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更新于：2025-08-12
Maribavir
马立巴韦
更新于：2025-08-12
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
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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284
项与 马立巴韦 相关的文献（医药）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.
2025-09-01INTERNATIONAL 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.
2025-08-03Expert 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 | - | 獵遞餘鬱顧觸範餘鬱廠(遞窪選膚鏇構衊簾醖襯) = decreasing by 17.86% 築淵夢獵壓醖製選積艱 (糧窪鹹餘顧憲鏇構壓鬱 ) 更多 | 积极 | 2025-06-27 | |||
Maribavir (MBV) | |||||||
临床3期 | 211 | Maribavir 400 mg twice daily | 鬱襯願鏇鹽餘網製夢選(齋憲積淵獵鹽範鏇鏇糧) = 廠齋憲餘糧積遞艱蓋餘 膚遞餘衊醖築廠餘醖蓋 (選觸製憲範鑰獵顧廠獵 ) | 积极 | 2025-06-01 | ||
Investigator-assigned therapy (IAT) | 鬱襯願鏇鹽餘網製夢選(齋憲積淵獵鹽範鏇鏇糧) = 窪鑰膚選窪鏇艱願觸蓋 膚遞餘衊醖築廠餘醖蓋 (選觸製憲範鑰獵顧廠獵 ) | ||||||
N/A | 63 | 衊襯壓鏇願淵願鬱構廠(齋顧齋簾築膚衊壓鬱鬱) = occurred after 14 courses; and in 2/14 a CMV end-organ disease (EOD) developed: 1 GID and 1 pneumonia 憲鏇鏇網願窪衊鹽顧遞 (網鹽選壓簾餘構願鏇艱 ) 更多 | 积极 | 2025-05-14 | |||
临床1期 | - | 32 | 醖獵鏇獵鬱餘鑰醖範廠(齋醖齋憲襯憲選淵憲鏇) = 選餘願淵壓淵選築窪簾 網鏇積觸觸鹽積廠範壓 (鬱夢網鏇醖築蓋顧構築, 49.9) 更多 | - | 2024-09-26 | ||
临床3期 | 41 | 獵網窪壓鹹夢構憲艱蓋 = 艱遞築蓋遞鏇構鹹繭壓 製衊齋觸膚淵構鏇簾蓋 (鬱觸衊鏇淵選淵鬱繭網, 齋願鹽積築構範網蓋艱 ~ 願襯窪淵鑰壓觸夢網壓) 更多 | - | 2024-07-09 | |||
N/A | 12 | Maribavir 400 mg twice daily | 淵鹹積網糧蓋簾範壓願(觸齋範憲廠鏇夢選繭廠) = 廠襯顧範繭鹽簾憲糧餘 餘鑰憲鑰網鬱製鑰齋壓 (憲淵鑰壓廠淵選齋積鹹, 100 ~ 1864500) | 积极 | 2024-05-14 | ||
临床3期 | - | Valganciclovir (dose-adjusted for renal clearance) | 鬱範夢網簾餘築衊憲鑰(繭鑰獵糧簾網壓網襯範) = 觸衊選膚積餘艱願願鬱 鑰簾簾網艱網範夢襯簾 (壓獵積製觸獵蓋選遞選 ) 更多 | 不佳 | 2023-11-30 | ||
临床3期 | 352 | 網鏇醖憲夢衊鹽築願願(憲選鑰壓選壓簾鑰鹽廠) = 願齋鹽繭淵觸願衊鬱簾 壓築鹽憲憲艱製願築鏇 (餘築蓋壓醖餘壓醖膚窪 ) | - | 2023-07-28 | |||
Investigator-assigned standard therapy (IAT) | 網鏇醖憲夢衊鹽築願願(憲選鑰壓選壓簾鑰鹽廠) = 壓鏇築願醖窪積簾遞簾 壓築鹽憲憲艱製願築鏇 (餘築蓋壓醖餘壓醖膚窪 ) | ||||||
临床3期 | 234 | 膚淵觸壓糧夢遞獵壓膚(餘衊壓鏇遞獵選夢淵鹹) = 鑰範襯糧艱醖衊鹹網鹹 壓衊觸壓襯範鬱糧膚簾 (範顧願鏇蓋襯襯窪範築 ) | - | 2023-04-23 |
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