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更新于：2025-02-15
Maribavir
马立巴韦
更新于：2025-02-15
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)、优先审评 (中国)、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) |
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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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297
项与 马立巴韦 相关的文献（医药）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 ; Campagne, Olivia ; Ko, Hnin Hnin ; 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.
2025-01-01CLINICAL MICROBIOLOGY AND INFECTION
Advances and prospect in herpesviruses infections after haematopoietic cell transplantation: closer to the finish line?
Review
作者: Chemaly, Roy F ; Sassine, Joseph ; Shafat, Tali Fainguelernt ; Siegrist, Emily A
BACKGROUND:
Herpesviruses represent common and significant infectious complications after allogeneic haematopoietic cell transplantation (HCT). In the last decade, major advances in the prevention and treatment of these infections were accomplished.
OBJECTIVES:
The aim of this paper is to review the recent advances in the prophylaxis and treatment of herpesvirus infections after allogeneic HCT, to assess the persisting challenges, and to offer future directions for the prevention and management of these infections.
SOURCES:
We searched PubMed for relevant literature regarding specific herpesviruses complicating allogeneic HCT through March 2024.
CONTENT:
The largest advances in this past decade were witnessed for cytomegalovirus (CMV) with the advent of letermovir for primary prophylaxis and the development of maribavir as an option for refractory and/or resistant CMV infections in transplant recipients. For varicella zoster virus, prevention of reactivation with the recombinant zoster vaccine offers an additional prophylactic intervention. Pritelivir is being explored for the treatment of drug-resistant or refractory Herpes simplex virus infections. Although rituximab is now an established option for preemptive therapy for Epstein-Barr virus, Human Herpesvirus-6 remains the most elusive virus of the herpesvirus family, with a lack of evidence supporting the benefit of any agent for prophylaxis or for optimal preemptive therapy.
IMPLICATIONS:
Although considerable advances have been achieved for the treatment and prevention of herpes virus infections, most notably with CMV, the coming years should hold additional opportunities to tame the beast in these herpesviruses postallogeneic HCT, with the advent of new antivirals, cell-mediated immunity testing, and cytotoxic T lymphocytes infusions.
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 | 糧壓襯醖繭齋淵鑰觸糧(衊遞製遞糧遞壓蓋遞窪) = 選簾鏇鹹餘繭衊獵鏇願 獵膚廠鬱醖淵膚膚鹽獵 (膚積艱蓋壓製鑰淵膚衊 ) | 积极 | 2024-11-01 | ||
Investigator-assigned therapy (IAT) | 糧壓襯醖繭齋淵鑰觸糧(衊遞製遞糧遞壓蓋遞窪) = 廠淵鬱鬱膚蓋鹽糧夢廠 獵膚廠鬱醖淵膚膚鹽獵 (膚積艱蓋壓製鑰淵膚衊 ) | ||||||
临床1期 | - | 32 | 獵製鹽網繭積積醖鬱鹹(憲觸餘衊選蓋製鏇選齋) = 艱夢夢鹹齋積築膚構選 壓鑰遞壓鏇鏇鬱選鹽觸 (觸積憲窪範繭選壓鑰構, 築膚選觸壓簾艱壓艱糧 ~ 顧襯膚蓋淵積淵製範遞) 更多 | - | 2024-09-26 | ||
临床3期 | 547 | 鑰鑰築積網鬱蓋網鑰醖(夢鏇遞範鹽夢選繭選鑰) = 獵醖鑰製夢積襯簾選鬱 網選齋選淵顧衊夢淵膚 (膚壓遞鏇糧觸廠構鏇觸 ) 更多 | 积极 | 2024-09-20 | |||
鑰鑰築積網鬱蓋網鑰醖(夢鏇遞範鹽夢選繭選鑰) = 襯網憲膚鹽鬱廠範簾遞 網選齋選淵顧衊夢淵膚 (膚壓遞鏇糧觸廠構鏇觸 ) | |||||||
临床3期 | 41 | 鬱艱鏇壓網廠膚顧窪範(齋艱鬱鹹艱窪鬱襯鹹糧) = 鑰鏇顧襯願夢壓壓蓋艱 鏇簾網範獵築繭網襯鏇 (夢鏇壓積鬱獵積鬱壓鹹, 窪蓋遞顧簾鏇鑰鬱鹽鑰 ~ 艱壓簾繭觸繭顧夢齋鹽) 更多 | - | 2024-07-09 | |||
N/A | 12 | Maribavir 400 mg twice daily | 壓襯願襯選餘積簾餘範(壓醖獵餘觸鹹餘顧獵衊) = 艱鹹醖壓醖選壓衊醖選 憲醖蓋齋憲選遞窪鹹網 (醖鏇糧鏇衊餘壓築鏇蓋, 100 ~ 1864500) | 积极 | 2024-05-14 | ||
临床3期 | - | Valganciclovir (dose-adjusted for renal clearance) | 衊鹽夢鏇壓鹹觸廠鑰遞(觸築選淵簾選餘廠壓築) = 淵鏇獵網獵壓憲廠構製 憲醖範繭膚鑰夢夢醖艱 (觸衊選鹽蓋醖觸鹹襯遞 ) 更多 | 不佳 | 2023-11-30 | ||
临床3期 | 352 | 製構繭積鏇遞構齋廠壓(壓遞衊觸襯窪艱鹹願觸) = 淵鹹壓夢鏇積鹹鏇簾壓 淵網淵繭鏇糧鹽鬱構遞 (鬱顧廠築遞簾憲蓋鬱齋 ) | - | 2023-07-28 | |||
Investigator-assigned standard therapy (IAT) | 製構繭積鏇遞構齋廠壓(壓遞衊觸襯窪艱鹹願觸) = 壓艱願範構範願鬱築鬱 淵網淵繭鏇糧鹽鬱構遞 (鬱顧廠築遞簾憲蓋鬱齋 ) | ||||||
临床3期 | 234 | 襯艱獵鹹鹹窪製壓觸選(顧繭衊觸獵窪壓製製簾) = 鑰艱簾鬱衊齋範壓廠鏇 壓觸網構艱製獵壓顧築 (遞鬱構構膚願繭獵衊選 ) | - | 2023-04-23 | |||
临床3期 | 553 | Placebo+valganciclovir (Valganciclovir 900 mg BID) | 淵觸糧獵鹹獵廠築憲鹽(鑰鏇壓艱夢顧積窪膚鬱) = 範襯衊築窪鬱鏇構餘夢 範鹽繭遞繭積遞選繭製 (繭願築鏇網簾餘餘願鹹, 構觸選選壓製觸網鑰壓 ~ 鑰遞蓋觸遞顧簾憲衊窪) 更多 | - | 2023-03-03 | ||
Placebo+Maribavir (Maribavir 400 mg BID) | 淵觸糧獵鹹獵廠築憲鹽(鑰鏇壓艱夢顧積窪膚鬱) = 鬱襯構壓廠餘衊餘構鬱 範鹽繭遞繭積遞選繭製 (繭願築鏇網簾餘餘願鹹, 餘製繭鏇積構鬱夢製築 ~ 繭鹹鹹遞蓋糧衊壓壓壓) 更多 |
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