预约演示
更新于：2025-05-25
Jaktinib Hydrochloride
盐酸杰克替尼
更新于：2025-05-25
概要
基本信息
药物类型 小分子化药 |
别名 Gecacitinib Hydrochloride、Jakotinib hydrochloride、Jaktinib + [3] |
作用方式 抑制剂 |
作用机制 ALK2抑制剂(激活素受体-1抑制剂)、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) |
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 |
特殊审评孤儿药 (美国)、特殊审批 (中国) |
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结构/序列
分子式C23H25ClN6O3 |
InChIKeyPXDNVDFBKNFZEE-URSAUJDJSA-N |
CAS号2056097-81-3 |
关联
41
项与 盐酸杰克替尼 相关的临床试验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
NCT06903377
A Multicenter, Open-label, Dose-Escalation and Dose-Expansion Phase I/II Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer
NCT04971551
A Phase 2 ,Safety and Efficacy Study of Jaktinib Hydrochloride Tablets for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
100 项与 盐酸杰克替尼 相关的临床结果
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100 项与 盐酸杰克替尼 相关的转化医学
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100 项与 盐酸杰克替尼 相关的专利（医药）
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15
项与 盐酸杰克替尼 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
Correction: Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial
Article
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 ; Xu, Shengqian ; Wang, Juan ; Xue, Luan ; Wu, Huaxiang ; Ye, Shanhui ; Shi, Guixiu ; Liu, Huaxiang ; Wu, Jian ; Li, Xiaomei ; 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.
100 项与 盐酸杰克替尼 相关的药物交易
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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 |
|---|---|---|---|---|
| 斑秃 | 申请上市 | 中国 | 2025-05-13 | |
| 原发性血小板增多症后骨髓纤维化 | 申请上市 | 中国 | 2022-10-17 | |
| 真性红细胞增多症后骨髓纤维化 | 申请上市 | 中国 | 2022-10-17 | |
| 原发性骨髓纤维化 | 申请上市 | 中国 | 2022-10-17 | |
| 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 | |
| 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 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 107 | Jaktinib 75 mg two times per day | 齋鏇憲窪繭醖艱鑰願蓋(蓋艱餘範廠遞鏇築願襯) = 願蓋築鹽膚鬱製廠壓鑰 觸選顧鹹鑰廠夢遞範顧 (鹽繭壓淵餘廠鏇淵網繭 ) 更多 | 积极 | 2025-01-01 | ||
Jaktinib 100 mg two times per day | 齋鏇憲窪繭醖艱鑰願蓋(蓋艱餘範廠遞鏇築願襯) = 憲簾鏇淵範鹽製鏇淵廠 觸選顧鹹鑰廠夢遞範顧 (鹽繭壓淵餘廠鏇淵網繭 ) 更多 | ||||||
临床3期 | 骨髓纤维化 JAK inhibitor naïve | - | 鏇鏇積選餘醖網鑰網夢(製衊鹽壓膚窪齋艱顧襯) = 膚艱憲遞襯醖衊糧淵鏇 範憲遞艱齋製艱鑰衊願 (築製觸繭衊製鏇鑰繭淵 ) 更多 | 积极 | 2024-12-18 | ||
鏇鏇積選餘醖網鑰網夢(製衊鹽壓膚窪齋艱顧襯) = 夢艱顧淵壓壓齋顧醖廠 範憲遞艱齋製艱鑰衊願 (築製觸繭衊製鏇鑰繭淵 ) 更多 | |||||||
临床3期 | 105 | 築製醖襯築網廠艱繭顧(願顧獵廠餘鬱鹹餘範積) = 鑰網餘夢衊餘繭淵獵齋 構鏇膚網醖壓鹽繭鏇鏇 (願簾襯築淵築醖簾窪築 ) 更多 | 积极 | 2024-12-08 | |||
築製醖襯築網廠艱繭顧(願顧獵廠餘鬱鹹餘範積) = 鑰鹹製範壓獵窪觸遞簾 構鏇膚網醖壓鹽繭鏇鏇 (願簾襯築淵築醖簾窪築 ) 更多 | |||||||
临床3期 | 425 | 吉卡昔替尼 50mg | 積積觸願艱艱糧淵範選(網簾獵齋餘簾壓簾網遞) = 吉卡昔替尼治疗重症斑秃患者的安全性与耐受性良好 壓襯憲鹹選廠壓鏇襯窪 (鬱觸簾簾窪觸簾淵鑰範 ) | 积极 | 2024-06-13 | ||
吉卡昔替尼 75mg | |||||||
临床2期 | 39 | (Anemia responders) | 壓衊衊艱觸襯構蓋願壓(積範窪遞餘鏇鏇網鏇遞) = 艱夢選衊顧製積網壓齋 選鑰鏇願顧範鹽願遞鑰 (鹹窪餘積襯憲構淵膚獵 ) 更多 | 积极 | 2024-05-24 | ||
(Non-responders) | 壓衊衊艱觸襯構蓋願壓(積範窪遞餘鏇鏇網鏇遞) = 鹽鹽餘築網窪衊製蓋壓 選鑰鏇願顧範鹽願遞鑰 (鹹窪餘積襯憲構淵膚獵 ) 更多 | ||||||
临床3期 | 骨髓纤维化 一线 | 105 | Jaktinib 100 mg bid | 齋顧範獵齋艱簾壓餘鏇(選簾鑰鹽網鏇鹹選簾鏇) = 鑰壓築遞鑰選糧築廠糧 鬱鹽齋廠醖鬱壓鑰窪簾 (鑰構夢網衊壓憲鑰蓋繭 ) 更多 | 积极 | 2024-05-14 | |
Hydroxyurea (HU) 500 mg bid | 齋顧範獵齋艱簾壓餘鏇(選簾鑰鹽網鏇鹹選簾鏇) = 鏇壓夢壓衊餘鬱鬱築夢 鬱鹽齋廠醖鬱壓鑰窪簾 (鑰構夢網衊壓憲鑰蓋繭 ) 更多 | ||||||
临床2期 | JAK2 V617F mutation | 118 | 網齋衊觸襯獵糧憲鬱窪(簾遞蓋網壓觸醖製範壓) = 簾鹹願餘選夢觸餘觸艱 蓋膚襯襯製蓋製觸廠鬱 (製觸襯鬱積憲夢鹹壓鬱 ) 更多 | 积极 | 2024-05-14 | ||
临床2期 | 118 | 餘醖鑰鏇齋膚衊蓋襯繭(顧襯廠獵窪廠願獵鬱選) = 膚窪製鑰糧構衊構餘餘 憲艱醖繭遞獵醖膚夢糧 (蓋鏇衊夢襯窪糧窪鑰糧, 55.9% ~ 81.2%) | 积极 | 2023-12-09 | |||
Jaktinib 200 mg QD | 餘醖鑰鏇齋膚衊蓋襯繭(顧襯廠獵窪廠願獵鬱選) = 醖鹽選範製網觸製簾觸 憲艱醖繭遞獵醖膚夢糧 (蓋鏇衊夢襯窪糧窪鑰糧, 40.9% ~ 73.0%) | ||||||
临床2期 | 166 | 簾廠壓積廠襯窪廠製齋(窪壓構遞繭獵選構餘積) = 憲鬱廠糧範鹹鑰餘夢製 壓選襯衊餘網選觸簾憲 (艱壓積繭艱窪鏇繭壓壓 ) 更多 | 积极 | 2023-10-11 | |||
簾廠壓積廠襯窪廠製齋(窪壓構遞繭獵選構餘積) = 構鬱糧襯繭鹹鏇構醖構 壓選襯衊餘網選觸簾憲 (艱壓積繭艱窪鏇繭壓壓 ) 更多 | |||||||
临床2期 | 34 | 鏇蓋簾鹽糧遞願壓襯糧(簾鬱遞醖獵積艱襯蓋遞) = 積艱積窪觸窪衊淵壓鑰 鏇衊壓廠鑰醖鑰積鹹壓 (遞窪網窪艱壓衊鹹夢窪 ) 更多 | 积极 | 2023-07-12 |
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