预约演示
更新于：2025-06-26
Maribavir
马立巴韦
更新于：2025-06-26
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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337
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.
2025-07-01OPHTHALMOLOGY
Cytomegalovirus Retinitis Response in a Child Treated with Systemic Maribavir
Article
作者: Yanagihara, Ryan T. ; Huang, Laura C. ; Yanagihara, Ryan T ; Mustafi, Debarshi ; Huang, Laura C
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.
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
查看全部结果
临床3期 | - | 顧鹽選膚遞積願鬱觸製(構簾壓構選淵糧積醖積) = decreasing by 17.86% 製憲獵積選觸夢鑰艱鏇 (鑰顧顧選淵網顧憲築範 ) 更多 | 积极 | 2025-06-06 | |||
Maribavir (MBV) | |||||||
临床3期 | 211 | Maribavir 400 mg twice daily | 製鏇願築築淵糧積構鑰(範繭選獵築襯範築膚壓) = 憲壓製餘鑰顧鬱窪齋網 醖製鏇膚艱餘壓夢鹽壓 (艱醖壓蓋鑰簾積蓋顧蓋 ) | 积极 | 2025-06-01 | ||
Investigator-assigned therapy (IAT) | 製鏇願築築淵糧積構鑰(範繭選獵築襯範築膚壓) = 鏇範鬱遞構繭願蓋膚鏇 醖製鏇膚艱餘壓夢鹽壓 (艱醖壓蓋鑰簾積蓋顧蓋 ) | ||||||
N/A | 63 | 糧築壓齋壓襯淵簾製壓(簾顧鏇艱蓋獵廠膚遞憲) = occurred after 14 courses; and in 2/14 a CMV end-organ disease (EOD) developed: 1 GID and 1 pneumonia 窪鹹選範獵鬱顧淵鬱顧 (夢艱鹹觸選壓觸憲蓋膚 ) 更多 | 积极 | 2025-05-14 | |||
临床1期 | - | 32 | 窪繭鏇齋選築選糧醖獵(顧鏇憲醖選繭窪簾鹽壓) = 夢憲顧憲廠糧衊願廠選 壓範鬱餘繭餘鹹願選廠 (積鑰鑰網獵淵顧衊醖醖, 49.9) 更多 | - | 2024-09-26 | ||
临床3期 | 41 | 窪壓窪鬱願窪鹹壓製遞 = 網齋艱廠淵蓋觸壓構遞 壓築襯築選範餘餘襯鏇 (餘願遞糧壓鏇淵膚壓艱, 鹹壓窪淵憲醖鬱壓壓齋 ~ 鏇廠糧餘夢膚鹹願襯繭) 更多 | - | 2024-07-09 | |||
N/A | 12 | Maribavir 400 mg twice daily | 衊淵顧獵艱鑰蓋齋糧構(願簾鏇壓餘觸顧選積繭) = 積築鑰膚艱築鏇網廠衊 艱憲願蓋糧簾構鏇夢餘 (衊鏇鏇餘鹹繭鏇網膚積, 100 ~ 1864500) | 积极 | 2024-05-14 | ||
临床3期 | - | Valganciclovir (dose-adjusted for renal clearance) | 夢憲醖繭選衊鹹艱齋鑰(鑰範夢顧齋觸範衊餘壓) = 積積憲淵齋廠顧築選鏇 顧遞簾鹽壓顧壓鑰蓋廠 (網範鏇淵選淵醖願壓構 ) 更多 | 不佳 | 2023-11-30 | ||
临床3期 | 352 | 遞選範艱築壓襯夢壓遞(窪衊鹹鹹憲鏇鹹壓廠築) = 鹹艱範淵簾襯醖範選憲 鹽製夢鏇選醖膚鑰觸構 (選糧觸積醖繭鑰構窪艱 ) | - | 2023-07-28 | |||
Investigator-assigned standard therapy (IAT) | 遞選範艱築壓襯夢壓遞(窪衊鹹鹹憲鏇鹹壓廠築) = 願鹹襯淵壓糧網鹽選醖 鹽製夢鏇選醖膚鑰觸構 (選糧觸積醖繭鑰構窪艱 ) |
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