{"id":"paxlovid","rwe":[{"pmid":"41876769","year":"2026","title":"Paxlovid shows organ-specific and age-specific impacts on risk of developing post-acute sequelae of COVID-19.","finding":"","journal":"Communications medicine","studyType":"Clinical Study"},{"pmid":"41832695","year":"2026","title":"The JN.1 Variant: Emergence and Global Spread.","finding":"","journal":"Current pharmaceutical design","studyType":"Clinical Study"},{"pmid":"41788322","year":"2026","title":"Effectiveness of Nirmatrelvir/Ritonavir in Unvaccinated COVID-19 Patients Treated in the Emergency Department: A Retrospective Propensity-Matched Cohort Analysis.","finding":"","journal":"Therapeutic advances in pulmonary and critical care medicine","studyType":"Clinical Study"},{"pmid":"41740581","year":"2026","title":"Integration of computational and experimental techniques for the discovery of PL(pro) covalent inhibitors. When large virtual screening and rational design meet.","finding":"","journal":"European journal of medicinal chemistry","studyType":"Clinical Study"},{"pmid":"41739653","year":"2026","title":"Therapeutic Approaches to Treat SARS-CoV-2.","finding":"","journal":"ChemMedChem","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"J05AE30","category":"atc"},{"label":"Active","category":"status"},{"label":"COVID-19","category":"indication"},{"label":"Pfizer, Inc.","category":"company"},{"label":"Approved 2020s","category":"decade"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antiviral Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Protease Inhibitors","category":"pharmacology"},{"label":"Viral Protease Inhibitors","category":"pharmacology"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":160.74,"date":"","count":54,"signal":"Drug interaction","source":"DrugCentral FAERS","actionTaken":"Reported 54 times (LLR=161)"},{"llr":111.66,"date":"","count":44,"signal":"Acute kidney injury","source":"DrugCentral FAERS","actionTaken":"Reported 44 times (LLR=112)"},{"llr":102.258,"date":"","count":39,"signal":"Toxicity to various agents","source":"DrugCentral FAERS","actionTaken":"Reported 39 times (LLR=102)"}],"commonSideEffects":[{"effect":"Drug interaction","drugRate":"LLR 161","severity":"common"},{"effect":"Acute kidney injury","drugRate":"LLR 112","severity":"common"},{"effect":"Toxicity to various agents","drugRate":"LLR 102","severity":"common"}]},"trials":[],"aliases":[],"company":"Pfizer","patents":[{"source":"FDA Orange Book via DrugCentral","expires":"2041-10-31","territory":"US","patentNumber":"11541034"},{"source":"FDA Orange Book via DrugCentral","expires":"2041-08-05","territory":"US","patentNumber":"11351149"}],"pricing":[],"allNames":"paxlovid (copackaged)","offLabel":[],"synonyms":["nirmatrelvir","paxlovid","PF-07321332"],"timeline":[{"date":"2022-01-28","type":"positive","source":"DrugCentral","milestone":"EMA approval (Pfizer Europe MA EEIG)"},{"date":"2022-02-10","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Pfizer Japan Inc)"},{"date":"2023-05-25","type":"positive","source":"DrugCentral","milestone":"FDA approval (Pfizer, Inc.)"}],"aiSummary":"Paxlovid (Copackaged) is a small molecule modality developed by Pfizer, Inc. for the treatment of COVID-19. It was FDA approved in 2023 and is currently owned by Pfizer, Inc. The commercial status of Paxlovid is patented, and it is used to treat COVID-19. Key safety considerations include potential interactions with other medications and monitoring for liver enzyme elevations. As a COVID-19 treatment, Paxlovid has become a crucial tool in managing the pandemic.","brandName":"Paxlovid (Copackaged)","ecosystem":[{"indication":"COVID-19","otherDrugs":[{"name":"bamlanivimab","slug":"bamlanivimab","company":"Eli Lilly and Company"},{"name":"casirivimab","slug":"casirivimab","company":"Regeneron Pharmaceuticals, Inc."},{"name":"etesevimab","slug":"etesevimab","company":"Eli Lilly and Company"},{"name":"imdevimab","slug":"imdevimab","company":"Regeneron Pharmaceuticals, Inc."}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","explanation":"Imagine your body's cells are under attack by the COVID-19 virus. Paxlovid helps by blocking a specific enzyme that the virus needs to multiply and spread. This allows your immune system to fight off the infection more effectively.","oneSentence":"Paxlovid works by inhibiting the activity of the SARS-CoV-2 protease enzyme, which is essential for the virus's replication.","technicalDetail":"Paxlovid contains a combination of nirmatrelvir and ritonavir, which inhibit the SARS-CoV-2 main protease (Mpro) enzyme, preventing the virus from replicating and reducing the severity of COVID-19 symptoms."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Nirmatrelvir%2Fritonavir","title":"Nirmatrelvir/ritonavir","extract":"Nirmatrelvir/ritonavir, sold under the brand name Paxlovid, is a co-packaged medication used as a treatment for COVID-19. It contains the antiviral medications nirmatrelvir and ritonavir and was developed by Pfizer. Nirmatrelvir inhibits SARS-CoV-2 main protease, while ritonavir is a strong CYP3A inhibitor, slowing down nirmatrelvir metabolism and therefore boosting its effect. It is taken by mouth.","wiki_history":"==History==\nNirmatrelvir belongs to a family of 3C-like protease inhibitors developed in the late 2010s against feline coronavirus, while ritonavir is an antiretroviral drug developed in the 1980s and used since the 1990s to inhibit the enzyme that metabolizes other protease inhibitors.\n\nThe primary data supporting the US Food and Drug Administration (FDA) emergency use authorization for nirmatrelvir/ritonavir were from the EPIC-HR trial, a randomized, double-blind, placebo-controlled clinical trial studying nirmatrelvir/ritonavir for the treatment of non-hospitalized symptomatic adults with a laboratory-confirmed diagnosis of SARS-CoV-2 infection. Participants were 18 years of age and older with a pre-specified risk factor for progression to severe disease, or were 60years and older regardless of pre-specified chronic medical conditions. Nirmatrelvir/ritonavir significantly reduced the proportion of people with COVID19-related hospitalization or death from any cause by 88% compared to placebo among participants treated within five days of symptom onset and who did not receive COVID19 therapeutic monoclonal antibody treatment.\n\nIn August 2021, Pfizer began a phase II/III trial of nirmatrelvir/ritonavir for COVID19 in standard-risk individuals with COVID19 known as EPIC-SR. Interim results of this trial were announced in December 2021, and final results were released in June 2022.\n\nNirmatrelvir/ritonavir has been evaluated in the treatment of COVID19 in standard-risk individuals in the EPIC-SR trial.\n\nIn May 2023, nirmatrelvir/ritonavir received FDA approval for the treatment of mild-to-moderate COVID19 in adults who are at high risk for progression to severe COVID19, including hospitalization or death. In November 2023, the FDA revised the EUA for nirmatrelvir/ritonavir to authorize EUA- or NDA-labeled nirmatrelvir/ritonavir for the treatment of mild-to-moderate COVID19 in people aged twelve years of age and older weighing at least , who are at high risk for progres","wiki_society_and_culture":"== Society and culture ==\nthumb|US packaging for Paxlovid, the branded form of nirmatrelvir/ritonavir, as of 2022\n\n===Legal status===\n====Canada====\nHealth Canada approved the use of the co-packaged medication in January 2022.\n\n====China====\nIn February 2022, China approved the medication for the treatment of adults who have mild to moderate COVID19 and are at a high risk of progressing to a severe condition.\n\n====European Union====\nThe European Medicines Agency (EMA) approved the co-packaged medication for the treatment of COVID19 in the EU in January 2022.\n\n====Japan====\nThe Japanese Ministry of Health, Labour and Welfare approved the use of the co-packaged medication for treating adults in February 2022.\n\n====Singapore====\nThe Singapore Health Sciences Authority approved the use of the co-packaged medication for treating adults in February 2022.\n\n====South Korea====\nSouth Korea approved the use of the co-packaged medication in December 2021.\n\n====United Kingdom====\nThe United Kingdom approved the use of the co-packaged medication in December 2021.\n\n====United States====\nIn November 2021, Pfizer submitted an application to the US Food and Drug Administration (FDA) for emergency use authorization for the co-packaged medication. The authorization was granted in December 2021, for people aged twelve years of age or older who are infected with COVID19 and are at risk.\n\nIn January 2024, the FDA revised the emergency use authorization (EUA) and stated that nirmatrelvir/ritonavir manufactured and labeled in accordance with the EUA under US distribution would remain authorized for use through the earlier of the labeled or extended expiration date, or through March 2024. In March 2024, the FDA revised the emergency use authorization to no longer cover EUA-labeled nirmatrelvir/ritonavir. The emergency use authorization also continues to authorize prescribing of nirmatrelvir/ritonavir by a state-licensed pharmacist to treat mild to moderate COVID-19 in people aged twelve yea"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5520","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=paxlovid","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=paxlovid","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Nirmatrelvir%2Fritonavir","fields":["history","overview"],"source":"Wikipedia"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T02:27:03.180155","biosimilars":[],"competitors":[{"drugName":"saquinavir","drugSlug":"saquinavir","fdaApproval":"1995-12-06","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"indinavir","drugSlug":"indinavir","fdaApproval":"1996-03-13","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"ritonavir","drugSlug":"ritonavir","fdaApproval":"1996-03-01","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"nelfinavir","drugSlug":"nelfinavir","fdaApproval":"1997-03-14","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"amprenavir","drugSlug":"amprenavir","fdaApproval":"1999-04-15","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"fosamprenavir","drugSlug":"fosamprenavir","fdaApproval":"2003-10-20","genericCount":2,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"atazanavir","drugSlug":"atazanavir","fdaApproval":"2003-06-20","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"tipranavir","drugSlug":"tipranavir","fdaApproval":"2005-06-22","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"darunavir","drugSlug":"darunavir","fdaApproval":"2006-06-23","patentExpiry":"Jun 26, 2027","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"paxlovid","indications":{"approved":[{"name":"COVID-19","source":"DrugCentral","snomedId":840539006,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"saquinavir","brandName":"saquinavir","genericName":"saquinavir","approvalYear":"1995","relationship":"same-class"},{"drugId":"indinavir","brandName":"indinavir","genericName":"indinavir","approvalYear":"1996","relationship":"same-class"},{"drugId":"ritonavir","brandName":"ritonavir","genericName":"ritonavir","approvalYear":"1996","relationship":"same-class"},{"drugId":"nelfinavir","brandName":"nelfinavir","genericName":"nelfinavir","approvalYear":"1997","relationship":"same-class"},{"drugId":"amprenavir","brandName":"amprenavir","genericName":"amprenavir","approvalYear":"1999","relationship":"same-class"},{"drugId":"fosamprenavir","brandName":"fosamprenavir","genericName":"fosamprenavir","approvalYear":"2003","relationship":"same-class"},{"drugId":"atazanavir","brandName":"atazanavir","genericName":"atazanavir","approvalYear":"2003","relationship":"same-class"},{"drugId":"tipranavir","brandName":"tipranavir","genericName":"tipranavir","approvalYear":"2005","relationship":"same-class"},{"drugId":"darunavir","brandName":"darunavir","genericName":"darunavir","approvalYear":"2006","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05965726","phase":"PHASE2","title":"RECOVER-VITAL: Platform Protocol, Appendix to Measure the Effects of Paxlovid on Long COVID Symptoms","status":"COMPLETED","sponsor":"Kanecia Obie Zimmerman","startDate":"2023-07-26","conditions":["Long COVID-19","Long COVID"],"enrollment":964,"completionDate":"2025-03-13"},{"nctId":"NCT07450209","phase":"PHASE2","title":"COVID-19 Rapid Test-to-Treat With African American Churches (Faithful Response II)","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Missouri, Kansas City","startDate":"2024-05-15","conditions":["COVID-19 Testing Behaviors"],"enrollment":900,"completionDate":"2026-03-01"},{"nctId":"NCT05587894","phase":"PHASE2","title":"OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial","status":"RECRUITING","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2023-04-27","conditions":["COVID-19","Immunodeficiency"],"enrollment":256,"completionDate":"2027-06-30"},{"nctId":"NCT05041907","phase":"PHASE2","title":"Finding 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":"NCT07406217","phase":"PHASE2","title":"OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients","status":"RECRUITING","sponsor":"Calmy Alexandra","startDate":"2023-04-27","conditions":["COVID-19","Immunodeficiency"],"enrollment":256,"completionDate":"2026-06-30"},{"nctId":"NCT07072793","phase":"","title":"A US Study to Look at Loss of Work and Healthcare Costs for People Affected With Mild-to-moderate COVID 19 Who Have High Chances of the Disease Becoming Severe","status":"COMPLETED","sponsor":"Pfizer","startDate":"2024-10-31","conditions":["COVID-19 (Coronavirus Disease 2019)"],"enrollment":131005,"completionDate":"2024-11-15"},{"nctId":"NCT07157007","phase":"PHASE2","title":"Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19","status":"RECRUITING","sponsor":"Traws Pharma, Inc.","startDate":"2025-09-16","conditions":["COVID - 19"],"enrollment":90,"completionDate":"2026-03"},{"nctId":"NCT04746183","phase":"PHASE1,PHASE2","title":"AGILE (Early Phase Platform Trial for COVID-19)","status":"RECRUITING","sponsor":"University of Liverpool","startDate":"2020-07-03","conditions":["Covid19"],"enrollment":600,"completionDate":"2026-07-31"},{"nctId":"NCT06397144","phase":"PHASE1","title":"A Study on 2 Different Combination Tablets of Nirmatrelvir Plus Ritonavir to Compare Them With Marketed Paxlovid in Healthy Participants","status":"WITHDRAWN","sponsor":"Pfizer","startDate":"2025-08-15","conditions":["Biological Availability","Healthy Participants"],"enrollment":0,"completionDate":"2025-12-09"},{"nctId":"NCT04550936","phase":"","title":"A Study to Understand How the Use of Paxlovid Affected the Healthcare Use in People With Pre-existing Conditions.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-03-10","conditions":["Invasive Aspergillosis","Mucormycosis"],"enrollment":307,"completionDate":"2023-12-23"},{"nctId":"NCT07261085","phase":"","title":"A Study to Learn How Paxlovid [Nirmatrelvir-ritonavir/PF-07321332] Works in COVID-19 Patients Who Are Elderly or Have Medical Conditions.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2025-10-27","conditions":["COVID-19"],"enrollment":99000,"completionDate":"2026-03-30"},{"nctId":"NCT05595369","phase":"PHASE2","title":"RECOVER-VITAL: Platform Protocol to Measure the Effects of Antiviral Therapies on Long COVID Symptoms","status":"COMPLETED","sponsor":"Kanecia Obie Zimmerman","startDate":"2023-07-26","conditions":["Long COVID","Long Covid19"],"enrollment":963,"completionDate":"2025-03-13"},{"nctId":"NCT05852873","phase":"PHASE3","title":"PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway","status":"ACTIVE_NOT_RECRUITING","sponsor":"Haukeland University Hospital","startDate":"2023-05-12","conditions":["Post COVID-19 Condition, Unspecified","SARS-CoV2 Infection","COVID-19"],"enrollment":2000,"completionDate":"2027-06-11"},{"nctId":"NCT05576662","phase":"PHASE2","title":"Paxlovid for Treatment of Long Covid","status":"COMPLETED","sponsor":"Stanford University","startDate":"2022-11-08","conditions":["Post-acute Sequelae of SARS-CoV-2 Infection","Long COVID"],"enrollment":168,"completionDate":"2023-09-12"},{"nctId":"NCT05263908","phase":"","title":"A Study to Learn About PAXLOVID (a Commercial Medicine) In People With COVID-19","status":"COMPLETED","sponsor":"Pfizer","startDate":"2022-03-31","conditions":["SARS-CoV-2 Infection"],"enrollment":3346,"completionDate":"2023-07-10"},{"nctId":"NCT06291831","phase":"","title":"A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2024-03-13","conditions":["COVID-19"],"enrollment":3011,"completionDate":"2024-05-14"},{"nctId":"NCT07090486","phase":"","title":"A Study to Understand How the Use of Paxlovid Affected Healthcare Use in People With Pre-existing Conditions.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2025-04-15","conditions":["COVID-19"],"enrollment":14000,"completionDate":"2025-04-15"},{"nctId":"NCT05386472","phase":"PHASE1","title":"A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19","status":"TERMINATED","sponsor":"Pfizer","startDate":"2022-06-22","conditions":["COVID-19"],"enrollment":25,"completionDate":"2025-05-12"},{"nctId":"NCT07089680","phase":"","title":"A Study to Learn About the Study Medicine Paxlovid (Nirmatrelvir + Ritonavir) in Adults Aged 60 and Older Living in Korean Long-term Care Hospitals Who Have COVID-19","status":"NOT_YET_RECRUITING","sponsor":"Pfizer","startDate":"2025-08-18","conditions":["Coronavirus Disease 2019 (COVID-19)"],"enrollment":1200,"completionDate":"2025-11-30"},{"nctId":"NCT05890612","phase":"","title":"A Study on Paxlovid Once in the Market, to Observe Its Safety and Effectiveness in Patients Who Have a High Chance of Getting Severe COVID-19","status":"RECRUITING","sponsor":"Pfizer","startDate":"2023-11-29","conditions":["COVID-19"],"enrollment":3000,"completionDate":"2029-07-13"},{"nctId":"NCT06016556","phase":"","title":"A Study of COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia","status":"COMPLETED","sponsor":"Pfizer","startDate":"2023-10-17","conditions":["Covid-19"],"enrollment":250,"completionDate":"2024-04-09"},{"nctId":"NCT04885452","phase":"","title":"Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU ('Autorisation Temporaire d'Utilisation') OR or Authorisation for Early Access (AAP). A Prospectvie Cohort.","status":"COMPLETED","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2021-09-21","conditions":["SARS-CoV Infection","Covid19"],"enrollment":756,"completionDate":"2023-12-18"},{"nctId":"NCT05614349","phase":"PHASE3","title":"Canadian Adaptive Platform Trial of Treatments for COVID-19 in Community Settings","status":"ACTIVE_NOT_RECRUITING","sponsor":"Unity Health Toronto","startDate":"2023-01-16","conditions":["COVID-19"],"enrollment":797,"completionDate":"2025-06-28"},{"nctId":"NCT06792214","phase":"PHASE4","title":"Antiviral Strategies in the Prevention of Long-term Cardiovascular Outcomes Following COVID-19: The paxloviD/Remdesivir Effectiveness For the prEvention of loNg coviD Clinical Trial","status":"RECRUITING","sponsor":"Mount Sinai Hospital, Canada","startDate":"2025-01-03","conditions":["SARS CoV-2 Post-Acute Sequelae"],"enrollment":118,"completionDate":"2027-01"},{"nctId":"NCT06735300","phase":"","title":"Saliva PCR in Pregnant Women with COVID-19","status":"COMPLETED","sponsor":"National Cheng-Kung University Hospital","startDate":"2022-06-01","conditions":["Coronavirus Disease 2019 (COVID-19) Pneumonia"],"enrollment":37,"completionDate":"2022-10-07"},{"nctId":"NCT05823896","phase":"PHASE2","title":"ImPROving Quality of LIFe in the Long COVID Patient","status":"COMPLETED","sponsor":"Karolinska Institutet","startDate":"2023-05-01","conditions":["Post-COVID-19 Syndrome","Long COVID","Long Covid19","COVID-19","POTS - Postural Orthostatic Tachycardia Syndrome","Post COVID-19 Condition","Post-COVID Syndrome","Post COVID-19 Condition, Unspecified","Postinfectious Inflammation","Postinfectious Disorder"],"enrollment":219,"completionDate":"2024-11-28"},{"nctId":"NCT05668091","phase":"PHASE2","title":"A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir in Adults with Long COVID.","status":"COMPLETED","sponsor":"Harlan M Krumholz","startDate":"2023-04-14","conditions":["Long COVID"],"enrollment":100,"completionDate":"2024-08-21"},{"nctId":"NCT06441955","phase":"PHASE4","title":"Covid-19 Long Haul Preventative and Health Promotion Care Clinical Trial Acceleration Program.","status":"RECRUITING","sponsor":"Well- Konnect Healthcare Services and Research Firm","startDate":"2024-03-01","conditions":["COVID-19, Long Haul"],"enrollment":100,"completionDate":"2030-09-30"},{"nctId":"NCT05271929","phase":"PHASE3","title":"Early High-Titre Convalescent Plasma in Clinically Vulnerable Individuals With Mild COVID-19","status":"TERMINATED","sponsor":"Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen","startDate":"2022-04-01","conditions":["COVID-19"],"enrollment":120,"completionDate":"2024-06-17"},{"nctId":"NCT05898672","phase":"PHASE1","title":"A Study to Learn About the Study Medicine Called Nirmatrelvir/Ritonavir in People Who Are Healthy Volunteers Co-administered the Medicine Rosuvastatin","status":"COMPLETED","sponsor":"Pfizer","startDate":"2023-06-09","conditions":["Pharmacokinetics","Healthy Volunteers"],"enrollment":12,"completionDate":"2023-08-10"},{"nctId":"NCT05567952","phase":"PHASE2","title":"A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment With Nirmatrelvir/Ritonavir","status":"COMPLETED","sponsor":"Pfizer","startDate":"2022-10-19","conditions":["COVID-19"],"enrollment":436,"completionDate":"2024-02-09"},{"nctId":"NCT05487040","phase":"PHASE1","title":"A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease","status":"TERMINATED","sponsor":"Pfizer","startDate":"2022-09-07","conditions":["COVID-19"],"enrollment":15,"completionDate":"2023-07-11"},{"nctId":"NCT05438602","phase":"PHASE2","title":"A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System","status":"COMPLETED","sponsor":"Pfizer","startDate":"2022-08-03","conditions":["COVID-19"],"enrollment":158,"completionDate":"2023-11-13"},{"nctId":"NCT05525910","phase":"PHASE1","title":"Relative Bioavailability Study of Nirmatrelvir/Ritonavir 4 Different Fixed Dose Combination Tablets Relative to the Commercial Tablets in Healthy Participants","status":"COMPLETED","sponsor":"Pfizer","startDate":"2022-08-31","conditions":["Biological Availability","Healthy Participants"],"enrollment":15,"completionDate":"2022-11-07"},{"nctId":"NCT02735707","phase":"PHASE3","title":"Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia","status":"RECRUITING","sponsor":"UMC Utrecht","startDate":"2016-04-11","conditions":["Community-acquired Pneumonia, Influenza, COVID-19"],"enrollment":20000,"completionDate":"2028-02"},{"nctId":"NCT04483960","phase":"PHASE3","title":"Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Melbourne","startDate":"2020-07-28","conditions":["SARS-CoV-2 Infection (COVID-19)"],"enrollment":2200,"completionDate":"2025-12-31"},{"nctId":"NCT05544786","phase":"PHASE1","title":"Relative Bioavailability Study of Nirmatrelvir/Ritonavir Oral Powder Relative to the Commercial Tablets and Estimation of the Effect of Food on Bioavailability of the Nirmatrelvir/Ritonavir Oral Powder in Healthy Participants.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2022-09-28","conditions":["Biological Availability"],"enrollment":12,"completionDate":"2022-11-29"},{"nctId":"NCT06349655","phase":"","title":"The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19","status":"COMPLETED","sponsor":"The First Affiliated Hospital of Zhengzhou University","startDate":"2023-12-05","conditions":["COVID-19","Azvudine"],"enrollment":32864,"completionDate":"2024-03-10"},{"nctId":"NCT05996770","phase":"","title":"Evaluation of the Safety and Efficacy of Azvudine and Paxlovid in the Treatment of Hospitalized Patients With COVID-19","status":"UNKNOWN","sponsor":"Xiao Li，MD","startDate":"2024-06-01","conditions":["Paxlovid","Azvudine","COVID-19"],"enrollment":1500,"completionDate":"2024-12-30"},{"nctId":"NCT05997485","phase":"","title":"A Study to Learn About the Patients With COVID-19 Prescribed Paxlovid in Morocco","status":"WITHDRAWN","sponsor":"Pfizer","startDate":"2024-03-30","conditions":["COVID-19 Drug Treatment"],"enrollment":0,"completionDate":"2024-06-30"},{"nctId":"NCT06076863","phase":"NA","title":"Pharmacist Management of Paxlovid eVisits","status":"COMPLETED","sponsor":"Kaiser Permanente","startDate":"2023-10-09","conditions":["COVID-19","Quality of Care"],"enrollment":2478,"completionDate":"2024-01-11"},{"nctId":"NCT05624840","phase":"","title":"Safety and Clinical and Virologic Outcomes in CKD Patients Treated With Nirmatrelvir-ritonavir","status":"COMPLETED","sponsor":"Chinese University of Hong Kong","startDate":"2022-11-07","conditions":["COVID-19","Chronic Kidney Disease stage4","Chronc Kidney Disease Stage 5"],"enrollment":85,"completionDate":"2023-02-01"},{"nctId":"NCT04381936","phase":"PHASE3","title":"Randomised Evaluation of COVID-19 Therapy","status":"RECRUITING","sponsor":"University of Oxford","startDate":"2020-03-19","conditions":["Severe Acute Respiratory Syndrome"],"enrollment":70000,"completionDate":"2036-06-30"},{"nctId":"NCT05894603","phase":"","title":"Effectiveness and Safety of New Oral Antivirals for COVID-19","status":"UNKNOWN","sponsor":"Universidade do Porto","startDate":"2022-08-01","conditions":["COVID-19"],"enrollment":211,"completionDate":"2024-06-30"},{"nctId":"NCT05938140","phase":"PHASE4","title":"Efficiency and Safety of Paxlovid for COVID-19 Patients With Severe Chronic Kidney Disease","status":"UNKNOWN","sponsor":"Chinese PLA General Hospital","startDate":"2023-06-22","conditions":["COVID-19","Renal Insufficiency, Chronic"],"enrollment":30,"completionDate":"2025-05-30"},{"nctId":"NCT05638919","phase":"","title":"Real World COVID-19 Antiviral Effectiveness Research","status":"UNKNOWN","sponsor":"Clinical Research Centre, Malaysia","startDate":"2022-12-06","conditions":["COVID-19"],"enrollment":660,"completionDate":"2023-07-31"},{"nctId":"NCT05792865","phase":"","title":"A Registry Study of Patients Hospitalized With Confirmed COVID-19","status":"UNKNOWN","sponsor":"Beijing Chao Yang Hospital","startDate":"2023-03-30","conditions":["COVID-19"],"enrollment":488,"completionDate":"2023-12-30"},{"nctId":"NCT05545319","phase":"PHASE2","title":"A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People With Weakened Immune Systems or at Increased Risk for Poor Outcomes Who Are Hospitalized Due to Severe COVID-19","status":"WITHDRAWN","sponsor":"Pfizer","startDate":"2022-12-13","conditions":["Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)","Coronavirus Disease 2019 (COVID-19)","Immunocompromised","Hospitalization","Child, Hospitalized"],"enrollment":0,"completionDate":"2024-01-06"},{"nctId":"NCT05749445","phase":"","title":"Appropriate Evaluation of Antiviral Therapy With Nirmatrelvir-ritonavir in Hospitalized Patients","status":"UNKNOWN","sponsor":"First People's Hospital of Hangzhou","startDate":"2022-12-15","conditions":["Hospitalized Patients"],"enrollment":200,"completionDate":"2023-04"},{"nctId":"NCT05694962","phase":"PHASE2","title":"Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia","status":"UNKNOWN","sponsor":"Jiangsu Cancer Institute & Hospital","startDate":"2023-01","conditions":["COVID-19 Pneumonia"],"enrollment":40,"completionDate":"2024-12"},{"nctId":"NCT05491330","phase":"PHASE1","title":"Bioequivalence Study of Nirmatrelvir & Ritonavir From Copaxid 150 +100 mg Tablets (Eva Pharma, Egypt) Versus Paxlovid 150 + 100 mg Film Coated Tablets (Pfizer Europe, Belgium)","status":"COMPLETED","sponsor":"Genuine Research Center, Egypt","startDate":"2022-08-21","conditions":["Healthy"],"enrollment":28,"completionDate":"2022-10-27"},{"nctId":"NCT05682586","phase":"PHASE3","title":"UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients","status":"UNKNOWN","sponsor":"Shanghai East Hospital","startDate":"2023-01-09","conditions":["Mesenchymal Stem Cell","COVID-19 Pneumonia"],"enrollment":60,"completionDate":"2023-07-01"},{"nctId":"NCT05642910","phase":"NA","title":"The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial","status":"UNKNOWN","sponsor":"Southeast University, China","startDate":"2022-10-18","conditions":["SARS-CoV-2 Infection"],"enrollment":540,"completionDate":"2023-04-30"},{"nctId":"NCT05618600","phase":"","title":"Scripps-eMed Covid-19 Study: A Prospective Monitoring Study for Those Individuals Treated With Paxlovid","status":"UNKNOWN","sponsor":"Scripps Translational Science Institute","startDate":"2022-08-04","conditions":["COVID-19"],"enrollment":800,"completionDate":"2024-01"},{"nctId":"NCT05341609","phase":"PHASE3","title":"Efficacy and Safety of JT001 (VV116) Compared With Paxlovid","status":"COMPLETED","sponsor":"Vigonvita Life Sciences","startDate":"2022-04-04","conditions":["COVID-19"],"enrollment":822,"completionDate":"2022-05-31"},{"nctId":"NCT05532852","phase":"NA","title":"Efficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study","status":"UNKNOWN","sponsor":"Ruijin Hospital","startDate":"2022-07-01","conditions":["COVID-19 Pneumonia"],"enrollment":728,"completionDate":"2023-10"},{"nctId":"NCT05366192","phase":"PHASE4","title":"The Safety of Paxlovid in Hemodialysis Patients With Covid-19","status":"COMPLETED","sponsor":"RenJi Hospital","startDate":"2022-05-06","conditions":["Safety Issues"],"enrollment":18,"completionDate":"2022-06-08"},{"nctId":"NCT05387369","phase":"","title":"A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19","status":"RECRUITING","sponsor":"Huashan Hospital","startDate":"2022-03-21","conditions":["COVID-19"],"enrollment":2000,"completionDate":"2027-03-30"},{"nctId":"NCT05386433","phase":"EARLY_PHASE1","title":"Paxlovid in the Treatment of COVID-19 Patients With Uremia","status":"UNKNOWN","sponsor":"Ruijin Hospital","startDate":"2022-06","conditions":["COVID-19","Uremia"],"enrollment":40,"completionDate":"2022-08"}],"_emaApprovals":[{"date":"2022-01-28","status":"Authorised","company":"Pfizer Europe MA EEIG"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"_patentsChecked":true,"crossReferences":{"MMSL":"354383","NDDF":"018919","UNII":"7R9A5P7H32","CHEBI":"CHEBI:170007","VANDF":"4041063","INN_ID":"12161","RXNORM":"2587892","UMLSCUI":"C5545149","ChEMBL_ID":"CHEMBL4802135","KEGG_DRUG":"D12244","DRUGBANK_ID":"DB16691","PDB_CHEM_ID":" ZGW","PUBCHEM_CID":"155903259","IUPHAR_LIGAND_ID":"11503","MESH_SUPPLEMENTAL_RECORD_UI":"C000718217"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2023-","companyName":"Pfizer","relationship":"Original Developer"},{"period":"2022","companyName":"Pfizer Europe MA EEIG","relationship":"EMA Licensee"},{"period":"2022","companyName":"Pfizer Japan Inc","relationship":"PMDA Licensee"}],"publicationCount":712,"therapeuticAreas":["Immunology"],"_revenueScrapedAt":"2026-03-31 14:05:45.012475+00","atcClassification":{"source":"DrugCentral","atcCode":"J05AE30","allCodes":["J05AE30"]},"biosimilarFilings":[],"originalDeveloper":"Pfizer, Inc.","recentPublications":[{"date":"2026 Mar 24","pmid":"41876769","title":"Paxlovid shows organ-specific and age-specific impacts on risk of developing post-acute sequelae of COVID-19.","journal":"Communications medicine"},{"date":"2026 Mar 13","pmid":"41832695","title":"The JN.1 Variant: Emergence and Global Spread.","journal":"Current pharmaceutical design"},{"date":"2026 Jan-Dec","pmid":"41788322","title":"Effectiveness of Nirmatrelvir/Ritonavir in Unvaccinated COVID-19 Patients Treated in the Emergency Department: A Retrospective Propensity-Matched Cohort Analysis.","journal":"Therapeutic advances in pulmonary and critical care medicine"},{"date":"2026 Apr 15","pmid":"41740581","title":"Integration of computational and experimental techniques for the discovery of PL(pro) covalent inhibitors. When large virtual screening and rational design meet.","journal":"European journal of medicinal chemistry"},{"date":"2026 Feb 25","pmid":"41739653","title":"Therapeutic Approaches to Treat SARS-CoV-2.","journal":"ChemMedChem"}],"_revenueClearedDupe":"nirmatrelvir","companionDiagnostics":[],"genericManufacturerList":[],"status":"discontinued","companyName":"Pfizer","companyId":"pfizer","modality":"Small Molecule","firstApprovalDate":"2023","enrichmentLevel":3,"visitCount":4,"patentsNormalised":[{"patent_number":"11351149","territory":"US","patent_type":null,"expiry_date":"2041-08-05T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"11541034","territory":"US","patent_type":null,"expiry_date":"2041-10-31T00:00:00.000Z","status":"active","paragraph_iv_filed":false}],"trialStats":{"total":5,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}