A Study to Investigate the Effects of Repeated Intravenous Administration of NPC-06 on the Pharmacokinetics of Amenamevir in Japanese Healthy Adult Male Volunteers. (NPC-06-7)

Start Date14 Dec 2022

Sponsor / Collaborator

Nobelpharma Co., Ltd.

JPRN-jRCTs031190208

/ CompletedPhase 4

The effectiveness and the safety of AMNV in patient with herpes zoster treated with immunosuppressive agents:exploratory Study (SAPPHIRE study)

Start Date13 Feb 2020

Sponsor / Collaborator-

JPRN-jRCT2080224871

/ CompletedPhase 3

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

Start Date01 Sep 2019

Sponsor / Collaborator

Maruho Co., Ltd.

100 Clinical Results associated with Amenamevir

100 Translational Medicine associated with Amenamevir

100 Patents (Medical) associated with Amenamevir

Literatures (Medical) associated with Amenamevir

01 Jul 2026·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Amenamevir for acyclovir‐resistant genital HSV ‐2 infection in people living with HIV

Letter

Author: Pourcher, V. ; Destoop, J. ; Jary, A. ; Monsel, G. ; Bleibtreu, A. ; Cordel, H. ; Boutolleau, D. ; Ouedraogo, E.

01 May 2026·Cell Chemical Biology

Structural insights into inhibition mechanism of the helicase-primase complex from human herpesvirus 1

Article

Author: Sengoku, Toru ; Okada, Chikako ; Kobayashi, Shunsuke ; Miyagishi, Toma ; Hamada, Keisuke ; Fukuzawa, Kaori ; Kise, Yoshiaki ; Oguni, Asako ; Kono, Hidetoshi ; Sato, Ko ; Nureki, Osamu ; Ishida, Hisashi

Human herpesviruses (HHVs) are widespread pathogens causing severe diseases, especially in immunocompromised individuals, and are linked to neurodegenerative and autoimmune disorders. Current antiviral therapies primarily target the α-subfamily, with limited options for β- and γ-subfamilies. The helicase-primase complex (HPC) is essential for viral DNA replication and represents a key antiviral target, but its structure and inhibition mechanisms were previously unclear. Here, cryo-EM structures of the HHV1 (α-subfamily) HPC bound to single-stranded DNA and two clinical inhibitors, amenamevir and pritelivir, are reported. The HPC features flexible helicase and primase modules, with both inhibitors binding a shared allosteric pocket in the helicase module. Structural, biochemical, and molecular dynamics analyses indicate that these inhibitors lock the helicase in an open, inactive conformation. Combined molecular dynamics and fragment molecular orbital analyses explain the α-subfamily selectivity and distinct antiviral spectra of these drugs. These findings provide a structural framework to guide the development of novel inhibitors targeting β- and γ-subfamily herpesviruses.

01 Mar 2026·INTERNATIONAL JOURNAL OF STD & AIDS

Use of short-course oral amenamevir (helicase-primase inhibitor) for the treatment of thymidine analogue-resistant herpes simplex lesions

Article

Author: Soni, Suneeta ; Baker, Harriet ; Babu, Chitra ; Richardson, Claire ; Altidor, Martine

Case presentations:

Case 1: 55-year-old Liberian man living with HIV presented with an enlarging, hypertrophic lesion on his inner thigh. This had been diagnosed as HSV-2 by PCR. Despite treatment with acyclovir, the lesion persisted. It had also failed to respond to topical therapies and cidofovir. Further molecular diagnostics showed that it was thymidine analogue-resistant HSV. A novel oral, anti-viral agent, amenamevir was used with success.

Case 2:

A 37-year-old Ghanaian woman living with HIV presented with recurrent painful confirmed HSV-2 genital ulceration. Despite escalating treatment from acyclovir to cidofovir, the HSV lesions failed to respond. A seven-day course of oral amenamevir provided excellent resolution of the lesions.

Conclusion:

These two cases highlight the challenges in managing aciclovir-resistant herpes simplex lesions and the swift resolution following treatment with a novel therapeutic agent, amenamevir. Early recognition of resistant HSV lesions allows for prompt outsourcing of alternative, novel anti-viral therapies such as amenamevir.

News (Medical) associated with Amenamevir

05 Jun 2024

·www.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

License out/inDrug Approval

24 Feb 2023

·www.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

Drug ApprovalClinical Study

21 Jan 2021

·www.biospace.com

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 Deals associated with Amenamevir

External Link

KEGG	Wiki	ATC	Drug Bank
D10564	Amenamevir	J05AX26	DB11701

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Herpes Simplex	Japan	Maruho Co., Ltd.	24 Feb 2023
Herpes Zoster	Japan	Maruho Co., Ltd.	03 Jul 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Kaposi Varicelliform Eruption	Phase 3	Japan	Maruho Co., Ltd.	01 Nov 2013
Herpes Genitalis	Phase 3	Japan	Maruho Co., Ltd.	01 Aug 2013
Herpes Labialis	Phase 3	Japan	Maruho Co., Ltd.	01 Aug 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01959295 (CTgov)	Phase 3	Herpes Genitalis \| Herpes Labialis \| Herpes Simplex	468	ASP2151 (ASP2151)	zieomlvlta = byuhdmskbd huqokmapug (vwqbbseisc, jgfcjgryay - csrtpdpzyl) View more	-	09 Oct 2024
				ASP2151 placebo (ASP2151 Placebo)	zieomlvlta = ixupgoopkz huqokmapug (vwqbbseisc, uzncugyowd - bpdfysdjrc) View more
NCT02209324 (CTgov)	Phase 3	Kaposi Varicelliform Eruption \| Herpes Genitalis \| Herpes Simplex	275	ASP2151	pcnqjtekda = gilejvklwi orwjxmswhe (aqjfvnniqn, tvoghbcotj - smctlmuwmz) View more	-	27 Sep 2024
NCT02321748 (CTgov)	Phase 1	-	24	Montelukast+ASP2151 (Montelukast)	vehzgjnctv(hnepfmfggc) = xjgkwawmlz espikalmhr (tsymtlifsh, 24.9) View more	-	14 Jan 2019
				Montelukast+ASP2151 (ASP2151)	vehzgjnctv(hnepfmfggc) = bbsbxcgstm espikalmhr (tsymtlifsh, 25.7) View more
NCT02223351 (CTgov)	Phase 1	Herpes Zoster \| Herpes Simplex	48	ASP2151 (400 mg ASP2151 Alone)	fxpeobqkot(fjnxixtfov) = rkcwttpejs tsqeggekon (aihkpllfte, 25.4) View more	-	11 Jan 2019
				ASP2151+Ritonavir (400mg ASP2151 With Ritonavir)	fxpeobqkot(fjnxixtfov) = ioxgjsmsgo tsqeggekon (aihkpllfte, 21.9) View more
NCT01959841 (CTgov)	Phase 3	Herpes Zoster	751	ASP2151 (ASP2151(200 mg))	pfpgiptvux = hnubvmpexw yshdwuxffc (owwlaldsnd, makmfovbgn - fnssdyxrff) View more	-	18 Oct 2018
				ASP2151 (ASP2151(400mg))	pfpgiptvux = fwepswqmbs yshdwuxffc (owwlaldsnd, yegwnedoxy - bqphniqxfg) View more
NCT00486200 (Pubmed \| J Infect Dis)	Phase 2	Herpes Genitalis	695	ASP2151 100 mg	sqknexskql(lldrtffvpk) = xtofhzzfbk vzhlouhzhi (txallszbjk )	-	01 Apr 2012
				ASP2151 200 mg	sqknexskql(lldrtffvpk) = grxiffypwv vzhlouhzhi (txallszbjk )

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