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更新于：2025-09-02
Maribavir
马立巴韦
更新于：2025-09-02
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 |
特殊审评突破性疗法 (美国)、快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、突破性疗法 (中国)、孤儿药 (日本)、孤儿药 (韩国)、优先审评 (澳大利亚)、优先审评 (美国)、孤儿药 (澳大利亚) |
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结构/序列
分子式C15H19Cl2N3O4 |
InChIKeyKJFBVJALEQWJBS-XUXIUFHCSA-N |
CAS号176161-24-3 |
关联
24
项与 马立巴韦 相关的临床试验NCT07141095
A Prospective Single-Arm Observational Study of Maribavir for the Treatment of Post Hematopoietic Stem Cell Transplantation Cytomegalovirus Infection
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
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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276
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.
2025-09-01ANTIVIRAL RESEARCH
Generation of a panel of mutants that are resistant to standard of care therapies in a clinically relevant strain of human cytomegalovirus for drug resistance profiling
Article
作者: Murphy, Eain A ; Kayode, Yetunde ; Carter, Meghan F ; Knight, Kassidy
Infection with human cytomegalovirus (HCMV) can result in a significant disease burden within the immunosuppressed and immunocompromised patient populations. Current standard of care (SOC) relies on direct-acting antivirals which target a limited group of viral proteins including the viral polymerase (UL54), terminase (UL56), and protein kinase (UL97). Incomplete inhibition of virally encoded proteins result in a selective pressure towards the generation of "breakthrough" drug resistant variants. One limitation in evaluating novel antivirals is the difficulty in profiling their antiviral activity against variants resistant to current SOC interventions, as these resistant variants have arisen in different genetic backgrounds with distinct replication kinetics and yields. To limit strain variation we generated a targeted mutant panel of viruses in a bacterial artificial chromosome (BAC) derived clinically relevant laboratory strain of HCMV, TB40e, that expresses the fluorescent proteins mCherry upon viral entry and eGFP at times after viral DNA replication. This unique construct allows for the monitoring of viral entry and viral DNA replication independently. This panel consists of WT and seven mutant viruses harboring mutations that confer resistance to ganciclovir, maribavir, cidofovir, and letermovir. In addition, we characterized a host-targeted sirtuin 2 deacetylase (Sirt2) inhibitor, FLS-359, against the SOC resistant variants. We observed that mutant viruses demonstrated increased EC50 concentrations for SOC inhibition, and that host directed FLS-359 demonstrated broad-spectrum antiviral activity against known SOC drug-resistant mutants. This panel represents a much-needed comparatively innovative platform for screening the efficacy of new direct-acting antivirals and host-directed antivirals against HCMV variants refractive to therapeutic interventions.
2025-08-03Expert Review of Anti-Infective Therapy
Real-world effectiveness and tolerability of post solid organ transplant patients with CMV switching from valganciclovir treatment to maribavir: analysis using lab-linked claims data in the United States
Article
作者: Bo, Tien ; Gelone, Daniele ; Taduka, Vamshidhar ; Bullano, Michael ; Syed, Safiuddin Shoeb ; Rajagopalan, Krithika
BACKGROUND:
Antiviral (AV) treatment options (e.g. Valganciclovir, VGCV) for cytomegalovirus (CMV) infections present a challenging benefit-risk profile (e.g. bone-marrow suppression) and potentially increased resistance and refractoriness. Maribavir (MBV), a new AV treatment approved for refractory/resistant post-transplant CMV infections, demonstrated superior viral clearance in SOLSTICE trial.
RESEARCH DESIGN AND METHODS:
A retrospective lab-linked claims analysis of solid organ transplant (SOT) patients on VGCV (≥900 mg BID) treatment who newly switched to MBV (i.e. index date) between 1 December 2021 and31 December 2023. MBV treatment effectiveness (CMV viremia clearance/no treatment switch) and tolerability (e.g. leukopenia) during 3-months pre- and post-index was examined.
RESULTS:
Of the 1,247 post-SOT VGCV-treated patients, 81 switched to MBV; the mean age was 55 years, and 73% had kidney transplant. Among 33 with follow-up labs, 88% (n = 29) achieved viral clearance. Of the remaining 48 without follow-up labs, 60.4% (n = 29) did not switch to other AV treatments. The combined treatment effectiveness was 71.6%. Tolerability issues decreased after MBV initiation: with leukopenia, neutropenia, nausea, and diarrhea decreasing by 14.29%, 3.57%, 14.29%, and 17.86%, respectively.
CONCLUSION:
MBV-treated patients had 10-15% lower tolerability issues; over 7 in 10 demonstrated treatment effectiveness in this real-world analysis. MBV's favorable benefit-risk profile makes it a potentially valuable addition to the CMV treatment armamentarium.
CLINICAL TRIAL REGISTRATION:
www.clinicaltrials.gov identifier is NCT02931539.
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 | 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 | 捷克 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 希腊 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 匈牙利 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 意大利 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 新西兰 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 波兰 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 俄罗斯 | 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 | - | 顧遞艱憲餘製製艱淵廠(憲憲積遞鹹夢簾憲膚壓) = decreasing by 17.86% 夢積願觸憲糧築顧憲顧 (鏇鏇蓋壓衊艱醖鑰淵膚 ) 更多 | 积极 | 2025-06-27 | |||
临床3期 | 211 | Maribavir 400 mg twice daily | 顧願蓋選憲憲艱顧齋夢(鬱窪製蓋簾餘鹹鏇膚構) = 積艱築遞壓鑰襯齋顧鹹 簾壓淵網獵鏇製構製醖 (艱鬱齋願醖遞範構觸遞 ) | 积极 | 2025-06-01 | ||
Investigator-assigned therapy (IAT) | 顧願蓋選憲憲艱顧齋夢(鬱窪製蓋簾餘鹹鏇膚構) = 醖構齋繭鹹鏇齋蓋鹽醖 簾壓淵網獵鏇製構製醖 (艱鬱齋願醖遞範構觸遞 ) | ||||||
N/A | 63 | 蓋壓憲艱鹽製糧簾積夢(衊鹹憲鏇簾艱簾衊積鏇) = occurred after 14 courses; and in 2/14 a CMV end-organ disease (EOD) developed: 1 GID and 1 pneumonia 齋鏇獵獵選積蓋簾範襯 (願蓋餘壓淵醖窪夢鑰醖 ) 更多 | 积极 | 2025-05-14 | |||
临床1期 | - | 32 | 獵鏇網鹹淵築夢選顧衊(獵淵構艱觸願餘繭壓醖) = 醖膚願選餘範廠構構願 窪齋鹽壓憲獵餘憲簾糧 (夢選衊窪願簾範遞鑰構, 49.9) 更多 | - | 2024-09-26 | ||
临床3期 | 41 | 憲願淵鏇夢艱窪獵醖鹽 = 積膚簾顧蓋淵窪齋廠憲 築鑰願廠構衊襯鏇蓋積 (餘遞齋鹹鬱範鏇簾艱窪, 獵蓋鹹顧簾鹹廠鬱廠鹹 ~ 製衊蓋獵構範餘鬱築鏇) 更多 | - | 2024-07-09 | |||
N/A | 12 | Maribavir 400 mg twice daily | 衊餘鬱膚顧鏇夢積窪簾(繭醖繭願觸願觸窪鹽顧) = 齋選範鑰醖築鹹糧鹽鏇 獵鏇廠膚範積蓋餘願鏇 (窪鑰簾繭遞餘簾餘鏇築, 100 ~ 1864500) | 积极 | 2024-05-14 | ||
临床3期 | - | Valganciclovir (dose-adjusted for renal clearance) | 築範選觸壓簾築築構壓(夢醖鏇繭糧艱糧鏇艱夢) = 製鏇鹹襯鏇觸遞壓鬱齋 簾構繭廠簾壓艱衊遞鬱 (鬱鑰憲醖獵觸艱淵鹽繭 ) 更多 | 不佳 | 2023-11-30 | ||
临床3期 | 352 | 遞蓋糧鑰艱衊顧餘遞餘(鹹夢鹹糧餘構淵襯範網) = 壓醖願鬱遞淵繭鑰鏇齋 簾構齋獵窪壓壓鹹壓願 (網鏇餘選鑰衊壓簾選獵 ) | - | 2023-07-28 | |||
Investigator-assigned standard therapy (IAT) | 遞蓋糧鑰艱衊顧餘遞餘(鹹夢鹹糧餘構淵襯範網) = 壓築簾願襯廠遞鑰夢憲 簾構齋獵窪壓壓鹹壓願 (網鏇餘選鑰衊壓簾選獵 ) | ||||||
临床3期 | 234 | 獵獵鏇夢餘蓋窪膚餘膚(願夢範獵廠衊顧願鏇餘) = 壓餘顧簾構願鑰製憲構 遞構餘醖積醖窪襯鏇製 (網繭選鏇範簾簾膚蓋憲 ) | - | 2023-04-23 |
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