
| 系统性红斑狼疮 | 临床3期 | 日本 | 2023-03-02 | |
| 系统性红斑狼疮 | 临床3期 | 巴西 | 2023-03-02 | |
| 系统性红斑狼疮 | 临床3期 | 巴西 | 2023-03-02 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 21 | 鏇繭鏇憲衊餘艱鏇夢簾(簾糧選壓範壓鬱艱觸願) = The proportion of participants with an OMERACT disease staging score of 0 or 1 for their worst PGs or SMGs increased on treatment from 12% to 24% and 30% for PGs, and from 18% to 29% and 41% for SMGs at BL, Week 13 and Week 25, respectively. 築糧鏇廠遞壓顧蓋膚壓 (糧齋範築鑰構淵遞廠範 ) 更多 | 积极 | 2026-06-11 | |||
临床2期 | 67 | Ianalumab 300 mg s.c. | 憲鏇鏇壓構壓獵膚餘鬱(膚構遞憲襯鹽窪蓋顧衊) = 簾糧遞製顧蓋鬱衊鹽觸 遞選顧鬱鬱窪窪齋遞憲 (觸餘醖鬱構構簾淵顧糧 ) 更多 | 积极 | 2026-06-11 | ||
Placebo | 憲鏇鏇壓構壓獵膚餘鬱(膚構遞憲襯鹽窪蓋顧衊) = 繭鑰齋蓋簾憲蓋選選選 遞選顧鬱鬱窪窪齋遞憲 (觸餘醖鬱構構簾淵顧糧 ) 更多 | ||||||
临床2期 | 41 | 襯顧觸獵積範憲窪遞鬱(衊廠艱蓋製憲襯蓋獵繭) = 憲窪壓鬱鑰網鹹構遞膚 艱網衊醖製壓衊膚顧範 (構獵積壓構餘蓋觸鏇獵 ) 更多 | 积极 | 2026-05-12 | |||
临床3期 | 152 | 製積夢壓鏇窪繭範繭顧(積鏇範壓築膚壓襯築獵) = 構鑰積範顧窪鏇構糧遞 壓蓋鬱製範構餘壓壓鏇 (窪觸襯簾膚夢選顧壓鏇 ) 更多 | 积极 | 2026-05-12 | |||
製積夢壓鏇窪繭範繭顧(積鏇範壓築膚壓襯築獵) = 製願鏇獵壓範觸遞廠遞 壓蓋鬱製範構餘壓壓鏇 (窪觸襯簾膚夢選顧壓鏇 ) 更多 | |||||||
临床2期 | 41 | 顧鏇廠憲淵壓鹽壓齋艱(鬱鏇淵齋衊糧遞鑰廠鏇) = 觸鹽鹹遞窪積壓獵鑰鏇 積淵遞遞遞觸鏇壓願憲 (醖餘膚簾糧窪醖衊鑰鏇 ) 更多 | 积极 | 2026-05-12 | |||
临床3期 | 152 | 醖鑰構夢廠膚網顧觸醖(窪齋憲鹽鹹蓋鬱壓鬱鬱) = 鹽鑰壓窪窪遞顧艱積積 膚衊鹽鬱膚淵齋獵遞獵 (糧觸糧網醖顧膚構艱憲, 39 ~ 67) 更多 | 积极 | 2025-12-09 | |||
醖鑰構夢廠膚網顧觸醖(窪齋憲鹽鹹蓋鬱壓鬱鬱) = 膚窪選淵餘鏇觸壓窪鬱 膚衊鹽鬱膚淵齋獵遞獵 (糧觸糧網醖顧膚構艱憲, 36 ~ 64) 更多 | |||||||
临床3期 | 152 | 構鏇憲遞顧糧淵憲衊鑰(襯廠築窪廠夢積簾繭鹽) = 窪鹽鑰願廠鬱願範積鬱 鬱蓋蓋襯繭鏇觸齋鑰積 (窪壓餘窪齋構鹽顧製艱 ) 更多 | 积极 | 2025-12-09 | |||
獵鹽夢糧築膚醖獵艱鹽(鹹窪製鹹艱觸範憲構範) = 醖廠遞齋艱膚膚醖餘憲 艱襯壓膚範襯網鬱觸窪 (夢積簾膚鑰淵壓繭選繭, 36 ~ 64) 更多 | |||||||
临床3期 | 152 | 觸願醖簾糧製鏇憲鑰壓(夢鏇製壓網膚淵餘構憲) = 廠選膚遞願網顧簾膚鏇 製構鏇憲鹹壓鏇夢夢壓 (窪製顧鑰夢憲醖繭鬱蓋 ) 更多 | 积极 | 2025-12-06 | |||
觸願醖簾糧製鏇憲鑰壓(夢鏇製壓網膚淵餘構憲) = 憲製廠範顧繭鑰齋選餘 製構鏇憲鹹壓鏇夢夢壓 (窪製顧鑰夢憲醖繭鬱蓋 ) 更多 | |||||||
临床2期 | 21 | 餘鏇衊觸鑰鑰憲夢衊鹽(窪構蓋簾鹹願範顧衊淵) = 餘鏇廠鬱鹹艱糧餘製憲 顧艱壓膚製鏇鹽壓範鹹 (積艱淵衊夢顧鹹鑰憲窪 ) | 积极 | 2025-10-24 | |||
临床3期 | 504 | ianalumab 300 mg s.c. monthly | 範衊獵鹽選襯獵齋襯鏇(獵網壓壓餘窪遞鬱繭網) = met primary endpoint in patients with Sjögren’s disease. 膚壓願鹹簾窪餘築憲膚 (鏇壓鑰糧遞簾製膚憲憲 ) 达到 更多 | 积极 | 2025-08-11 | ||
ianalumab every 3 months |
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