预约演示
更新于：2025-03-28
Ivosidenib
艾伏尼布
更新于：2025-03-28
概要
基本信息
药物类型 小分子化药 |
别名 Ivosidenib (USAN/INN)、AG-120、CS 3010 + [8] |
靶点 |
作用方式 抑制剂 |
作用机制 IDH1抑制剂(细胞质异柠檬酸脱氢酶[NADP]抑制剂) |
在研适应症 |
非在研适应症 |
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 美国 (2018-07-20), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、附条件批准 (中国)、孤儿药 (韩国)、孤儿药 (澳大利亚)、临床急需境外新药 (中国)、优先审评 (澳大利亚) |
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结构/序列
分子式C28H22ClF3N6O3 |
InChIKeyWIJZXSAJMHAVGX-DHLKQENFSA-N |
CAS号1448347-49-6 |
关联
57
项与 艾伏尼布 相关的临床试验NCT06707493
A Randomized, Placebo-Controlled Phase 2 Study of IDH1 Inhibition Using Ivosidenib As Maintenance Therapy for IDH1-mutant Acute Myeloid Leukemia Following Allogeneic Stem Cell Transplantation
NCT06717958
A Prospective, Single-arm, Open-label, Multicenter Phase II Trial Evaluating the Efficacy and Safety of Ivosidenib Maintenance Therapy After Allogeneic Stem Cell Transplantation (alloSCT) in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Neoplasia (MD) Carrying an IDH1 Mutation
ChiCTR2400094961
A single-arm, open-label Phase II clinical study on the efficacy and safety of Ivosidenib combined with Nab-paclitaxel sequentially followed by radiotherapy in the treatment of advanced solid tumors
100 项与 艾伏尼布 相关的临床结果
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100 项与 艾伏尼布 相关的转化医学
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100 项与 艾伏尼布 相关的专利（医药）
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389
项与 艾伏尼布 相关的文献（医药）2025-04-01INTERNATIONAL JOURNAL OF SURGICAL PATHOLOGY
Spectrum of Findings Seen in Patients With
IDH1/2-Mutant
Cholangiocarcinoma
Article
作者: Afghan, Maaz Khan ; Rocca, Juan ; Currie, Brian Michael ; Javaid, Sana ; Hissong, Erika ; Golden, Encouse ; Kasi, Pashtoon Murtaza ; Samstein, Benjamin ; Popa, Elizabeta ; Khan, Sahrish ; Lutfi, Areeb ; Kierans, Andrea Siobhan
Background:
Cholangiocarcinoma—with a growing incidence rate and poor prognosis—is not an uncommon cancer. Molecular profiling can reveal actionable aberrations in at least a third of the tumors. This is especially so in the case of intrahepatic cholangiocarcinoma (ICC), where mutations in the isocitrate dehydrogenase 1 and 2 genes (
IDH1/2
) make up 15%–20% of these tumors.
IDH1/2
mutant ICC is a rare disease that has not been adequately reported. To expand the spectrum of findings seen in these patients, we present a single institution case series.
Methods and results:
We descriptively characterize the clinical, radiological, and histopathological findings of 12 such patients.
IDH1/2
mutant ICC was found in elderly women, with two-thirds of patients having additional co-mutations. Anecdotally, patients who did receive systemic and/or locoregional therapies had long-term durable outcomes.
Conclusion:
Our findings indicate an increasing need to personalize an approach for these patients with specific molecular alterations. With the advent of the
IDH1
inhibitor ivosidenib and other inhibitors in this space,
IDH1/2
mutation have both prognostic and predictive value. Our series builds upon the patterns and findings seen in these patients.
2025-03-11Blood Advances
Advancing drug development in myelodysplastic syndromes
Review
作者: Zeidan, Amer M. ; McGraw, Kathy L. ; Jen, Emily Y. ; DeZern, Amy E. ; Buckstein, Rena ; Mina, Alain ; Pavletic, Steven ; Calvo, Katherine R. ; Wroblewski, Tanya ; Ehrlich, Lori A. ; Norsworthy, Kelly ; Aplan, Peter D. ; Scott, Bart ; Tinsley-Vance, Sara ; Verma, Amit ; Garcia, Jacqueline S. ; Komrokji, Rami ; Foran, James M. ; Garcia-Manero, Guillermo ; Sekeres, Mikkael A. ; Kim, Nina ; Cunningham, Lea
Abstract:
Myelodysplastic syndromes/neoplasms (MDSs) are heterogeneous stem cell malignancies characterized by poor prognosis and no curative therapies outside of allogeneic hematopoietic stem cell transplantation. Despite some recent approvals by the US Food and Drug Administration, (eg, luspatercept, ivosidenib, decitabine/cedazuridine, and imetelstat), there has been little progress in the development of truly transformative therapies for the treatment of patients with MDS. Challenges to advancing drug development in MDS are multifold but may be grouped into specific categories, including criteria for risk stratification and eligibility, response definitions, time-to-event end points, transfusion end points, functional assessments, and biomarker development. Strategies to address these challenges and optimize future clinical trial design for patients with MDS are presented here.
2025-03-01Translational Oncology
HNF4α inhibits the malignancy of intrahepatic cholangiocarcinoma by suppressing the Wnt signaling pathway
Article
作者: Zhang, Xin ; Xiao, Meng-Chao ; Xu, Wen-Ping ; Ding, Cheng-Hong ; Jiang, Nan ; Luo, Yuan-Yuan ; Liu, Shu-Qing ; Xie, Wei-Fen ; Xu, Bo-Nan ; Liu, Yi-Long ; Deng, Juan
Previous studies have demonstrated that intrahepatic cholangiocarcinoma (ICC) may derive from transdifferentiation of hepatocytes, so transforming ICC cells into hepatocytes could be a potential strategy for treating ICC. Hepatocyte nuclear factor 4α (HNF4α), a master transcription factor in the liver, has been demonstrated to induce the differentiation of hepatocellular carcinoma, while its effects on ICC remains unclear. Ivosidenib, an isocitrate dehydrogenase 1 (IDH1) inhibitor, is a novel targeted drug for ICC patients. However, drug resistance limits its clinical efficacy. In the present study, we found that the downregulation of HNF4α expression was associated with aggressive tumor behavior and poor prognosis in ICC patients. Upregulation of HNF4α inhibited proliferation, migration, invasion and colony-formation ability, increased the expression of hepatocyte functional genes in ICC cells in vitro, and suppressed the growth of subcutaneous tumors in vivo. Importantly, HNF4α adenovirus treatment significantly reduced the tumor burden of Akt/NICD-induced primary ICC in mice. Furthermore, HNF4α enhanced the sensitivity of ICC cells to ivosidenib both in vitro and in vivo. RNA sequencing revealed that HNF4α suppressed several cancer-related pathways, including Wnt signaling pathway. The agonist of Wnt signaling pathway partially blocked the inhibitory effect of HNF4α on the proliferation and resistance to ivosidenib of ICC cells. These results identify HNF4α as a tumor suppressor for ICC and a potential sensitizer to ivosidenib in ICC patients. The reintroduction of HNF4α might help achieve more effective and precise targeted therapy, benefiting the survival of patients with ICC.
278
项与 艾伏尼布 相关的新闻（医药）2025-03-27
·医药观澜
临床结果优先审批临床3期申请上市孤儿药
2025-03-09
抗体药物偶联物申请上市临床研究临床申请临床1期
2025-02-13
·摩熵医药
100 项与 艾伏尼布 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 |
|---|---|---|---|
| 骨髓增生异常综合征 | 美国 | 2023-10-24 | |
| IDH1突变的胆管癌 | 澳大利亚 | 2023-04-06 | |
| IDH1突变急性髓性白血病 | 中国 | 2022-01-30 | |
| IDH1突变急性髓性白血病 | 中国 | 2022-01-30 | |
| 胆管癌 | 美国 | 2021-08-25 | |
| 急性髓性白血病 | 美国 | 2018-07-20 |
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 |
|---|---|---|---|---|
| 软骨肉瘤 | 临床3期 | 美国 | 2024-07-09 | |
| 软骨肉瘤 | 临床3期 | 美国 | 2024-07-09 | |
| 软骨肉瘤 | 临床3期 | 日本 | 2024-07-09 | |
| 软骨肉瘤 | 临床3期 | 日本 | 2024-07-09 | |
| 软骨肉瘤 | 临床3期 | 澳大利亚 | 2024-07-09 | |
| 软骨肉瘤 | 临床3期 | 澳大利亚 | 2024-07-09 | |
| 软骨肉瘤 | 临床3期 | 巴西 | 2024-07-09 | |
| 软骨肉瘤 | 临床3期 | 巴西 | 2024-07-09 | |
| 软骨肉瘤 | 临床3期 | 加拿大 | 2024-07-09 | |
| 软骨肉瘤 | 临床3期 | 加拿大 | 2024-07-09 |
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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1期 | 16 | 壓遞憲範淵鑰獵鑰選膚(蓋選餘鏇積鏇積範顧壓) = 餘積製襯淵鑰鬱遞醖淵 選鹹鑰鬱廠獵齋憲廠積 (壓齋範積艱選遞選鏇齋 ) | - | 2025-01-23 | |||
临床2期 | 11 | 積獵淵繭窪鏇醖獵憲築(蓋淵膚觸襯鹹廠夢選築) = 網鹹網築夢製膚窪鹽艱 鹹願獵窪製範繭繭構艱 (繭選廠範選夢壓襯鑰膚 ) 更多 | 积极 | 2024-12-09 | |||
(Adult patients 18 years or older with R/R AML or high-risk MDS harboring an IDH1 mutation) | 積獵淵繭窪鏇醖獵憲築(蓋淵膚觸襯鹹廠夢選築) = 襯積顧築鬱願壓簾齋蓋 鹹願獵窪製範繭繭構艱 (繭選廠範選夢壓襯鑰膚 ) 更多 | ||||||
临床1期 | 31 | 襯憲窪齋範簾鹹顧製齋(膚醖蓋廠選鹽製簾壓製) = 憲夢蓋淵網顧築鑰鹹獵 鹹壓鹹鹹遞積繭憲壓顧 (憲鬱鏇齋選齋鏇鬱衊鹽 ) 更多 | 积极 | 2024-12-09 | |||
襯憲窪齋範簾鹹顧製齋(膚醖蓋廠選鹽製簾壓製) = 獵簾壓艱願顧鹽糧選襯 鹹壓鹹鹹遞積繭憲壓顧 (憲鬱鏇齋選齋鏇鬱衊鹽 ) 更多 | |||||||
临床3期 | 急性髓性白血病 IDH1m | - | 壓壓觸壓淵遞簾衊艱膚(繭選遞夢襯窪餘衊願選): HR = 0.39 (95% CI, 0.24 ~ 0.64) 更多 | 积极 | 2024-12-09 | ||
N/A | - | 糧艱醖衊齋鏇鏇選範繭(鏇鏇襯選鬱鏇淵襯蓋範) = 餘積製選鑰憲廠壓鏇鹽 壓獵網齋網觸鏇鹹襯淵 (簾鹽艱鬱衊衊構蓋網鏇 ) 更多 | - | 2024-12-08 | |||
N/A | - | Ivosidenib (IVO) and venetoclax (VEN) | 蓋觸衊獵築鑰鹹簾製鬱(簾鬱餘蓋遞糧繭範夢鬱) = 蓋製艱醖繭壓遞衊廠夢 鑰範鏇鹹觸醖鹽餘糧顧 (窪築鏇選憲窪淵齋膚獵 ) | - | 2024-12-08 | ||
Ivosidenib (IVO), venetoclax (VEN), and azacitidine (AZA) | 蓋觸衊獵築鑰鹹簾製鬱(簾鬱餘蓋遞糧繭範夢鬱) = 壓構壓網艱餘選鏇廠範 鑰範鏇鹹觸醖鹽餘糧顧 (窪築鏇選憲窪淵齋膚獵 ) | ||||||
临床1/2期 | 56 | 繭顧餘網鬱憲繭選繭鬱(蓋壓鹽衊觸糧艱憲壓壓) = 範襯齋製壓壓齋襯鹽窪 築窪簾襯廠觸糧壓廠簾 (淵獵窪齋獵願淵範憲願 ) 更多 | 积极 | 2024-12-07 | |||
(received SCT) | 餘衊製糧製壓淵選網簾(繭範築鬱顧網衊糧網糧) = 觸顧鹹鏇憲顧觸範簾觸 選鹹觸餘繭築遞齋壓壓 (顧積憲顧鹹鑰積窪鹹鏇, 85.2 ~ 100) | ||||||
N/A | 77 | 願憲願鏇淵蓋衊醖簾鬱(製積窪艱醖製鏇艱鬱膚) = 艱鹹餘遞齋網襯廠窪醖 構積憲選廠簾憲鏇遞醖 (艱願築憲觸鏇獵構繭繭 ) 更多 | 积极 | 2024-11-11 | |||
N/A | 21 | 鹽膚憲衊廠鑰襯積繭積(觸遞鹽鹹獵鏇鹽顧齋壓) = N=4 壓糧繭範鬱艱餘簾願繭 (憲鬱餘餘憲齋製製醖壓 ) 更多 | - | 2024-11-11 | |||
N/A | IDH1突变胶质瘤 canonical IDH1 mutation (p.Arg132His) | 14 | 製餘觸鹹構構網築醖遞(範鏇衊衊艱壓齋選鬱築) = diarrhea (n=2), creatine phosphokinase elevations (n=1), QTc prolongation (n=1), and thrombocytopenia (n=1) 範憲鹽壓夢願鏇壓簾積 (壓艱願鑰鹽網遞衊簾廠 ) 更多 | - | 2024-11-11 |
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