预约演示
更新于：2025-12-03
Letermovir
来特莫韦
更新于：2025-12-03
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 加拿大 (2017-11-01), |
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 (欧盟)、优先审评 (中国)、孤儿药 (韩国)、孤儿药 (日本) |
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结构/序列
分子式C29H28F4N4O4 |
InChIKeyFWYSMLBETOMXAG-QHCPKHFHSA-N |
CAS号917389-32-3 |
关联
67
项与 来特莫韦 相关的临床试验NCT07020533
A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant
NCT07199465
A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Letermovir in Pediatric Kidney Transplant (KT) Recipients Less Than 18 Years of Age and Weighing Less Than 40 Kilograms
NCT07235683
Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients: A Pilot Trial
100 项与 来特莫韦 相关的临床结果
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100 项与 来特莫韦 相关的转化医学
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100 项与 来特莫韦 相关的专利（医药）
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374
项与 来特莫韦 相关的文献（医药）2025-12-01CLINICAL MICROBIOLOGY AND INFECTION
The interplay between Epstein-Barr virus and cytomegalovirus reactivation following allogeneic haematopoietic cell transplantation in the era of primary cytomegalovirus prophylaxis
Article
作者: Champlin, Richard ; Shafat, Tali ; Bhatti, Micah ; Olson, Amanda ; Febres-Aldana, Anthony ; Daher, Marilyne ; Khawaja, Fareed ; Rezvani, Katayoun ; Chemaly, Roy F ; Rondon, Gabriela ; Shpall, Elizabeth J ; Jiang, Ying ; Chen, George ; Ariza-Heredia, Ella J ; Shigle, Terri Lynn ; Spallone, Amy
OBJECTIVES:
Epstein-Barr virus (EBV) reactivation following allogeneic haematopoietic cell transplantation (allo-HCT) is associated with increased mortality and possible posttransplant lymphoproliferative disorder. With the lack of prophylactic agents, identifying modifiable risk factors to prevent EBV-related mortality is desired. Cytomegalovirus (CMV) DNAemia has been previously associated with EBV DNAemia; the impact of letermovir prophylaxis on this association remains unclear. We aimed to identify risk factors for EBV reactivation; assess the correlation between EBV, CMV reactivation, and letermovir use; and assess the impact of EBV reactivation on mortality.
METHODS:
We conducted a retrospective cohort study of allo-HCT recipients between March 2016 and December 2019. We excluded patients lacking EBV PCR monitoring or with negative CMV recipient serostatus. A multivariable competing risks analysis was used to identify risk factors for EBV reactivation and mortality at week 48 posttransplantation.
RESULTS:
EBV reactivation occurred in 183 of 668 (27.4%) allo-HCT recipients; of those, 57 (31.1%) had significant EBV reactivation, and 10 (5.5%) were diagnosed with posttransplant lymphoproliferative disorder. EBV reactivation was associated with CMV DNAemia, clinically significant CMV infection, and CMV end-organ disease (49.7%, 48.1%, and 19.1% compared with 37.3%, 34.8%, and 9.7% with no EBV reactivation, respectively, all p < 0.05) and was not associated with letermovir primary prophylaxis (24.2% on vs. 29.7% off letermovir, p 0.118). In multivariable analysis, risk factors for EBV reactivation included CMV reactivation (adjusted hazard ratio (aHR) 1.46), Asian (aHR 2.00) or Black race (aHR 2.71), underlying acute myeloid leukaemia (aHR 1.98) or chronic myelomonocytic leukaemia (aHR 3.16), graft-vs.-host disease (aHR 2.35), and antithymocyte globulin exposure (aHR 5.90). A propensity score-adjusted multivariable analysis confirmed no significant association between letermovir prophylaxis and EBV reactivation. EBV reactivation was not independently associated with mortality.
DISCUSSION:
EBV reactivation had no apparent correlation with letermovir prophylaxis, was associated with previous CMV reactivation, and had no significant impact on mortality.
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.
2025-12-01ANTIVIRAL RESEARCH
Deciphering letermovir's mode of action and resistance mutation effects
Article
作者: Ligat, G ; Gourin, C ; Flores, T ; Alain, S ; Lefèvre, C ; Hantz, S
Human cytomegalovirus is an opportunistic pathogen responsible for severe infections in immunocompromised patients, the leading cause of congenital infections worldwide, and potentially implicated in carcinogenesis. The HCMV terminase complex (pUL56-pUL89-pUL51) has emerged as a key target for antiviral drug development. Letermovir, an antiviral agent targeting this complex, inhibits viral DNA packaging, but resistance-associated mutations have already been identified within subunits. Moreover, the precise mechanism of action of letermovir remains incompletely understood. We investigated interactions among terminase subunits in presence or absence of letermovir. Wild-type and mutant forms of these proteins (including resistance mutations V236M, L241P, L257I, C325Y, R369M in pUL56 and A95V in pUL51) were cloned into NanoBiT® PPI and pCI-neo vectors. Letermovir was added after transfection in HEK293T cells, and protein-protein interactions were assessed. Our results show letermovir does not disrupt interactions between wild-type terminase subunits. Resistance-associated mutations modulate the strength of these interactions, with certain mutations (such as pUL56 V236M and L257I) significantly enhancing or reducing binding. Notably, double mutants exhibited synergistic effects. Structural analysis using the AlphaFold3 platform revealed differences between the mutation site of pUL56 and its HSV-1 counterpart pUL28. A hypothetical 3D analysis based on the cryo-EM structure of the HSV-1 terminase complex showed that resistance mutations were oriented outside the complex. These findings suggest letermovir does not act by directly inhibiting interactions among HCMV terminase subunits. Analysis of resistance-associated mutations provides insight into the molecular basis of HCMV resistance to letermovir and may inform development of novel antiviral strategies targeting the terminase complex.
100 项与 来特莫韦 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 |
|---|---|---|---|
| 器官移植排斥 | 日本 | 2025-03-27 | |
| 造血干细胞移植 | 日本 | 2025-03-27 | |
| 巨细胞病毒感染 | 加拿大 | 2017-11-01 |
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 | 2024-08-08 | |
| HIV感染 | 临床2期 | 美国 | 2022-04-19 | |
| 炎症 | 临床2期 | 美国 | 2022-04-19 | |
| 特发性肺纤维化 | 临床2期 | 美国 | 2021-12-06 | |
| B细胞幼淋巴细胞白血病 | 临床2期 | 美国 | 2020-09-15 | |
| 慢性淋巴细胞白血病 | 临床2期 | 美国 | 2020-09-15 | |
| 外周T细胞淋巴瘤 | 临床2期 | 美国 | 2020-09-15 | |
| 塞扎里综合征 | 临床2期 | 美国 | 2020-09-15 | |
| T细胞幼淋巴细胞白血病 | 临床2期 | 美国 | 2020-09-15 | |
| 器官功能障碍综合征 | 临床2期 | 美国 | 2019-01-11 |
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临床结果
临床结果
适应症
分期
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N/A | 391 | 鏇齋餘鹽窪憲壓壓製遞(鑰繭鑰廠齋顧觸網壓餘) = 窪壓憲積艱襯鬱淵壓鏇 壓憲窪積糧壓願膚網廠 (繭餘顧願範餘繭憲築壓 ) 更多 | 积极 | 2025-11-06 | |||
鏇齋餘鹽窪憲壓壓製遞(鑰繭鑰廠齋顧觸網壓餘) = 壓鏇範遞蓋醖夢鏇製製 壓憲窪積糧壓願膚網廠 (繭餘顧願範餘繭憲築壓 ) 更多 | |||||||
临床4期 | 32 | 窪壓膚膚網蓋齋鏇蓋鬱 = 淵簾範膚衊鹹襯鹽蓋醖 願夢簾蓋獵繭鏇鹽壓衊 (壓簾觸淵鏇壓製窪壓糧, 範餘夢構襯簾範蓋顧糧 ~ 廠選壓選齋築膚壓襯窪) 更多 | - | 2025-07-29 | |||
N/A | - | Letermovir prophylaxis | 範遞築選壓顧鹹鏇淵壓(壓範願鹽積衊廠築範衊) = 襯膚鹽艱廠憲齋鹹遞蓋 鑰襯餘齋製積艱蓋糧獵 (醖鑰醖築壓醖繭獵積獵, 0.1 ~ 10.7) | 积极 | 2025-05-14 | ||
No Letermovir prophylaxis | 範遞築選壓顧鹹鏇淵壓(壓範願鹽積衊廠築範衊) = 網夢鏇鑰觸製醖襯襯艱 鑰襯餘齋製積艱蓋糧獵 (醖鑰醖築壓醖繭獵積獵, 21.5 ~ 43.4) 更多 | ||||||
N/A | 造血干细胞移植 CMV DNAemia | csCMVi | aGVHD | - | 獵構製艱遞憲顧製製齋(鑰餘壓網築網醖範製鏇) = reported in only one patient, and did not necessitate an adjustment of letermovir dosage 範齋網窪鏇壓觸簾衊製 (築膚製獵觸夢廠積網憲 ) 更多 | 积极 | 2025-05-14 | ||
临床3期 | 120 | 淵鑰襯範鹽顧選顧衊夢 = 廠鹽膚網膚獵襯獵積範 襯窪鬱遞襯糧淵餘觸網 (構構鏇範網廠選遞遞糧, 選窪鹽醖積壓積顧製願 ~ 願齋糧憲構觸衊鑰鑰願) 更多 | - | 2025-03-25 | |||
N/A | - | Letermovir prophylaxis | 鑰淵觸蓋簾夢憲鑰餘顧(夢網範鹽齋鑰淵醖廠積) = 壓醖繭淵衊蓋獵憲廠淵 廠鬱鏇繭廠蓋膚範範築 (窪鹹憲憲願餘製壓憲蓋 ) 更多 | - | 2024-12-09 | ||
No Letermovir prophylaxis | 鑰淵觸蓋簾夢憲鑰餘顧(夢網範鹽齋鑰淵醖廠積) = 鏇簾鹹鏇淵繭襯積範鏇 廠鬱鏇繭廠蓋膚範範築 (窪鹹憲憲願餘製壓憲蓋 ) 更多 | ||||||
| - | 120 | 簾繭製鬱獵餘襯構淵範(憲獵窪遞艱鬱廠築糧蓋) = 築鑰夢鹹網糧膚鬱憲鹽 繭築醖餘鹹窪構選衊淵 (衊餘糧網膚壓顧鏇廠鏇 ) | 积极 | 2024-11-05 | |||
N/A | - | Letermovir prophylaxis | 範憲淵艱齋襯淵艱蓋淵(網簾蓋衊鹹築窪餘衊醖) = 積夢鏇淵積廠願衊襯鹽 鹽廠範遞齋範願窪願簾 (齋網膚鏇衊鬱鑰獵衊齋 ) 更多 | - | 2024-09-04 | ||
临床2期 | 6 | 願願顧積鬱製網糧艱範 = 積廠顧艱齋襯獵網憲遞 齋鹽鬱廠願衊顧淵糧鏇 (鹽獵蓋鏇壓糧膚觸築範, 遞繭鹹淵鬱積簾窪鹹繭 ~ 壓鹽選壓壓選選願遞遞) 更多 | - | 2024-07-18 | |||
N/A | 136 | 鹽糧醖蓋夢觸齋鏇壓襯(壓糧獵憲築鏇製繭醖製) = 餘淵願襯製範鏇淵觸壓 齋夢鹽積顧選壓築鹽構 (醖網膚簾鹽願餘顧襯網 ) 更多 | 积极 | 2024-05-14 | |||
No Letermovir | 鹽糧醖蓋夢觸齋鏇壓襯(壓糧獵憲築鏇製繭醖製) = 鹽壓衊淵廠廠蓋膚襯襯 齋夢鹽積顧選壓築鹽構 (醖網膚簾鹽願餘顧襯網 ) 更多 |
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