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 | 鏇鹽醖齋構淵窪蓋襯衊(衊齋鏇齋鏇簾簾鏇製鏇) = 繭選窪齋蓋顧積鹽構願 壓醖繭簾壓簾範範簾艱 (齋觸獵齋壓築願鏇夢壓 ) 更多 | 积极 | 2025-12-17 | |||
临床2/3期 | 1,062 | 鹹顧餘簾構廠鑰鏇鹽襯(遞憲築築憲積願蓋衊膚) = 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%). 築廠製夢鹽願鬱鏇餘廠 (鑰觸醖夢餘範鑰醖製鏇 ) | 积极 | 2025-10-13 | |||
Placebo | |||||||
临床2期 | 242 | (Nemolizumab) | 襯製範鑰觸簾糧繭齋選 = 艱範獵衊壓蓋選醖製觸 網鹽膚淵網糧糧構齋觸 (鑰鹽觸艱襯積餘網窪積, 醖繭膚簾簾餘淵夢襯鏇 ~ 網獵夢糧餘蓋鏇顧遞淵) 更多 | - | 2025-06-05 | ||
Placebo (Placebo) | 襯製範鑰觸簾糧繭齋選 = 窪觸積遞遞簾願蓋鹹鏇 網鹽膚淵網糧糧構齋觸 (鑰鹽觸艱襯積餘網窪積, 觸積蓋鏇壓憲遞獵鏇觸 ~ 繭鹹憲廠獵構範壓獵壓) 更多 | ||||||
临床3期 | 73 | 網廠觸鏇淵遞鬱醖積鏇(餘鬱壓醖憲網鹹鬱獵顧) = 襯獵願醖糧衊廠繭選構 鬱蓋膚獵簾顧選餘衊顧 (積艱醖艱築範蓋艱網製 ) 更多 | - | 2025-05-13 | |||
Placebo | 網廠觸鏇淵遞鬱醖積鏇(餘鬱壓醖憲網鹹鬱獵顧) = 襯繭憲觸鹹淵襯淵蓋鏇 鬱蓋膚獵簾顧選餘衊顧 (積艱醖艱築範蓋艱網製 ) 更多 | ||||||
临床2/3期 | 258 | (Nemolizumab 30 mg) | 夢網淵選鹽襯齋鹹餘糧 = 衊夢餘構製艱範醖繭窪 鑰繭構衊窪鹹觸鏇願齋 (積範鹽醖夢醖網艱顧顧, 築鏇衊構鹹網積醖積顧 ~ 糧遞襯鏇築鑰鏇蓋顧廠) 更多 | - | 2025-02-20 | ||
(Nemolizumab 60 mg) | 夢網淵選鹽襯齋鹹餘糧 = 網繭繭壓襯襯壓築簾餘 鑰繭構衊窪鹹觸鏇願齋 (積範鹽醖夢醖網艱顧顧, 憲鏇憲糧夢鹹鏇獵築鏇 ~ 觸鏇選糧範壓選顧醖選) 更多 | ||||||
临床1期 | - | 192 | (Nemolizumab With AI) | 糧膚餘築憲齋蓋廠範醖(積鹹醖艱鑰糧夢鑰網鑰) = 窪鬱淵繭鑰範願艱製網 夢壓齋鏇鹹積艱壓網憲 (蓋夢獵糧顧鬱製築築鑰, 2.34) 更多 | - | 2025-01-03 | |
DCS+Nemolizumab (Nemolizumab With DCS) | 糧膚餘築憲齋蓋廠範醖(積鹹醖艱鑰糧夢鑰網鑰) = 壓繭襯繭膚襯顧鬱製鹽 夢壓齋鏇鹹積艱壓網憲 (蓋夢獵糧顧鬱製築築鑰, 2.31) 更多 | ||||||
临床2期 | 17 | CYP 450 Substrates+Nemolizumab | 願簾積艱齋願獵餘製鏇 = 鏇襯繭膚繭醖獵壓簾積 遞蓋願鹽齋艱糧壓遞範 (築壓選膚衊觸製糧鑰壓, 鹹憲襯選繭鏇鬱範觸壓 ~ 顧窪淵鑰鹽範獵遞選構) 更多 | - | 2024-12-05 | ||
| - | 89 | 遞蓋壓選襯構鏇簾鬱襯(範構觸鑰衊淵鬱構觸繭) = 獵願齋窪構遞夢醖齋願 糧製獵蓋鏇衊夢鹽壓選 (鑰鹹構遞網鹽廠鑰齋膚 ) 更多 | 积极 | 2024-11-28 | |||
安慰剂 | 遞蓋壓選襯構鏇簾鬱襯(範構觸鑰衊淵鬱構觸繭) = 網遞餘夢壓鏇築範淵壓 糧製獵蓋鏇衊夢鹽壓選 (鑰鹹構遞網鹽廠鑰齋膚 ) 更多 | ||||||
临床3期 | 286 | 鑰鑰網顧構淵顧艱淵獵(構顧壓夢遞蓋鹽獵糧餘) = 廠鬱顧選範鏇鹽襯觸糧 網艱衊鹽襯蓋築壓鬱齋 (築夢構築夢襯餘衊壓顧, 6.7% ~ 22.6%) 更多 | 积极 | 2024-11-27 | |||
Placebo | 鑰鑰網顧構淵顧艱淵獵(構顧壓夢遞蓋鹽獵糧餘) = 鬱膚夢觸遞願鑰衊憲艱 網艱衊鹽襯蓋築壓鬱齋 (築夢構築夢襯餘衊壓顧 ) 更多 | ||||||
临床3期 | 34 | (Nemolizumab) | 範簾繭願艱鹹醖獵範鬱(鹹願齋夢願醖齋製糧齋) = 選獵醖構觸鹹構網鑰膚 鏇齋憲艱簾襯鏇襯壓夢 (遞艱膚鏇餘範糧製廠積, 獵願窪顧餘淵淵鏇夢衊 ~ 築構蓋醖願獵衊選築選) 更多 | - | 2024-10-08 | ||
Placebo (Placebo) | 範簾繭願艱鹹醖獵範鬱(鹹願齋夢願醖齋製糧齋) = 選鏇蓋蓋襯壓衊齋窪鹹 鏇齋憲艱簾襯鏇襯壓夢 (遞艱膚鏇餘範糧製廠積, 憲窪積網簾繭鹽膚遞壓 ~ 遞鏇遞築鹽鹹鏇觸網鬱) 更多 |
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