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更新于：2026-02-02
Lusutrombopag
芦曲泊帕
更新于：2026-02-02
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 日本 (2015-09-28), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国) |
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结构/序列
分子式C29H32Cl2N2O5S |
InChIKeyNOZIJMHMKORZBA-KJCUYJGMSA-N |
CAS号1110766-97-6 |
关联
31
项与 芦曲泊帕 相关的临床试验CTR20253101
评估受试制剂芦曲泊帕片（规格：3mg）与参比制剂芦曲泊帕片（Mulpleta®规格：3mg）在健康成年受试者餐后状态下的单中心、随机、开放、单剂量、两周期、交叉生物等效性研究
CTR20253034
芦曲泊帕片（3mg）在中国健康人群中单次给药的人体生物等效性临床试验
CTR20252752
芦曲泊帕片(3mg)在中国健康人群中空腹和餐后状态下单次给药的人体生物等效性临床试验方案
100 项与 芦曲泊帕 相关的临床结果
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100 项与 芦曲泊帕 相关的转化医学
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100 项与 芦曲泊帕 相关的专利（医药）
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82
项与 芦曲泊帕 相关的文献（医药）2025-10-14Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi
[Efficacy and safety of lusutrombopag monotherapy for cyclosporine A-refractory, transfusion-dependent non-severe aplastic anemia].
Article
作者: Zhou, Y X ; Han, B ; Chen, M ; Wei, Y Y ; Liu, Z W ; Yang, C
This study retrospectively analyzed 12 patients with transfusion-dependent, non-severe aplastic anemia (TD-NSAA) refractory to cyclosporine A (CsA) , who were treated with lusutrombopag monotherapy. These patients either had a variety of chronic comorbidities or medication-related risks, or they were unresponsive to or intolerant of other thrombopoietin receptor agonists (TPO-RA) . The median treatment duration with lusutrombopag was 4 months (range: 3-11 months) , while the median follow-up period was 8 months (range: 6-11 months) . The overall response (OR) rates at months 3, 6, and the end of follow-up were 50.0%, 58.3%, and 50.0%, respectively, with a median time to OR of 2 months (range: 1-4 months) . Complete response (CR) rates were 8.3%, 16.7%, and 16.7% at the same time points, with a median time to CR of 4 months (range: 2-5 months) . Adverse events were all Grade 1, with an incidence rate of 25.0%. During follow-up, one patient experienced a loss of OR after discontinuing treatment, with a relapse rate of 14.3%; no clonal evolution or mortality was observed. These findings suggest that lusutrombopag is both effective and well-tolerated in CsA-refractory TD-NSAA patients and represents a promising therapeutic option for those with poor treatment tolerability.
2025-09-15INTERNAL MEDICINE
Usefulness of Repeated Lusutrombopag Administration in Clinical Practice and Its Correlation with the Simulation Software-Predicted Platelet Count: A Multicenter Study
Article
作者: Morishita, Asahiro ; Tani, Joji ; Kurosaki, Masayuki ; Tamada, Takashi ; Ogawa, Chikara ; Manabe, Takushi ; Ochi, Hironori ; Yoshioka, Naoki ; Takaki, Shintaro ; Nakahara, Mai ; Nakamura, Shinichiro ; Takuma, Kei ; Fujii, Hideki ; Kobara, Hideki ; Fujita, Koji ; Tsuji, Keiji ; Oura, Kyoko ; Akahane, Takehiro ; Izumi, Namiki ; Mori, Nami ; Tadokoro, Tomoko ; Arai, Hirotaka
Objective Lusutrombopag is recommended for severe thrombocytopenia (<5.0×104/μL) in patients with chronic liver disease who are scheduled to undergo invasive procedures. However, reports on the efficacy of repeated lusutrombopag dosing are scarce. It is also not known whether lusutrombopag causes the platelet count to exceed 5.0×104/μL. We evaluated the efficacy of repeated lusutrombopag dosing and the efficacy of the platelet prediction simulation software program. Methods We evaluated the number of platelet elevations according to the number of lusutrombopag administrations. We also evaluated the correlation between the highest software-predicted platelet count and the platelet count measured in actual clinical practice. Patients This retrospective study included 236 patients treated with lusutrombopag at 11 medical institutions in Japan. Results The platelet count increased with the number of lusutrombopag administrations (1, 2, 3, 4, >4) in all groups, and no significant difference was found among the groups (p=0.169). In all groups, the platelet counts reached their highest levels at 8-14 days after treatment with lusutrombopag (p=0.243). There was a correlation between the highest software-predicted platelet count and the platelet count measured in actual clinical practice in all dose frequency groups; however, the correlation was the strongest in the one-dose group (r=0.74, p<0.0001). Conclusion Frequent lusutrombopag administration is therefore both effective and safe, and a platelet prediction simulation software program is thus considered to be useful in practice.
2025-08-01Translational Pediatrics
Development and validation of a prognostic prediction model based on coagulation-related genes and clinical factors in acute leukemia
Article
作者: Gao, Haihong ; Zhan, Yi ; Lan, Tian ; Chen, Yong
Background:
Acute leukemia (AL) is one of the most prevalent pediatric malignancies with highly heterogeneous clinical outcomes. Coagulation-related genes (CRGs) play a crucial role in tumours, but their value in combination with clinical factors for prognostic prediction in AL is unclear. This study aims to develop a prognostic model based on the CRGs signature, with the goal of improving prognostic monitoring and identifying potential therapeutic targets for pediatric AL.
Methods:
We collected transcriptomic and clinical data of pediatric AL patients from the Therapeutically Applicable Research to Generate Effective Treatments (TARGET) and The Cancer Genome Atlas (TCGA) databases, including age, gender, and white blood cell count (WBC). Molecular subtypes related to CRGs were identified via non-negative matrix factorization (NMF). A CRGs-based gene signature was developed using the least absolute shrinkage and selection operator (LASSO) and regression analyses. The model was built on a training set and validated independently. Time-dependent receiver operating characteristic (ROC) was used to assess the predictive accuracy of the model for 1-, 3-, and 5-year overall survival (OS). Nomograms were constructed combining CRGs characteristics and clinical factors, and their clinical utility was assessed using calibration curves and decision curve analysis (DCA). Immune infiltration was quantified using the single-sample gene set enrichment analysis (ssGSEA) and the microenvironment cell populations-counter (MCPcounter) algorithm. Kaplan-Meier (K-M) survival analysis was performed to assess the correlation between signature gene expression and OS. Moreover, molecular docking was utilized to investigate the potential interactions between signature genes and small-molecule drugs. Expression of key genes was confirmed by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Results:
A total of 103 AL patients were included as a training set. Risk stratification based on the median risk score of CRGs showed a significant difference in OS between the two groups (P<0.001), with the low-risk group having a better prognosis. The area under the curves (AUCs) of the model for 1-, 3-, and 5-year survival prediction in the training set were 0.711, 0.762, and 0.718, respectively, and the AUC values in the independent validation set also showed good agreement. Analysis integrating risk scores with clinical data indicated that the CRGs signature could serve as an independent prognostic factor. The nomogram constructed based on CRGs features and key clinical variables showed good fit and potential clinical net effect. Molecular docking analysis revealed stable binding interactions between PROS1 and the small-molecule drugs, avatrombopag and lusutrombopag.
Conclusions:
In this study, a robust prognostic model incorporating CRGs was constructed to effectively predict survival outcomes in paediatric AL patients. The model helps to enable individualised risk stratification and guide targeted therapy. In addition, avatrombopag and lusutrombopag as potential therapeutic agents provide new ideas for precision medicine in paediatric AL.
91
项与 芦曲泊帕 相关的新闻（医药）2026-01-30
2026-01-28
疫苗诊断试剂
100 项与 芦曲泊帕 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 |
|---|---|---|---|
| 血小板减少症 | 日本 | 2015-09-28 |
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 |
|---|---|---|---|---|
| 慢性肝病 | 临床3期 | - | 2015-06-15 | |
| 慢性血小板减少症 | 临床2期 | 美国 | 2010-04-29 | |
| 免疫性血小板减少症 | 临床2期 | 美国 | 2010-03-18 |
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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3期 | 66 | 壓壓蓋餘襯餘齋鏇壓製(選鑰製艱範醖齋醖網餘) = 繭夢餘蓋艱廠積窪膚鹹 憲簾鹹窪鑰積鹽蓋糧淵 (範鬱繭壓衊淵獵糧簾窪 ) 更多 | 积极 | 2022-10-18 | |||
Placebo | 壓壓蓋餘襯餘齋鏇壓製(選鑰製艱範醖齋醖網餘) = 鏇衊繭網積鹽築鏇鏇鏇 憲簾鹹窪鑰積鹽蓋糧淵 (範鬱繭壓衊淵獵糧簾窪 ) 更多 | ||||||
临床2期 | 19 | 鑰鹽繭願獵蓋構願艱築 = 鬱餘鏇製構顧廠蓋鏇築 築鏇齋鏇廠憲鑰餘觸鬱 (壓築糧夢淵淵鹹獵衊製, 襯遞蓋築選選鹹築餘鹹 ~ 廠衊製遞願夢醖壓簾鬱) 更多 | - | 2021-02-26 | |||
临床2期 | 20 | Placebo (Placebo) | 蓋糧鹽齋餘遞鹽膚遞顧 = 窪膚選壓膚餘顧築淵廠 壓餘網憲艱鏇積獵製淵 (鏇齋淵壓壓鏇願選憲衊, 膚鏇鏇艱膚糧構艱餘壓 ~ 範網遞糧鹹艱製膚憲餘) 更多 | - | 2021-02-24 | ||
(Lusutrombopag 0.5 mg) | 蓋糧鹽齋餘遞鹽膚遞顧 = 範膚糧願蓋醖糧艱夢壓 壓餘網憲艱鏇積獵製淵 (鏇齋淵壓壓鏇願選憲衊, 淵觸憲餘憲製鹹夢鏇鹹 ~ 網壓膚獵構衊簾夢築鹹) 更多 | ||||||
临床1期 | 8 | 獵積餘選鑰齋夢壓製壓(醖齋衊築鏇繭獵艱鑰鏇) = 獵襯鬱選蓋遞壓鹹淵膚 鏇選淵願窪蓋鹹顧願糧 (鑰蓋餘夢齋廠淵艱夢鑰 ) | - | 2019-06-10 | |||
N/A | - | 餘網淵鏇壓選糧願築壓(鏇製糧鬱窪壓蓋遞鹽餘) = Lower BE rates, regardless of severity and timing of onset, were observed for LUSU alone vs PBO+PT. Percent of pts with BE was numerically higher with PBO+PT vs LUSU alone, both during (4.8% vs 3.2%) and post-procedure (7.1% vs 4.0%). Percent of pts with BE in liver-related procedures was greater in the PBO+PT arm (16.1%) vs LUSU alone (11.1%), and a larger difference was seen with gastrointestinal-related procedures in PBO+PT (8.9%) vs LUSU alone (2.0%) 鑰糧憲選鏇淵壓壓鹽廠 (壓構觸鑰夢鹹膚襯廠鹹 ) | - | 2019-04-13 | |||
Placebo+Platelet Transfusion | |||||||
临床3期 | 427 | 觸鏇膚艱餘襯蓋廠艱醖(顧艱夢遞齋餘齋範繭艱) = 淵壓觸鹹範製築選顧糧 鹹鹽選淵網製夢鏇鹹鬱 (範網窪膚齋鹽憲襯餘網 ) 更多 | 积极 | 2018-10-01 | |||
Placebo | 觸鏇膚艱餘襯蓋廠艱醖(顧艱夢遞齋餘齋範繭艱) = 製艱艱夢齋簾鏇積衊製 鹹鹽選淵網製夢鏇鹹鬱 (範網窪膚齋鹽憲襯餘網 ) 更多 | ||||||
临床3期 | 215 | (Lusutrombopag) | 衊壓壓鏇衊壓鏇廠觸遞 = 醖獵衊鑰遞顧淵醖網範 範網餘鹽衊築觸醖糧積 (積製顧廠築鹹築膚夢襯, 憲襯鹽鹹齋鬱衊簾艱鹽 ~ 衊夢製鹹構範觸蓋襯淵) 更多 | - | 2018-09-25 | ||
Placebo (Placebo) | 衊壓壓鏇衊壓鏇廠觸遞 = 願餘鑰膚鑰壓鹽鹽憲襯 範網餘鹽衊築觸醖糧積 (積製顧廠築鹹築膚夢襯, 鏇憲糧淵築淵廠繭簾願 ~ 鏇範膚獵願夢鹹餘糧窪) 更多 |
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