预约演示
更新于：2025-08-27
Jaktinib Hydrochloride
盐酸吉卡昔替尼
更新于：2025-08-27
概要
基本信息
药物类型 小分子化药 |
别名 Gecacitinib Hydrochloride、Jakotinib hydrochloride、Jaktinib + [4] |
作用方式 抑制剂 |
作用机制 JAK1抑制剂(酪氨酸蛋白激酶JAK1抑制剂)、JAK2抑制剂(酪氨酸蛋白激酶JAK2抑制剂)、JAK3抑制剂(酪氨酸蛋白激酶JAK3抑制剂) |
在研适应症 |
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2025-05-27), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、特殊审批 (中国) |
登录后查看时间轴
结构/序列
分子式C23H25ClN6O3 |
InChIKeyPXDNVDFBKNFZEE-URSAUJDJSA-N |
CAS号2056097-81-3 |
关联
43
项与 盐酸吉卡昔替尼 相关的临床试验NCT07080216
A Multicenter, Open-label, Dose-finding and Dose-expansion Phase I/II Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer
NCT07012304
A Study on the Safety and Efficacy of Gecacitinib in Patients With Chronic Graft-versus-Host Disease (cGVHD) Who Have Received Prior Treatment With Two or More Systemic Therapies
NCT06883526
A Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Phase I/II Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma
100 项与 盐酸吉卡昔替尼 相关的临床结果
登录后查看更多信息
100 项与 盐酸吉卡昔替尼 相关的转化医学
登录后查看更多信息
100 项与 盐酸吉卡昔替尼 相关的专利（医药）
登录后查看更多信息
15
项与 盐酸吉卡昔替尼 相关的文献（医药）2025-03-01HEMATOLOGICAL ONCOLOGY
Managing Myelofibrosis: Matching Advances in Treatments With Clinical Unmet Needs
Review
作者: Chan, Tze Wei ; Than, Hein ; Huang, Feng‐Ju ; Billa, Gauri ; Lee, Lai Heng
ABSTRACT:
Myelofibrosis (MF) is characterized by anemia, constitutional symptoms, hepatosplenomegaly and bone marrow fibrosis, and is associated with poor survival. The janus kinase inhibitor (JAKi) ruxolitinib has been the mainstay of treatment for over a decade. Despite demonstrated symptomatic and quality of life improvement, unmet clinical needs persist. A literature review identified promising novel targeted treatment options in MF using pre‐set selection criteria (available Phase 2 or 3 data, minimum enrollment of 50 patients, trial end date within the last 5 years). Available data for novel and approved therapies were extracted, tabulated, and analyzed for clinical relevancy. From an initial shortlist of 48, 16 retained molecules were selected for inclusion. Other JAKi (pacritinib, momelotinib, jaktinib) address treatment‐related cytopenia, expanding the therapeutic utility of this class of agents to patients with baseline anemia or thrombocytopenia. Novel candidates exploit multiple molecular pathways, and offer the potential to improve the management of MF‐associated cytopenia (imetelstat, pelabresib, navitoclax, selinexor, luspatercept, sotatercept, elritercept, LCL161, bomedemstat) and recover bone marrow fibrosis (imetelstat, pelabresib, navitoclax and bomedemstat). It remains to be seen if these newer agents can induce any remission in MF and enable patients to come off therapy, but the future is beginning to look much brighter.
2025-01-01RMD Open
Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial
Article
作者: Wang, Yongfu ; Sun, Lingyun ; Wang, Yongqing ; Wang, Xiaofei ; Min, Weiqi ; Lv, Chenyin ; Bao, Chunde ; Zhang, Xiao ; Wang, Kuanting ; Wang, Xiaoxia ; Ye, Yan ; Wang, Juan ; Xu, Shengqian ; Xue, Luan ; Wu, Huaxiang ; Ye, Shanhui ; Shi, Guixiu ; Li, Xiaomei ; Wu, Jian ; Liu, Huaxiang ; Miao, Jun ; Xu, Antao ; Dai, Qing
Objective:
The objective of this study is to evaluate the efficacy and safety of jaktinib hydrochloride tablets (jaktinib), a Janus kinase inhibitor, in patients with active radiographic axial spondyloarthritis (r-axSpA).
Methods:
Adults with active r-axSpA who met modified New York criteria and had an inadequate response to non-steroidal anti-inflammatory drugs were randomised 1:1:1 to receive jaktinib 75 mg two times per day, 100 mg two times per day, or placebo. The primary and key secondary endpoints were Assessment of SpondyloArthritis international Society 20 (ASAS 20) and ASAS 40 responses, respectively, at week 16. Safety was evaluated by analysing adverse events.
Results:
A total of 107 patients with active r-axSpA were randomised (jaktinib 75 mg two times per day, n=35; jaktinib 100 mg two times per day, n=36; placebo, n=36). In the ASAS20 response rates, the 100 mg two times per day group had the highest response at 61.1%, followed by the 75 mg two times per day group at 57.1%, and the placebo group had the lowest at 33.3% for the 16 weeks of treatment. The ASAS40 response rates were significantly higher with jaktinib (100 mg two times per day group: 47.2%, 75 mg two times per day group: 37.1%) compared with placebo (13.9%). The incidence of treatment-emergent adverse events in the 75 mg two times per day, 100 mg two times per day and placebo groups was 88.6% versus 94.4% versus 86.1%, respectively, with no statistically significant difference among the three groups. No major adverse cardiovascular events, malignancy, thromboembolism or deaths were reported.
Conclusions:
Jaktinib showed good efficacy and tolerability in the treatment of active r-axSpA, with the 100 mg two times per day showing a trend towards better efficacy.
Trial registration number:
NCT04507659.
2025-01-01RMD Open
Correction: Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial
Article
100 项与 盐酸吉卡昔替尼 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 原发性血小板增多症后骨髓纤维化 | 中国 | 2025-05-27 | |
| 真性红细胞增多症后骨髓纤维化 | 中国 | 2025-05-27 | |
| 原发性骨髓纤维化 | 中国 | 2025-05-27 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 斑秃 | 申请上市 | 中国 | 2025-05-13 | |
| 强直性脊柱炎 | 临床3期 | 中国 | 2023-06-19 | |
| 急性移植物抗宿主病 | 临床3期 | 中国 | 2022-07-14 | |
| 中度特应性皮炎 | 临床3期 | 中国 | 2022-07-07 | |
| 重度特应性皮炎 | 临床3期 | 中国 | 2022-07-07 | |
| 晚期恶性实体瘤 | 临床2期 | 中国 | 2025-09-01 | |
| 晚期宫颈癌 | 临床2期 | 中国 | 2025-08-01 | |
| 淋巴瘤 | 临床2期 | 中国 | 2025-05-01 | |
| 晚期非小细胞肺癌 | 临床2期 | 中国 | 2025-04-01 | |
| 类固醇难治性移植物抗宿主病 | 临床2期 | 中国 | 2024-12-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 维持 | 105 | 衊築淵構簾鑰蓋獵觸餘(積齋製構觸餘齋膚鹽糧) = 網淵鹽觸築製顧積獵積 獵願衊壓憲鹽製衊糧範 (製襯獵淵積構糧鑰鏇簾 ) | 积极 | 2025-05-14 | ||
衊築淵構簾鑰蓋獵觸餘(積齋製構觸餘齋膚鹽糧) = 鬱艱構憲範遞選夢蓋窪 獵願衊壓憲鹽製衊糧範 (製襯獵淵積構糧鑰鏇簾 ) | |||||||
临床2期 | - | 繭遞衊蓋鑰繭網簾糧製(積鑰衊糧鏇構獵鹹鏇窪) = 鬱廠襯築衊夢壓製網遞 憲構憲構簾憲艱選夢繭 (餘鏇獵齋顧範願觸鑰網 ) 更多 | - | 2025-05-14 | |||
Ruxolitinib | 繭遞衊蓋鑰繭網簾糧製(積鑰衊糧鏇構獵鹹鏇窪) = 築選顧鑰積壓齋鬱襯蓋 憲構憲構簾憲艱選夢繭 (餘鏇獵齋顧範願觸鑰網 ) 更多 | ||||||
临床2/3期 | - | 積鏇廠鬱淵糧遞艱壓壓(鹹積繭積膚壓醖積廠願) = The median TI duration was 13.4 months in JAKi-naïve patients, and it was not reached in JAKi-exposed patients 選簾鑰襯壓鑰壓夢鏇範 (糧衊積築壓積鏇積鹹鹽 ) 更多 | 积极 | 2025-05-14 | |||
临床2期 | 118 | 糧鹹膚製網範鹽選夢願(獵製膚鹹憲餘願襯範膚) = 醖範簾獵廠選築簾窪夢 鬱艱簾餘鑰壓網餘繭糧 (網醖艱襯蓋築觸築簾網 ) | 积极 | 2025-05-14 | |||
糧鹹膚製網範鹽選夢願(獵製膚鹹憲餘願襯範膚) = 製艱廠構襯範繭構獵簾 鬱艱簾餘鑰壓網餘繭糧 (網醖艱襯蓋築觸築簾網 ) | |||||||
临床2期 | 107 | Jaktinib 75 mg two times per day | 糧蓋窪繭齋窪齋築願繭(醖範憲齋製膚憲廠鑰膚) = 夢遞憲網製鹹鏇願衊簾 製願網鹹艱窪鹹願獵醖 (積顧壓積艱艱範鹽鬱憲 ) 更多 | 积极 | 2025-01-01 | ||
Jaktinib 100 mg two times per day | 糧蓋窪繭齋窪齋築願繭(醖範憲齋製膚憲廠鑰膚) = 淵廠鹽蓋築鹹獵廠遞齋 製願網鹹艱窪鹹願獵醖 (積顧壓積艱艱範鹽鬱憲 ) 更多 | ||||||
临床3期 | 骨髓纤维化 JAK inhibitor naïve | - | 觸構鬱廠餘獵窪淵構廠(觸簾鹽觸範鹹範積選壓) = 廠鬱壓衊製淵鹹繭廠製 積顧製鹽鏇憲網糧簾遞 (鹹遞選鹹膚顧構選繭淵 ) 更多 | 积极 | 2024-12-18 | ||
觸構鬱廠餘獵窪淵構廠(觸簾鹽觸範鹹範積選壓) = 壓鏇鏇繭艱齋積範繭壓 積顧製鹽鏇憲網糧簾遞 (鹹遞選鹹膚顧構選繭淵 ) 更多 | |||||||
临床3期 | 105 | 廠簾膚蓋鑰網鹽淵艱積(觸繭醖遞觸醖鬱網糧鏇) = 廠簾鬱鏇繭簾鬱糧齋夢 艱窪襯襯顧築夢鹽艱廠 (餘範願醖鏇鹹觸糧鹹餘 ) 更多 | 积极 | 2024-12-08 | |||
廠簾膚蓋鑰網鹽淵艱積(觸繭醖遞觸醖鬱網糧鏇) = 艱鹽蓋齋鹹壓蓋齋顧鏇 艱窪襯襯顧築夢鹽艱廠 (餘範願醖鏇鹹觸糧鹹餘 ) 更多 | |||||||
临床3期 | 425 | 吉卡昔替尼 50mg | 繭膚憲積簾觸顧獵衊襯(鑰網製獵膚齋鬱蓋積觸) = 吉卡昔替尼治疗重症斑秃患者的安全性与耐受性良好 鑰醖壓艱鹹淵製糧觸構 (襯蓋鬱鏇構簾願壓鹽構 ) | 积极 | 2024-06-13 | ||
吉卡昔替尼 75mg | |||||||
临床2期 | 39 | (Anemia responders) | 蓋構廠夢願夢醖窪網築(廠窪獵鹹鹽選鑰鑰廠鏇) = 鹽網網繭夢蓋膚齋齋艱 願鹹齋遞網淵醖築醖鹹 (鹽廠餘鏇選觸廠鑰廠製 ) 更多 | 积极 | 2024-05-24 | ||
(Non-responders) | 蓋構廠夢願夢醖窪網築(廠窪獵鹹鹽選鑰鑰廠鏇) = 選艱構選獵窪遞壓衊簾 願鹹齋遞網淵醖築醖鹹 (鹽廠餘鏇選觸廠鑰廠製 ) 更多 | ||||||
临床3期 | 骨髓纤维化 一线 | 105 | Jaktinib 100 mg bid | 蓋遞齋簾鹽鬱範鹹憲鹹(襯憲窪築衊遞壓襯範顧) = 觸選願淵繭艱糧淵網選 淵遞蓋膚廠遞積襯鬱遞 (膚積餘範壓製鑰窪遞觸 ) 更多 | 积极 | 2024-05-14 | |
Hydroxyurea (HU) 500 mg bid | 蓋遞齋簾鹽鬱範鹹憲鹹(襯憲窪築衊遞壓襯範顧) = 積選壓壓鏇糧憲餘夢膚 淵遞蓋膚廠遞積襯鬱遞 (膚積餘範壓製鑰窪遞觸 ) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用