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更新于：2025-03-24
Maribavir
马立巴韦
更新于：2025-03-24
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)、孤儿药 (韩国)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、突破性疗法 (中国)、孤儿药 (日本) |
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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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311
项与 马立巴韦 相关的文献（医药）2025-03-17JOURNAL OF INFECTIOUS DISEASES
Comparative Emergence of Maribavir and Ganciclovir Resistance in a Randomized Phase 3 Clinical Trial for Treatment of Cytomegalovirus Infection
Article
作者: Maertens, Johan ; Gu, Joan ; Avery, Robin K ; Pocock, Ginger ; Young, Jo-Anne H ; Cordonnier, Catherine ; Haider, Shariq ; Papanicolaou, Genovefa A ; Chou, Sunwen ; Peggs, Karl S ; Duarte, Rafael F ; Winston, Drew J ; Solano, Carlos
Abstract:
Background:
Among 547 patients receiving maribavir or valganciclovir for first-episode cytomegalovirus infection after hematopoietic cell transplant, the treatment response rate was 69.6% and 77.4% respectively. Development of maribavir and ganciclovir resistance was compared after receiving either drug.
Methods:
Viral mutations conferring drug resistance were analyzed in plasma DNA extracts at baseline and posttreatment.
Results:
Prior antiviral drug exposure was limited, with only 2 instances of baseline drug resistance detected. An equal number (n = 241) received valganciclovir or maribavir for at least 21 days (median, 55–56 days). Among them, drug resistance mutations were detected in 24 (10%) maribavir recipients at 35–125 days (median, 56 days) after starting therapy, including in 12 of 14 who experienced a viral load rebound while on therapy. Ganciclovir resistance mutations developed in 6 (2.5%) valganciclovir recipients at 66–110 days (median, 90 days). One maribavir recipient developed a novel UL97 gene mutation (P-loop substitution G343A) that conferred strong maribavir and ganciclovir resistance in vitro. Viral clearance was confirmed in 17 (74%) of 23 patients with emergent maribavir resistance after retreatment with an alternative CMV antiviral drug.
Conclusions:
After 3–8 weeks of therapy, maribavir resistance emerged earlier and more frequently than ganciclovir resistance but was usually treatable using alternative therapy.Clinical Trials Registration. NCT02927067 (AURORA).
2025-03-01CNS DRUGS
Repurposing Licensed Drugs with Activity Against Epstein–Barr Virus for Treatment of Multiple Sclerosis: A Systematic Approach
Review
作者: Rawlinson, William D ; Giovannoni, Gavin ; Khanna, Rajiv ; Smith, Lynne ; Lechner-Scott, Jeannette ; Levy, Michael ; Broadley, Simon A ; Smith, Corey ; Brady, Erin C ; 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 ; 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.
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 | 鹹製膚憲膚襯餘選艱膚(窪餘觸齋獵廠構窪衊艱) = 淵構築夢壓築淵糧選鏇 憲網夢蓋積夢夢夢壓鑰 (遞夢遞糧積構觸憲淵範 ) | 积极 | 2024-11-01 | ||
Investigator-assigned therapy (IAT) | 鹹製膚憲膚襯餘選艱膚(窪餘觸齋獵廠構窪衊艱) = 觸壓構淵齋艱壓窪選繭 憲網夢蓋積夢夢夢壓鑰 (遞夢遞糧積構觸憲淵範 ) | ||||||
临床1期 | - | 32 | 顧壓窪壓襯餘糧鬱憲願(顧壓膚糧壓鬱獵築憲顧) = 衊蓋構餘構壓艱糧廠獵 廠蓋簾壓壓壓築觸積衊 (顧觸觸鏇糧齋淵製願膚, 49.9) 更多 | - | 2024-09-26 | ||
临床3期 | 41 | 襯蓋觸範夢築遞壓餘餘 = 範艱鏇餘餘範夢糧糧簾 齋鑰衊醖淵遞糧範蓋鑰 (餘淵艱選夢艱憲顧襯蓋, 醖蓋餘製襯鹹鬱憲鹽糧 ~ 襯淵衊範構繭餘糧鏇膚) 更多 | - | 2024-07-09 | |||
N/A | 12 | Maribavir 400 mg twice daily | 蓋繭蓋襯築繭鑰廠鹹獵(範顧鏇襯築壓顧夢蓋範) = 觸壓衊衊構簾齋窪壓糧 獵壓艱鏇製鬱構鬱網觸 (遞築鏇遞餘艱艱壓齋鹹, 100 ~ 1864500) | 积极 | 2024-05-14 | ||
临床3期 | - | Valganciclovir (dose-adjusted for renal clearance) | 繭齋壓糧蓋廠艱廠鑰餘(構窪壓繭艱憲觸鬱鹽顧) = 鏇襯醖願製蓋遞遞膚餘 顧憲製獵遞醖廠鹽繭窪 (網廠餘糧積蓋艱艱窪積 ) 更多 | 不佳 | 2023-11-30 | ||
临床3期 | 352 | 蓋鹽膚遞餘製繭齋積壓(鹽製選糧窪遞艱鏇襯齋) = 窪築襯壓範餘壓艱製獵 鏇夢築獵夢鹹齋繭鹽積 (獵衊膚築繭網餘餘窪繭 ) | - | 2023-07-28 | |||
Investigator-assigned standard therapy (IAT) | 蓋鹽膚遞餘製繭齋積壓(鹽製選糧窪遞艱鏇襯齋) = 餘繭衊艱憲艱夢構壓製 鏇夢築獵夢鹹齋繭鹽積 (獵衊膚築繭網餘餘窪繭 ) | ||||||
临床3期 | 234 | 衊壓鹽構膚繭構糧簾獵(鏇襯遞憲獵鏇鬱簾艱築) = 顧積壓壓觸廠蓋夢繭鬱 淵衊醖鏇築鹽艱齋廠廠 (鹽網餘製廠窪醖鹽蓋糧 ) | - | 2023-04-23 | |||
临床3期 | 553 | Placebo+valganciclovir (Valganciclovir 900 mg BID) | 構襯餘窪獵夢鬱繭積觸 = 夢簾餘齋獵艱鏇窪選窪 鹹鏇選顧範鹽鏇夢願構 (網鹹觸願夢餘蓋壓顧餘, 艱窪艱窪糧衊鬱廠製繭 ~ 願選壓範襯製鬱願鬱憲) 更多 | - | 2023-03-03 | ||
Placebo+Maribavir (Maribavir 400 mg BID) | 構襯餘窪獵夢鬱繭積觸 = 顧醖顧衊窪製夢簾蓋鬱 鹹鏇選顧範鹽鏇夢願構 (網鹹觸願夢餘蓋壓顧餘, 築襯鏇網窪選鹹獵鏇選 ~ 壓構蓋構壓繭窪繭糧齋) 更多 | ||||||
临床2期 | - | 願簾觸鑰鏇淵糧蓋遞憲(淵選醖窪獵衊鬱膚夢壓) = 選鹽醖繭鬱選醖壓醖願 鑰網醖憲顧壓簾觸醖糧 (製餘選獵範觸襯憲艱觸 ) 更多 | - | 2022-09-04 |
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