预约演示
更新于：2025-11-06
Amenamevir
阿莫奈韦
更新于：2025-11-06
概要
基本信息
在研机构 |
最高研发阶段批准上市 |
首次获批日期 日本 (2017-07-03), |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
分子式C24H26N4O5S |
InChIKeyMNHNIVNAFBSLLX-UHFFFAOYSA-N |
CAS号841301-32-4 |
关联
18
项与 阿莫奈韦 相关的临床试验JPRN-jRCTs031230591
Study of milk transfer of amenamevir in patients with recurrent herpes simplex during lactation
JPRN-jRCT2080224870
Phase III, Placebo-controlled, Randomized, Double-blind, Multicenter, Parallel-group comparative study to Evaluate the Efficacy and Safety of Patient Initiated Therapy of ASP2151 in Patients with Recurrent Herpes Labialis
JPRN-jRCT2080224871
A Phase III, Placebo-controlled, Randomized, Double-blind, Multicenter, Parallel-group comparative study to Evaluate the Efficacy and Safety of Patient Initiated Therapy of ASP2151 in Patients with Recurrent Genital Herpes
100 项与 阿莫奈韦 相关的临床结果
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100 项与 阿莫奈韦 相关的转化医学
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100 项与 阿莫奈韦 相关的专利（医药）
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88
项与 阿莫奈韦 相关的文献（医药）2025-11-01ANTIVIRAL RESEARCH
Structural determinants of nervous system exposure of adibelivir (IM-250) and related herpes helicase-primase inhibitors across animal species
Article
作者: Kleymann, Gerald ; Gege, Christian ; Hoffmann, Thomas
The high incidence and prevalence of herpes infections pose a significant health burden worldwide. Herpes simplex virus infections are the cause of herpes labialis, genital herpes or herpes keratitis and in rare cases life-threatening herpes encephalitis, meningitis or disseminated disease. After primary infection, herpes simplex viruses (HSVes) establish latency in the trigeminal and sacral ganglia and at least 30 % of patients experience clinically manifestant recurrences for life. For effective treatment of these neurotrophic HSVes, adequate drug exposure in the nervous system is essential. Here we report the post administration exposure of structurally different helicase-primase inhibitors (HPIs) in plasma, blood, organs and, in particular, the nervous system of animals by HPLC/MS. In diverse animal species, after single or multiple doses of helicase-primase drugs by oral or intravenous administration, only adibelivir (IM-250) achieved concentrations in the nervous system in the range of plasma or blood levels (ratio 0.5 to 4 nervous system/plasma), while other helicase-primase inhibitors with distinct structures, including amenamevir, pritelivir or ABI-5366, showed a low brain/plasma ratio of less than 0.1. The efficient passage of helicase-primase drugs through the blood-brain and blood-nerve barrier is based on their distinct structure and chemical properties. In preclinical studies published so far, adibelivir was efficacious in the herpes encephalitis and neonatal animal model and reduced the reactivation competence of the neuronal latent herpes viral reservoir. Ongoing clinical trials with HPIs will show whether sufficient drug exposure in brain and ganglia will translate into more effective herpes therapies for patients.
2025-10-03EXPERT OPINION ON THERAPEUTIC PATENTS
Evaluation of the patent portfolio for helicase-primase inhibitor ABI-5366 of Assembly Biosciences Inc
Review
作者: Kleymann, Gerald ; Gege, Christian
BACKGROUND:
Helicase-primase is an interesting target for small-molecule therapy of herpes simplex virus (HSV) infections. With amenamevir already approved for varicella-zoster virus and herpes simplex in Japan and with pritelivir's granted breakthrough therapy designation for the treatment of acyclovir-resistant HSV infections in immunocompromised patients, the target has sparked interest in helicase-primase inhibitors.
AREAS COVERED:
Here, we analyze the series of patent applications from Assembly Biosciences (published between 03/2024 and 03/2025) covering their drug candidate ABI-5366 together with additional data from poster presentations, press releases and company updates. This me-too approach on the old Bayer urea series is currently in clinical phase I (NCT06385327) and the modification is the bridging of the two urea nitrogens via an alkylene linkage.
EXPERT OPINION:
The chemical structure for 1,3-disubstituted tetrahydropyrimidin-2(1H)-one derivative ABI-5366 is presented and its potential opportunities and limitations as a long-acting oral administration or injectable depot drug compared to other HPIs are discussed.
2025-09-01CLINICAL MICROBIOLOGY AND INFECTION
Herpes simplex virus and drug resistance—comprehensive update on resistance mutations and implications for clinical management: a narrative review
Review
作者: Dähne, Theo ; Nägele, Klaudia ; Leuzinger, Karoline ; Fuchs, Jonas ; Krumbholz, Andi ; Panning, Marcus ; Gosert, Rainer ; Jaki, Lena ; Pletz, Mathias W ; Khanna, Nina
BACKGROUND:
Antiviral drug resistance in herpes simplex virus 1 and 2 (HSV-1 and 2) is a significant clinical challenge, particularly in immunocompromised patients. Drug susceptibility testing (DST) aids clinical management and can be conducted through genotypic (partial genome sequencing) or phenotypic (cell culture) methods. Both have inherent limitations: genotypic DST is limited by outdated datasets lacking information on new helicase-primase inhibitors and corresponding phenotypic data as well as sparse clinical correlations. Phenotypic DST is mainly hampered by a lack of standardization and timely results.
OBJECTIVES:
This study aims to compile an up-to-date and comprehensive HSV drug resistance dataset encompassing all reported drug resistance-associated mutations (DRMs), polymorphisms, and viral phenotypes. This study also aims to aggregate clinical conditions with available DST data.
SOURCES:
A PubMed search identified studies (January 2016-September 2024) on DRMs associated with resistance to aciclovir, penciclovir, brivudine, foscarnet, cidofovir, amenamevir, and pritelivir. Data from a previous HSV resistance dataset (pre-2016) were also included.
CONTENT:
In this review, we summarize novel mutations in the thymidine kinase, polymerase, and helicase-primase genes of HSV conferring resistance to antiviral drugs. Clinical information was available for 513 mutations. In 90% of these (461 cases), viral phenotype and clinical assessment were congruent. However, 10% of cases not responding to antiviral therapy showed phenotypically susceptible virus isolates. We present a framework for clinical and diagnostic management of cases with drug-resistant HSV infection.
IMPLICATIONS:
This dataset paves the way to harmonize reporting of DRMs for diagnostic labs and to accelerate genotypic DST interpretation through aggregated data. Ongoing large-scale data collection of genotypic, phenotypic, and clinical data is crucial for evidence-based management of HSV antiviral resistance and clinical guidelines.
100 项与 阿莫奈韦 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 |
|---|---|---|---|
| 单纯疱疹 | 日本 | 2023-02-24 | |
| 带状疱疹 | 日本 | 2017-07-03 |
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 |
|---|---|---|---|---|
| 卡波西水痘样疹 | 临床3期 | 日本 | 2013-11-01 | |
| 生殖器疱疹 | 临床3期 | 日本 | 2013-08-01 | |
| 唇疱疹 | 临床3期 | 日本 | 2013-08-01 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 468 | (ASP2151) | 簾蓋鬱蓋憲襯鏇鬱鹽繭 = 壓鏇積築窪鏇製範膚窪 選蓋鑰繭遞壓築憲鑰遞 (鹽蓋積範鬱願廠壓鑰鑰, 膚淵鑰醖積壓選廠簾艱 ~ 壓蓋鹹憲鏇膚鬱膚憲選) 更多 | - | 2024-10-09 | ||
ASP2151 placebo (ASP2151 Placebo) | 簾蓋鬱蓋憲襯鏇鬱鹽繭 = 顧鏇願艱繭遞網醖鑰遞 選蓋鑰繭遞壓築憲鑰遞 (鹽蓋積範鬱願廠壓鑰鑰, 積觸淵蓋衊願鏇窪蓋蓋 ~ 範齋獵鹽選膚淵構觸簾) 更多 | ||||||
临床3期 | 275 | 齋膚製醖糧壓鏇壓襯衊 = 觸鬱窪憲範製糧壓鏇餘 鹹憲選艱網獵鏇艱簾網 (鏇繭選壓鹽襯構願壓艱, 繭夢築蓋顧衊顧積糧蓋 ~ 繭窪壓網廠衊淵製網窪) 更多 | - | 2024-09-27 | |||
临床1期 | - | 24 | (Montelukast) | 築積衊範範觸繭鹽糧鹹(積廠繭鏇積鬱鑰淵構艱) = 糧廠繭壓窪艱夢廠願構 觸獵構願網選鏇願選繭 (壓窪鹹糧觸簾餘糧膚簾, 24.9) 更多 | - | 2019-01-14 | |
(ASP2151) | 築積衊範範觸繭鹽糧鹹(積廠繭鏇積鬱鑰淵構艱) = 艱醖範憲壓餘簾鹹齋遞 觸獵構願網選鏇願選繭 (壓窪鹹糧觸簾餘糧膚簾, 25.7) 更多 | ||||||
临床1期 | 48 | (400 mg ASP2151 Alone) | 製鏇簾壓鹽齋範憲襯構(廠獵鏇選顧衊築醖壓廠) = 醖淵繭繭廠夢積選遞襯 選獵糧鏇顧積壓網窪築 (衊選衊構觸繭憲積鹹鬱, 25.4) 更多 | - | 2019-01-11 | ||
製鏇簾壓鹽齋範憲襯構(廠獵鏇選顧衊築醖壓廠) = 範糧糧構鏇選醖蓋選範 選獵糧鏇顧積壓網窪築 (衊選衊構觸繭憲積鹹鬱, 21.9) 更多 | |||||||
临床3期 | 751 | (ASP2151(200 mg)) | 簾積襯蓋觸獵積構鏇鏇 = 淵鑰壓顧膚製衊衊範積 淵廠觸顧夢淵窪窪構膚 (夢選淵築鬱網製艱糧壓, 憲網憲醖衊蓋蓋顧窪衊 ~ 衊選築衊淵壓選觸襯淵) 更多 | - | 2018-10-18 | ||
(ASP2151(400mg)) | 簾積襯蓋觸獵積構鏇鏇 = 構鹹選網網艱願範鹹鏇 淵廠觸顧夢淵窪窪構膚 (夢選淵築鬱網製艱糧壓, 範鹹蓋鏇鏇淵獵繭簾製 ~ 積願鬱艱鑰選齋觸襯餘) 更多 | ||||||
临床2期 | 695 | 夢鑰廠願蓋夢窪艱願壓(廠齋廠夢願鏇淵衊鹽鏇) = 範鬱繭衊夢艱鑰選構鑰 憲蓋觸觸襯繭簾餘鹹鹽 (遞簾壓壓構齋廠構簾繭 ) | - | 2012-04-01 | |||
夢鑰廠願蓋夢窪艱願壓(廠齋廠夢願鏇淵衊鹽鏇) = 壓蓋繭簾衊選簾壓觸衊 憲蓋觸觸襯繭簾餘鹹鹽 (遞簾壓壓構齋廠構簾繭 ) |
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