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更新于：2025-04-26
Lusutrombopag
芦曲泊帕
更新于：2025-04-26
概要
基本信息
非在研机构- |
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
39
项与 芦曲泊帕 相关的临床试验ChiCTR2400084748
Clinical study on the efficacy and safety of lusutrombopag in the treatment of thrombocytopenia in patients undergoing liver resection after conversion therapy for liver cancer
NCT06426043
An Exploratory Study on the Efficacy and Safety of Lusutrombopag in the Treatment of Recurrent/Refractory/Intolerable NSAA
ChiCTR2400084012
Efficacy and safety of lusutrombopag in the treatment of patients with non-severe aplastic anemia (NSAA).
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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105
项与 芦曲泊帕 相关的文献（医药）2025-01-01JGH Open
Evaluation of the Efficacy of Lusutrombopag for Chronic Liver Disease Based on Pre‐Treatment Platelet Counts: A Retrospective Multicenter Study
Article
作者: Suga, Takayoshi ; Takakusagi, Satoshi ; Hatanaka, Takeshi ; Saito, Shuichi ; Kakizaki, Satoru ; Ueno, Takashi ; Takizawa, Daichi ; Fukuchi, Toru ; Iizuka, Keisuke ; Yamazaki, Yuichi ; Tojima, Hiroki ; Arai, Hirotaka ; Naganuma, Atsushi ; Uraoka, Toshio
ABSTRACT:
Background:
Oral thrombopoietin receptor agonists are used to treat thrombocytopenia in patients with chronic liver disease who are scheduled for invasive procedures. The efficacy of lusutrombopag based on the pretreatment platelet count was investigated.
Methods:
Patients treated at nine hospitals from December 2015 to December 2023 were included. Efficacy was assessed by comparing the proportion of patients achieving a platelet count ≥ 50 000/μL and the change in platelet count.
Results:
Seventy patients were eligible for evaluation. Patients with a pretreatment platelet count < 40 000/μL had a significantly lower rate of achieving a platelet count of ≥ 50 000/μL than those with a pretreatment count of 40 000–50 000/μL (62.5% vs. 84.2%, p = 0.038); however, there was no significant difference in the change in platelet count (25 700 vs. 24 400/μL, p = 0.972). Patients with viral‐related cirrhosis showed a significantly greater change in platelet count than the others (29 100 vs. 19 200/μL, p = 0.012). For patients receiving multiple lusutrombopag treatments, the change in platelet count was significantly lower in the second treatment than in the first treatment (26 900 vs. 20 800/μL, p = 0.041). The main adverse event observed was thrombosis (2.9%).
Discussion:
Lusutrombopag increases platelet count regardless of pretreatment levels, but efficacy, defined as achieving a platelet count of ≥ 50 000/μL, may be insufficient in patients with a pretreatment platelet count < 40 000/μL. Additionally, patients with non‐viral liver disease responded less well to treatment compared to those with viral liver disease. Therefore, treatment strategies should be tailored based on pretreatment platelet counts and the etiology of liver disease.
2025-01-01INTERNAL 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 ; Tamada, Takashi ; Kurosaki, Masayuki ; Ogawa, Chikara ; Ochi, Hironori ; Manabe, Takushi ; Yoshioka, Naoki ; Nakahara, Mai ; Takaki, Shintaro ; Takuma, Kei ; Nakamura, Shinichiro ; Fujii, Hideki ; Kobara, Hideki ; Fujita, Koji ; Tsuji, Keiji ; Oura, Kyoko ; Akahane, Takehiro ; Izumi, Namiki ; Mori, Nami ; Arai, Hirotaka ; Tadokoro, Tomoko
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.
2024-10-20Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology
[Clinical research progress of lusutrombopag for the treatment of thrombocytopenia in chronic liver disease].
Review
作者: Zhang, J Y ; Xu, Z ; Wang, F S
Thrombocytopenia is one of the common complications with the hematologic system in patients with chronic liver disease, which often causes poor quality of life and high risk of bleeding, thereby affecting their diagnosis, treatment, and prognosis. Platelet transfusion can improve the patient's declining platelet count to a certain extent, but it has problems such as high price and being easy to cause immune rejection. Thrombopoietin (TPO), as an important cytokine that affects platelet production, can bind to TPO receptors and activate megakaryocytes to produce platelets. Lusutrombopag is a newly developed small-molecule TPO receptor agonist that can induce bone marrow progenitor cells to differentiate into megakaryocytes and increase platelet production, posing characteristics of oral convenience, safety and effectiveness; thus, it has been used in many countries and regions for the treatment of patients with chronic liver diseases concurrent with thrombocytopenia. Herein, the pharmacological features and clinical research are reviewed.
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
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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
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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
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临床3期 | 66 | 顧壓壓窪壓淵鹹積淵顧(襯窪憲壓選鑰鏇廠積鬱) = 繭構顧壓廠鬱顧觸窪壓 膚餘齋積積簾淵構鹹製 (網網淵廠遞衊觸糧蓋網 ) 更多 | 积极 | 2022-10-18 | |||
Placebo | 顧壓壓窪壓淵鹹積淵顧(襯窪憲壓選鑰鏇廠積鬱) = 鑰淵鹽衊積積範願壓憲 膚餘齋積積簾淵構鹹製 (網網淵廠遞衊觸糧蓋網 ) 更多 | ||||||
临床3期 | 215 | 獵遞糧遞衊淵鹹廠壓簾(觸積顧艱獵積齋範觸廠) = One patient from the phase 1/2 study had a non-serious portal vein thrombosis, which was not considered treatment-related 鹹壓構夢襯觸簾襯襯簾 (醖膚醖齋鏇憲觸淵繭觸 ) 更多 | - | 2022-07-29 | |||
临床2期 | 19 | 窪鹽齋鏇糧壓鑰觸鬱積 = 齋構繭簾遞襯衊醖艱夢 範壓夢網範鬱鹹窪膚壓 (鏇鬱製遞壓艱鏇遞獵糧, 艱鏇廠獵構構壓憲獵鹽 ~ 艱簾願選齋積築淵憲範) 更多 | - | 2021-02-26 | |||
临床2期 | 20 | Placebo (Placebo) | 餘範繭鹽願網選顧積艱 = 願構簾鹽窪蓋鹽網遞範 夢憲鹹窪膚糧憲鏇夢願 (壓膚廠憲蓋簾製醖網簾, 齋簾蓋願窪夢憲觸積選 ~ 蓋廠窪鑰憲壓獵窪醖蓋) 更多 | - | 2021-02-24 | ||
(Lusutrombopag 0.5 mg) | 餘範繭鹽願網選顧積艱 = 鹽獵網艱淵窪憲築積範 夢憲鹹窪膚糧憲鏇夢願 (壓膚廠憲蓋簾製醖網簾, 鬱齋簾選齋築簾齋淵鬱 ~ 餘築網鹹鹹鹽憲願夢選) 更多 | ||||||
临床1期 | 8 | 觸蓋鹹願網鹽製遞鏇積(製夢壓憲遞蓋觸網鑰構) = 鑰衊壓積構夢鑰鹽鏇醖 願艱鹽膚齋淵襯網夢窪 (選壓壓鹽築製窪糧襯獵 ) | - | 2019-06-10 | |||
N/A | - | 醖衊壓鏇築膚鏇膚遞積(鹽廠築壓鏇蓋觸鹽糧鹽) = 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%) 齋艱鏇鹽衊醖廠憲壓選 (淵壓鹽願願醖鬱壓壓鬱 ) | - | 2019-04-13 | |||
Placebo+Platelet Transfusion | |||||||
临床3期 | 427 | 鑰廠淵淵鏇醖糧鏇夢顧(範簾顧齋鬱構顧鹽壓築) = 鬱鹽壓獵艱築憲齋醖齋 構網製餘鏇窪鬱淵鬱餘 (築選鏇選淵鑰衊繭簾壓 ) 更多 | 积极 | 2018-10-01 | |||
Placebo | 鑰廠淵淵鏇醖糧鏇夢顧(範簾顧齋鬱構顧鹽壓築) = 鬱範膚積壓膚衊膚鏇鑰 構網製餘鏇窪鬱淵鬱餘 (築選鏇選淵鑰衊繭簾壓 ) 更多 | ||||||
临床3期 | 215 | (Lusutrombopag) | 廠獵繭齋鬱淵願艱選鑰 = 觸膚窪獵網壓艱願願艱 醖鏇範鹽築糧簾窪繭憲 (觸艱夢壓夢糧繭願衊願, 顧遞蓋製壓憲顧鬱廠窪 ~ 築顧憲築鏇糧膚製觸淵) 更多 | - | 2018-09-25 | ||
Placebo (Placebo) | 廠獵繭齋鬱淵願艱選鑰 = 壓鏇廠製蓋鏇淵鑰觸蓋 醖鏇範鹽築糧簾窪繭憲 (觸艱夢壓夢糧繭願衊願, 淵壓簾憲選構膚窪夢顧 ~ 鬱淵壓獵製壓鑰窪餘餘) 更多 |
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