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更新于：2025-05-15
Maribavir
马立巴韦
更新于：2025-05-15
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)、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)、突破性疗法 (美国) |
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结构/序列
分子式C15H19Cl2N3O4 |
InChIKeyKJFBVJALEQWJBS-XUXIUFHCSA-N |
CAS号176161-24-3 |
关联
22
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
NCT06555432
Post-Marketing Surveillance (Usage Results Study) of LIVTENCITY Tablet (Maribavir) for the Approved Indications in South Korea
CTR20243548
评估受试制剂马立巴韦片与参比制剂（LIVTENCITY®）在健康成年受试者餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究
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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327
项与 马立巴韦 相关的文献（医药）2025-05-01TRANSPLANTATION
Dynamics and Evolution of Donor-derived Cytomegalovirus Infection in 3 Solid Organ Transplant Recipients With the Same Multiorgan Donor
Article
作者: Vanuytsel, Tim ; Vos, Robin ; Debaveye, Yves ; Andrei, Graciela ; Vanhoutte, Thomas ; Horsten, Fien ; Chou, Sunwen ; Snoeck, Robert ; Naesens, Maarten ; Maes, Piet ; Pirenne, Jacques ; Gillemot, Sarah
Background.:
Cytomegalovirus (CMV) infection poses a significant risk to immunosuppressed transplant recipients, manifesting through primary infection, reinfection, or reactivation.
Methods.:
We analyzed the emergence of drug resistance in CMV infection in 3 patients who were later found to have received an allograft from a shared, deceased donor. The seronegative transplant recipients developed symptomatic CMV infections after bowel/pancreas, kidney, or lung transplantation. Prospective Sanger sequencing was used to identify mutations in the viral DNA polymerase (DP) and protein kinase (PK). DP and PK variants were retrospectively quantified by targeted next-generation sequencing. The impact of the novel DP-A505G substitution on drug susceptibility was assessed using a recombinant virus. Whole-genome sequencing of clinical CMV samples was enabled through target DNA enrichment.
Results.:
The DP-A505G substitution was found in all patient samples and could be associated with a natural polymorphism. A subsequent review of the patients’ clinical histories revealed that they had all received organs from a single donor. The CMV infection exhibited divergent evolution among the patients: patient 1 developed resistance to ganciclovir and foscarnet because of 2 DP mutations (V715M and V781I), patient 2 showed no genotypic resistance, and patient 3 developed ganciclovir (PK-L595S) and maribavir resistance (PK-T409M). Interpatient variation across the entire CMV genome was minimal, with viral samples clustering in phylogenetic analysis.
Conclusions.:
All 3 transplant recipients were infected with the same donor-derived CMV strain and readily developed different drug susceptibility profiles. This underscores the importance of judicious antiviral drug use and surveillance in preventing antiviral resistance emergence.
2025-05-01JOURNAL OF MEDICAL VIROLOGY
Human Cytomegalovirus Virion‐Associated mRNA as a Marker of Productive Infection in Immunocompromised Patients
Article
作者: Baldanti, Fausto ; Giardina, Federica ; Cassaniti, Irene ; Mura, Omar ; Rampino, Teresa ; Mele, Dalila ; Campanini, Giulia ; Pattonieri, Eleonora Francesca ; Seminari, Elena ; Sammartino, José Camilla ; Gregorini, Marilena ; Compagno, Francesca ; Pitrolo, Antonino Maria Guglielmo ; d'Angelo, Piera ; Briganti, Domenica Federica ; Nicola Polverelli ; Ramus, Marina ; Paolucci, Stefania ; Lilleri, Daniele
ABSTRACT:
Human Cytomegalovirus (HCMV) transcripts (including UL21.5 mRNA) have been found to be packaged in virions, and their detection in plasma may indicate the presence of infectious viral particles. The objective of this study was to verify whether UL21.5 mRNA detected in the plasma was indeed encapsulated in viral particles, representing an indirect marker of active replication. To distinguish between virion‐packaged and free‐floating RNA, plasma samples from 22 immunocompromised patients were tested before and after ribonuclease (RNAse) digestion. UL21.5 mRNA was detected 1–2 weeks before preemptive therapy administration in 20 episodes (from 18 patients) of clinically significant DNAemia, while it was undetectable in three of the four patients with transient, self‐resolving DNAemia. After RNAse digestion, UL21.5 mRNA was still detectable, with a median reduction of 0.1 (IQR: 0–0.3) Log10. Concentrations of UL21.5 mRNA in plasma correlated significantly with HCMV DNA in whole blood or plasma (R = 0.67), and 75% of samples positive for UL21.5 mRNA had HCMV DNA concentrations above 104 copies/mL blood or 103 copies/mL plasma. Moreover, UL21.5 mRNA was positive in patients who developed HCMV infection resistant to letermovir or maribavir, whereas it was undetectable in the plasma of patients with transient self‐resolving DNAemia blips during letermovir prophylaxis (not associated with drug‐resistance). HCMV UL21.5 mRNA in plasma is virion‐associated and represents a marker for productive HCMV infection. The determination of UL21.5 mRNA could improve current strategies for the management of HCMV infection in immunocompromised patients.
2025-04-14Journal of Chemical Information and Modeling
Proteomic Learning of Gamma-Aminobutyric Acid (GABA) Receptor-Mediated Anesthesia
Article
作者: Shi, Yazhou ; Zhou, Tianshou ; Qiu, Huahai ; Chen, Long ; Zhu, Yueying ; Wei, Guo-Wei ; Jiang, Jian ; Zhang, Bengong
Anesthetics are crucial in surgical procedures and therapeutic interventions, but they come with side effects and varying levels of effectiveness, calling for novel anesthetic agents that offer more precise and controllable effects. Targeting Gamma-aminobutyric acid (GABA) receptors, the primary inhibitory receptors in the central nervous system, could enhance their inhibitory action, potentially reducing side effects while improving the potency of anesthetics. In this study, we introduce a proteomic learning of GABA receptor-mediated anesthesia based on 24 GABA receptor subtypes by considering over 4000 proteins in protein-protein interaction (PPI) networks and over 1.5 millions known binding compounds. We develop a corresponding drug-target interaction network to identify potential lead compounds for novel anesthetic design. To ensure robust proteomic learning predictions, we curated a data set comprising 136 targets from a pool of 980 targets within the PPI networks. We employed three machine learning algorithms, integrating advanced natural language processing (NLP) models such as pretrained transformers and autoencoder embeddings. Through a comprehensive screening process, we evaluated the side effects and repurposing potential of over 180,000 drug candidates targeting the GABRA5 receptor. Additionally, we assessed the ADMET (absorption, distribution, metabolism, excretion, and toxicity) properties of these candidates to identify those with near-optimal characteristics. This approach also involved optimizing the structures of existing anesthetics. Our work presents an innovative strategy for the development of new anesthetic drugs, optimization of anesthetic use, and a deeper understanding of potential anesthesia-related side effects.
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 | 衊鹽壓繭憲鏇襯醖顧積(築鹽製遞蓋網鹽齋鏇鬱) = 遞壓襯夢觸積衊廠鹹築 鹽選獵齋構窪鹹壓夢築 (夢襯範積鏇齋選網鹹膚 ) | 积极 | 2024-11-01 | ||
Investigator-assigned therapy (IAT) | 衊鹽壓繭憲鏇襯醖顧積(築鹽製遞蓋網鹽齋鏇鬱) = 糧製願繭窪夢鏇壓選築 鹽選獵齋構窪鹹壓夢築 (夢襯範積鏇齋選網鹹膚 ) | ||||||
临床1期 | - | 32 | 襯鏇築遞艱餘願糧窪觸(鬱襯願淵鏇膚簾膚餘簾) = 繭廠餘觸衊鹹鑰淵範鑰 範簾鹹構選膚衊繭蓋鬱 (選製膚齋願窪鬱醖積襯, 49.9) 更多 | - | 2024-09-26 | ||
临床3期 | 41 | 齋艱繭糧簾範積鹽憲製 = 鏇顧艱繭廠鑰衊淵壓鹹 壓襯製積願壓願艱繭鑰 (廠網餘蓋觸醖糧繭艱獵, 膚壓夢顧糧艱醖築鏇醖 ~ 夢蓋遞夢醖蓋繭觸選淵) 更多 | - | 2024-07-09 | |||
N/A | 12 | Maribavir 400 mg twice daily | 願選鏇鬱鏇艱鬱製廠襯(壓觸艱顧膚鹹網糧遞網) = 鬱襯構廠廠膚壓鑰鏇築 遞積積網鹽齋鹹製觸壓 (選網構顧網鹽願襯遞衊, 100 ~ 1864500) | 积极 | 2024-05-14 | ||
临床3期 | - | Valganciclovir (dose-adjusted for renal clearance) | 遞繭範餘願醖蓋廠憲積(獵壓醖糧蓋齋蓋顧製繭) = 遞選醖網壓製夢廠壓築 窪願鏇鏇衊餘餘鏇鬱顧 (鹹淵鬱製廠醖鬱簾蓋蓋 ) 更多 | 不佳 | 2023-11-30 | ||
临床3期 | 352 | 憲壓壓構齋夢構糧廠鏇(廠糧選醖製齋選衊淵鹽) = 膚膚廠廠衊淵糧膚膚範 夢鑰顧選獵蓋壓艱鹽繭 (積廠繭衊製衊齋膚鬱艱 ) | - | 2023-07-28 | |||
Investigator-assigned standard therapy (IAT) | 憲壓壓構齋夢構糧廠鏇(廠糧選醖製齋選衊淵鹽) = 製憲艱遞網襯願窪遞鹹 夢鑰顧選獵蓋壓艱鹽繭 (積廠繭衊製衊齋膚鬱艱 ) | ||||||
临床3期 | 234 | 襯積夢獵製範構衊鹹壓(夢願艱積築積鹽醖艱廠) = 範顧觸顧襯觸廠簾廠顧 襯襯繭簾齋鏇醖廠鏇壓 (繭構壓顧壓膚蓋顧鑰齋 ) | - | 2023-04-23 | |||
临床3期 | 553 | Placebo+valganciclovir (Valganciclovir 900 mg BID) | 製壓構淵網鏇鏇廠艱遞 = 餘糧鹹簾夢夢製憲衊獵 築網鏇築衊淵積齋襯鏇 (壓壓範鑰願築壓鹹範獵, 獵鬱遞蓋憲憲積夢憲積 ~ 鹽構繭鏇鬱醖壓繭壓製) 更多 | - | 2023-03-03 | ||
Placebo+Maribavir (Maribavir 400 mg BID) | 製壓構淵網鏇鏇廠艱遞 = 鹽繭築夢簾鹹糧選齋鬱 築網鏇築衊淵積齋襯鏇 (壓壓範鑰願築壓鹹範獵, 憲獵淵壓網鹹繭鏇鏇觸 ~ 膚鬱鹹餘窪選網遞願鑰) 更多 | ||||||
临床2期 | - | 淵願網蓋糧夢構願廠醖(壓獵夢壓衊遞淵糧網繭) = 鬱構憲鹽築構簾艱鬱淵 糧淵選獵壓構膚夢遞鹹 (蓋壓願願範襯簾構襯糧 ) 更多 | - | 2022-09-04 |
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