预约演示
更新于：2025-11-18
Maribavir
马立巴韦
更新于：2025-11-18
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 (韩国)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、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CTR20253525
马立巴韦片人体生物等效性研究
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
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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189
项与 马立巴韦 相关的文献（医药）2025-12-01Blood Research
CMV infections after HSCT: prophylaxis and treatment
Review
作者: Chung, Haerim
Abstract:
Cytomegalovirus (CMV) infection remains a major complication in recipients of hematopoietic stem cell transplantation (HSCT) and contributes significantly to morbidity and mortality. Effective CMV prevention and management are essential for improving transplant outcomes. Preventive strategies include antiviral prophylaxis and preemptive treatments (PET). Letermovir, a terminase complex inhibitor, has become the standard of care for primary prophylaxis in CMV-seropositive recipients because of its efficacy and favorable safety profile. PET involves regular monitoring of CMV DNAemia via polymerase chain reaction (PCR) and initiation of antiviral therapy, most commonly ganciclovir or valganciclovir, upon detection of early viral reactivation. Refractory or resistant CMV infections present a significant therapeutic challenge and often require switching to a different antiviral class while awaiting genotypic resistance testing. Maribavir, a UL97 kinase inhibitor, has demonstrated superior efficacy and improved tolerability compared to conventional therapies in the phase 3 SOLSTICE trial, making it a promising therapy for refractory or resistant CMV. Optimal CMV management requires a risk-adapted, individualized approach that integrates prophylaxis, early detection, and timely intervention to reduce CMV-related complications.
2025-12-01PEDIATRIC BLOOD & CANCER
Successful Use of Maribavir for Secondary CMV Prophylaxis in a Pediatric HSCT Patient
Letter
作者: McLaughlin, Laura ; Joshua, Broadman ; Curtis, Donna J. ; Goodell, Erin Barthelmess ; Lind, Katherine T. ; Strommen, Amanda
2025-10-01Journal of Managed Care & Specialty Pharmacy
Optimizing maribavir management: The role of health system specialty pharmacies in access, monitoring, and waste reduction
Article
作者: Gargurevich, Nicolas ; Renfro, Chelsea P. ; Choi, Leena ; Oboh, Strong ; Donald, Dustin R. ; Zuckerman, Autumn D. ; Dee, Kevin
BACKGROUND:
Cytomegalovirus (CMV) infection is a common complication in transplant recipients, with refractory or resistant infections making up a subset of this population. Maribavir, indicated for CMV infection that is refractory to first-line treatments, is a high-cost, limited-distribution specialty medication that requires frequent laboratory monitoring to assess efficacy.
OBJECTIVE:
To evaluate outcomes of health system specialty pharmacy (HSSP) management of maribavir including waste and cost avoidance, medication access, and pharmacist interventions during treatment.
METHODS:
This study was a single-center, retrospective cohort analysis of patients prescribed maribavir from April 1, 2022, to August 1, 2024. Included patients were prescribed maribavir for posttransplant CMV infection/disease that was refractory to treatment with ganciclovir, valganciclovir, cidofovir, or foscarnet. Outcomes included the number of dispenses that were reduced by pharmacist interventions that led to medication waste avoidance and the cost avoidance of these interventions, time to medication access, and the number of pharmacist interventions recommending laboratory tests or medication discontinuation during treatment. Descriptive statistics were used for analysis. To estimate costs avoided by pharmacy and payer, cost avoidance was calculated by multiplying the 14-day supply of maribavir that was not dispensed during the final treatment course because of pharmacist intervention by the average wholesale price (AWP), AWP minus 20% (AWP-20%), and wholesale acquisition cost (WAC).
RESULTS:
Included patients (N = 33) were predominately male (64%) with a median age of 62 years (interquartile range [IQR] = 50-66 years). Five patients were required to repeat treatment with maribavir multiple times because of CMV reactivation totaling 41 unique instances of maribavir use. The most common transplant type was kidney (n = 11), and all patients were donor CMV positive (n = 33). 29 patients were able to fill with the institution's HSSP with 36 instances of maribavir use and 113 fills of maribavir. Of these 36 instances, 12 (33%) had the final dispense of the treatment course reduced because of pharmacist intervention, amounting to a cost avoidance range of $143,421 (AWP-20%) to $179,276 (AWP). Maribavir insurance prior approval (PA) was required for 31 (76%) instances of medication use, with median PAs occurring the same day as referral (IQR = 0-2). Of the 41 instances of maribavir use, 8 (20%) required an intervention from the pharmacist recommending CMV laboratory testing be completed.
CONCLUSIONS:
Pharmacists successfully obtained timely insurance PAs for maribavir. During treatment, pharmacists reduced unnecessary fills, resulting in large cost and waste avoidance. Future research is needed to evaluate the long-term effects of interventions by specialty pharmacists on maribavir patient outcomes.
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 | - | 製選願鹽夢顧淵鬱膚醖(鏇遞衊製鹽齋遞願簾糧) = decreasing by 17.86% 糧蓋憲獵築獵顧積遞衊 (壓網襯範襯夢獵範築觸 ) 更多 | 积极 | 2025-06-27 | |||
临床3期 | 211 | Maribavir 400 mg twice daily | 壓鏇衊淵網製觸膚膚鏇(選顧餘獵醖窪網餘築積) = 鏇選遞襯願遞鑰獵糧簾 製獵鹽餘蓋憲製艱衊糧 (製艱遞鏇簾觸構鹹遞鬱 ) | 积极 | 2025-06-01 | ||
Investigator-assigned therapy (IAT) | 壓鏇衊淵網製觸膚膚鏇(選顧餘獵醖窪網餘築積) = 鹽範廠網餘憲淵願糧繭 製獵鹽餘蓋憲製艱衊糧 (製艱遞鏇簾觸構鹹遞鬱 ) | ||||||
N/A | 63 | 鏇願構窪蓋糧鹹齋壓獵(鏇齋簾獵簾積鹽齋鏇艱) = occurred after 14 courses; and in 2/14 a CMV end-organ disease (EOD) developed: 1 GID and 1 pneumonia 廠選蓋構壓遞膚積繭膚 (鏇膚齋壓齋遞壓憲簾繭 ) 更多 | 积极 | 2025-05-14 | |||
临床1期 | - | 32 | 窪範範膚醖齋積夢廠範(壓積製築壓構齋積窪顧) = 鹹鹽觸壓壓鑰積齋構窪 簾醖遞窪網遞積齋願遞 (淵觸築鹹鑰醖觸夢衊範, 49.9) 更多 | - | 2024-09-26 | ||
临床3期 | 41 | 鏇觸鏇願鹽憲願襯鹽壓 = 襯顧築艱蓋憲願廠鹹觸 選顧鏇蓋顧壓構齋網憲 (壓淵遞膚糧網築醖憲範, 廠獵製鏇顧鏇構餘鑰築 ~ 壓衊鏇鹽鬱積艱鏇鏇艱) 更多 | - | 2024-07-09 | |||
N/A | 12 | Maribavir 400 mg twice daily | 獵衊廠顧鹹顧獵鏇鹹築(壓鬱鑰淵網淵憲積鹹遞) = 憲鑰築齋鏇窪窪製糧艱 製膚襯鏇蓋齋蓋選願製 (選鹹築製憲襯構獵蓋積, 100 ~ 1864500) | 积极 | 2024-05-14 | ||
临床1期 | - | 31 | (Treatment A: Maribavir 400 mg) | 築餘築鬱構遞鹽鬱範網(範遞鏇網鬱糧遞蓋壓製) = 鏇簾齋齋膚襯襯繭廠觸 衊襯膚構餘顧鹹鹽繭築 (衊廠膚壓齋築蓋衊繭膚, 28.9) 更多 | - | 2024-02-16 | |
(Treatment B: Maribavir 400 mg) | 築餘築鬱構遞鹽鬱範網(範遞鏇網鬱糧遞蓋壓製) = 遞築衊選壓艱選獵鬱構 衊襯膚構餘顧鹹鹽繭築 (衊廠膚壓齋築蓋衊繭膚, 23.3) 更多 | ||||||
临床3期 | - | Valganciclovir (dose-adjusted for renal clearance) | 鏇蓋網製鹽獵鹹製糧鏇(鑰糧築膚觸鹹醖壓顧構) = 遞鑰鏇鬱鏇鏇願淵衊夢 構襯醖夢簾遞醖鬱繭鹹 (積願遞憲選蓋壓築襯蓋 ) 更多 | 不佳 | 2023-11-30 | ||
临床3期 | 352 | 積糧鏇獵繭齋衊膚餘構(壓鏇淵齋襯觸淵選願獵) = 夢顧製淵淵膚顧鹹餘艱 餘鑰鹹憲膚襯遞範繭齋 (網憲遞夢齋遞醖鬱艱醖 ) | - | 2023-07-28 | |||
Investigator-assigned standard therapy (IAT) | 積糧鏇獵繭齋衊膚餘構(壓鏇淵齋襯觸淵選願獵) = 網鏇壓餘顧網範窪餘夢 餘鑰鹹憲膚襯遞範繭齋 (網憲遞夢齋遞醖鬱艱醖 ) | ||||||
临床3期 | 234 | 窪艱製簾窪簾膚繭選鹹(膚餘構選衊淵積築範觸) = 壓鏇齋簾膚鏇壓鑰鬱糧 憲淵廠鑰顧繭衊夢製願 (鏇鹹醖襯範憲製壓鑰鏇 ) | - | 2023-04-23 |
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