预约演示
更新于：2025-09-01
Ivarmacitinib
硫酸艾玛昔替尼
更新于：2025-09-01
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2025-03-18), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (中国) |
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结构/序列
分子式C18H24N8O6S2 |
InChIKeyXVVWQCLRGHYWPI-OOWXMNGOSA-N |
CAS号1639419-51-4 |
关联
45
项与 硫酸艾玛昔替尼 相关的临床试验ChiCTR2500105444
A Clinical Study on the Efficacy and Safety of Ivarmacitinib in IgG4-Related Disease
ChiCTR2500105703
Efficacy and Safety of Ivarmacitinib in Patients with Polymyalgia Rheumatica: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
ChiCTR2500104514
A prospective phase II clinical trial evaluating the efficacy and safety of chemotherapy combined with immune checkpoint inhibitors and ivarmacitinib in first-line treatment of extensive stage small cell lung cancer
100 项与 硫酸艾玛昔替尼 相关的临床结果
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100 项与 硫酸艾玛昔替尼 相关的转化医学
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100 项与 硫酸艾玛昔替尼 相关的专利（医药）
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31
项与 硫酸艾玛昔替尼 相关的文献（医药）2025-07-01JAMA Dermatology
Ivarmacitinib for Moderate to Severe Atopic Dermatitis in Adults and Adolescents
Article
作者: Lu, Jianyun ; Li, Jingyi ; Xu, Lihong ; Loo, Wei Jing ; Toth, Darryl ; Sauder, Maxwell ; Zhang, Jianzhong ; Chen, Aijun ; Song, Zhiqiang ; Yang, Bin ; Wu, Jiyuan ; Li, Yijing ; Tao, Xiaohua ; Wu, Liming ; Li, Hongyi ; Gooderham, Melinda ; Zhao, Yan ; Han, Jiande
Importance:
Ivarmacitinib, a selective oral Janus kinase 1 (JAK1) inhibitor, has demonstrated efficacy for treating adults with moderate to severe atopic dermatitis (AD) in a phase 2 trial.
Objective:
To evaluate the efficacy and adverse events of ivarmacitinib in adolescents and adults with moderate to severe AD.
Design, Setting, and Participants:
This multicenter, double-blind, placebo-controlled phase 3 randomized clinical trial included patients aged 12 to 75 years with moderate to severe AD. Patients were enrolled from 53 sites in Canada and China from April 2021 to April 2022. Data were analyzed from July 11 to September 27, 2023.
Interventions:
Patients were randomized (1:1:1) to receive once-daily 4- or 8-mg ivarmacitinib or placebo for 16 weeks.
Main Outcomes and Measures:
Co-primary end points were the proportions of patients achieving an Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline and an Eczema Area and Severity Index score improvement of 75% (EASI-75) at week 16.
Results:
Of 336 randomized patients (mean [SD] age, 31.1 [15.4] years; 213 [63.4%] male; 286 [85.1%] Asian), 113 received 4-mg ivarmacitinib, 112 received 8-mg ivarmacitinib, and 111 received placebo. At week 16, significantly more patients in the 4-mg ivarmacitinib group (41 of 113 [36.3%]; 95% CI, 27.5%-45.9%; P < .001) and the 8-mg ivarmacitinib group (47 of 112 [42.0%]; 95% CI, 32.7%-51.7%; P < .001) achieved an IGA score of 0 or 1 with at least a 2-grade improvement compared to the placebo group (10 of 111 [9.0%]; 95% CI, 4.4%-15.9%). EASI-75 responses were also significantly higher in the ivarmacitinib groups: 61 patients (54.0%; 95% CI, 44.4%-63.4%; P < .001) in the 4-mg group, and 74 (66.1%; 95% CI, 56.5%-74.8%; P < .001) in 8-mg group compared to 24 patients (21.6%; 95% CI, 14.4%-30.4%) in the placebo group. Treatment-emergent adverse events were reported by 78 patients (69.0%) in the 4-mg group, 74 (66.1%) in the 8-mg group, and 72 (64.9%) in the placebo group. Serious treatment-emergent adverse events occurred in 3 patients (2.7%) in the 4-mg group, 2 (1.8%) in the 8-mg group, and 3 (2.7%) in the placebo group.
Conclusions and Relevance:
This phase 3 randomized clinical trial determined that once-daily ivarmacitinib demonstrated significant efficacy and a favorable risk-benefit profile for treating moderate to severe AD in adults and adolescents. These results support the potential of ivarmacitinib as a new therapeutic option.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04875169
2025-06-21DRUGS
Ivarmacitinib Sulfate: First Approval.
Article
作者: Keam, Susan J
Ivarmacitinib sulfate (ivarmacitinib; ®), a selective Janus kinase 1 (JAK1) inhibitor, is being developed by Jiangsu Hengrui Pharmaceuticals Co, Ltd Co, Ltd for the treatment of immune-mediated inflammatory diseases. In March 2025, ivarmacitinib was approved for use in adult patients with active ankylosing spondylitis (AS) who have responded poorly to or are intolerant to ≥ 1 tumour necrosis factor (TNF) inhibitors in China. In March 2025, ivarmacitinib was also approved in China for use in adult patients with moderate to severe active rheumatoid arthritis (RA) who have responded poorly to or are intolerant to ≥ 1 TNF inhibitors. In April 2025, ivarmacitinib was approved in China for use in adult patients with moderate to severe atopic dermatitis (AD) who have had an inadequate response or intolerance to topical or other systemic treatments. This article summarizes the milestones in the development of ivarmacitinib leading to this first approval for the treatment of adult patients with active AS.
2025-04-01Journal of Cosmetic Dermatology
The Relative Efficacy and Safety of Monotherapies for Alopecia Areata: A Network Meta‐Analysis Study
Review
作者: Mirmirani, Paradi ; Bamimore, Mary A. ; Piguet, Vincent ; Talukder, Mesbah ; Gupta, Aditya K.
ABSTRACT:
Background:
Scant evidence exists for the relative efficacy of therapies for alopecia areata (AA)—including those approved by the Food and Drug Administration, namely, baricitinib, deuruxolitinib, and ritlecitinib.
Aims:
We determined the relative efficacy and safety of monotherapy with janus kinase inhibitors (JAKIs), apremilast, and dupilumab.
Methods:
Following a systematic review, we conducted Bayesian network meta‐analysis (NMAs) that produced Surface Under the Cumulative RAnking (SUCRA) values and point estimates for pairwise relative effects; we also performed sensitivity analyses.
Results:
In total, regimens with eight various JAKIs were compared, namely, ruxolitinib, ATI‐501, baricitinib, brepocitinib, deuruxolitinib, ivarmacitinib, ritlecitinib, and tofacitinib. Our analyses ranked “deuruxolitinib 12 mg twice daily for 24 weeks,” the most efficacious insofar as “proportion of participants achieving SALT ≤ 20 at 24 weeks” (SALT20) (SUCRA = 92.6%), and “proportion of participants achieving SALT ≤ 10 at 24 weeks” (SALT10) (SUCRA = 97.7%). As per SALT20, the highest‐ranked regimen was more efficacious than “baricitinib 2 mg once daily for 24 weeks” (odds ratio [OR] = 5.37, 95% credible interval [CI] = 1.59, 13.70, p < 0.05). Furthermore, the efficacy of the FDA‐approved JAKIs exhibited a dose‐dependent relationship; for instance, baricitinib 4 mg once daily for 24 weeks was more efficacious than “baricitinib 2 mg once daily for 24 weeks” in terms of SALT20 (OR = 2.25, 95% CI = 1.56, 3.21, p < 0.05). Results from our sensitivity analyses support that our base analyses were robust.
Conclusions:
We produced high‐quality evidence on the comparative effectiveness of monotherapies for AA with various regimens of 8 JAKIs, including the FDA‐approved ones. Our findings can improve clinicians' decision‐making and update guidelines for medical practice.
343
项与 硫酸艾玛昔替尼 相关的新闻（医药）2025-08-31
·信狐药迅
2025-08-29
·摩熵医药
优先审批引进/卖出临床2期申请上市
2025-08-25
·米内网
专利到期并购免疫疗法引进/卖出
100 项与 硫酸艾玛昔替尼 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 |
|---|---|---|---|
| 斑秃 | 中国 | 2025-06-24 | |
| 中度特应性皮炎 | 中国 | 2025-04-01 | |
| 重度特应性皮炎 | 中国 | 2025-04-01 | |
| 类风湿关节炎 | 中国 | 2025-03-25 | |
| 强直性脊柱炎 | 中国 | 2025-03-18 |
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 |
|---|---|---|---|---|
| 轻度特应性皮炎 | 申请上市 | 中国 | 2025-02-15 | |
| 特应性皮炎 | 申请上市 | 中国 | 2023-06-09 | |
| 中轴性脊柱关节炎 | 临床3期 | 中国 | 2022-08-16 | |
| 非放射性轴性脊柱关节炎 | 临床3期 | 中国 | 2022-08-16 | |
| 溃疡性结肠炎 | 临床3期 | 美国 | 2021-11-05 | |
| 溃疡性结肠炎 | 临床3期 | 中国 | 2021-11-05 | |
| 溃疡性结肠炎 | 临床3期 | 波兰 | 2021-11-05 | |
| 溃疡性结肠炎 | 临床3期 | 乌克兰 | 2021-11-05 | |
| 银屑病关节炎 | 临床3期 | 中国 | 2021-08-30 | |
| 非节段型白癜风 | 临床3期 | 中国 | 2020-01-29 |
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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 | 336 | Ivarmacitinib 4mg | 顧積獵遞積積糧窪餘獵(鬱構積蓋齋築衊餘艱簾) = 夢築夢壓襯壓顧獵齋淵 襯選範壓製構築淵鏇膚 (齋壓醖窪觸繭艱齋憲製, 44.4 ~ 63.4) 更多 | 积极 | 2025-07-01 | ||
顧積獵遞積積糧窪餘獵(鬱構積蓋齋築衊餘艱簾) = 繭壓繭夢積網網淵艱願 襯選範壓製構築淵鏇膚 (齋壓醖窪觸繭艱齋憲製, 56.5 ~ 74.8) 更多 | |||||||
临床3期 | 330 | 艾玛昔替尼 4 mg QD | 糧鏇淵廠選淵壓願襯遞(遞鏇淵膚膚鹽獵鹽繭鑰) = 鹽鹽選壓積夢窪繭鑰艱 衊鑰簾廠衊淵夢築積襯 (膚醖鏇襯遞觸獵獵鑰憲 ) 更多 | 积极 | 2025-03-11 | ||
艾玛昔替尼 8 mg QD | 糧鏇淵廠選淵壓願襯遞(遞鏇淵膚膚鹽獵鹽繭鑰) = 鹹製蓋獵鹽壓築構積餘 衊鑰簾廠衊淵夢築積襯 (膚醖鏇襯遞觸獵獵鑰憲 ) 更多 | ||||||
临床2期 | 114 | NB-UVB phototherapy active treatment+ARQ-252 cream 0.3% (Active IP and Active Phototherapy) | 鬱憲築餘醖衊網鬱簾窪(構積壓窪鹹簾膚餘壓鬱) = 糧鬱積選網廠顧鑰餘膚 鬱餘顧蓋範糧鑰積蓋鹹 (構廠築願繭壓遞廠憲窪, 25.0121) 更多 | - | 2024-07-12 | ||
NB-UVB phototherapy sham treatment+ARQ-252 cream 0.3% (Active IP and Sham Phototherapy) | 鬱憲築餘醖衊網鬱簾窪(構積壓窪鹹簾膚餘壓鬱) = 遞鹽襯鬱簾願鬱鏇觸鏇 鬱餘顧蓋範糧鑰積蓋鹹 (構廠築願繭壓遞廠憲窪, 11.8841) 更多 | ||||||
NEWS 人工标引  | 临床2/3期 | 373 | 齋顧繭簾醖範壓鹹鬱艱(鹽繭觸鹹齋獵膚積鬱憲) = 艱鹹鬱築簾蓋選餘艱鑰 淵壓遞簾獵願窪衊糧遞 (獵憲廠夢鑰醖齋鏇衊願 ) 更多 | 积极 | 2024-06-15 | ||
Placebo | 齋顧繭簾醖範壓鹹鬱艱(鹽繭觸鹹齋獵膚積鬱憲) = 鑰築觸網襯鏇簾鏇構齋 淵壓遞簾獵願窪衊糧遞 (獵憲廠夢鑰醖齋鏇衊願 ) 更多 | ||||||
临床3期 | 566 | 鹹醖醖製網襯網襯鬱膚(範獵糧選範構糧鹽願餘) = 構膚齋願選蓋窪憲顧選 鹽繭鬱蓋餘遞艱繭蓋糧 (繭積壓鬱糧鏇繭淵鹹壓 ) 更多 | 积极 | 2024-06-12 | |||
鹹醖醖製網襯網襯鬱膚(範獵糧選範構糧鹽願餘) = 鏇獵餘壓鑰憲壓壓鑰壓 鹽繭鬱蓋餘遞艱繭蓋糧 (繭積壓鬱糧鏇繭淵鹹壓 ) 更多 | |||||||
临床2/3期 | 350 | 鬱網鹹醖艱膚窪鏇顧蓋(獵廠選齋壓鏇獵範簾餘) = 齋窪遞廠願襯憲衊夢壓 鹹繭繭簾壓衊繭淵繭構 (糧築築鹽衊範鏇鑰蓋襯 ) 更多 | 积极 | 2024-06-05 | |||
Placebo | 鬱網鹹醖艱膚窪鏇顧蓋(獵廠選齋壓鏇獵範簾餘) = 獵遞範顧網鹽遞餘鑰願 鹹繭繭簾壓衊繭淵繭構 (糧築築鹽衊範鏇鑰蓋襯 ) 更多 | ||||||
临床1/2期 | 230 | (Cohort 1: ARQ-252 Cream 0.3% QD) | 鏇製憲餘淵鏇鏇鹹餘窪 = 鏇積蓋構艱壓遞鏇淵網 鏇夢膚簾窪齋淵夢鏇鏇 (範繭糧觸顧艱遞醖構鹹, 蓋襯蓋壓積淵襯製鬱觸 ~ 獵膚觸鏇艱淵製願製壓) 更多 | - | 2024-04-05 | ||
(Cohort 2: ARQ-252 Cream 0.3% QD) | 窪窪製鑰鹽膚壓範獵遞 = 齋簾壓構鹽窪觸糧鹽網 醖膚選壓襯範鹽醖顧願 (醖齋鹽範鬱鏇鑰鏇鹽廠, 繭廠網膚衊餘顧蓋醖醖 ~ 願衊淵鏇醖鏇襯衊選獵) 更多 | ||||||
临床1期 | 18 | 齋選蓋廠觸獵糧糧鹽願(廠艱遞襯構簾膚襯構憲) = 壓鏇襯繭積鬱蓋鏇窪憲 獵鑰齋壓壓艱廠鑰蓋獵 (選膚憲糧膚鹹鹹鹹窪廠 ) 更多 | - | 2023-12-10 | |||
临床2期 | 105 | (Active Comparator: SHR0302 Dose A) | 積鹽鑰製顧築願積艱壓 = 襯範廠觸衊蓋餘築醖膚 淵鑰選膚餘憲範鏇衊襯 (醖繭網構鬱膚餘艱觸夢, 襯衊簾衊構鏇繭齋憲積 ~ 繭網鹹鹽鏇淵廠網鬱築) 更多 | - | 2023-05-09 | ||
(Active Comparator: SHR0302 Dose B) | 積鹽鑰製顧築願積艱壓 = 衊範網繭選窪膚鏇窪壓 淵鑰選膚餘憲範鏇衊襯 (醖繭網構鬱膚餘艱觸夢, 齋廠醖築窪積鏇艱壓鏇 ~ 憲鹽醖觸繭顧積鹹顧夢) 更多 | ||||||
临床3期 | 336 | 鏇鏇膚窪夢鏇憲鹹窪觸(窪製獵築顧鑰廠遞願憲) = 鹽製選鹽齋網襯遞壓網 鏇鑰膚遞夢獵鏇壓鹽繭 (繭觸醖遞襯齋顧鹹鑰築 ) 达到 更多 | 积极 | 2023-03-18 | |||
鏇鏇膚窪夢鏇憲鹹窪觸(窪製獵築顧鑰廠遞願憲) = 遞醖膚構鏇醖鹽壓膚網 鏇鑰膚遞夢獵鏇壓鹽繭 (繭觸醖遞襯齋顧鹹鑰築 ) 达到 更多 |
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