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

开始日期2019-09-25

申办/合作机构

Maruho Co., Ltd.

JPRN-jRCT2080224871

/ Completed临床3期

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

开始日期2019-09-20

申办/合作机构

Maruho Co., Ltd.

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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项与阿莫奈韦相关的文献（医药）

2025-08-01·JOURNAL OF THE NEUROLOGICAL SCIENCES

Characteristics of meningitis/encephalitis in adult patients with varicella-zoster virus infection: Experience from tertiary centers in Saga prefecture, Japan

Article

作者: Koike, Haruki ; Eriguchi, Makoto ; Goto, Yuta ; Yoshikawa, Masaaki ; Kosugi, Masafumi ; Tanaka, Koya ; Takashima, Hiroshi ; Iwasaki, Megumi ; Goto, Hirofumi ; Hirahara, Rintaro ; Inoue, Yukako ; Kawanami, Takeru ; Tsumura, Keisuke ; Suzuyama, Kohei ; Tsutsumi, Masaomi ; Ono, Natsuki ; Shichijo, Chika ; Ide, Toshihiro

OBJECTIVE:

To clarify the characteristics of meningitis/encephalitis resulting from the varicella-zoster virus (VZV) in adult patients in Saga Prefecture, Japan, since the availability of amenamevir.

METHODS:

We retrospectively examined the characteristics of consecutive adult patients diagnosed with VZV meningitis/encephalitis referred to five tertiary hospitals covering Saga Prefecture from September 2017 to August 2023. We also investigated the trend in using antiviral agents for herpes zoster treatment by using administrative claim data from the Japanese Medical Data Center (JMDC) database.

RESULTS:

The Glasgow Outcome Scale (GOS) and modified Rankin Scale (mRS) at the peak phase were not significantly associated with the age of patients, whereas the mRS at 1 month and GOS and mRS scores at the last assessment tended to be worse as the age of onset increases (P < 0.01, 0.05, and 0.001, respectively), indicating poorer outcomes in elderly patients. The prescription rate of amenamevir for herpes zoster treatment in our patients was 57.1 % (8 of 14 cases), which was significantly higher than that of the JMDC database in Saga Prefecture alone (28.1 %, P < 0.05) and across Japan (25.8 %, P < 0.01). GOS and mRS at baseline, 1 month, and the last assessment were not significantly different between patients receiving amenamevir and those receiving other antiviral agents for herpes zoster treatment.

CONCLUSION:

Our study results suggested poorer outcomes in elderly patients and a high proportion of patients prescribed amenamevir. Lower the CSF transfer rate of amenamevir may increase the risk of developing meningitis/encephalitis in patients with herpes zoster.

2025-07-01·VETERINARY MICROBIOLOGY

Host helicase DHX36 inhibits pseudorabies virus proliferation by unwinding the G-quadruplex in the 3’UTR of IE180

Article

作者: Zheng, Yingge ; Bai, Yuqing ; Wang, Daozhong ; Guo, Lijun ; Li, Qingling ; Chen, Xi ; Wei, Dengguo ; Luo, Dehua

The balance between proliferation and persistence of pseudorabies virus (PRV) in the host is crucial for its long-term survival. Understanding the mechanisms that regulate viral survival may offer new strategies for disease prevention and control. The immediate-early gene 180 (IE180) is essential for PRV replication, and we previously identified a G-quadruplex (PQS18-1) located in the 3' untranslated region (3'UTR) of IE180 that enhances its expression and promotes viral replication. However, the mechanisms by which this G-quadruplex is unwound and contributes to immune evasion remain unclear. In this study, we identified the host helicase DHX36 as a binding partner of PQS18-1 through RNA pull-down assays. Both in vitro and cellular experiments demonstrated that DHX36 destabilizes the G-quadruplex, thereby suppressing gene expression and regulating PRV replication. Our findings reveal a novel host-virus interaction mechanism involving G-quadruplex structures and helicase activity, which may offer new targets for therapeutic intervention.

2025-05-01·CLINICAL 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.

项与阿莫奈韦相关的新闻（医药）

2024-06-05

·maruho.co.jp

Maruho and Hyphens Pharma Announce Exclusive License Agreement for Anti-herpes Virus Agent (INN: Amenamevir) in 10 ASEAN Countries

Osaka (Japan), June 5, 2024 - Maruho Co., Ltd. ("Maruho", Head Office: Osaka, Japan, President and CEO: Atsushi Sugita) and Hyphens Pharma Pte. Ltd., a subsidiary of Hyphens Pharma International Limited ("Hyphens", Head Office: Singapore, Chairman, Executive Director and CEO: Lim See Wah) announced that the two companies have entered into a license agreement under which Maruho will license to Hyphens the rights to develop and commercialize the anti-herpes virus agent amenamevir (JNN/INN), manufactured and marketed in Japan by Maruho, hereinafter referred to as "the product", in 10 ASEAN (Association of Southeast Asian Nations)*1 countries. Under the terms of the agreement, Maruho grants Hyphens an exclusive license to develop and market the product in 10 ASEAN countries. Hyphens will proceed with the development activities necessary to bring the product to market. After the product is commercialized, Hyphens will pay royalties to Maruho based on commercialization milestones. The product exhibits high antiviral activity against the varicella-zoster virus and the herpes simplex virus by inhibiting the activity of the helicase-primase complex, which is essential for viral DNA replication. In 2012, Maruho and Astellas Pharma Inc. executed a license agreement for the development and commercialization of the product. Maruho proceeded with development in Japan and the product was approved for the indications of "herpes zoster" in 2017 and "recurrent herpes simplex" in 2023. The product is currently manufactured and commercialized under the brand name of "Amenalief® Tablets 200 mg" in Japan. In its 5th Medium-Term Plan, initiated in October 2023, Maruho introduced a new business strategy termed the "Asia Dermatology Hub Concept." Maruho established a local subsidiary in China*2 in February 2024 and is promoting business development in Asian countries and regions. This agreement is an effort to realize business development in Asia and to respond to the unmet needs of patients in ASEAN countries who have limited options for herpes treatment. Maruho and Hyphens, which both specialize in dermatology, will work to bring smiles to the faces of patients suffering from viral skin diseases such as herpes zoster and herpes simplex in the countries and regions covered by this agreement. Note The information contained in this news release in regard to pharmaceutical and developmental products is not intended for the purpose of promotion, advertising or medical advice. (*1) Thailand, Indonesia, Malaysia, Philippines, Singapore, Vietnam, Brunei, Cambodia, Myanmar, Laos (*2) Establishment of a local subsidiary in China (February 2024) https://www.maruho.co.jp/english/information/20240222.html [References] Maruho Launches Anti-Herpes Virus Agent "Amenalief Tab. 200mg" in Japan (2017/09/02) https://www.maruho.co.jp/english/information/2017090702.html Maruho Receives Manufacturing and Marketing Approval for a Partial Change of the Indication and Dosage/Administration for Anti-herpes Virus Agent "Amenalief Tab. 200mg" for the Treatment of Recurrent Herpes Simplex in Japan (2023/02/24) https://www.maruho.co.jp/english/information/20230224.html About HyphensHyphens Pharma International Limited and its subsidiaries (the "Group") is Singapore's leading specialty pharmaceutical and consumer healthcare group, leveraging on its diverse footprint in ASEAN countries. The Group has a direct presence in Singapore, Vietnam, Malaysia, Indonesia, and the Philippines, and is supplemented by a marketing and distribution network covering 14 other markets. The Group's core business comprises Specialty Pharma Principals, Proprietary Brands, and Medical Hypermart & Digital. Besides marketing and selling a range of specialty pharmaceutical products in selected ASEAN countries through exclusive distributorship or licensing and supply agreements with brand principals mainly from Europe and the United States, the Group also develops, markets, and sells its own proprietary range of dermatological and health supplement products. For more information, please visit https://www.hyphensgroup.com/ About MaruhoMaruho Co., Ltd. has its head office in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,566 employees (as of the end of September 2023), and net sales were approximately 85.71 billion yen in its fiscal year ended September 30, 2023. With the mission "More smiles, brighter life for you.", Maruho aims to help realize a society where everyone can live with a smile. For more information, please visit www.maruho.co.jp/english/ Contact Information: Maruho Co., Ltd. Public Relations Group, Corporate Planning Dept. Tel：+81-(0)6-6371-8831 Fax：+81-(0)6-6371-8679 Email：kouhou@mii.maruho.co.jp

引进/卖出上市批准

2023-02-24

·maruho.co.jp

Maruho Receives Manufacturing and Marketing Approval for a Partial Change of the Indication and Dosage/Administration for Anti-herpes Virus Agent "Amenalief Tab. 200mg" for the Treatment of Recurrent Herpes Simplex in Japan

Osaka (Japan), February 24, 2023 - Maruho Co., Ltd. ("Maruho", Head Office: Osaka, Japan,President and CEO: Atsushi Sugita) announces that it has received manufacturing and marketing approval from the Ministry of Health, Labor and Welfare for a partial change of the indication and dosage/administration for anti-herpes virus agent "Amenalief® Tab. 200mg" (JAN/INN: amenamevir; hereinafter referred to as "the product") for the treatment of recurrent herpes simplex in Japan. Herpes simplex is a general term for infectious diseases caused by the herpes simplex virus that infects the skin and mucous membranes (lips, eyes, genitals, etc.). Common types include labial herpes and genital herpes. Recurrent herpes simplex is a disease that develops when the herpes simplex virus that has been latently infected in the ganglia after a primary infection, is reactivated by stimuli such as stress or a weakened immune system. Additionally, it is characterized by repeated recurrence of symptoms, and many patients experience discomfort such as itching and tingling before skin symptoms such as erythema (redness), papules and blisters develop. The partial change of the indication and dosage/administration approval received today is recognized as "Patient Initiated Treatment" (PIT) for patients with recurrent herpes simplex when they become aware of the initial symptoms.1) Early treatment is possible by taking the prescribed 1200mg of this drug once after meals within 6 hours after the appearance of the initial symptoms of recurrent herpes simplex. It is hoped that this drug will be more convenient for patients since only one dose is required. Maruho, specializing in dermatology, will strive to further contribute to patients and medical professionals by providing new options for the treatment of recurrent herpes simplex. Note The information contained in this news release in regard to pharmaceutical and developmental products is not intended for the purpose of promotion, advertising or medical advice. Product Profile Brand Name Amenalief® Tab. 200mg JAN/INN Amenamevir Formulation/Dose Film coated tablets containing 200mg of amenamevir in 1 tablet Indication (Additional content is underlined) Herpes Zoster Recurrent Herpes Simplex Dosage and Administration (Additional content is underlined) (Herpes Zoster) General administration for adults is 400mg of amenamevir once a day administered orally after a meal. (Recurrent Herpes Simplex) General administration for adults is 1200mg of amenamevir administered orally after a meal. References １） Shinichiro Yasumoto, Patient-initiated-treatment (PIT) in the management of patients with recurrent herpes simplex, Japanese Journal of Clinical Dermatology, 74 (5), 135 (2020) About Amenalief Tab.Amenalief Tab. is an oral anti-herpes virus agent with a novel mechanism of action containing the non-nucleic acid analog amenamevir, created in Japan by Astellas Pharma Inc. By inhibiting the activity of the helicase-primase complex, an essential enzyme for DNA replication of the herpesvirus, it exhibits antiviral activity by suppressing double-stranded DNA cleavage and RNA primer synthesis. Maruho manufactures and commercializes the product in Japan and it has been used for the treatment of herpes zoster since 2017. Maruho's initiatives for disease caused by herpesMaruho is working to help patients suffering from herpes labialis and genital herpes to understand the diseases correctly and take appropriate measures in the event of a recurrence. Through the comprehensive herpes information site "What's herpes?" the causes and remedies for cold sores and genital herpes are explained. (https://www.maruho.co.jp/kanja/herpes/） (As Maruho markets treatments for customers in Japan, the information is only provided in Japanese). About MaruhoMaruho Co., Ltd. has its head office in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,547 employees (as of the end of September 2022), and net sales were approximately 85.67 billion yen in its fiscal year ended September 30, 2022. Pursuing its long-term corporate vision of "Excellence in Dermatology," Maruho is striving to improve the health and quality of life of people all over the world. For more information, please visit https://www.maruho.co.jp/english/ Contact Information: Maruho Co., Ltd. Corporate Communications Dept. Tel：+81-(0)6-6371-8831 Fax：+81-(0)6-6371-8679 e-mail：kouhou@mii.maruho.co.jp

上市批准临床研究

2021-01-21

·BioSpace

Chemo Drug Potentially More Potent than Remdesivir Against Coronavirus

Researchers with Shenzhen Institutes of Advanced Technology in China used a variety of computational techniques to simulate drug-virus interactions. They then screened 1,906 existing drugs to evaluate which ones might inhibit replication of SARS-CoV-2, the virus that causes COVID-19. From this broad screening, they identified four drugs that had potential to prevent replication of the virus, which they then tested in laboratory experiments. Two of the drugs, pralatrexate, a chemotherapy, and azithromycin, an antibiotic, were successful at preventing replication of the virus. More lab experiments demonstrated that pralatrexate had stronger viral inhibition than Gilead Sciences’ remdesivir, which is currently the only approved drug for COVID-19. They published their research in the journal PLOS Computational Biology. Pralatrexate is marketed by Acrotech Biopharma under the trade name Folotyn. It is indicated for relapsed or refractory peripheral T-cell lymphoma. Like many chemotherapeutics, it comes with a wide range of serious side effects, including low blood cell counts—platelets, white blood cells, and red blood cells—mucositis, which is inflamed mucous membranes, severe skin reactions, tumor lysis syndrome (TLS), increased risk of serious reactions in kidney patients, fever, dehydration, nausea, as well as significant risk for pregnant and nursing women. As a result, the authors note that immediate use of the drug for COVID-19 patients is not guaranteed, but believe their approach was useful in identifying drugs that can be repurposed. “We have demonstrated the value of our novel hybrid approach that combines deep-learning technologies with more traditional simulations of molecular dynamics,” said Haiping Zhang, study author. The research team is working to develop more computational methods for creating novel molecular structures that could be developed into new drugs to treat COVID-19. The screening method focused on viral RNA-dependent RNA polymerase (RdRp), a promising therapeutic target. The authors write that other computational drug screening methods are based on molecular docking, deep learning or Molecular Dynamics. Most of these typically depend upon a single technique or lack experimental validation. “Each computation method,” they write, “with its underlying philosophy, often has its own strong and weak points, while a proper combination and modification of such methods could provide a better solution. Previously, we have developed two deep learning-based models to estimate protein-ligand interactions: DFCNN and DeepBindBC. DFCNN uses molecular vector data of protein pocket and ligand, instead of spatial information at interaction site, to estimate the protein-ligand pair as binding or non-binding with a probability value between 0 and 1. DeepBindBc estimates the binding possibility from atom contact information at interaction surface of a modelled 3D protein-ligand complex. The input of DeepBindBC contains spatial information of the protein-ligand interface, thus it strongly complements DFCNN.” Their hybrid screening procedure was made up of DFCNN, DeepBindBC, Autodoc Vina, pocket localized molecular dynamics simulation, metadynamics, and their own inhouse-developed tools. They screened potential drugs from the TargetMol-Approved_Drug_Library, which contains 1,906 currently marketed drugs. One of the findings, less focused on COVID-19, but of particular interest to validation of the screening approach, was that DFCNN, DeepBindBC and Autodock Vina predicted different drug compounds as top hits. For example, amenamevir and azithromycin had better scores on Autodock Vina, while odanacatib and nitisinone had higher DFCNN scores. Azithromycin, with hydroxychloroquine, an anti-malarial, had demonstrated efficacy in treating COVID-19 earlier in the pandemic, but subsequent studies have failed to show that either drug is effective in treating COVID-19. For that matter, a large World Health Organization (WHO) study failed to prove remdesivir’s effectiveness in hospitalized patients, resulting in the organization issuing a conditional recommendation against its use.

100 项与阿莫奈韦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10564	阿莫奈韦	J05AX26	DB11701

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
单纯疱疹	日本	Maruho Co., Ltd.	2023-02-24
带状疱疹	日本	Maruho Co., Ltd.	2017-07-03

未上市

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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	Maruho Co., Ltd.	2013-11-01
生殖器疱疹	临床3期	日本	Maruho Co., Ltd.	2013-08-01
唇疱疹	临床3期	日本	Maruho Co., Ltd.	2013-08-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01959295 (CTgov)	临床3期	生殖器疱疹 \| 唇疱疹 \| 单纯疱疹	468	ASP2151 (ASP2151)	壓夢窪選夢製憲鑰衊願 = 簾艱網製廠艱顧淵膚鑰選餘鏇醖窪製艱憲夢膚 (遞顧窪齋遞壓鬱製選糧, 夢構廠鑰鬱鬱繭製鬱觸 ~ 蓋鏇觸鏇積築積選淵襯) 更多	-	2024-10-09
				ASP2151 placebo (ASP2151 Placebo)	壓夢窪選夢製憲鑰衊願 = 遞夢顧窪鹹廠製築襯鹽選餘鏇醖窪製艱憲夢膚 (遞顧窪齋遞壓鬱製選糧, 構鹽鏇網繭鬱齋襯鹽夢 ~ 繭餘襯廠鹽繭範鹹憲遞) 更多
NCT02209324 (CTgov)	临床3期	卡波西水痘样疹 \| 生殖器疱疹 \| 单纯疱疹	275	ASP2151	鏇遞餘齋淵積觸衊壓襯 = 繭獵鬱簾鹽積選網網願襯壓製獵壓範糧膚簾齋 (憲窪範糧醖繭積觸夢獵, 衊遞窪繭窪壓觸觸鑰獵 ~ 衊鹹餘齋築艱餘顧遞襯) 更多	-	2024-09-27
NCT02321748 (CTgov)	临床1期	-	24	Montelukast+ASP2151 (Montelukast)	膚糧網衊鏇簾糧簾窪壓(膚鏇糧顧壓夢獵艱獵淵) = 鏇廠製膚鬱範網製夢糧窪鹹鹹簾鹽壓鏇願顧顧 (廠獵願願淵積餘獵艱艱, 24.9) 更多	-	2019-01-14
				Montelukast+ASP2151 (ASP2151)	膚糧網衊鏇簾糧簾窪壓(膚鏇糧顧壓夢獵艱獵淵) = 遞餘糧積醖獵顧憲築構窪鹹鹹簾鹽壓鏇願顧顧 (廠獵願願淵積餘獵艱艱, 25.7) 更多
NCT01959841 (CTgov)	临床3期	带状疱疹	751	ASP2151 (ASP2151(200 mg))	鹽製餘顧廠築廠鑰夢醖 = 憲壓憲鹹窪繭蓋網築網憲願蓋憲淵觸選夢艱繭 (憲衊遞構製觸遞繭蓋艱, 憲構鬱網憲齋鬱糧選築 ~ 齋壓遞廠憲獵廠網窪積) 更多	-	2018-10-18
				ASP2151 (ASP2151(400mg))	鹽製餘顧廠築廠鑰夢醖 = 鹽醖構鹽衊積積鏇壓顧憲願蓋憲淵觸選夢艱繭 (憲衊遞構製觸遞繭蓋艱, 鹽襯遞鹽壓顧鏇夢顧夢 ~ 製糧觸淵襯窪憲鑰構壓) 更多
NCT00486200 (Pubmed \| J Infect Dis)	临床2期	生殖器疱疹	695	ASP2151 100 mg	範鹽齋醖獵壓選製襯廠(製窪糧鬱願製繭鹽顧構) = 醖蓋憲築淵選顧顧壓鹹糧憲餘鑰積鏇構選鏇壓 (鏇構鹹觸壓鏇構鬱鑰夢 )	-	2012-04-01
				ASP2151 200 mg	範鹽齋醖獵壓選製襯廠(製窪糧鬱願製繭鹽顧構) = 齋憲憲廠鹽簾糧網餘選糧憲餘鑰積鏇構選鏇壓 (鏇構鹹觸壓鏇構鬱鑰夢 )