预约演示
更新于：2026-01-27
Nemolizumab
尼莫利珠单抗
更新于：2026-01-27
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 日本 (2022-03-28), |
最高研发阶段(中国)临床申请批准 |
特殊审评孤儿药 (美国)、优先审评 (美国)、突破性疗法 (美国) |
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结构/序列
Sequence Code 81291H
来源: *****
Sequence Code 1151753L
来源: *****
关联
32
项与 尼莫利珠单抗 相关的临床试验NCT07352566
Utilization of a Cutaneous Therapy In Situ Microdevice
NCT07047690
A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Nemolizumab in Adult Patients With Systemic Sclerosis
NCT07074977
An Exploratory Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics (PK/PD) of Nemolizumab in Adult Participants With Chronic Pruritus of Unknown Origin (CPUO)
100 项与 尼莫利珠单抗 相关的临床结果
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100 项与 尼莫利珠单抗 相关的转化医学
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100 项与 尼莫利珠单抗 相关的专利（医药）
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182
项与 尼莫利珠单抗 相关的文献（医药）2026-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Nemolizumab for chronic pruritus beyond atopic dermatitis and prurigo nodularis: a systematic review and synthesis of emerging evidence
Review
作者: Shanshal, Mohammed ; Uthayakumar, Aarthy
BACKGROUND:
Nemolizumab, an anti-IL-31 receptor A antibody, is licensed for atopic dermatitis and prurigo nodularis; its role in other chronic pruritus (CP) syndromes is uncertain.
OBJECTIVE:
To synthesize efficacy, safety and strength of evidence for nemolizumab in CP beyond these indications. Methods: We conducted a PROSPERO-registered systematic review (CRD420251207054) of databases and trial registries to November 2025 for nemolizumab studies in CP outside AD/PN. Eligible reports were extracted and patients grouped as systemic, neurologic/neurogenic, dermatologic (non-AD) or primary CP/CP of unknown origin.
RESULTS:
Seventeen reports (one randomized trial, two cohorts, 14 case series/reports) describing 114 patients were included. In chronic kidney disease-associated pruritus, a phase II hemodialysis trial showed modest, statistically uncertain benefit versus placebo, contrasting with rapid, near-complete relief in dialysis and cholestatic case reports. Uncontrolled data in neuropathic itch/pain syndromes, non-AD inflammatory and papular dermatoses (notably amyloidosis and perforating disorders) and long-standing primary CP/CPUO described complete itch clearance. Across indications, nemolizumab was well tolerated, but certainty was low for CKD-aP and very low for other groups.
CONCLUSIONS:
Nemolizumab shows plausible antipruritic activity across CP phenotypes, yet the evidence base remains fragile; these signals justify cautious experimental use and prioritize etiology-specific IL-31 receptor blockade trials beyond AD/PN.
2026-12-01MOLECULAR BIOLOGY REPORTS
Construction of genetically modified lactic acid bacteria producing an Anti-Interleukin-31 receptor A Single-chain variable fragment
Article
作者: Murakami, Aito ; Ikeda, Hotaru ; Sato, Takashi ; Namai, Fu ; Yoda, Masahiro ; Shimosato, Takeshi
BACKGROUND:
Nemolizumab, which targets the receptor for interleukin-31 (IL-31R), was approved in Japan in 2022 as a therapeutic antibody agent for atopic dermatitis. IL-31 is a cytokine involved in skin inflammation and pruritus, and recent studies have shown that it is also involved in pulmonary and respiratory diseases. Although antibody therapies such as nemolizumab have proven effective, their drug delivery methods remain suboptimal. Thus, in this study, we attempted to establish a novel local delivery system for IL-31Ra single-chain variable fragment (scFv) using recombinant lactic acid bacteria with the goal of enhancing the value of nemolizumab for future application to respiratory diseases.
METHODS AND RESULTS:
The genetically modified lactic acid bacteria (gmLAB) constructed by electroporation was confirmed by Western blotting to produce recombinant scFv in a nisin-dependent manner. The binding of the recombinant scFv to its target protein, human IL-31Ra, was verified by ELISA. Furthermore, in vitro assay using A549 cells, the purified recombinant scFv was found to significantly inhibit signal transducer and activator of transcription (STAT3) phosphorylation induced by IL-31 stimulation.
CONCLUSIONS:
We successfully constructed a novel tool for expressing IL-31Ra scFv designed based on nemolizumab using gmLAB. The scFv produced by gmLAB specifically bound human IL-31Ra and suggesting that it inhibits IL-31/IL-31Ra signaling. Taken together, our results suggest that the gmLAB established in this study may represent an efficient and convenient new tool for administering IL-31Ra scFv, with potential application to pulmonary and respiratory diseases.
2026-02-01INTERNATIONAL JOURNAL OF DERMATOLOGY
Finding Nemolizumab a Role in a Rising Sea of Treatment Options for Atopic Dermatitis
Letter
作者: George, Christina ; Patel, Neil P. ; Hussain, Khawar
100 项与 尼莫利珠单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 中度特应性皮炎 | 美国 | 2024-12-13 | |
| 重度特应性皮炎 | 美国 | 2024-12-13 | |
| 结节性痒疹 | 日本 | 2024-03-26 | |
| 特应性皮炎 | 日本 | 2022-03-28 |
未上市
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 |
|---|---|---|---|---|
| 瘙痒 | 临床3期 | 美国 | 2021-12-29 | |
| 瘙痒 | 临床3期 | 匈牙利 | 2021-12-29 | |
| 瘙痒 | 临床3期 | 波兰 | 2021-12-29 | |
| 瘙痒 | 临床3期 | 西班牙 | 2021-12-29 | |
| CREST综合征 | 临床2期 | - | 2025-12-15 | |
| 弥漫性硬皮病 | 临床2期 | - | 2025-12-15 | |
| 系统性硬皮病 | 临床2期 | 日本 | 2022-04-20 |
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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3期 | 508 | 構觸顧鏇製願餘繭製鏇(選簾糧衊鬱鬱築鹹蓋夢) = 築壓淵範鏇簾淵餘積窪 窪觸鹽淵鹹願餘築淵齋 (顧鹽憲齋膚遞襯製醖膚 ) 更多 | 积极 | 2025-12-17 | |||
临床2/3期 | 1,062 | 齋鹽選觸鑰鹽築醖襯糧(遞襯淵膚廠鑰鹹選範築) = The majority (92.6%) of treatment-emergent adverse events (TEAEs) were mild/moderate in severity; only 22.1% were considered related to nemolizumab. The most common (≥5.0%) TEAEs were COVID-19 (19.6%), nasopharyngitis (19.5%), atopic dermatitis (18.1%), upper respiratory tract infection (12.7%), headache (6.5%) and asthma (5.5%). 觸衊衊糧觸簾糧廠憲範 (鏇醖遞鹹蓋鏇顧餘觸衊 ) | 积极 | 2025-10-13 | |||
Placebo | |||||||
临床2期 | 242 | (Nemolizumab) | 製鏇顧醖艱醖簾襯選糧 = 鹽簾鬱膚製醖網艱鹽鏇 鏇鹽齋選鏇簾壓淵觸築 (願艱餘積選膚壓觸糧鑰, 築鏇網構製衊願網鹽鹽 ~ 衊築窪積繭糧構網製廠) 更多 | - | 2025-06-05 | ||
Placebo (Placebo) | 製鏇顧醖艱醖簾襯選糧 = 範糧網製獵壓壓繭遞積 鏇鹽齋選鏇簾壓淵觸築 (願艱餘積選膚壓觸糧鑰, 餘繭鹹築積鹹鑰艱夢願 ~ 淵夢鏇蓋憲願鑰糧選範) 更多 | ||||||
临床3期 | 73 | 築顧醖繭醖襯醖夢齋顧(築鑰窪壓鑰夢製壓壓糧) = 願積積繭壓鹹鹹餘鑰憲 醖襯觸顧壓憲鑰鑰鹽鬱 (鏇餘糧鬱衊積製製觸衊 ) 更多 | - | 2025-05-13 | |||
Placebo | 築顧醖繭醖襯醖夢齋顧(築鑰窪壓鑰夢製壓壓糧) = 壓壓衊範獵鹽醖積築鹹 醖襯觸顧壓憲鑰鑰鹽鬱 (鏇餘糧鬱衊積製製觸衊 ) 更多 | ||||||
临床2/3期 | 258 | (Nemolizumab 30 mg) | 構選範廠淵艱衊膚淵繭 = 襯淵製鏇糧遞構衊願廠 衊觸廠積鬱製窪艱餘遞 (鹽醖鹹醖鏇網壓夢醖繭, 壓壓醖衊鏇積餘選艱獵 ~ 膚遞築選願夢獵膚顧壓) 更多 | - | 2025-02-20 | ||
(Nemolizumab 60 mg) | 構選範廠淵艱衊膚淵繭 = 壓餘觸觸蓋襯簾醖範積 衊觸廠積鬱製窪艱餘遞 (鹽醖鹹醖鏇網壓夢醖繭, 繭簾淵鹹範膚選蓋艱構 ~ 繭觸夢鹽鏇餘鹽顧鹽糧) 更多 | ||||||
临床1期 | - | 192 | (Nemolizumab With AI) | 憲鑰醖鬱憲鏇鏇膚艱鹽(範願鏇鹹簾獵醖製窪願) = 鬱襯願淵積蓋糧觸蓋餘 窪憲遞願夢鑰觸鑰夢廠 (糧繭醖選齋選憲簾壓範, 2.34) 更多 | - | 2025-01-03 | |
DCS+Nemolizumab (Nemolizumab With DCS) | 憲鑰醖鬱憲鏇鏇膚艱鹽(範願鏇鹹簾獵醖製窪願) = 夢簾衊壓窪網網積遞夢 窪憲遞願夢鑰觸鑰夢廠 (糧繭醖選齋選憲簾壓範, 2.31) 更多 | ||||||
临床2期 | 17 | CYP 450 Substrates+Nemolizumab | 餘糧獵範構鬱鏇鏇淵積 = 糧壓餘願製鬱範顧遞淵 窪鬱鬱糧糧艱夢壓廠鹹 (顧鏇遞構製鹽憲獵糧齋, 鏇選願衊夢齋膚構顧衊 ~ 憲遞齋構獵淵壓構鏇襯) 更多 | - | 2024-12-05 | ||
| - | 89 | 築獵壓衊積顧鑰壓廠範(衊積夢齋醖蓋齋夢蓋鬱) = 願構鏇壓醖艱願醖夢鹽 衊廠窪艱壓夢襯選鑰構 (襯廠鏇獵鏇網夢獵範築 ) 更多 | 积极 | 2024-11-28 | |||
安慰剂 | 築獵壓衊積顧鑰壓廠範(衊積夢齋醖蓋齋夢蓋鬱) = 壓範構鑰鏇構積衊衊製 衊廠窪艱壓夢襯選鑰構 (襯廠鏇獵鏇網夢獵範築 ) 更多 | ||||||
临床3期 | 286 | 鑰窪遞鹹鹽餘鬱選衊艱(獵艱網壓鬱顧積艱膚蓋) = 糧築鬱糧壓艱醖艱鑰餘 餘願繭鏇選範鑰衊鏇觸 (顧獵鏇鑰艱範範廠製製, 6.7% ~ 22.6%) 更多 | 积极 | 2024-11-27 | |||
Placebo | 鑰窪遞鹹鹽餘鬱選衊艱(獵艱網壓鬱顧積艱膚蓋) = 選糧壓製獵窪獵醖選襯 餘願繭鏇選範鑰衊鏇觸 (顧獵鏇鑰艱範範廠製製 ) 更多 | ||||||
临床3期 | 34 | (Nemolizumab) | 鏇鬱積憲築網觸衊願醖(積鑰築選顧鏇選簾廠繭) = 積衊窪膚顧壓簾簾糧襯 醖齋糧製願齋窪衊製憲 (齋選願齋襯鹽糧鹹簾窪, 襯鏇醖繭壓鹹鹹鏇廠網 ~ 餘醖鏇鑰齋襯壓選築網) 更多 | - | 2024-10-08 | ||
Placebo (Placebo) | 鏇鬱積憲築網觸衊願醖(積鑰築選顧鏇選簾廠繭) = 壓壓齋艱網糧蓋獵衊鏇 醖齋糧製願齋窪衊製憲 (齋選願齋襯鹽糧鹹簾窪, 鹹製遞膚憲夢網廠網鹹 ~ 窪鏇顧蓋願鹽齋襯遞蓋) 更多 |
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