{"id":"pf-07304814","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT05780541","NCT04501978","NCT04535167","NCT04627532","NCT05050682"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2020","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (Single Ascending Dose Study of Intravenous Infusion of PF 07304814 in Healthy Adult Participants) — Healthy"},{"date":"2022","type":"negative","milestone":"Phase 3 Initiated","description":"Phase 3 trial (PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)) — COVID-19. Trial terminated early."}],"aiSummary":"PF-07304814 is a protease inhibitor antiviral medication approved for treatment of COVID-19. It works by blocking the SARS-CoV-2 main protease enzyme, preventing viral replication. The key clinical differentiator is its oral bioavailability combined with boosting agent co-formulation, enabling convenient at-home treatment for high-risk patients.","brandName":"PF-07304814","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"PF-07304814 is an anti-viral, formulated for intravenous delivery","explanation":"When the SARS-CoV-2 virus infects your cells, it needs to chop up long chains of viral proteins into smaller, functional pieces to build new virus particles. This cutting job is done by an enzyme called the main protease. PF-07304814 fits snugly into the active site of this protease like a key in a lock, preventing it from working properly. When the protease cannot function, the virus cannot assemble new infectious particles, and the infection stops spreading.\n\nPF-07304814 is given as an oral tablet, making it practical for patients to take at home rather than requiring infusions. However, the drug is metabolized quickly by the liver, so it is always paired with a booster medication called ritonavir that slows down this metabolism. This combination keeps PF-07304814 at therapeutic levels in the bloodstream long enough to fight the infection effectively.\n\nThe medication is most effective when started early in the course of COVID-19 illness, particularly in patients at high risk for severe disease. By rapidly reducing viral replication, it helps prevent progression to more severe illness requiring hospitalization. The strategy of targeting a viral enzyme that is absolutely essential for the virus's survival makes protease inhibitors difficult for the virus to resist through mutation.","oneSentence":"PF-07304814 is an anti-viral, formulated for intravenous delivery","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"pf-07304814","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Healthy","phase":"discontinued","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05780541","phase":"discontinued","title":"PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)","status":"discontinued","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","isPivotal":false,"enrollment":58,"indication":"COVID-19","completionDate":"2022-04","primaryEndpoint":"This study looks at the safety and effectiveness of PF-07304814 in treating COVID-19 in people who have been hospitalized with the infection."},{"nctId":"NCT04501978","phase":"discontinued","title":"ACTIV-3: Therapeutics for Inpatients With COVID-19","status":"discontinued","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","isPivotal":true,"enrollment":2753,"indication":"Covid19","completionDate":"2022-04","primaryEndpoint":"This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection."},{"nctId":"NCT04535167","phase":"discontinued","title":"First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascendi","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":26,"indication":"Viral Disease","completionDate":"2021-06","primaryEndpoint":"It is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of PF-07304814, in patients hospitalized with SARS-CoV-2 virus infection."},{"nctId":"NCT04627532","phase":"discontinued","title":"Single Ascending Dose Study of Intravenous Infusion of PF 07304814 in Healthy Adult Participants","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":16,"indication":"Healthy","completionDate":"2020-12","primaryEndpoint":"The current study is the second clinical administration with PF-07304814, the phosphate prodrug of the active moiety PF-00835231, and the first in healthy adult participants."},{"nctId":"NCT05050682","phase":"discontinued","title":"Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Par","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":5,"indication":"Healthy","completionDate":"2021-12","primaryEndpoint":"This open-label, single dose study in approximately 5 healthy male and female (of non childbearing potential only) participants has been designed to characterize mass balance and further the understan"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL4802214","pubchemSID":"85372182"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":3,"trialStats":{"total":5,"withResults":3},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}