预约演示
更新于：2025-08-30
Ponatinib Hydrochloride
盐酸普纳替尼
更新于：2025-08-30
概要
基本信息
药物类型 小分子化药 |
别名 ponatinib、Ponatinib hydrochloride (JAN/USAN)、泊那替尼 + [9] |
靶点 |
作用方式 抑制剂 |
作用机制 Bcr-Abl抑制剂(bcr-abl酪氨酸激酶抑制剂)、Tyrosine kinase inhibitors |
在研适应症 |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2012-12-14), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、孤儿药 (日本)、孤儿药 (韩国)、临床急需境外新药 (中国)、加速批准 (美国) |
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结构/序列
分子式C29H28ClF3N6O |
InChIKeyBWTNNZPNKQIADY-UHFFFAOYSA-N |
CAS号1114544-31-8 |
关联
90
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100 项与 盐酸普纳替尼 相关的临床结果
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100 项与 盐酸普纳替尼 相关的转化医学
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100 项与 盐酸普纳替尼 相关的专利（医药）
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1,909
项与 盐酸普纳替尼 相关的文献（医药）2025-12-31Virulence
Ponatinib and other clinically approved inhibitors of Src and Rho-A kinases abrogate dengue virus serotype 2- induced endothelial permeability
Article
作者: Awasthi, Mansi ; Modak, Ayan ; Sobha, Archana ; Sreekumar, Easwaran ; Mishra, Srishti Rajkumar
Severe dengue often presents as shock syndrome with enhanced vascular permeability and plasma leakage into tissue spaces. In vitro studies have documented the role of Src family kinases (SFKs) and RhoA-kinases (ROCK) in dengue virus serotype 2 (DENV2)-induced endothelial permeability. Here, we show that the FDA-approved SFK inhibitors Bosutinib, Vandetanib and Ponatinib, as well as the ROCK inhibitors, Netarsudil and Ripasudil significantly inhibit DENV2-induced endothelial permeability. In cultured telomerase immortalized human microvascular endothelial cells (HMEC-1), treatment with these inhibitors reduced the phosphorylation of VE-Cadherin, Src and myosin light chain 2 (MLC2) proteins that were upregulated during DENV2 infection. It also prevented the loss of VE-Cadherin from the inter-endothelial cell junctions induced by viral infection. In in-vivo studies using DENV2-infected AG129 IFN receptor-α/β/γ deficient mice, ponatinib, when administered 24 h post-infection onwards, demonstrated significant benefits in improving body weight, clinical outcomes, and survival rates. While all virus-infected, untreated mice died by day-10 post-infection, 80% of the ponatinib-treated mice survived, and approximately 60% were still alive at the end of the 15-day observation period. The treatment also significantly reduced disease severity factors such as vascular leakage, thrombocytopenia; mRNA transcript levels of proinflammatory cytokines such as IL-1β and TNF-α; and restored liver function. Comparable effects were observed even when ponatinib treatment was initiated after symptom onset. The results highlight ponatinib as an effective therapeutic option in severe dengue; and also a similar potential for other FDA- approved SFK and ROCK inhibitors.
2025-12-31Hematology
Ponatinib/blinatumomab for relapsed Philadelphia chromosome-positive leukemia as a bridge to allogeneic transplantation
Article
作者: Kato, Chika ; Shingai, Naoki ; Watanabe, Daisuke ; Toya, Takashi ; Shimabukuro, Masashi ; Sadaga, Yasutaka ; Sadato, Daichi ; Hirama, Chizuko ; Kambara, Yasuhiro ; Jinguji, Atsushi ; Okuyama, Yoshiki ; Harada, Yuka ; Sakai, Satoshi ; Najima, Yuho ; Mizuchi, Daisuke ; Kondo, Kaori ; Haraguchi, Kyoko ; Kato, Kana ; Kobayashi, Takeshi ; Doki, Noriko ; Shimizu, Hiroaki
We report three cases of ponatinib/blinatumomab (Pona/BLIN) combination therapy as a bridge to allogeneic hematopoietic cell transplantation (allo-HCT) in patients with relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (r/r-Ph + ALL) or lymphoid chronic myeloid leukemia blast crisis (CML-BC). Case 1: A 60-year-old man with Ph + ALL achieved molecular complete remission (mCR) with Pona/BLIN after relapse following initial dasatinib-based treatment and subsequently underwent allo-HCT. Case 2: A 39-year-old man with Ph + ALL achieved hematological CR (hCR) with one cycle of inotuzumab ozogamicin and mCR with Pona/BLIN after post-transplant relapse but developed extramedullary relapse with BCR::ABL-negative clone and underwent a second allo-HCT in non-remission. He subsequently developed hematological relapse. Case 3: A 57-year-old woman initially diagnosed with myeloid CML-BC achieved mCR with chemotherapy regimens and dasatinib maintenance but relapsed as lymphoid CML-BC. She achieved hCR with Pona/BLIN and proceeded to allo-HCT. None of the cases developed grade 3 or higher adverse events during treatment. These cases suggest that Pona/BLIN combination therapy is safe and effective as a bridging strategy to allo-HCT, but extramedullary relapse caused by BCR::ABL-negative blasts can occur.
2025-12-01Hematology
Real-world outcomes in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia or chronic myeloid leukemia treated with ponatinib - final 6-year results from a Belgian registry.
Article
作者: Vrelust, Inge ; Benghiat, Fleur Samantha ; Van de Velde, Ann ; Lewalle, Philippe ; Gadisseur, Alain ; Selleslag, Dominik ; Meers, Stef ; Bailly, Benjamin ; Becker, Ann De ; Lejeune, Marie ; Triffet, Agnès ; Devos, Timothy ; Deeren, Dries ; Beck, Michael ; Mazure, Dominiek ; Janssen, Mia ; Granacher, Nikki ; Sebti, Hinde ; Theunissen, Koen ; Havelange, Violaine ; Vanstraelen, Gaëtan ; Vellemans, Hélène
BACKGROUND:
Ponatinib is a third-generation tyrosine kinase inhibitor (TKI) for treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in patients who fail or are intolerant to a second generation TKI or who carry the T315I mutation.
METHOD:
This is the final analysis of the Belgian ponatinib registry evaluating use of ponatinib in clinical practice, with data available for up to 6 years after reimbursement.
RESULT:
Forty-eight percent of 54 CML and 28% of 29 Ph+ ALL patients had received ≥3 previous TKIs. Before ponatinib, most patients had already achieved a response, including at least a major molecular response (MMR), in 19% of CML and 17% of Ph+ ALL patients. Ponatinib was initiated due to intolerance to previous TKIs in 50% of CML and 41% of Ph+ ALL patients. Median follow-up was 545 and 258 days for CML and Ph+ ALL patients, respectively. Best response to ponatinib was at least an MMR in 65% of CML and 55% of Ph+ ALL patients. Overall and progression-free survival were 85.8% and 83.8% in CML patients after 48 months of treatment, and 82.5% and 54.2% in Ph+ ALL patients after 30 months of treatment. Adverse reactions were reported by 85% of CML and 76% of Ph+ ALL patients, with 33% of CML and 24% of Ph+ ALL patients experiencing cardiovascular events.
CONCLUSION:
In line with previously published trials, these real-world data support use of ponatinib in CML and Ph+ ALL patients with resistance or intolerance to previous TKIs or carrying the T315I mutation.Trial registration: ClinicalTrials.gov identifier: NCT03678454; September 19, 2018.
100 项与 盐酸普纳替尼 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 |
|---|---|---|---|
| 慢性粒细胞性白血病 | 澳大利亚 | 2014-11-26 | |
| 加速期慢性骨髄性白血病 | 欧盟 | 2013-07-01 | |
| 加速期慢性骨髄性白血病 | 冰岛 | 2013-07-01 | |
| 加速期慢性骨髄性白血病 | 列支敦士登 | 2013-07-01 | |
| 加速期慢性骨髄性白血病 | 挪威 | 2013-07-01 | |
| 急性转化期慢性粒细胞性白血病 | 欧盟 | 2013-07-01 | |
| 急性转化期慢性粒细胞性白血病 | 冰岛 | 2013-07-01 | |
| 急性转化期慢性粒细胞性白血病 | 列支敦士登 | 2013-07-01 | |
| 急性转化期慢性粒细胞性白血病 | 挪威 | 2013-07-01 | |
| 慢性期慢性髓性白血病 | 欧盟 | 2013-07-01 | |
| 慢性期慢性髓性白血病 | 冰岛 | 2013-07-01 | |
| 慢性期慢性髓性白血病 | 列支敦士登 | 2013-07-01 | |
| 慢性期慢性髓性白血病 | 挪威 | 2013-07-01 | |
| 费城染色体阳性急性淋巴细胞白血病 | 欧盟 | 2013-07-01 | |
| 费城染色体阳性急性淋巴细胞白血病 | 冰岛 | 2013-07-01 | |
| 费城染色体阳性急性淋巴细胞白血病 | 列支敦士登 | 2013-07-01 | |
| 费城染色体阳性急性淋巴细胞白血病 | 挪威 | 2013-07-01 | |
| 急性淋巴细胞白血病 | 美国 | 2012-12-14 | |
| 费城染色体阳性慢性粒细胞白血病 | 美国 | 2012-12-14 |
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 |
|---|---|---|---|---|
| 费城染色体阳性成人前体急性淋巴细胞白血病 | 临床2期 | 美国 | 2024-01-01 | |
| 费城染色体阳性白血病 | 临床2期 | 美国 | 2021-02-24 | |
| 费城染色体阳性白血病 | 临床2期 | 中国 | 2021-02-24 | |
| 费城染色体阳性白血病 | 临床2期 | 阿根廷 | 2021-02-24 | |
| 费城染色体阳性白血病 | 临床2期 | 澳大利亚 | 2021-02-24 | |
| 费城染色体阳性白血病 | 临床2期 | 巴西 | 2021-02-24 | |
| 费城染色体阳性白血病 | 临床2期 | 捷克 | 2021-02-24 | |
| 费城染色体阳性白血病 | 临床2期 | 法国 | 2021-02-24 | |
| 费城染色体阳性白血病 | 临床2期 | 意大利 | 2021-02-24 | |
| 费城染色体阳性白血病 | 临床2期 | 墨西哥 | 2021-02-24 |
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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
N/A | 583 | 淵廠醖顧廠觸築築壓蓋(壓選夢鹽製鬱壓糧顧艱) = 淵廠鹽積膚淵製遞願鏇 繭獵築構餘壓衊網製選 (願蓋衊獵糧衊淵範蓋簾 ) 更多 | 积极 | 2025-05-30 | |||
蓋積齋醖襯襯淵鏇繭廠(製遞蓋繭壓範積淵繭顧) = 積憲蓋鹽糧衊鑰選糧鬱 積廠鬱糧淵鬱鏇繭簾積 (觸選鬱積獵膚鑰蓋鬱壓 ) | |||||||
N/A | 338 | 艱顧範齋蓋廠齋膚襯襯(構壓糧製遞築築鹹糧範) = 遞蓋遞鹽繭窪壓顧襯築 顧鏇繭鑰壓醖蓋廠窪襯 (壓夢夢夢壓製夢鏇廠蓋, 0.751 ~ 0.930) | 积极 | 2025-05-30 | |||
临床2期 | 慢性粒细胞性白血病 TKI-resistant | 82 | 構鏇鑰廠淵獵憲醖繭襯(蓋膚憲襯壓製糧齋襯夢) = 醖構襯淵選鹽蓋選鏇鹹 憲艱鑰蓋餘積膚餘築憲 (壓鏇築選網襯繭製壓繭, 35% ~ 61%) 更多 | - | 2025-05-14 | ||
構鏇鑰廠淵獵憲醖繭襯(蓋膚憲襯壓製糧齋襯夢) = 鬱繭艱襯選鏇選鬱鹽遞 憲艱鑰蓋餘積膚餘築憲 (壓鏇築選網襯繭製壓繭, 24% ~ 71%) 更多 | |||||||
临床3期 | 残留肿瘤 BCR::ABL1 | 232 | 夢繭網鬱憲選襯構網窪(糧積淵願鏇願鹽鹹鹽膚) = TEAE rates with ponatinib/imatinib were 100%/98% (grade ≥3: 91%/94%); dose modification due to TEAEs: 71%/54% (discontinuation: 15%/9%; reduction: 16%/28%; interruption: 66%/41%) 繭鑰襯窪餘選窪衊築遞 (網壓衊壓鏇憲鑰簾憲鏇 ) 更多 | 积极 | 2025-05-14 | ||
临床2期 | 76 | 膚構夢網獵衊願製窪獵(壓鏇淵憲選簾齋衊壓窪) = 繭鹽簾築願顧糧鹹艱廠 艱構鏇顧廠淵壓鹽顧觸 (餘齋淵鏇繭壓網鬱築積 ) 更多 | 积极 | 2025-05-14 | |||
N/A | 202 | 衊廠膚願繭襯餘繭膚餘(願憲顧鹹齋繭襯襯醖廠) = 觸鹹顧鑰憲築繭醖築觸 範夢蓋襯淵膚齋鏇選築 (鹽鹹鹽糧鬱範鹽簾築襯, 64 ~ 72) 更多 | - | 2025-05-14 | |||
衊廠膚願繭襯餘繭膚餘(願憲顧鹹齋繭襯襯醖廠) = 衊鹽衊製築糧鬱艱鏇鹹 範夢蓋襯淵膚齋鏇選築 (鹽鹹鹽糧鬱範鹽簾築襯, 53 ~ 63) | |||||||
临床3期 | - | 繭鏇繭壓艱遞餘餘構選(衊網鹹壓壓獵齋鹽鬱築) = 獵範繭構積網憲窪觸鬱 蓋鬱網築壓艱範淵餘淵 (夢範積夢餘鏇襯鏇積構 ) 更多 | 积极 | 2025-04-01 | |||
临床2期 | 22 | laboratory biomarker analysis+ponatinib hydrochloride | 憲簾蓋餘膚鏇壓鹽獵齋 = 夢網顧壓艱選範壓願積 壓積醖艱鏇憲餘鏇艱積 (構築網獵構鬱鑰願獵夢, 願網襯構憲網齋願鏇蓋 ~ 鹹構觸膚壓夢膚艱繭鬱) 更多 | - | 2025-03-24 | ||
临床2期 | - | Ponatinib 30 mg QD | 夢顧鑰鹹膚鑰鏇襯積製(衊膚鹽選網齋鑰鹽襯廠) = 2 hematologic (grade 4 neutropenia at M6) 窪構網製網壓鹽選構鑰 (糧製淵顧窪蓋廠範願膚 ) | 积极 | 2024-12-08 | ||
Imatinib 400 mg QD | |||||||
N/A | - | Ponatinib-based therapy | 範鏇窪襯鬱鹽淵積醖鹽(餘蓋餘願鑰鏇簾鏇餘簾) = 築衊襯糧觸夢觸蓋網衊 願簾製築鬱齋夢簾築蓋 (醖膚鹹簾醖鑰艱築鑰衊 ) 更多 | - | 2024-12-08 | ||
Intensive chemotherapy (IC) | 鬱鏇蓋簾鑰築範襯積繭(鬱鑰蓋鏇範蓋膚窪積繭) = 壓遞鏇築願壓廠糧糧糧 鏇憲衊糧製膚顧鬱淵築 (窪廠觸網獵壓壓衊選艱 ) |
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