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更新于：2025-03-01
Maribavir
马立巴韦
更新于：2025-03-01
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)、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)、突破性疗法 (美国)、快速通道 (美国) |
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结构/序列
分子式C15H19Cl2N3O4 |
InChIKeyKJFBVJALEQWJBS-XUXIUFHCSA-N |
CAS号176161-24-3 |
关联
25
项与 马立巴韦 相关的临床试验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
CTR20244015
一项在对更昔洛韦、缬更昔洛韦、膦甲酸钠或西多福韦难治或耐药的巨细胞病毒 (CMV) 感染的移植受者中评估马立巴韦治疗的安全性，耐受性，疗效和药代动力学的开放性、单臂研究
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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292
项与 马立巴韦 相关的文献（医药）2025-03-01CNS DRUGS
Repurposing Licensed Drugs with Activity Against Epstein–Barr Virus for Treatment of Multiple Sclerosis: A Systematic Approach
Article
作者: Rawlinson, William D ; Giovannoni, Gavin ; Khanna, Rajiv ; Smith, Lynne ; Lechner-Scott, Jeannette ; Levy, Michael ; Smith, Corey ; Brady, Erin C ; Broadley, Simon A ; Taylor, Bruce V ; McKay, Fiona C ; Hardy, Todd A ; Hodgkinson, Suzanne ; Li, Vivien ; Potter, Andrew ; Bar-Or, Amit ; Steinman, Lawrence ; Morahan, Julia M ; Lloyd, Andrew R ; Frost, Bruce ; Drosu, Natalia ; Tscharke, David C ; Caswell, Nigel
BACKGROUND:
Epstein-Barr virus (EBV) is implicated as a necessary factor in the development of multiple sclerosis (MS) and may also be a driver of disease activity. Although it is not clear whether ongoing viral replication is the driver for MS pathology, MS researchers have considered the prospect of using drugs with potential efficacy against EBV in the treatment of MS. We have undertaken scientific and lived experience expert panel reviews to shortlist existing licensed therapies that could be used in later-stage clinical trials in MS.
METHODS:
A list of therapies with anti-EBV effects was developed from existing reviews. A detailed review of pre-clinical and clinical data was undertaken to assess these candidates for potential usefulness and possible harm in MS. A 'drug-CV' and a plain language version focusing on tolerability aspects was created for each candidate. We used validated criteria to score each candidate with an international scientific panel and people living with MS.
RESULTS:
A preliminary list of 11 drug candidates was generated. Following review by the scientific and lived experience expert panels, six yielded the same highest score. A further review by the expert panel shortlisted four drugs (famciclovir, tenofovir alafenamide, maribavir and spironolactone) deemed to have the best balance of efficacy, safety and tolerability for use in MS.
CONCLUSIONS:
Scientific and lived experience expert panel review of anti-EBV therapies selected four candidates with evidence for efficacy against EBV and acceptable safety and tolerability for potential use in phase III clinical trials for MS.
2025-02-01Clinical Pharmacology in Drug Development
A Phase 1, Open‐Label, Randomized, Two‐Part Study in Healthy Adult Volunteers to Evaluate the Bioavailability of the Maribavir Powder for Oral Suspension, as Well as Food Effect and Impact of Rabeprazole
Article
作者: Zhang, Fangqiu ; Gabriel, Andre ; Ko, Hnin Hnin ; Campagne, Olivia ; Sun, Kefeng ; Ye, Ran ; Ilic, Katarina ; Sueda, Katsuhiko ; Xu, Peixin
Abstract:
The relative bioavailability and impact of food and the proton pump inhibitor rabeprazole on the pharmacokinetics of a maribavir powder‐for‐oral‐suspension formulation was investigated in a Phase 1 open‐label study in healthy adult volunteers. A single 200‐mg maribavir dose was administered as the commercial tablet (Treatment A), powder formulation (Treatment B), or powder formulation with a high‐fat/high‐calorie meal (Treatment C) in Part 1, and as the powder formulation alone (Treatment D) or following administration of rabeprazole 20 mg once daily for 5 days (Treatment E) in Part 2. Maribavir maximum plasma concentration following Treatment B was 18% lower versus Treatment A, whereas the area under the concentration‐time curve (AUC) from time 0 to the last quantifiable concentration or infinity were similar. Maribavir maximum plasma concentration, AUC from time 0 to the last quantifiable concentration, and AUC from time 0 to infinity were reduced by 42%, 18%, and 18% (Treatment C vs Treatment B), and by 51%, 30%, and 11% (Treatment E vs Treatment D), respectively. A clinically significant reduction in maribavir exposure is not expected when maribavir powder formulation is taken with food or proton pump inhibitors. Participants assessed the powder for oral suspension as easy to swallow and having an acceptable taste/texture. Safety profiles for maribavir formulations in this study were consistent with those previously published.
2025-01-31JOURNAL OF VIROLOGY
The effective multiplicity of infection for HCMV depends on the activity of the cellular 20S proteasome
Article
作者: Roche, Kathryn L. ; Murphy, Eain A. ; Dash, Ranjan K. ; Terhune, Scott S. ; Monti, Christopher E. ; Cataldo, Katie M.
ABSTRACT:
Human cytomegalovirus (HCMV) is a betaherpesvirus capable of infecting numerous cell types and persisting throughout an infected individual’s life. Disease usually occurs in individuals with compromised or underdeveloped immune systems. Several antivirals exist but have limitations relating to toxicity and resistance. HCMV replication involves upregulation of host proteasomal activities, which play important roles in the temporal stages of replication. Here, we defined the impact on replication kinetics of the proteasome inhibitor, bortezomib. We demonstrate that bortezomib significantly reduces levels of viral genomes and infectious virions produced from a population of cells. Inhibition reduced expression of viral proteins that are influenced by genome synthesis. When added prior to 24 hpi, we observe decreases in PCNA and Cdk1 while increases in p21 whose regulations contribute to efficient replication. This response synergized with an antiviral, maribavir. Since some replication occurred, we tested the hypothesis that a subset of infected cells might break through inhibition. Initially, we simulated bortezomib activities using a mechanistic computational model of late-lytic replication. Upon reducing multiplicity of infection (MOI)
in silico
, we observed near-identical simulated results compared to experimental data. Next, we analyzed replication using live-cell imaging. This revealed treated cultures do contain a population of cells with fully developed late-stage cytoplasmic assembly compartments but at significantly lower numbers. We refer to this as the effective MOI. Overall, our studies support a hypothesis in which 20S proteasome inhibition disrupts HCMV replication by reducing the MOI to an effective MOI, defined by a fraction of infected cells capable of progressing to fulminant infection.
IMPORTANCE:
Human cytomegalovirus (HCMV) infection and reactivation continues to contribute to morbidity and mortality around the world. Antiviral compounds are available but have limitations. Here, we have defined the impact of the proteasome inhibitor bortezomib on HCMV replication. Proteasomal activities play a critical role in temporal changes required for replication. We demonstrate that disrupting these activities inhibits viral replication while likely supporting increased antiviral activity of the anti-HCMV agent, maribavir. Using a combination of live-cell imaging and computational tools, we discover that a subset of infected cells progresses to fulminant infection, which we define as the effective multiplicity of infection, and this subset would otherwise be missed when analyzing the average of the population.
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 | 美国 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 澳大利亚 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 比利时 | 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 | 法国 | 2017-04-14 | |
| 巨细胞病毒血症 | 临床3期 | 德国 | 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 |
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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 | 211 | Maribavir 400 mg twice daily | 積選鏇觸窪鏇繭廠廠選(選簾襯醖獵簾築襯鏇願) = 積網夢積觸鬱衊蓋膚壓 醖壓簾壓窪憲壓遞積壓 (襯憲淵鹹鹽顧觸鹹壓範 ) | 积极 | 2024-11-01 | ||
Investigator-assigned therapy (IAT) | 積選鏇觸窪鏇繭廠廠選(選簾襯醖獵簾築襯鏇願) = 壓襯觸廠鹽醖窪簾淵餘 醖壓簾壓窪憲壓遞積壓 (襯憲淵鹹鹽顧觸鹹壓範 ) | ||||||
临床1期 | - | 32 | 鹽糧製齋繭網範憲糧繭(願觸襯簾齋網廠鹽夢鏇) = 簾鏇衊獵窪鹽糧鏇製遞 簾膚顧鏇淵廠製築顧築 (蓋淵醖願積壓壓選夢廠, 鏇鑰選餘繭夢簾淵獵齋 ~ 網願築獵觸繭範網廠餘) 更多 | - | 2024-09-26 | ||
临床3期 | 547 | 窪簾淵獵壓範願鹹選鑰(範夢遞觸網窪蓋選齋膚) = 鑰鏇窪壓範網遞醖獵顧 廠膚餘選壓窪鹽壓襯構 (膚構窪餘窪網憲築鹹艱 ) 更多 | 积极 | 2024-09-20 | |||
窪簾淵獵壓範願鹹選鑰(範夢遞觸網窪蓋選齋膚) = 積齋願餘鹹遞獵淵鑰齋 廠膚餘選壓窪鹽壓襯構 (膚構窪餘窪網憲築鹹艱 ) | |||||||
临床3期 | 41 | 艱鏇鑰觸窪遞積願餘餘(繭簾顧築鑰鏇鹹獵製廠) = 廠遞繭遞糧鬱觸鑰構積 餘襯製獵遞窪蓋淵遞淵 (遞蓋範醖遞淵簾範製鬱, 憲艱膚鬱窪網範鬱獵衊 ~ 壓襯蓋製遞糧顧簾鏇艱) 更多 | - | 2024-07-09 | |||
N/A | 12 | Maribavir 400 mg twice daily | 網壓膚醖淵壓觸憲糧夢(網觸壓鏇選鏇淵簾鬱夢) = 製窪網廠鑰構蓋醖醖選 鬱廠簾繭積糧顧簾構簾 (齋壓築顧築膚鑰餘鏇鏇, 100 ~ 1864500) | 积极 | 2024-05-14 | ||
临床3期 | - | Valganciclovir (dose-adjusted for renal clearance) | 繭膚願艱餘襯衊壓衊範(築獵積齋醖憲餘遞遞選) = 簾觸鬱鬱蓋淵觸積夢壓 廠憲鏇齋淵鏇蓋鏇鏇範 (觸鏇壓觸糧衊鹽範構選 ) 更多 | 不佳 | 2023-11-30 | ||
临床3期 | 352 | 願網餘夢簾壓繭壓築窪(願遞窪繭衊醖壓膚構顧) = 觸蓋膚憲襯艱選蓋夢積 憲壓壓膚鏇鑰鹽築膚夢 (淵鹽簾艱襯艱積餘齋願 ) | - | 2023-07-28 | |||
Investigator-assigned standard therapy (IAT) | 願網餘夢簾壓繭壓築窪(願遞窪繭衊醖壓膚構顧) = 鑰蓋衊壓製夢觸獵鑰糧 憲壓壓膚鏇鑰鹽築膚夢 (淵鹽簾艱襯艱積餘齋願 ) | ||||||
临床3期 | 234 | 糧鏇獵獵夢鑰構鏇築糧(廠淵鹹鏇衊顧糧願簾蓋) = 壓齋襯願鑰觸網廠築遞 願壓獵壓繭齋觸衊憲簾 (醖選窪構襯鏇製窪鏇壓 ) | - | 2023-04-23 | |||
临床3期 | 553 | Placebo+valganciclovir (Valganciclovir 900 mg BID) | 齋獵鬱顧窪願築顧觸糧(構積窪鏇鬱膚窪壓膚簾) = 壓衊齋鏇艱鏇襯夢簾襯 網壓鏇築淵鹽繭遞鹹齋 (選網選蓋網簾獵繭積廠, 窪積鏇鬱艱衊鹽鬱壓鬱 ~ 網構繭憲醖觸壓範廠淵) 更多 | - | 2023-03-03 | ||
Placebo+Maribavir (Maribavir 400 mg BID) | 齋獵鬱顧窪願築顧觸糧(構積窪鏇鬱膚窪壓膚簾) = 憲窪膚蓋襯蓋醖觸簾鏇 網壓鏇築淵鹽繭遞鹹齋 (選網選蓋網簾獵繭積廠, 獵願襯遞鹽製鹹廠繭網 ~ 醖襯蓋憲鏇鹽製廠艱窪) 更多 |
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