{"id":"ensitrelvir","rwe":[{"pmid":"41893449","year":"2026","title":"Successful Treatment of Persistent and Relapsing COVID-19 with Ensitrelvir in a Patient with Obinutuzumab-Induced Long-Term B-Cell Depletion: A Case Report.","finding":"","journal":"Reports (MDPI)","studyType":"Clinical Study"},{"pmid":"41819156","year":"2026","title":"Optimization of pyridopyrimidinedione derivatives as non-covalent SARS-CoV-2 3CL protease inhibitors.","finding":"","journal":"Bioorganic & medicinal chemistry letters","studyType":"Clinical Study"},{"pmid":"41710745","year":"2026","title":"Characterization of the Cross-Resistance of SARS-CoV‑2 Main Protease Inhibitors, Ibuzatrelvir, Ensitrelvir, and Nirmatrelvir.","finding":"","journal":"ACS pharmacology & translational science","studyType":"Clinical Study"},{"pmid":"41672106","year":"2026","title":"Optimal preclinical models for human dose projection of SARS-CoV-2 small molecule direct-acting antivirals.","finding":"","journal":"Antiviral research","studyType":"Clinical Study"},{"pmid":"41662710","year":"2026","title":"Outpatient Treatment of Confirmed COVID-19: A Living, Rapid Review for the American College of Physicians (Version 3).","finding":"","journal":"Annals of internal medicine","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Disease caused by Severe acute respiratory syndrome coronavirus 2","category":"indication"},{"label":"Shionogi & Co., Ltd.","category":"company"}],"phase":"marketed","safety":{},"trials":[],"aliases":[],"company":"Shionogi & Co., Ltd.","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ENSITRELVIR","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:03:34.814023+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Ensitrelvir","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T02:03:43.232336+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:03:41.681933+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ENSITRELVIR","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:03:42.168700+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5183847/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:03:42.873084+00:00"}},"allNames":"xocova","offLabel":[],"synonyms":["ensitrelvir","ensitrelvir fumarate","ensitrelvir fumaric acid","xocova","S-217622"],"timeline":[{"date":"2022-11-22","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Shionogi & Co., Ltd.)"}],"approvals":[{"date":"2022-11-22","orphan":false,"company":"Shionogi & Co., Ltd.","regulator":"PMDA"}],"brandName":"Xocova","ecosystem":[{"indication":"Disease caused by Severe acute respiratory syndrome coronavirus 2","otherDrugs":[{"name":"remdesivir","slug":"remdesivir","company":"Gilead Sciences Inc"}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Xocova's exact mechanism of action is unknown, but it is believed to target the viral replication process, potentially through inhibition of viral enzymes or interference with viral RNA synthesis."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Ensitrelvir","title":"Ensitrelvir","extract":"Ensitrelvir, sold under the brand name Xocova is an antiviral medication used as a treatment for COVID-19. It was developed by Shionogi in partnership with Hokkaido University and acts as an orally active 3C-like protease inhibitor. It is taken by mouth.","wiki_history":"==History==\n, ensitrelvir had reached Phase III clinical trials. 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 molnupiravir. In a study of 428 patients, viral load was reduced, but symptoms were not significantly reduced.\n\nShionogi announced they had reached a preliminary agreement to supply 1million doses to the Japanese government once the drug is approved. The CEO said they could have capacity to make 10million doses a year.\n\nEnsitrelvir 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.","wiki_society_and_culture":"== Society and culture ==\n=== Legal status ===\nEnsitrelvir was approved for emergency use in Japan in November 2022, It was approved in Singapore in November 2023.\n\nIn April 2023, ensitrelvir was given a \"Fast Track\" designation from the US Food and Drug Administration. 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.\n\n=== Names ===\nEnsitrelvir is the international nonproprietary name (INN)."},"commercial":{"revenueYear":2024,"annualRevenue":400,"revenueSource":"Verified: Shionogi 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Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)","status":"RECRUITING","sponsor":"University of Oxford","startDate":"2021-09-30","conditions":["COVID-19"],"enrollment":3800,"completionDate":"2027-01"},{"nctId":"NCT05605093","phase":"PHASE3","title":"Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)","status":"TERMINATED","sponsor":"University of Minnesota","startDate":"2022-12-23","conditions":["COVID-19"],"enrollment":602,"completionDate":"2025-10-28"},{"nctId":"NCT05305547","phase":"PHASE3","title":"A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19","status":"COMPLETED","sponsor":"Shionogi","startDate":"2022-08-03","conditions":["SARS-CoV-2 Infection"],"enrollment":2093,"completionDate":"2024-05-24"},{"nctId":"NCT05897541","phase":"PHASE3","title":"Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 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