Ensitrelvir Fumaric Acid in Health care workers with SARS-CoV-2 Retrospective Chart Review - Tokyo Rinkai Hospital - - Ensitrelvir Fumaric Acid in Health care workers with SARS-CoV-2 Retrospective Chart Review - Tokyo Rinkai Hospital -

开始日期2024-04-12

申办/合作机构

Shionogi & Co., Ltd.

NCT06161688

/ Active, not recruiting临床2期IIT

Placebo-Controlled, Randomized Trial of Ensitrelvir (S-217622) for Viral Persistence and Inflammation in People Experiencing Long COVID (PREVAIL-LC)

Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID. This mechanism may be susceptible to antiviral therapy that blocks viral replication, which has the potential to alleviate long COVID symptoms. This trial will study the safety and efficacy of Ensitrelvir (S-217622), an antiviral, to treat individuals with Long COVID in an adult population.

开始日期2024-04-09

申办/合作机构

The University of California, San Francisco

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100 项与恩赛特韦相关的临床结果

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100 项与恩赛特韦相关的转化医学

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100 项与恩赛特韦相关的专利（医药）

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190

项与恩赛特韦相关的文献（医药）

2025-12-31·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Identification of broad-spectrum M ^pro inhibitors: a focus on high-risk coronaviruses and conserved interactions

Article

作者: Liu, Man ; Zhang, Wei ; Liu, Shun ; Peng, Wei ; Fang, Yuying ; Wang, Shunjing ; Sun, Zeyun ; Zhao, Li ; Zhang, Hongbo ; Tang, Zhenhao ; Huang, Xupeng ; Rao, Zixuan ; Zhong, Yihang ; Yu, Linyi ; Yan, Mengrong

The COVID-19 pandemic underscores the urgent need to develop broad-spectrum antivirals against coronaviruses (CoVs) to prepare for future outbreaks. In this study, we presented a systematic approach to developing broad-spectrum M^pro inhibitors, with a focus on high-risk CoVs. We optimised S-217622 as a lead compound, with the goal of enhancing conserved interactions within the S1, S2, and S3/S4 pockets of M^pro, leading to significantly improved inhibitory potency against representative CoVs. Compound 25 exhibited submicromolar activity across all ten CoVs, with IC₅₀ values below 0.1 μM for six of them. The X-ray co-crystal structure of SARS-CoV-2 M^pro in complex with compound 25 revealed the structural basis of conserved interactions contributing to its broad-spectrum activity. This study demonstrates the feasibility of reinforcing conserved interactions to develop M^pro inhibitors with broad-spectrum activity and provides valuable strategies for combating future pandemics caused by unknown CoVs.

2025-05-24·Journal of biomolecular structure & dynamics

Identification of approved drugs with ALDH1A1 inhibitory potential aimed at enhancing chemotherapy sensitivity in cancer cells: an in-silico drug repurposing approach

Article

作者: Paul, Sanjay Kumar ; Guendouzi, Abdelmadjid ; Banerjee, Agniswar ; Guendouzi, Abdelkrim ; Haldar, Rajen

The aldehyde dehydrogenase 1A1 (ALDH1A1) also known as retinal dehydrogenase, is an enzyme normally involved in the cellular metabolism, development and detoxification processes in healthy cells. However, it's also considered a cancer stem cell marker and its high levels of expression in several cancers, including breast, lung, ovarian, and colon cancer have been associated with poor prognosis and resistance to chemotherapy. Given its crucial role in chemotherapy resistance by detoxification of chemotherapeutic drugs, ALDH1A1 has attracted significant research interest as a potential therapeutic target for cancer. Though a few synthetic inhibitors of ALDH1A1 have been synthesized and their efficacy has been proved in-vitro and in-vivo studies, none of them have passed clinical trials so far. In this scenario, we have performed an in-silico study to verify whether any of the already approved drugs used for various purposes has the ability to inhibit catalytic activity of ALDH1A1, so that they can be repurposed for cancer therapy. Keeping in mind the feasibility of repurposing in a larger population we have selected the approved drugs from five widely used drug categories such as antibiotic, antiviral, antifungal, anti diabetic and antihypertensive for screening. Computational techniques like molecular docking, molecular dynamics simulations and MM-PBSA binding energy calculation have been used in this study to screen the approved drugs. Based on the logical analysis of results, we propose that three drugs - telmisartan, irbesartan and maraviroc can inhibit the catalytic activity of ALDH1A1 and thus can be repurposed to increase chemotherapy sensitivity in cancer cells.

2025-05-06·Microbiology Spectrum

Effectiveness of ensitrelvir for cough caused by COVID-19 Omicron variant in patients with asthma

Article

作者: Horita, Nobuyuki ; Yamura, Akihisa ; Ogata, Makoto ; Nakamori, Yasushi ; Ito, Tomoki ; Fukuda, Naoki ; Miyashita, Naoyuki

ABSTRACT:

In the post-acute coronavirus disease 2019 (COVID-19) period, patients with asthma had a significantly higher risk of cough than patients without a history of asthma. In particular, cases with persistent cough were increased during the Omicron variant epidemic. In this study, we evaluated the efficacy of ensitrelvir for the treatment of cough associated with COVID-19 Omicron variants in patients with asthma. This follows the Strengthening the Reporting of Observational Studies in Epidemiology statement. A total of 223 patients were registered in this study: 121 patients chose ensitrelvir, and 102 patients chose symptomatic treatment. Cough severity, frequency, and cough-specific quality of life were evaluated using the Japanese version of the Leicester Cough Questionnaire (J-LCQ). J-LCQ documented at baseline on days 4, 7, and 14 for all patients showed a steady improvement over time in both groups. In the mixed model for repeated measures model, which accounts for repeated measurements, the change in J-LCQ score from baseline was 2.1 points higher in the ensitrelvir group ( P <0.001). Additionally, patients who were using triple inhaled therapy at baseline showed a 2.3-point higher change in J-LCQ score from baseline ( P <0.001). Multiple regression analysis was performed at days 4, 7, and 14, with the change in J-LCQ score from baseline as the dependent variable. Ensitrelvir was associated with scores that were 3.1 points higher on day 4, 3.5 points higher on day 7, and 2.0 points higher on day 14 compared with symptomatic treatment ( P <0.001 for all). In conclusion, our results demonstrated that early administration of ensitrelvir may be effective as a treatment for cough due to the COVID-19 Omicron variant.

IMPORTANCE:

We evaluated the efficacy of ensitrelvir for the treatment of cough due to coronavirus disease 2019 (COVID-19) Omicron variant in patients with asthma. A total of 223 patients were registered in this study: 121 patients chose ensitrelvir, and 102 patients chose symptomatic treatment. Cough severity, frequency, and cough-specific quality of life were evaluated using the Japanese version of the Leicester Cough Questionnaire (J-LCQ). Multiple regression analysis was performed at days 4, 7, and 14, with the change in J-LCQ score from baseline as the dependent variable. Ensitrelvir was associated with scores that were 3.1 points higher on day 4, 3.5 points higher on day 7, and 2.0 points higher on day 14 compared with symptomatic treatment ( P <0.001 for all). Our results demonstrated that early administration of ensitrelvir may be effective as a treatment for cough due to the COVID-19 Omicron variant.

148

项与恩赛特韦相关的新闻（医药）

2025-05-07

·shionogi.com

Announcement of Agreement on Company Split (Simplified Absorption-Type Split) of Japan Tobacco Inc.'s Pharmaceutical Business and Acquisition of Shares of Akros Pharma Inc. by Shionogi Inc. (Making it a Subsidiary)

OSAKA, Japan, May 7, 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi" or the “Company”) today announced that at the Board of Directors meeting held on May 7, 2025, it resolved to succeed to the pharmaceutical business of Japan Tobacco Inc. (Headquarters: Minato-ku, Tokyo; President: Masamichi Terabatake; hereinafter referred to as "Japan Tobacco") (hereinafter referred to as "JT Pharmaceutical Business" or the "Business to be Split") through a company split (simplified absorption-type split) (hereinafter referred to as the "Absorption-Type Split") and to acquire all issued shares of Akros Pharma Inc. (a 100% sub-subsidiary of Japan Tobacco, headquartered in New Jersey, USA; hereinafter referred to as "Akros") by Shionogi Inc., a group company of Shionogi in the USA (hereinafter referred to as the "Share Acquisition"), and has entered into an agreement (hereinafter referred to as the "Agreement") regarding the same. In connection with the Agreement, the Company also resolved at the Board of Directors meeting held today to conduct a tender offer (hereinafter referred to as the "Tender Offer") for the common shares of Torii Pharmaceutical Co., Ltd. (hereinafter referred to as "Torii Pharmaceutical"), a consolidated subsidiary of Japan Tobacco, to make Torii Pharmaceutical a wholly-owned subsidiary of the Company (hereinafter referred to as the "Full Ownership"). For details on the Tender Offer, please refer to the "Notice of Commencement of Tender Offer for Shares of Torii Pharmaceutical Co., Ltd. (Securities Code: 4551)" released today. I. Purpose of the Absorption-Type Split and Share Acquisition (hereinafter referred to as the "Transaction") Shionogi's basic policy (SHIONOGI Group Heritage) is to always provide the best medicine (healthcare solutions) necessary to protect people's health. The Company engages in research and development, manufacturing, and sales activities of prescription drugs, over-the-counter drugs, and diagnostic agents. In 2020, the Company set forth the Vision (SHIONOGI Group Vision) that aims to achieve by 2030, "Creating the Future of Healthcare with a New Platform," and formulated the medium-term management plan Shionogi Transformation Strategy 2030 (STS2030) to realize this Vision. The Company is transforming into a Healthcare as a Service (HaaS) company that provides various healthcare services tailored to customer needs, not limited to the provision of prescription drugs, to comprehensively address the problems faced by patients and society worldwide. From fiscal 2020 to fiscal 2022, the Company aimed to contribute to the early end of the COVID-19 pandemic by providing not only therapeutic drugs but also total care solutions for COVID-19, including detection (epidemic prediction), prevention, diagnosis, and mitigation of severe cases. As a result, the Company obtained domestic approval for the COVID-19 therapeutic drug Xocova at an unprecedented speed, advancing its drug discovery capabilities. Additionally, the Company expanded its product and service offerings beyond prescription drugs, including its first vaccine and wastewater epidemiology survey service. Based on the achievements and lessons learned from these efforts, the path to realizing the SHIONOGI Group Vision became clearer, leading to the revision of STS2030 in 2023 and the start of STS2030 Revision. In STS2030 Revision, the three years from fiscal 2023 to fiscal 2025 are positioned as STS Phase 2, with the basic policy of global top-line growth centered on the infectious disease area and fostering growth drivers through aggressive investment, accelerating growth through transformation. In research and development, the Company focuses on high-impact infectious diseases and high-impact QOL diseases as priority areas. In infectious diseases, the Company has developed many innovative new drugs, such as the anti-HIV drugs (dolutegravir and cabotegravir), the for multidrug-resistant Gram-negative bacterial infections (cefiderocol), and the anti-influenza virus drug Xofluza, based on its strong foundation in small molecule drug discovery (creating drugs with molecular weights ranging from tens to hundreds). The Company aims to solve the problems faced by patients and society worldwide by further strengthening and expanding its strong foundation in small molecule drug discovery. On the other hand, JT Pharmaceutical Business has been engaged in research and development of prescription drugs since entering the business in 1987, aiming to create first-in-class small molecule drugs through stable research and development investment. Currently, under the business purpose of "valuing science, technology, and human resources and contributing to patients' health," Japan Tobacco conducts research and development, while Torii Pharmaceutical handles manufacturing, sales, and promotion activities, building an integrated value chain and maximizing synergies within the group. JT Pharmaceutical Business focuses on three priority research and development areas: cardiovascular, renal, and muscle, "immunology and inflammation, and central nervous system, with strengths in rapid clinical development through specialization on research and development in the small molecule drug discovery and collaboration between domestic and international research and development bases. To deliver new drugs created in-house to patients as early as possible, JT Pharmaceutical Business actively engages in out-licensing and partnerships with global mega-pharma companies, in addition to promoting in-house development. Shionogi has been considering collaboration with JT Pharmaceutical Business and Torii Pharmaceutical to realize the Vision of "Creating the Future of Healthcare with a New Platform" in STS2030 Revision. As a result of these considerations, the Company concluded that by adding the capabilities of JT Pharmaceutical Business, which has strengths in small molecule drug discovery and development , it would be possible to accelerate the advancement of promising pipeline projects and increase the responsiveness and efficiency of business operations through collaboration with the Company's pharmaceutical manufacturing functions. The Company proposed to Japan Tobacco the acquisition of JT Pharmaceutical Business and the full ownership of Torii Pharmaceutical, and after subsequent discussions, reached the Agreement. The Company believes that the Transaction will create a leading company that delivers innovative pharmaceuticals from Japan to the world, contributing to the health of patients and people worldwide, and contributing to the realization of a sustainable and healthy society. The Company also believes that the Transaction will provide opportunities for the employees of JT Pharmaceutical Business (including group companies) to continue to thrive with peace of mind. II. Overview of the Absorption-Type Split i. Summary of the Absorption-Type Split (1) Date (1) Date of Board Resolution for Agreement May 7, 2025 (2) Date of Agreement May 7, 2025 (3) Date of Board Resolution for Absorption-Type Split Agreement September, 2025 (planned) (4) Date of Absorption-Type Split Agreement September, 2025 (planned) (5) Effective Date of Absorption-Type Split December, 2025 (planned) (Note 1): The Absorption-Type Split falls under the simplified absorption-type split stipulated in Article 796, Paragraph 2 of the Companies Act for the Company, and Article 784, Paragraph 2 of the Companies Act for Japan Tobacco. Therefore, it will be carried out without the approval resolution of the shareholders' meeting. (Note 2): The schedule may be changed as necessary, considering the need for responses to approvals, registrations, notifications, etc., from relevant authorities, circumstances, and other various factors. (2) Method of Absorption-Type Split The Company will be the succeeding company, and Japan Tobacco will be the splitting company. (3) Allocation of Consideration The Company will pay 5,397 million yen to Japan Tobacco as consideration for the Absorption-Type Split. (4) Handling of Stock Acquisition Rights and Bonds with Stock Acquisition Rights Not applicable. (5) Increase or Decrease in Capital Due to Absorption-Type Split Not applicable. (6) Rights and Obligations to be Succeeded The Company will succeed to the assets, liabilities, and contractual rights and obligations related to the Absorption-Type Split, except for those separately specified in the Absorption-Type Split Agreement. (7) Prospects for Debt Performance The Company believes that there are no issues with performance of the debts that will become due after the effective date of the Absorption-Type Split. ii. Allocation of Consideration and Basis for the Absorption-Type Split (1) Basis and Reason for Allocation of Consideration The allocation of consideration was agreed upon after comprehensive discussions between both companies, taking into account the performance status and future prospects of the business to be split. (2) Matters Related to Calculation The Company has not obtained a valuation report from a valuation institution in connection with the Absorption-Type Split. (3) Prospect of Delisting and Its Reason Since the consideration involves the exchange of money, there is no prospect of delisting. (4) Measures to Ensure Fairness Not applicable. However, the Company has appointed Nishimura & Asahi Law Office as the legal advisor for the Absorption-Type Split and has received legal advice on various procedures, decision-making methods, and processes related to the Absorption-Type Split. Nishimura & Asahi Law Office does not have any significant interests that should be disclosed in relation to the Absorption-Type Split and is not a related party to the Company or Japan Tobacco. (5)Measures to Avoid Conflicts of Interest Not applicable. (Unit: million yen, unless otherwise specified.) i. Overview of JT Pharmaceutical Business (1) Content of JT Pharmaceutical Business Research and development of prescription drugs (2) Business Performance of JT Pharmaceutical Business Fiscal year ended December 2024 Net sales ¥44,942 million (3) Items and Amounts of Assets and Liabilities of the JT Pharmaceutical Business to be Succeeded (as of December 31, 2024) The assets (excluding shares of Torii Pharmaceutical and Akros) and liabilities, as well as other rights and obligations belonging to the JT pharmaceutical business, As stipulated in the absorption-type split agreement will be succeeded by our company. Assets Liabilities field book value field book value Current Assets ¥8,588 million Current Assets ¥5,448 million Fixed Liabilities ¥37,832 million Fixed Liabilities ¥9,875 million Total ¥46,420 million Total ¥15,323 million Note: The above amounts are calculated based on the balance sheet as of December 31, 2024, and the actual amounts to be succeeded will be adjusted for any increases or decreases up to the effective date. ii. Status After the Absorption-Type Split (1) Name of Company Shionogi & Co., Ltd. Japan Tobacco Inc. (2) Location 1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan 1-1, Toranomon 4-chome, Minato-ku, Tokyo (3) Representative Isao Teshirogi, Ph.D., Representative Director, President and CEO Masamichi Terabatake, President, Chief Executive Officer and Representative Director　 (4) Business Description Research, development, manufacturing and distribution of pharmaceuticals, diagnostic reagents and medical devices, etc. Manufacture, sale, import, etc., of manufactured tobacco (5) Paid-in Capital ¥21,279 million ¥100,000 million (6) Fiscal Year-End March 31 December 31 (7) Net Assets It is not confirmed at this time It is not confirmed at this time (8) Total Assets It is not confirmed at this time It is not confirmed at this time iii. Overview of Accounting Treatment For the accounting treatment related to the Absorption-Type Split, we plan to apply IFRS 3 'Business Combinations' and use the purchase method, with our Company as the acquiring entity. The amount of goodwill generated from this Absorption-Type Split is currently undecided, and we will inform you as soon as it is determined. iv. Future Outlook We are currently assessing the impact of this Absorption-Type Split on our consolidated performance, and will inform you as soon as it is determined. v. Other Noteworthy Matters The Agreement is contingent upon the absence of any factors hindering the execution of the stock acquisition, such as the issuance of a cease and desist order, based on the results of the Japan Fair Trade Commission's review of the notification under Article 10, Paragraph 2 of the Act on Prohibition of Private Monopolization and Maintenance of Fair Trade. II. Overview of this Stock Acquisition i. Overview of Our U.S. Subsidiary (Shionogi Inc.) Acquiring the Shares (1) Name of Company Shionogi Inc. (2) Location 400 Campus Drive, Florham Park, NJ 07932, USA (3) Representative President and Chief Executive Officer Nathan McCutcheon (4) Business Description Development, manufacturing, and sales of pharmaceuticals (5) Paid-in Capital 12 USD (as of March 31, 2024) (6) Date of Founding August 2008 (7) Major Shareholders and Shareholding Ratios Shionogi (100%) ii. Overview of the Subsidiary to be Acquired (1) Name of Company Akros Pharma Inc. (2) Location 302 Carnegie Center, Suite 300, Princeton, NJ 08540 (3) Job Title and Name of Representative President＆CEO Teppei Higuchi (4) Business Description Clinical development, joint research, and exploration of new technology projects overseas (5) Paid-in Capital 1,000 USD (as of December 31, 2024) (6) Date of Founding January 1999 (7) Net Assets 23,776 thousand USD (as of December 31, 2024) (8) Total Assets 32,986 thousand USD (as of December 31, 2024) (9) Major Shareholders and Shareholding Ratios JT AMERICA INC. (100%) ※ JT AMERICA INC. is a wholly owned subsidiary of Japan Tobacco Inc. (10) Relationship between Shionogi and said company Capital Relationship None. Personal Relationship None. Transactional Relationship None. Status as Related Party None. iii. Overview of the Counterparty in the Stock Acquisition (1) Name of Company JT AMERICA INC. (2) Location 112 W. 34th Street, 18th Floors, New York, NY 10120 (3) Job Title and Name of Representative President & CEO Toshimitsu Eguchi (4) Business Description Holding company functions in the U.S. for non-tobacco and non-food businesses (5) Paid-in Capital 51 thousand USD (as of December 31, 2024) (6) Date of Founding May 1988 (7) Net Assets 141,447 thousand USD (as of December 31, 2024) (8) Total Assets 142,125 thousand USD (as of December 31, 2024) (9) Major Shareholders and Ownership Ratios Japan Tobacco Inc.(100％) (10) Relationship between Shionogi and said company Capital Relationship None. Personal Relationship None. Business Relationship None. Related Party Relationship None. iv. Number of Shares to be Acquired, Acquisition Price, and the Status of Shareholding Before and After the Acquisition * The acquisition price has been converted at an exchange rate of 1 USD = 151.55 JPY (based on the average rate over the past six months). v. Date vi. Future Outlook We are currently assessing the impact of this stock acquisition on Shionogi’s consolidated financial results for the fiscal year ending March 2026. If it becomes necessary to revise the performance forecast, Shionogi will promptly disclose the information. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

并购引进/卖出

2025-04-01

·shionogi.com

Shionogi Initiates New Drug Application Submission for Ensitrelvir for Post-Exposure Prophylaxis with the U.S. Food and Drug Administration

OSAKA, Japan, April 1, 2025 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that it has initiated the rolling submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for its investigational oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”). The rolling submission of ensitrelvir for Post-Exposure Prophylaxis is being made based on the positive results from the Global Phase 3 Study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post-Exposure Prophylaxis (SCORPIO-PEP).1 COVID-19 continues to pose a health risk for many people and remains a public health threat, with thousands of hospitalizations and hundreds of deaths each week in the U.S.2,3,4 It can impact quality of life, lead to absence from work, cause long COVID, and progress to severe disease, hospitalization and death.2,3,4 With continually decreasing vaccination rates, waning immunity after vaccination, and the potential for new variants to emerge, additional treatment and preventive options for COVID-19 are needed.5,6 If this application is approved, ensitrelvir is expected to be the first orally-administered option for the post-exposure prophylaxis of COVID-19 Ensitrelvir was granted Fast Track designation by the FDA in 2025 for post-exposure prophylaxis of COVID-19 following contact with an individual who has COVID-19 and was granted Fast Track designation by the FDA in 2023 for the treatment of COVID-19. Shionogi is also in discussions with FDA regarding the treatment indication for COVID-19 with ensitrelvir. Ensitrelvir, known as Xocova® in countries where it is approved, received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19. In 2025, based on the favorable outcomes of the SCORPIO-PEP trial, a global Phase 3 post-exposure prevention study, an application was submitted in Japan to include additional benefits and efficacy related to the prevention of COVID-19. Shionogi submitted a supplemental New Drug Application for ensitrelvir in Japan for the post-exposure prophylaxis of COVID-19 in 2025. It became available in Singapore via a Special Access Route application in 2023, and it is currently under regulatory review in Taiwan. Ensitrelvir is an investigational drug outside of Japan and Singapore. In addition, the brand name Xocova® has not been approved for use outside of Japan and Singapore and pertains only to the approved drug in Japan and Singapore. About ensitrelvir Ensitrelvir is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the replication of the virus.7 Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting the 3CL protease.7 Shionogi evaluated the safety and efficacy of ensitrelvir through SCORPIO-SR, a Phase 3 study conducted in Asia, during the Omicron-dominant phase of the epidemic.8 In this study, ensitrelvir showed both clinical symptomatic efficacy (symptom resolution sustained for at least 24 hours) for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in a predominantly vaccinated population of patients with mild-to-moderate SARS-CoV-2 infection, regardless of risk factors.8 Regarding safety, most adverse events were mild in severity and no deaths were seen in the study.8 Among the most common treatment-related adverse events were temporary decreases in high-density lipoprotein and increased blood triglycerides, as observed in previous studies.8 The data from this study were published in JAMA Network Open. Additionally, the Phase 3 SCORPIO-HR study assessed ensitrelvir in a broad range of symptomatic, non-hospitalized participants with COVID-19, regardless of past SARS-CoV-2 infection. The study did not meet its primary endpoint of a statistically significant reduction in time to sustained resolution (symptom resolution sustained for at least 48 hours) of 15 common COVID-19 related symptoms for once-daily ensitrelvir compared to placebo.9 No new safety concerns were identified in the study, and treatment with ensitrelvir was well tolerated, with a similar adverse event profile as placebo.9 Shionogi recently announced that its global, double-blind, randomized, placebo-controlled Phase 3 study (SCORPIO-PEP) assessing ensitrelvir as oral post-exposure prophylaxis met the primary endpoint of preventing symptomatic COVID-19 through day 101. SCORPIO-PEP is the first and only Phase 3 study of a COVID-19 oral antiviral as a post-exposure prophylaxis to meet the primary endpoint of preventing COVID-19.* SCORPIO-PEP assessed 2,387 study participants aged 12 years and older with a negative screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment, who were exposed to a person living in their household with symptomatic COVID-19. Study participants were randomly assigned in a 1:1 ratio to receive ensitrelvir (125 mg) or placebo, once daily, and began treatment within three days of when the household member with COVID-19 began showing symptoms. Participants then continued ensitrelvir or placebo for five days. Overall, ensitrelvir was generally well tolerated, with similar rates of adverse events in the ensitrelvir group and the placebo group (15.1% and 15.5%, respectively).1 There were no COVID-19 related hospitalizations or deaths. An investigator-initiated research study with ensitrelvir is ongoing in hospitalized patients for the management of COVID-19 as part of the Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) platform protocol. STRIVE was developed under the auspices of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. Shionogi also recently released preliminary results from a multicenter, randomized, double-blind, placebo-controlled trial of ensitrelvir in mild to moderate COVID-19 patients aged 6 to under 12 years in Japan. The study confirmed safety and tolerability and found the pharmacokinetics of ensitrelvir in this age group similar to adults.10 Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html U.S. Media: ShionogiCommunications@shionogi.com SEU Press Office: pressoffice@shionogi.eu * Literature search conducted December 2024. Reference List: 1. Hayden F. Ensitrelvir to Prevent COVID-19 in Households: SCORPIO-PEP Phase III Placebo-Controlled Trial Results. Abstract 200. Presented at CROI 2025, San Francisco, CA: March 9-12, 2025. 2. Trends in United States COVID-19 Deaths, Emergency Department (ED) Visits, and Test Positivity by Geographic Area. The Centers for Disease Control and Prevention. Accessed March 26, 2025. Available at: https://covid-cdc-gov.libproxy1.nus.edu.sg/covid-data-tracker/#trends_weeklydeaths_select_00 3. Long COVID Basics. Centers for Disease Control and Prevention. Accessed February 24, 2025. Available at: https://www-cdc-gov.libproxy1.nus.edu.sg/covid/long-term effects/?CDC_AAref_Val=https://www-cdc-gov.libproxy1.nus.edu.sg/coronavirus/2019-ncov/long-term-effects/index.html. 4. COVID-NET Laboratory-confirmed COVID-19 hospitalizations. The Centers for Disease Control and Prevention. Accessed March 26, 2025. Available at: https://covid-cdc-gov.libproxy1.nus.edu.sg/covid-data-tracker/#covidnet-hospitalization-network 5. Carabelli AM, Peacock TP, Thorne LG, et al. SARS-CoV-2 variant biology: immune escape, transmission and fitness. Nature Reviews Microbiology. 18 Jan 2023;21:162–177. doi:10.1038/s41579-022-00841-7. 6. Kriss JL, Black CL, Razzaghi H, et al. Influenza, COVID-19, and Respiratory Syncytial Virus Vaccination Coverage Among Adults — United States, Fall 2024. MMWR Morb Mortal Wkly Rep. 21 Nov 2024;73:1044–1051. doi:10.15585/mmwr.mm7346a1. 7. Unoh Y, et al. Discovery of S-217622, a noncovalent oral SARS-CoV-2 3CL protease inhibitor clinical candidate for treating COVID-19. Journal of Medicinal Chemistry. 30 Mar 2022;65:9,6499-6512. doi:10.1021/acs.jmedchem.2c00117. 8. Yotsuyanagi H, et al. Efficacy and safety of 5-day oral Ensitrelvir for patients with mild to moderate COVID-19. JAMA Netw Open. 9 Feb 2024;7(2):e2354991. doi:10.1001/jamanetworkopen.2023.54991. 9. Luetkemeyer A, et al. Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial, Clinical Infectious Diseases, 2025;, ciaf029, https://doi-org.libproxy1.nus.edu.sg/10.1093/cid/ciaf029. 3rd Quarter of Fiscal 2024 Financial Results. January 31, 2025. Page 20. Accessed March 5, 2025. Available at: https://www.shionogi.com/content/dam/shionogi/jp/investors/ir-library/presentation-materials/fy2024/%EF%BC%93q/E_FY2024_3Q%20financial%20results_.pdf

临床3期临床结果快速通道财报申请上市

2025-03-27

·shionogi.com

Shionogi Submits Supplemental New Drug Application for Ensitrelvir in Japan for the Post-Exposure Prophylaxis of COVID-19.

OSAKA, Japan, March 27, 2025 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) submitted today supplemental New Drug Application (sNDA) in Japan for its investigational, oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) for post-exposure prophylaxis of COVID-19. The sNDA is based on the positive results from the Global Phase 3 Study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post-Exposure Prophylaxis (SCORPIO-PEP) 1, 2. COVID-19 remains a public health threat, with the disease exhibiting a high degree of risk as reflected by hospitalizations roughly six times that of influenza, and deaths approximately fifteen times higher in Japan. Vaccination is said to be the basis for preventing COVID-193. Nonetheless, with continually decreasing vaccination rates, waning immunity after vaccination, and the potential for new variants to emerge, it is challenging to fully prevent viral infection, symptom onset, or the severity of COVID-19 through vaccination alone. Therefore, post-exposure prophylaxis with timely use of an oral antiviral would be a valuable way to help prevent COVID-19 illness in people who have been exposed. If this application is approved, ensitrelvir is expected to be the first orally-administered option for the post-exposure prophylaxis of COVID-19. Ensitrelvir, known as Xocova® in countries where it is approved, received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19. It became available in Singapore via a Special Access Route application in 2023, and it is currently under regulatory review in Taiwan. Ensitrelvir was granted Fast Track designation by the FDA in 2025 for post-exposure prophylaxis of COVID-19 following contact with an individual who has COVID-19 and was granted Fast Track designation by the FDA in 2023 for the treatment of COVID-19. Ensitrelvir is an investigational drug outside of Japan and Singapore. In addition, the brand name Xocova® has not been approved for use outside of Japan and Singapore and pertains only to the approved drug in Japan and Singapore. About ensitrelvir Ensitrelvir is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the replication of the virus4. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting the 3CL protease4. Shionogi evaluated the safety and efficacy of ensitrelvir through SCORPIO-SR, a Phase 3 study conducted in Asia, during the Omicron-dominant phase of the epidemic5. In this study, ensitrelvir showed both clinical symptomatic efficacy (symptom resolution sustained for at least 24 hours) for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in a predominantly vaccinated population of patients with mild-to-moderate SARS-CoV-2 infection, regardless of risk factors5. Regarding safety, most adverse events were mild in severity and no deaths were seen in the study5. Among the most common treatment-related adverse events were temporary decreases in high-density lipoprotein and increased blood triglycerides, as observed in previous studies5. The data from this study were published in JAMA Network Open. Additionally, the Phase 3 SCORPIO-HR study assessed ensitrelvir in a broad range of symptomatic, non-hospitalized participants with COVID-19, regardless of past SARS-CoV-2 infection. The study did not meet its primary endpoint of a statistically significant reduction in time to sustained resolution (symptom resolution sustained for at least 48 hours) of 15 common COVID-19 related symptoms for once-daily ensitrelvir compared to placebo8. No new safety concerns were identified in the study, and treatment with ensitrelvir was well tolerated, with a similar adverse event profile as placebo6. Shionogi recently announced that its global, double-blind, randomized, placebo-controlled Phase 3 study (SCORPIO-PEP) assessing ensitrelvir as oral post-exposure prophylaxis met the primary endpoint of preventing COVID-191. SCORPIO-PEP is the first and only Phase 3 study of a COVID-19 oral antiviral as a post-exposure prophylaxis to meet the primary endpoint of preventing COVID-19.* SCORPIO-PEP assessed 2,387 study participants aged 12 years and older with a negative screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment, who were exposed to a person living in their household with symptomatic COVID-19. Study participants were randomly assigned in a 1:1 ratio to receive ensitrelvir (125 mg) or placebo, once daily, and began treatment within three days of when the household member with COVID-19 began showing symptoms. Participants then continued ensitrelvir or placebo for five days. Overall, ensitrelvir was generally well tolerated, with similar rates of adverse events in the ensitrelvir group and the placebo group (15.1% and 15.5%, respectively) 1. There were no COVID-19 related hospitalizations or deaths. An investigator-initiated research study with ensitrelvir is ongoing in hospitalized patients for the management of COVID-19 as part of the Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) platform protocol. STRIVE was developed under the auspices of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. Shionogi also recently released preliminary results from a multicenter, randomized, double-blind, placebo-controlled trial of ensitrelvir in mild to moderate COVID-19 patients aged 6 to under 12 years in Japan. The study confirmed safety and tolerability and found the pharmacokinetics of ensitrelvir in this age group similar to adults7. Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html U.S. Media: ShionogiCommunications@shionogi.com SEU Press Office: pressoffice@shionogi.eu * Literature search conducted December 2024. Reference List: 1. Hayden F. Ensitrelvir to Prevent COVID-19 in Households: SCORPIO-PEP Phase III Placebo-Controlled Trial Results. Abstract 200. Presented at CROI 2025, San Francisco, CA: March 9-12, 2025. 2. The changing threat of COVID-19. Centers for Disease Control and Prevention. Accessed February 24, 2025. Available at: https://www-cdc-gov.libproxy1.nus.edu.sg/ncird/whats-new/changing-threat-covid-19.html. 3. Recommendations on COVID-19 Vaccines (10th Edition). Available at: https://www.kansensho.or.jp/uploads/files/guidelines/2405_covid-19_10.pdf 4. Unoh Y, et al. Discovery of S-217622, a noncovalent oral SARS-CoV-2 3CL protease inhibitor clinical candidate for treating COVID-19. Journal of Medicinal Chemistry. 30 Mar 2022;65:9,6499-6512. doi:10.1021/acs.jmedchem.2c00117. 5. Yotsuyanagi H, et al. Efficacy and safety of 5-day oral Ensitrelvir for patients with mild to moderate COVID-19. JAMA Netw Open. 9 Feb 2024;7(2):e2354991. doi:10.1001/jamanetworkopen.2023.54991. 6. Luetkemeyer A, et al. Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial, Clinical Infectious Diseases, 2025;, ciaf029, https://doi-org.libproxy1.nus.edu.sg/10.1093/cid/ciaf029. 3rd Quarter of Fiscal 2024 Financial Results. January 31, 2025. Page 20. Accessed March 5, 2025. Available at: https://www.shionogi.com/content/dam/shionogi/jp/investors/ir-library/presentation-materials/fy2024/%EF%BC%93q/E_FY2024_3Q%20financial%20results_.pdf

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适应症	国家/地区	公司	日期
新型冠状病毒感染	日本	Shionogi & Co., Ltd.	2022-11-22

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适应症	最高研发状态	国家/地区	公司	日期
炎症	临床2期	美国	Shionogi, Inc.	2024-04-09
新冠肺炎后遗症	临床2期	美国	Shionogi, Inc.	2024-04-09

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NEWS 人工标引	N/A	新型冠状病毒感染	-	Ensitrelvir	製鹹鑰觸鹽願鹹鏇鹽遞(鑰構範膚窪壓鬱築願顧) = 夢艱餘簾糧獵願繭積選膚觸蓋製衊壓構構簾選 (築遞窪鑰襯糧鑰廠製鬱 ) 更多	积极	2025-03-20
				Placebo	製鹹鑰觸鹽願鹹鏇鹽遞(鑰構範膚窪壓鬱築願顧) = 蓋積淵範廠蓋壓構鏇齋膚觸蓋製衊壓構構簾選 (築遞窪鑰襯糧鑰廠製鬱 ) 更多
NCT05897541 (SCORPIO-PEP, Company_Website) 人工标引	临床3期	新型冠状病毒感染	-	Ensitrelvir	齋鏇範繭餘壓糧艱願簾(構範鹽鏇觸淵壓壓觸構) = 壓獵繭廠糧鑰憲鬱遞鹹廠鑰糧艱繭簾夢網膚鬱 (襯衊製蓋淵鹽構繭遞窪 ) 达到更多	积极	2025-03-17
				Placebo	齋鏇範繭餘壓糧艱願簾(構範鹽鏇觸淵壓壓觸構) = 廠齋壓糧繭襯繭築淵膚廠鑰糧艱繭簾夢網膚鬱 (襯衊製蓋淵鹽構繭遞窪 ) 达到更多