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

[+1]

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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181

项与恩赛特韦相关的文献（医药）

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.

2025-04-01·ANTIVIRAL RESEARCH

M49L and other drug resistance mutations emerging in individuals after administration of ensitrelvir in Japanese clinical settings

Article

作者: Fukuhara, Takasuke ; Saito, Fukuki ; Shimazu, Haruka ; Inoue, Akira ; Wada, Daiki ; Nakamori, Yasushi ; Maruyama, Shuhei ; Okuda, Kazuyuki ; Kashihara, Masami ; Ichikawa, Takaya

Recent in-vitro and in-vivo studies and analysis of genomic information registered in GISAID have raised concerns about drug resistance mutations such as M49L after treatment with the 3C-like protease inhibitor ensitrelvir. The aim of this study was to identify resistance gene mutations to 3C-like protease inhibitors, including M49L mutations, in Japanese clinical settings. Genomic analysis of samples from our hospital admissions showed M49L mutations associated with ensitrelvir treatment in three cases and M49L mutation unrelated to ensitrelvir treatment in three cases. In a study of cases with persistent infection or rebound in viral load after 5 days of ensitrelvir treatment, 10 of 16 patients had M49L mutations and 5 had M49I mutations. Resistance gene mutations following treatment with ensitrelvir were shown to emerge even within individual patients who were not immunocompromised. In a study of persistent SARS-CoV-2 infection in severely immunocompromised patients, various drug resistance mutations emerged, with the M49L mutation especially showing a tendency to be a majority mutation. The current status of drug resistance mutations occurring in individuals following administration of ensitrelvir in Japanese clinical settings was clinically investigated for the first time. Considering that the barrier to resistance to ensitrelvir is lower than that to other antiviral drugs and that M49L is a unique mutation that occurs quickly, tends to become a majority mutation, and is maintained thereafter through its ability to replicate, the spread of strains that have acquired ensitrelvir resistance should be closely monitored.

2025-04-01·JOURNAL OF INFECTION AND CHEMOTHERAPY

The time to return-to-work in healthcare workers with COVID-19 treated with ensitrelvir, a novel oral inhibitor of 3C-like protease of SARS-CoV-2: An observational study utilizing pre-existing data from a single hospital

Article

作者: Takahashi, Yusaku ; Kitazono, Masatoshi ; Sonoyama, Takuhiro ; Karibe, Hiroto ; Nagai, Naohito ; Katsuta, Makoto ; Yamaguchi, Tomoyoshi ; Ariwa, Yasuko

While treatment with anti-SARS-CoV-2 agents holds promise for managing healthcare workers with COVID-19, studies on this topic are limited. This study evaluated the time to return-to-work and remaining symptoms among healthcare workers with COVID-19 who received ensitrelvir and those who did not receive anti-SARS-CoV-2 drugs. This observational cohort study included healthcare workers diagnosed with COVID-19 between June and September 2023 at a single facility in Japan. Participants returned to work if they met all the following criteria: ≥5 days post-COVID-19 onset, fever resolution, and negative antigen test. The primary endpoint was the days from disease onset to return-to-work. We also evaluated the persistence of each symptom on the date of return-to-work, and the clinical and virological outcomes on the first scheduled date of return-to-work (Trial registration: UMIN000054128). The study enrolled 60 participants in the ensitrelvir group and 42 in the non-antiviral group. The mean number of days (SD) to return-to-work was 6.9 days (±1.6) in the ensitrelvir group and 7.7 days (±1.9) in the non-antiviral group. On the date of return-to-work, 4 participants in the non-antiviral group had taste disorders and 2 had smell disorders. On the first scheduled date of return-to-work (i.e. the date of first antigen test after onset), 56.7 % of participants in the ensitrelvir group and 33.3 % in the non-antiviral group had recovered, with the antigen test negativity in 76.7 % and 52.4 %, respectively. Ensitrelvir treatment for healthcare workers experiencing COVID-19 appeared to be associated with early symptom amelioration with viral load reduction, and shorter time to return-to-work.

145

项与恩赛特韦相关的新闻（医药）

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

临床3期临床结果财报快速通道紧急使用授权

2025-03-20

·drugs

Ensitrelvir Effectively Prevents Spread of COVID-19 in Households

THURSDAY, March 20, 2025 -- For household contacts of individuals with COVID-19 , taking ensitrelvir within 72 hours of symptoms is effective at preventing infection and generally well tolerated, according to a study presented at the annual Conference on Retroviruses and Opportunistic Infections, held from March 9 to 12 in San Francisco. Akimasa Fukushi, M.D., of Shionogi & Co., Ltd, in Osaka, Japan, and colleagues randomly assigned household contacts (HHC) of index patients (IP) with COVID-19 to receive either ensitrelvir (1,030 participants; day 1: 375 mg; day 2 to 5: 125 mg) or placebo (1,011 participants) within 72 hours of symptom onset in the IP. The researchers found that the overall proportion of HHC developing confirmed COVID-19 was significantly lower in the ensitrelvir group (2.9 percent) versus the placebo group (9.0 percent; risk ratio [RR], 0.33) for HHC with central laboratory-confirmed SARS-CoV-2 negativity by reverse transcription polymerase chain reaction (RT-PCR). For HHC regardless of central laboratory RT-PCR results at baseline, similar results were seen (RR, 0.43). Across both groups, the proportions developing treatment-emergent adverse events (TEAEs; 15.1 percent for ensitrelvir and 15.5 percent for placebo) or serious TEAEs (0.2 versus 0.2 percent) were similar, as were the TEAEs seen in >1.5 percent of patients in either group: headache (2.9 versus 2.5 percent), diarrhea (1.8 versus 1.3 percent), and influenza (1.1 versus 1.6 percent). No COVID-19-related hospitalizations or fatalities were seen. "In addition to vaccination, postexposure 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, especially people at high risk for severe disease," presenting author Frederick G. Hayden, M.D., from the University of Virginia in Charlottesville, said in a statement. The study was funded by Shionogi & Co., Ltd, the manufacturer of ensitrelvir. Abstract More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果临床研究

100 项与恩赛特韦相关的药物交易

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研发状态

批准上市

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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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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05897541 (SCORPIO-PEP, Company_Website) 人工标引	临床3期	新型冠状病毒感染	-	Ensitrelvir	壓觸觸艱鹽網廠鏇襯顧(繭壓鹹構製窪憲窪窪繭) = 鬱齋繭醖醖夢遞廠鹹繭範選鬱憲壓製構選淵獵 (餘膚獵網獵襯鏇簾簾觸 ) 达到更多	积极	2025-03-17
				Placebo	壓觸觸艱鹽網廠鏇襯顧(繭壓鹹構製窪憲窪窪繭) = 築選膚襯壓膚廠簾繭顧範選鬱憲壓製構選淵獵 (餘膚獵網獵襯鏇簾簾觸 ) 达到更多
Corporate Publications 人工标引	临床2/3期	新型冠状病毒感染	-	S-217622	壓餘壓齋範淵窪衊鑰憲(築觸簾艱鹹願蓋膚窪網) = On day four of treatment (following the third dose), the proportion of patients with positive viral titer decreased by approximately 90% versus placebo. 積壓鹽顧窪壓範獵製鹹 (醖艱醖膚遞獵願襯壓築 ) 更多	积极	2022-04-24
				Placebo