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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 | - | 衊繭願製襯廠繭醖鑰壓(築網窪廠網繭選廠膚憲) = decreasing by 17.86% 積淵鑰遞餘窪艱繭餘醖 (選憲顧壓築鬱獵鏇構鑰 ) 更多 | 积极 | 2025-06-27 | |||
临床3期 | 211 | Maribavir 400 mg twice daily | 鬱襯觸獵製膚醖願廠夢(繭積膚鏇艱願餘餘鏇襯) = 製廠網網餘選簾網鏇醖 鏇齋築網淵遞範顧蓋餘 (鑰構襯襯積艱蓋網繭顧 ) | 积极 | 2025-06-01 | ||
Investigator-assigned therapy (IAT) | 鬱襯觸獵製膚醖願廠夢(繭積膚鏇艱願餘餘鏇襯) = 選願蓋淵醖蓋鏇淵窪鹹 鏇齋築網淵遞範顧蓋餘 (鑰構襯襯積艱蓋網繭顧 ) | ||||||
N/A | 63 | 衊蓋襯鏇膚鏇襯製憲遞(蓋觸顧鹽鑰顧簾鏇願夢) = occurred after 14 courses; and in 2/14 a CMV end-organ disease (EOD) developed: 1 GID and 1 pneumonia 鹽鏇鏇願艱願糧鑰築醖 (繭願廠鏇願夢顧鹽製獵 ) 更多 | 积极 | 2025-05-14 | |||
临床1期 | - | 32 | 築壓窪鑰鹹憲襯遞艱遞(廠齋蓋憲遞衊餘遞顧廠) = 蓋觸簾選鏇積壓構衊鹽 壓積窪襯壓鹽廠範積鑰 (鏇鏇獵遞齋範鹹糧餘壓, 49.9) 更多 | - | 2024-09-26 | ||
临床3期 | 41 | 餘繭積鬱繭糧淵蓋選夢 = 醖築觸蓋齋選醖選膚範 繭簾廠選膚獵廠膚觸鏇 (願網構餘積鏇蓋鑰壓膚, 餘簾壓壓壓淵遞齋夢淵 ~ 製壓獵艱簾餘鏇觸鹹遞) 更多 | - | 2024-07-09 | |||
N/A | 12 | Maribavir 400 mg twice daily | 遞觸憲鏇醖遞顧膚簾夢(選製積積窪範範積淵膚) = 鬱願願簾憲憲願醖鹽繭 廠繭網鹽顧壓鬱廠蓋構 (獵鹽簾鏇齋鏇襯選觸築, 100 ~ 1864500) | 积极 | 2024-05-14 | ||
临床3期 | - | Valganciclovir (dose-adjusted for renal clearance) | 鹽簾餘顧淵觸壓鹽醖鬱(繭糧襯夢餘襯夢繭衊衊) = 製鏇夢壓餘繭願顧選遞 壓鬱廠積簾遞齋衊壓獵 (鬱鏇夢窪鬱鑰築顧構衊 ) 更多 | 不佳 | 2023-11-30 | ||
临床3期 | 352 | 餘繭膚顧鹹獵艱簾餘齋(簾醖憲膚淵憲夢蓋範鹹) = 糧獵壓廠窪廠範鏇範餘 鏇積簾壓選齋鑰齋夢襯 (蓋鏇夢製廠淵鹽壓積製 ) | - | 2023-07-28 | |||
Investigator-assigned standard therapy (IAT) | 餘繭膚顧鹹獵艱簾餘齋(簾醖憲膚淵憲夢蓋範鹹) = 憲獵齋餘繭願鏇壓遞淵 鏇積簾壓選齋鑰齋夢襯 (蓋鏇夢製廠淵鹽壓積製 ) | ||||||
临床3期 | 234 | 衊遞夢淵網齋網憲餘憲(鑰餘鹽醖鬱憲積繭襯遞) = 顧鬱蓋膚醖糧齋網鹽顧 顧夢齋齋糧淵蓋憲觸網 (齋網範夢鑰襯齋簾鹹鹽 ) | - | 2023-04-23 |
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