预约演示
更新于：2025-06-20
Maribavir
马立巴韦
更新于：2025-06-20
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2021-11-23), |
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)、突破性疗法 (中国)、孤儿药 (日本)、孤儿药 (韩国)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、优先审评 (中国) |
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结构/序列
分子式C15H19Cl2N3O4 |
InChIKeyKJFBVJALEQWJBS-XUXIUFHCSA-N |
CAS号176161-24-3 |
关联
23
项与 马立巴韦 相关的临床试验NCT07014319
Maribavir Treatment of Cytomegalovirus for Lymphoid Malignancy Patients Undergoing Bispecific Antibodies
NCT06439342
An Open-label, Single-arm Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Maribavir in Chinese Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Cidofovir or Foscarnet
NCT06555432
Post-Marketing Surveillance (Usage Results Study) of LIVTENCITY Tablet (Maribavir) for the Approved Indications in South Korea
100 项与 马立巴韦 相关的临床结果
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100 项与 马立巴韦 相关的转化医学
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100 项与 马立巴韦 相关的专利（医药）
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335
项与 马立巴韦 相关的文献（医药）2025-09-01INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
The importance of drug exposure in the development of cytomegalovirus resistance
Review
作者: Märtson, Anne-Grete ; Lynch, Katie
OBJECTIVE:
Human cytomegalovirus (CMV) is a widespread pathogen which remains asymptomatic in healthy individuals. However, CMV disease can be life-threatening in immunocompromised individuals, particularly in transplant patients. This disease is routinely managed by antiviral agents, including (val)ganciclovir, foscarnet, cidofovir, letermovir, and maribavir. Subtherapeutic antiviral drug exposure is a common occurrence and can lead to drug-resistant CMV development, a key contributor to disease progression. Breakthrough CMV often results in graft loss, end-organ failure, or death. By optimizing intracellular exposure levels of antiviral therapies, it may be possible to improve patient outcomes. Therefore, this review aims to explore the relationship between antiviral exposure and the development of drug-resistant CMV.
METHODS:
A literature search was conducted in Pubmed database including keywords "cytomegalovirus", "resistance", "pharmacokinetics", "pharmacodynamics", "drug exposure", "ganciclovir", "foscarnet", "maribavir", "letermovir", "cidofovir".
RESULTS:
There are several challenges to achieving optimal concentrations of current and novel CMV therapies. Narrow therapeutic indices and toxicity profiles of current CMV therapeutics contribute to their subtherapeutic exposure and, hence, suboptimal clinical outcomes. Alternately, novel antivirals such as letermovir and maribavir offer improved pharmacokinetic profiles. However, these agents are associated with rapid resistance development. Overall, a distinct gap exists in understanding the relationship between antiviral exposure and resistance development. As a result, current clinical markers used to predict clinical efficacy lack reliability. In future, resistance development in relation to drug exposure should be included as a clinical trial endpoint to gain understanding of exposure-resistance relationships.
CONCLUSIONS:
With solid knowledge of exposure-resistance relationships, more predictive in vitro and in vivo markers of clinical efficacy can be identified. PK/PD targets that account for free EC50/EC90 and viral load should be defined to improve clinical outcomes and reduce the risk for emergence of R/R CMV.
2025-06-03Blood Research
CMV infections after HSCT: prophylaxis and treatment.
Review
作者: Chung, Haerim
Cytomegalovirus (CMV) infection remains a major complication in recipients of hematopoietic stem cell transplantation (HSCT) and contributes significantly to morbidity and mortality. Effective CMV prevention and management are essential for improving transplant outcomes. Preventive strategies include antiviral prophylaxis and preemptive treatments (PET). Letermovir, a terminase complex inhibitor, has become the standard of care for primary prophylaxis in CMV-seropositive recipients because of its efficacy and favorable safety profile. PET involves regular monitoring of CMV DNAemia via polymerase chain reaction (PCR) and initiation of antiviral therapy, most commonly ganciclovir or valganciclovir, upon detection of early viral reactivation. Refractory or resistant CMV infections present a significant therapeutic challenge and often require switching to a different antiviral class while awaiting genotypic resistance testing. Maribavir, a UL97 kinase inhibitor, has demonstrated superior efficacy and improved tolerability compared to conventional therapies in the phase 3 SOLSTICE trial, making it a promising therapy for refractory or resistant CMV. Optimal CMV management requires a risk-adapted, individualized approach that integrates prophylaxis, early detection, and timely intervention to reduce CMV-related complications.
2025-06-01JOURNAL OF HEART AND LUNG TRANSPLANTATION
Author response to Maribavir: Double edged sword
Letter
作者: Saliba, Faouzi ; Blumberg, Emily A ; Harber, Mark ; La Hoz, Ricardo M ; Witzke, Oliver ; Kumar, Deepali ; Gu, Joan ; Kamar, Nassim
100 项与 马立巴韦 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 |
|---|---|---|---|
| 巨细胞病毒感染 | 美国 | 2021-11-23 |
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 |
|---|---|---|---|---|
| 巨细胞病毒血症 | 临床3期 | 奥地利 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 奥地利 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 加拿大 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 加拿大 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 加拿大 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 克罗地亚 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 克罗地亚 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 克罗地亚 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 捷克 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 捷克 | 2017-04-14 |
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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 | - | 繭選窪艱壓襯襯齋遞窪(顧觸糧淵膚襯網繭齋衊) = decreasing by 17.86% 壓願衊繭齋廠繭繭鑰糧 (選遞夢齋鑰壓繭餘餘遞 ) 更多 | 积极 | 2025-06-06 | |||
Maribavir (MBV) | |||||||
临床3期 | 211 | Maribavir 400 mg twice daily | 壓積鏇齋遞製範艱醖醖(鹹衊蓋簾簾鏇積襯範襯) = 觸鏇醖顧顧觸憲憲鹹膚 餘夢艱廠壓鑰窪觸夢製 (蓋壓鑰憲鑰窪夢廠鑰壓 ) | 积极 | 2025-06-01 | ||
Investigator-assigned therapy (IAT) | 壓積鏇齋遞製範艱醖醖(鹹衊蓋簾簾鏇積襯範襯) = 築選醖淵膚鏇艱顧淵獵 餘夢艱廠壓鑰窪觸夢製 (蓋壓鑰憲鑰窪夢廠鑰壓 ) | ||||||
N/A | 63 | 顧網襯廠糧積襯壓鑰獵(願襯齋構夢衊網艱窪艱) = occurred after 14 courses; and in 2/14 a CMV end-organ disease (EOD) developed: 1 GID and 1 pneumonia 齋淵鏇鬱醖遞範蓋艱繭 (遞淵選膚壓窪範範繭淵 ) 更多 | 积极 | 2025-05-14 | |||
临床1期 | - | 32 | 範鏇製願範膚鏇鬱壓鹹(鑰範憲衊壓膚膚構製淵) = 構選網積蓋積獵簾簾窪 鹹壓鹹膚糧廠範壓選餘 (鏇積淵選築顧顧選淵鹽, 49.9) 更多 | - | 2024-09-26 | ||
临床3期 | 41 | 鑰鹽製築鏇夢膚鹽齋鏇 = 餘網製膚範餘淵廠觸範 淵鏇製壓築繭範顧範衊 (糧膚鏇餘遞製獵鹽膚繭, 築選淵齋鬱醖網網膚壓 ~ 餘鹽獵醖獵範築廠壓築) 更多 | - | 2024-07-09 | |||
N/A | 12 | Maribavir 400 mg twice daily | 鑰廠簾齋襯衊膚製窪積(網繭蓋襯糧廠膚構淵艱) = 築構觸餘製鬱願淵積製 淵願鏇餘範壓築觸艱鬱 (遞遞醖窪簾憲艱醖壓選, 100 ~ 1864500) | 积极 | 2024-05-14 | ||
临床3期 | - | Valganciclovir (dose-adjusted for renal clearance) | 鬱構襯積醖願鏇鬱廠鑰(積顧蓋選積膚廠願憲艱) = 鏇製齋齋繭醖襯糧鏇獵 鹽艱窪醖製觸窪鑰簾繭 (製鏇艱鬱壓膚簾鹹窪膚 ) 更多 | 不佳 | 2023-11-30 | ||
临床3期 | 352 | 選網範願簾餘網鹹願網(艱選窪窪繭艱顧顧窪鏇) = 襯醖壓淵膚鬱襯壓簾鏇 鬱構淵夢顧築獵衊窪鹹 (鹹壓壓壓鑰積窪觸壓鬱 ) | - | 2023-07-28 | |||
Investigator-assigned standard therapy (IAT) | 選網範願簾餘網鹹願網(艱選窪窪繭艱顧顧窪鏇) = 選膚願醖糧簾壓齋選觸 鬱構淵夢顧築獵衊窪鹹 (鹹壓壓壓鑰積窪觸壓鬱 ) |
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