Pharmaceutical compound EnsitrelvirClinical dataTrade namesXocovaOther namesS-217622Routes ofadministrationBy mouthATC codeJ05AE11 (WHO) Legal statusLegal status JP: Rx-only[1] Pharmacokinetic dataElimination half-life42–48 hours[2]Identifiers IUPAC name 1-(2,4,5-Trifluorobenzyl)-3-[(1-methyl-1H-1,2,4-triazol-3-yl)methyl]-(6E)-6-[(6-chloro-2-methyl-2H-indazol-5-yl)imino]-1,3,5-triazinane-2,4-dione CAS Number2647530-73-02757470-18-9PubChem CID162533924DrugBankDB18834ChemSpider115007411UNIIPX665RAA3HKEGGD12353Chemical and physical dataFormulaC22H17ClF3N9O2Molar mass531.88 g·mol−13D model (JSmol)Interactive image SMILES Cn1cnc(CN2C(=O)N(Cc3cc(F)c(F)cc3F)C(=N\c3cc4cn(C)nc4cc3Cl)\NC2=O)n1 InChI InChI=1S/C22H17ClF3N9O2/c1-32-7-12-4-18(13(23)5-17(12)30-32)28-20-29-21(36)35(9-19-27-10-33(2)31-19)22(37)34(20)8-11-3-15(25)16(26)6-14(11)24/h3-7,10H,8-9H2,1-2H3,(H,28,29,36)Key:QMPBBNUOBOFBFS-UHFFFAOYSA-N Xocova in a Japanese blister pack
Ensitrelvir, sold under the brand name Xocova is an antiviral medication used as a treatment for COVID-19.[3][4][5][6] It was developed by Shionogi in partnership with Hokkaido University and acts as an orally active 3C-like protease inhibitor.[7][8] It is taken by mouth.[9][10][11]
The most common adverse events include transient decreases in high-density lipoprotein and increased blood triglycerides.[9]
Medical uses[edit]Ensitrelvir is indicated for the treatment of COVID-19.[9]
History[edit]As of 2022[update], ensitrelvir had reached Phase III clinical trials.[12] The Japanese government is reportedly considering allowing Shionogi permission to apply for approval for medical use before the final steps of trials are completed, potentially speeding up the release for sale. This conditional early approval system has previously been used in Japan to accelerate the progression to market of other antiviral drugs targeting COVID-19, including remdesivir and molnupirir.[13] In a study of 428 patients, viral load was reduced, but symptoms were not significantly reduced.[14]
In February 2022, the company sought emergency approval from regulators in Japan.[4][14]
Shionogi announced they had reached a preliminary agreement to supply 1 million doses to the Japanese government once the drug is approved. The CEO said they could he capacity to make 10 million doses a year.[15]
Ensitrelvir may be effective in treating smell and taste loss from COVID-19 infection. In a 2023 study, the drug was associated with a 39% reduction in these symptoms.[16]
Society and culture[edit] Legal status[edit]Ensitrelvir was approved for emergency use in Japan in November 2022,[9][4][5] before gaining full approval in March 2024.[1] It was approved in Singapore in November 2023.[17]
In April 2023, ensitrelvir was given a "Fast Track" designation from the US Food and Drug Administration.[18] In September 2025, the FDA accepted a New Drug Application from the manufacturer for ensitrelvir as post-exposure prophylaxis (PEP) for COVID-19, with a scheduled decision date in June 2026.[19]
Names[edit]Ensitrelvir is the international nonproprietary name (INN).[20]
Research[edit]Ensitrelvir has been investigated for use as potential post-exposure prophylaxis (PEP) for SARS-CoV-2 infection.[21][22] The SCORPIO-PEP trial, a global Phase 3 study, assessed the safety and efficacy of ensitrelvir in preventing symptomatic COVID-19 among household contacts of individuals with confirmed SARS-CoV-2 infection.[22][23][24][25] In 2025, the trial found the treatment with ensitrelvir significantly reduced the incidence of symptomatic COVID-19 in people who had a household exposure to the illness compared to a placebo. In clinical observations, only 2.9% of the ensitrelvir group developed symptoms, versus 9.0% in the control group, representing a 67% reduction in risk.[26][27][28][29]
An April 2024 pre-clinical study in a mouse model investigating ensitrelvir demonstrated its potential use as a pre-exposure prophylactic (PrEP) against developing COVID-19. When administered 24 hours before viral exposure, a single dose of ensitrelvir significantly increased survival rates, inhibited weight loss, and suppressed viral replication in aged mice.[30]
A retrospective study conducted between November 2022 and July 2023 using a large Japanese health insurance database suggested that ensitrelvir may be effective in reducing hospitalization risk in outpatients at high risk for severe COVID-19. The study found a significantly lower risk of hospitalization and a reduced need for respiratory monitoring and oxygen therapy in the ensitrelvir group compared to the control group.[31] In addition, other clinical study shows that early ensitrelvir treatment resulted in rapid symptom relief and significant viral load reduction, with no adverse events, viral rebound, or PASC symptoms, demonstrating its potential efficacy and safety.[32]
In May 2024, Shionogi announced that in a phase 3 trial (SCORPIO-HR), ensitrelvir did not achieve its primary endpoint of a statistically significant reduction in the time to sustained resolution of 15 common COVID-19 symptoms compared to placebo. However, the drug did meet key secondary endpoints, including demonstrating a significant reduction in viral RNA levels, a shorter time to achieve the first negative infectious viral titer in nasal swabs compared to placebo, and a shorter resolution time of 6 symptoms.[33]
References[edit] ^ a b "Japan health ministry approves Shionogi's COVID drug Xocova". NHK WORLD. 5 March 2024. Retrieved 6 March 2024. ^ Shimizu R, Sonoyama T, Fukuhara T, Kuwata A, Matsuo Y, Kubota R (October 2022). "Safety, Tolerability, and Pharmacokinetics of the Novel Antiviral Agent Ensitrelvir Fumaric Acid, a SARS-CoV-2 3CL Protease Inhibitor, in Healthy Adults". Antimicrobial Agents and Chemotherapy. 66 (10): e0063222. doi:10.1128/aac.00632-22. PMC 9578392. PMID 36094202. ^ McCarthy MW (December 2022). "Ensitrelvir as a potential treatment for COVID-19". Expert Opinion on Pharmacotherapy. 23 (18): 1995–1998. doi:10.1080/14656566.2022.2146493. PMID 36350029. S2CID 253418404. ^ a b c Fujikawa M (22 November 2022). "Japan Approves First Homegrown Covid-19 Antiviral Pill". The Wall Street Journal. Retrieved 28 November 2022. ^ a b "Shionogi's Covid antiviral lands first approval in Japan's new emergency approval pathway". Endpoints News. 22 November 2022. Retrieved 28 November 2022. ^ "Xocova: Powerful New Japanese Pill for Coronirus Treatment". BioPharma News. February 2022. ^ Unoh Y, Uehara S, Nakahara K, Nobori H, Yamatsu Y, Yamamoto S, et al. (May 2022). "Discovery of S-217622, a Noncovalent Oral SARS-CoV-2 3CL Protease Inhibitor Clinical Candidate for Treating COVID-19". Journal of Medicinal Chemistry. 65 (9): 6499–6512. doi:10.1021/acs.jmedchem.2c00117. PMC 8982737. PMID 35352927. ^ "Shionogi presents positive Ph II/III results for COVID-19 antiviral S-217622". thepharmaletter.com. 31 January 2022. ^ a b c d "Xocova (Ensitrelvir Fumaric Acid) Tablets 125mg Approved in Japan for the Treatment of SARS-CoV-2 Infection, under the Emergency Regulatory Approval System". Shionogi (Press release). 22 November 2022. Retrieved 28 November 2022. ^ "Shionogi's new COVID pill appears to ease omicron symptoms". Nikkei Asia. 21 December 2021. ^ Uraki R, Kiso M, Iida S, Imai M, Takashita E, Kuroda M, et al. (IASO study team) (May 2022). "Characterization and antiviral susceptibility of SARS-CoV-2 Omicron/BA.2". Nature. 607 (7917): 119–127. Bibcode:2022Natur.607..119U. doi:10.1038/s41586-022-04856-1. PMC 10579982. PMID 35576972. S2CID 248833104. ^ Tyndall JD (May 2022). "S-217622, a 3CL Protease Inhibitor and Clinical Candidate for SARS-CoV-2". Journal of Medicinal Chemistry. 65 (9): 6496–6498. doi:10.1021/acs.jmedchem.2c00624. PMID 35507419. S2CID 248513467. ^ "Japan to consider early approval for Shionogi COVID-19 pill". Japan Times. 8 February 2022. ^ a b "Japan's Shionogi seeks approval for COVID-19 pill". Reuters. 25 February 2022. ^ "Japan's Shionogi signs government supply pact for pill to fight COVID". Reuters. 25 March 2022. ^ Lenharo M (17 October 2023). "New pill helps COVID smell and taste loss fade quickly". Nature. doi:10.1038/d41586-023-03244-7. PMID 37853192. S2CID 264303912. ^ "Shionogi reports data from Phase III portion of Covid-19 drug trial". Clinical Trials Arena. 12 February 2024. Retrieved 6 March 2024. ^ Ducharme J (25 January 2024). "When Will We Get New COVID-19 Drugs?". Time. Retrieved 6 March 2024. ^ Abene S (2 September 2025). "FDA Accepts Shionogi's NDA for Ensitrelvir Oral Antiviral in COVID-19 Postexposure Prevention". Contagion Live. Retrieved 26 December 2025. ^ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information. 36 (3): 89. hdl:10665/363551. ^ Cosdon N (31 March 2023). "Ensitrelvir: A COVID-19 Antiviral That Remains Effective Against New Variants". ContagionLive. Retrieved 28 October 2023. ^ a b "Shionogi presses on with Xocova research following Japanese approval". The Pharma Letter. 16 February 2023. Retrieved 28 October 2023. ^ "Studies Currently Enrolling". University of Kansas Medical Center. Archived from the original on 28 October 2023. Retrieved 28 October 2023. SCORPIO-PEP is a 28-day study to assess the prevention of COVID-19 infection in those who he been exposed through household contact. ^ "Shionogi Enrolls the First Participant in Japan in its Global Phase 3 Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection" (Press release). Osaka, Japan. 9 June 2023. Retrieved 28 October 2023. ^ "The SCORPIO-PEP Study". SCORPIO-PEP. Shionogi Inc. Archived from the original on 11 May 2024. Retrieved 4 July 2024. ^ Gunaratne SH, Tieu HV, Wilkin TJ, Taylor BS (June 2025). "CROI 2025: The Challenges of Sustaining Viral Suppression, Addressing Advanced HIV Disease, and Ending the HIV Epidemic Targets" (PDF). Topics in Antiviral Medicine. 33 (3): 569–595. PMC 12324711. PMID 40802985. ^ Ernst D (8 November 2024). "Ensitrelvir Looks Promising for COVID-19 Postexposure Prophylaxis". MPR. Retrieved 25 January 2025. ^ "Antiviral Prevents Symptomatic COVID-19 in Post-Exposure Prophylactic Study". ContagionLive. 29 October 2024. Retrieved 25 January 2025. ^ Swift R (29 October 2024). "Japan's Shionogi says Phase 3 study showed COVID pill reduces transmission". Reuters. Retrieved 25 January 2025. ^ Nobori H, Baba K, Kuroda T, Baba K, Matsumoto K, Yoshida S, et al. (April 2024). "Prophylactic effect of ensitrelvir in mice infected with SARS-CoV-2". Antiviral Research. 224 105852. doi:10.1016/j.antiviral.2024.105852. PMID 38428748. ^ Takazono T, Fujita S, Komeda T, Miyazawa S, Yoshida Y, Kitanishi Y, et al. (August 2024). "Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19". Infectious Diseases and Therapy. 13 (8): 1821–1833. doi:10.1007/s40121-024-01010-4. PMC 11266320. PMID 38941067. ^ Abe S, Wannigama DL, Suzuki Y, Akaneya D, Igarashi J, Suto M, et al. (1 December 2024). "Real world effectiveness of early ensitrelvir treatment in patients with SARS-CoV-2, a retrospective case series". New Microbes and New Infections. 62 101522. doi:10.1016/j.nmni.2024.101522. ISSN 2052-2975. PMC 11567130. PMID 39552926. ^ Abene S (14 May 2024). "Ensitrelvir's Impact in COVID-19 Symptom Management and Relief". ContagionLive. 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Linka Zhang Wenhong Researchers Awang Bulgiba Awang Mahmud Roberto Burioni Chen Wei Kizzmekia Corbett Andrea Crisanti Peter Daszak Christian Drosten Neil Ferguson Dale Fisher George F. Gao Azra Ghani Sarah Gilbert Guan Yi Kentaro Iwata Katalin Karikó Matt Keeling Trudie Lang Li Lanjuan W. Ian Lipkin Ma Xiaowei Shabir Madhi Allison McGeer Camilla Rothe Shi Zhengli Moncef Slaoui Mike Tildesley John Todd Wang Chen Wang Guangfa Drew Weissman Yuen Kwok-yung Zeng Guang Zhang Jixian Zhang Yongzhen Zhong Nanshan OfficialsWHO Tedros Adhanom (Director-General of the WHO) Bruce Aylward (Team lead of WHO-China COVID-19 mission) Maria Van Kerkhove (Technical Lead for COVID-19 response) Michael J. Ryan (Executive Director of the WHO Health Emergencies Programme) By location Frank Atherton (Wales) Ashley Bloomfield (New Zealand) Catherine Calderwood (Scotland) Chang Shan-chwen (Taiwan) Anutin Charnvirakul (Thailand) Chen Shih-chung (Taiwan) Kenneth Chuang Yin-ching (Taiwan) Victor Costache (Romania) Fabrizio Curcio (Italy) Carmen Deseda (Puerto Rico) Jaap van Dissel (the Netherlands) Christian Drosten (Germany) Francisco Duque III (Philippines) Anthony Fauci (United States) Francesco Paolo Figliuolo (Italy) Graça Freitas (Portugal) Henrique Gouveia e Melo (Portugal) Matt Hancock (United Kingdom) Hamad Hasan (Lebanon) Greg Hunt (Australia) Tony Holohan (Ireland) Jeong Eun-kyeong (South Korea) Fahrettin Koca (Turkey) Li Keqiang (China) Hugo López-Gatell Ramírez (Mexico) Michael McBride (Northern Ireland) Oriol Mitjà (Andorra) Zweli Mkhize (South Africa) Doni Monardo (Indonesia) Alma Möller (Iceland) Saeed Namaki (Iran) Ala Nemerenco (Moldova) Nguyễn Thanh Long (Vietnam) Noor Hisham Abdullah (Malaysia) Ali Pilli (Northern Cyprus) Daniel Salinas (Uruguay) Jérôme Salomon (France) Fernando Simón (Spain) Gregor Smith (Scotland) Su Ih-jen (Taiwan) Łukasz Szumowski (Poland) Theresa Tam (Canada) Anders Tegnell (Sweden) Þórólfur Guðnason (Iceland) Sotiris Tsiodras (Greece) Harsh Vardhan (India) Víðir Reynisson (Iceland) Carla Vizzotti (Argentina) Vlad Voiculescu (Romania) Chris Whitty (United Kingdom) Lawrence Wong (Singapore) Jeff Zients (United States) Others Chen Qiushi Brett Crozier Fang Bin Fang Fang Joseph Ashitey Hammond Li Zehua Captain Tom Moore Qiu Menghuang Ren Zhiqiang List of deaths due to COVID-19 Data (templates)Global Cases, deaths, recoveries by country Tests, cases, tests per capita, cases per capita by country Tests, cases, tests per capita, cases per capita by country subdivision WHO situation reports cases deaths World map by countries: confirmed per capita China Hospital beds by country Lockdowns Africa Algeria Angola Benin Botswana Burkina Faso Burundi Cameroon Comoros Egypt Eswatini Ethiopia Ghana cases chart Ivory Coast Kenya Libya Malawi Mali Mauritania Mauritius Morocco (including occupied Western Sahara) Mozambique Nigera cases chart São Tomé and Príncipe Senegal Seychelles Sierra Leone South Africa cases chart South Sudan Sudan Tanzania Togo Tunisia Uganda Zambia Zimbabwe cases chart Americas Bolivia Brazil Canada by province vaccinations by province Chile by commune Colombia Costa Rica cases chart Cuba Dominican Republic Ecuador El Salvador Guatemala Haiti Honduras Mexico cases chart Nicaragua Panama Paraguay Peru United States by state Uruguay Venezuela Asia Afghanistan Armenia Artsakh Azerbaijan Bahrain Bangladesh by division Bhutan cases chart Brunei Cambodia cases chart summary China cases chart confirmed per capita lockdowns by province Hong Kong Macau Cyprus East Timor Egypt Georgia India Indonesia cases chart Iran cases chart Iraq Israel cases chart Japan cases chart Jordan Kazakhstan Kuwait cases chart Kyrgyzstan Laos Lebanon Malaysia cases chart charts Myanmar cases chart summary Nepal cases chart Oman cases chart Pakistan cases chart Philippines cases chart areas of quarantine vaccinations chart Qatar Russia cases chart by federal subject Saudi Arabia Singapore South Korea cases chart vaccinations charts Sri Lanka Syria Taiwan vaccination charts Tajikistan Thailand cases chart Turkey cases chart United Arab Emirates cases chart Uzbekistan cases chart Vietnam statistics charts Yemen Europe Albania Austria cases chart Belarus Belgium cases chart Bosnia and Herzegovina Bulgaria cases chart Croatia Cyprus Czech Republic Denmark cases chart Faroe Islands Estonia cases chart Finland France cases chart Germany cases chart Greece Hungary Iceland cases chart Ireland cases chart Italy cases chart statistics charts vaccinations chart Kosovo Latvia cases chart Lithuania cases chart Luxembourg Malta Moldova Monaco Montenegro Netherlands North Macedonia Norway cases chart Poland cases chart by voivodeship Portugal cases chart Romania cases chart Russia cases chart by federal subject San Marino Serbia Slovakia cases chart by region Slovenia cases chart Spain cases chart Sweden cases chart Switzerland cases chart Turkey cases chart Ukraine United Kingdom Gibraltar vaccinations chart daily by nation Vatican City Oceania Australia by state/territory Fiji French Polynesia New Caledonia New Zealand Papua New Guinea Solomon Islands Others Antarctica Diamond Princess Portals: Medicine Viruses COVID-19