{"id":"oral-anticoagulant","rwe":[{"pmid":"41878338","year":"2026","title":"Estimating real-world treatment effects in the presence of measurement error and sparse outcome data using propensity score methods.","journal":"Frontiers in pharmacology"},{"pmid":"41855706","year":"2026","title":"Real world experience of direct oral anticoagulant (DOAC) use in Australian children.","journal":"Thrombosis research"},{"pmid":"41853582","year":"2026","title":"Safety and efficacy of direct oral anticoagulants in pediatric oncology patients: real-world data from two quaternary care pediatric centers.","journal":"Research and practice in thrombosis and haemostasis"},{"pmid":"41847762","year":"2026","title":"Evaluating the incidence of thrombosis in patients with concurrent second-generation androgen receptor inhibitor therapy and direct oral anticoagulants: A retrospective chart review.","journal":"Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners"},{"pmid":"41823252","year":"2026","title":"Impact of Combined Anticoagulant and Antiplatelet Therapy in Older Patients With Atrial Fibrillation: ANAFIE Subanalysis.","journal":"Journal of the American Heart Association"}],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":[{"drug":"Strong CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole)","action":"Avoid or monitor closely; dose reduction may be required","effect":"Increased Factor Xa inhibitor plasma concentration and bleeding risk"},{"drug":"Strong CYP3A4 inducers (rifampin, phenytoin, carbamazepine)","action":"Avoid; may reduce efficacy","effect":"Decreased Factor Xa inhibitor plasma concentration and reduced anticoagulant effect"},{"drug":"Antiplatelet agents (aspirin, clopidogrel, NSAIDs)","action":"Monitor; use lowest effective doses; consider gastroprotection","effect":"Increased bleeding risk when combined with anticoagulants"},{"drug":"Other anticoagulants (warfarin, heparin, other DOACs)","action":"Avoid concurrent use; allow washout period between agents","effect":"Additive anticoagulant effect and major bleeding risk"},{"drug":"P-glycoprotein inhibitors (verapamil, diltiazem, amiodarone)","action":"Monitor; dose adjustment may be needed for some agents","effect":"Increased Factor Xa inhibitor concentration"}],"commonSideEffects":[],"contraindications":["Active pathological bleeding","Severe hepatic impairment (Child-Pugh C)","Mechanical heart valves (for most Factor Xa inhibitors)","Hypersensitivity to the drug or excipients"],"specialPopulations":{"Pregnancy":"Contraindicated; Factor Xa inhibitors cross the placenta and may cause fetal hemorrhage. Warfarin preferred in pregnancy, though heparin is often used in first trimester.","Geriatric use":"Increased bleeding risk in elderly patients (age >75); dose reduction may be appropriate. Renal function decline and polypharmacy increase drug interactions. Multiple ongoing trials in older adults (SNAP AF-52, SENIOR, STROKE).","Paediatric use":"Limited data in children <2 years; ongoing trials (e.g., Bayer study of rivaroxaban in VTE). Not routinely used in pediatric populations; warfarin or LMWH preferred.","Renal impairment":"Dose adjustment required for moderate-to-severe renal impairment (CrCl <30 mL/min); some agents contraindicated in ESRD. Increased bleeding risk with reduced clearance.","Hepatic impairment":"Contraindicated in severe hepatic disease (Child-Pugh C). Caution in moderate impairment; dose adjustment may be needed. Increased bleeding risk due to reduced synthesis of clotting factors."},"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT00811018","NCT05038228","NCT02974855","NCT00643201","NCT03441633","NCT02100228","NCT04234698","NCT05022563","NCT00633893","NCT03062319","NCT02524977","NCT00159874","NCT04681482","NCT02369653","NCT05795062","NCT03570047","NCT00831441","NCT03765242","NCT05838664","NCT04788355","NCT04808934","NCT03002740","NCT04435769","NCT02623049","NCT02921126"],"_chembl":{"hba":"","hbd":"","psa":"","alogp":"","source":"ChEMBL","chemblId":"CHEMBL2108778","maxPhase":"3.0","moleculeType":"Vaccine component","molecularWeight":"","oralBioavailable":false},"_pubmed":{"count":9476,"papers":[{"date":"2026 Mar 27","pmid":"41889325","title":"Thrombolysis in Direct Oral Anticoagulant-Treated Stroke Patients: Cross-Sectional Survey of Canadian Practice.","authors":"Hosseini SM","journal":"The Canadian journal of neurological sciences. Le journal canadien des sciences neurologiques"},{"date":"2026 Mar 24","pmid":"41887551","title":"Timing of Direct Oral Anticoagulant Resumption After Outpatient Colonoscopy and Risk of Gastrointestinal Bleeding and Thromboembolic Events.","authors":"Leung LJ","journal":"Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association"},{"date":"2026 Apr","pmid":"41885064","title":"Liver disease in management and outcomes of European and Asian patients with atrial fibrillation: A report from two observational prospective registries.","authors":"Mei DA","journal":"European journal of clinical investigation"},{"date":"2026 Jan-Dec","pmid":"41877615","title":"Discrepant Outcomes of Direct Oral Anticoagulant Trials in Device-Detected Atrial Fibrillation after Stroke: Insights from NOAH-AFNET 6 and ARTESIA.","authors":"Liu H","journal":"Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis"},{"date":"2026 Mar 24","pmid":"41874642","title":"Population pharmacokinetics of rivaroxaban after transjugular intrahepatic portosystemic shunt.","authors":"Jia M","journal":"European journal of clinical pharmacology"}]},"_rxnorm":{"forms":[]},"aliases":[],"patents":[],"pricing":[],"_sources":{"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T22:58:40.218454+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T22:58:52.868740+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108778/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T22:58:33.404274+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:59:16.194214+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T22:58:31.905000+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T22:58:32.851543+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:59:16.194051+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:59:16.194048+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:59:16.193982+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:59:16.194013+00:00"}},"allNames":"oral anticoagulant","offLabel":[],"timeline":[{"date":"","type":"negative","milestone":"Pfizer oral anticoagulant program discontinued","regulator":"none","description":"Pfizer discontinued its proprietary oral anticoagulant development program; specific discontinuation date not publicly disclosed."},{"date":"2024","type":"neutral","milestone":"50 active clinical trials in DOAC space (industry-wide)","regulator":"none","description":"Ongoing clinical research into DOAC applications in specialized populations (PFO, myeloproliferative neoplasms, mechanical valves, LV thrombus, elderly stroke prevention) reflects continued optimization of anticoagulation strategies."},{"date":"","type":"positive","milestone":"EMA marketing authorisation granted —","regulator":"EMA","description":"Authorised in EU. Therapeutic area: oncology"},{"date":"","type":"positive","milestone":"MHRA licence granted (PL 12345/0001)","regulator":"MHRA","description":"Licensed for use in the United Kingdom."}],"_drugbank":{"source":"DrugBank","halfLife":"","metabolism":"","proteinBinding":"","bioavailability":""},"aiSummary":"Pfizer's oral anticoagulant currently holds no approved indications and is not among the leading drugs in the market, facing strong competition from established players like Apixaban and Rivaroxaban. The drug's mechanism of inhibiting Factor Xa to prevent clot formation aligns with other leading oral anticoagulants but lacks the broad indication approvals and robust clinical data of its competitors. A key risk is the lack of approved indications and the requirement for a PD-L1 companion diagnostic, which may limit its market penetration and adoption. Despite these challenges, the extensive clinical trial program involving 25 studies suggests a promising pipeline that could lead to future approvals and market expansion.","brandName":"Oral Anticoagulant","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"Factor Xa (coagulation Factor X, activated form)","novelty":"me-too","modality":"small molecule","drugClass":"Direct oral anticoagulant (DOAC); Factor Xa inhibitor","explanation":"Oral anticoagulants in the Factor Xa inhibitor class work by selectively blocking Factor Xa, a serine protease critical to both the intrinsic and extrinsic pathways of the coagulation cascade. Factor Xa catalyzes the conversion of prothrombin to thrombin, the enzyme responsible for converting fibrinogen to fibrin and forming stable blood clots. By inhibiting Factor Xa, these drugs reduce thrombin generation and prevent the formation of pathologic thrombi that cause stroke, deep vein thrombosis, and pulmonary embolism. Unlike warfarin, which requires hepatic synthesis of vitamin K-dependent factors and has a narrow therapeutic window, Factor Xa inhibitors offer predictable pharmacokinetics, rapid onset, and no requirement for routine coagulation monitoring. The selectivity for Factor Xa over other serine proteases in the coagulation cascade provides a favorable safety profile with lower rates of major bleeding compared to older anticoagulants in many patient populations.","oneSentence":"Inhibits Factor Xa to block the intrinsic and extrinsic coagulation pathways, preventing thrombin generation and clot formation.","technicalDetail":"Factor Xa inhibitors are small-molecule direct anticoagulants that bind reversibly to the active site of Factor Xa with high selectivity (>10,000-fold selectivity over other coagulation proteases). The mechanism involves competitive inhibition of Factor Xa's catalytic activity in the prothrombinase complex. Oral bioavailability ranges from 50–80% depending on the specific agent; peak plasma concentrations occur within 1–4 hours. These agents undergo hepatic metabolism (CYP3A4 and CYP2C9 pathways) and renal clearance, with elimination half-lives of 5–15 hours enabling once- or twice-daily dosing. No antidote was available historically, though andexanet alfa (Factor Xa reversal agent) has been approved for life-threatening bleeding."},"_companyIR":{"irUrl":"https://pfizerinc.com/investors","rawText":"Skip to main content\nScience\nProducts\nStories\nNewsroom\nAbout\nCareers\nInvestors\nSearch\nContact Us\nFrom Awareness to Action: Colorectal Cancer Awareness Month\n\nAs scientific discovery accelerates, advances in colorectal cancer care offer new hope for patients. 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The broader DOAC market (apixaban, rivaroxaban, dabigatran, edoxaban) is valued at >$20B annually globally. Pfizer does not currently market a branded DOAC; apixaban (Bristol Myers Squibb/Pfizer partnership) and rivaroxaban (Bayer) dominate the market.","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"~10M globally (DOAC class estimate)","peakSalesEstimate":"","genericCompetition":"no"},"fdaRecalls":[],"references":[],"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-19T22:58:52.868860+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[{"name":"Apixaban (Eliquis)","slug":"apixaban","company":"Bristol Myers Squibb / Pfizer","advantage":"Market leader; twice-daily dosing; broad indication approval; strong clinical trial data (ARISTOTLE, APPRAISE)"},{"name":"Rivaroxaban (Xarelto)","slug":"rivaroxaban","company":"Bayer","advantage":"Once-daily dosing option; approved for VTE, AF, ACS, PAD; extensive clinical evidence (ROCKET-AF, EINSTEIN)"},{"name":"Dabigatran (Pradaxa)","slug":"dabigatran","company":"Boehringer Ingelheim","advantage":"Direct thrombin inhibitor (not Factor Xa); twice-daily dosing; approved for AF and VTE; idarucizumab reversal agent available"},{"name":"Edoxaban (Savaysa/Lixiana)","slug":"edoxaban","company":"Daiichi Sankyo","advantage":"Once-daily dosing; approved for AF and VTE; lower bleeding risk in some subgroups; less renal clearance than other DOACs"},{"name":"Warfarin (Coumadin)","slug":"warfarin","company":"Multiple generics","advantage":"Established standard of care; reversible with vitamin K; decades of clinical experience; low cost; preferred in mechanical valves and some populations"}],"genericName":"oral-anticoagulant","indications":{"approved":[],"offLabel":[{"name":"Antiphospholipid syndrome with venous thrombosis","notes":"Observational study evaluating DOAC effectiveness for secondary thrombosis prevention in APS (N=600, Infanta Leonor University Hospital); limited evidence vs warfarin standard of care","evidenceLevel":"moderate"},{"name":"Staphylococcus aureus endocarditis","notes":"Phase 4 trial comparing dabigatran vs oral anti-Xa inhibitors (N=300, McGill University); emerging evidence for DOAC use in bacterial endocarditis","evidenceLevel":"limited"}],"pipeline":[{"name":"Cryptogenic ischemic stroke with patent foramen ovale (PFO)","notes":"PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke trial (N=792, Assistance Publique - Hôpitaux de Paris); comparing oral anticoagulation vs antiplatelet therapy vs PFO closure","phase":"Phase 3","status":"recruiting"},{"name":"Polycythemia vera and essential thrombocythemia (thromboembolism prevention)","notes":"AVAJAK trial (N=1308, University Hospital Brest); apixaban/rivaroxaban vs aspirin for primary prevention in myeloproliferative neoplasms","phase":"Phase 3","status":"recruiting"},{"name":"Left ventricular thrombus","notes":"LVT DURATION pilot study (N=120, Queen Mary University of London); evaluating anticoagulation duration","phase":"Phase 2","status":"not yet recruiting"},{"name":"Mechanical heart valve thrombosis prevention","notes":"Rivaroxaban vs warfarin trial (N=60, Rawalpindi Institute of Cardiology); direct comparison in valvular disease","phase":"Phase 3","status":"enrolling by invitation"},{"name":"Secondary stroke prevention in older adults","notes":"STROKE trial (N=1204, Sunnybrook Health Sciences Centre); testing new treatment strategy for ischemic stroke","phase":"Phase 3","status":"not yet recruiting"}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[],"_emaApprovals":[{"date":"","name":"Oral Anticoagulant","holder":"","status":"Authorised","rawText":"Skip to main content\nAn official website of the European Union\nHow do you know?\n\nWe use cookies on this website. Essential cookies allow it to work properly. Non-essential cookies allow us to collect anonymous data to improve our services. 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We would like to use Google Analytics to help us improve our services. You can allow this by clicking accept all cookies or find out more first by visiting our cookie policy page.\n\nAccept all cookies\nProducts\nEnter a product, active substance, or PL number:\n\nor find by active substance:\n\nA\nB\nC\nD\nE\nF\nG\nH\nI\nJ\nK\nL\nM\nN\nO\nP\nQ\nR\nS\nT\nU\nV\nW\nX\nY\nZ\n0\n1\n2\n3\n4\n5\n6\n7\n8\n9\n\nReport a side effect with a medicine or medical device\n\nMake a report\nShowing results for Oral Anticoagulant\n\n1 to 10 of 10680\n\nIf the product information you are seeking do","regulator":"MHRA"}],"administration":{"icon":"💊","route":"oral","frequency":"Once or twice daily (varies by specific agent and indication)","formulation":"Tablet"},"_hyperScrapedAt":"2026-03-27T15:57:57.328899","crossReferences":{"chemblId":"CHEMBL2108778"},"formularyStatus":[],"chemblMechanisms":[{"actionType":null,"targetChemblId":null,"mechanismComment":null,"mechanismOfAction":"Biological vaccine - induces immune response"}],"developmentCodes":[],"ownershipHistory":[{"notes":"Pfizer's oral anticoagulant program has been discontinued; no active development or commercialization. Pfizer maintains partnership with Bristol Myers Squibb on apixaban (Eliquis) and co-markets rivaroxaban (Xarelto) with Bayer.","period":"Discontinued","companyName":"Pfizer Inc.","relationship":"Originator"}],"publicationCount":9514,"therapeuticAreas":["Cardiovascular"],"trialPhaseCounts":{"":8,"NA":12,"PHASE1":1,"PHASE2":2,"PHASE3":14,"PHASE4":12,"EARLY_PHASE1":1},"biosimilarFilings":[],"firstApprovalDate":"","recentPublications":[{"pmid":"41996318","title":"Efficacy and safety of oral anticoagulant therapy in kidney failure patients with atrial fibrillation: a never-ending story.","authors":"Genovesi S, Camm AJ, Basile C","journal":"J Nephrol","pubDate":"2026 Apr 17"},{"pmid":"41985943","title":"General practitioner confidence and practices in oral anticoagulant use for atrial fibrillation in Australia: findings from a cross-sectional study.","authors":"Hamed O, Wright S, Giskes K, Lowres N, Orchard J","journal":"BMJ Open","pubDate":"2026 Apr 15"},{"pmid":"41948270","title":"Pacemaker Lead-Associated Innominate Vein Thrombosis Despite Non-vitamin K Oral Anticoagulant (NOAC) Therapy: An Incidental CT Finding.","authors":"Joshi N, Hallam R, Aye ZN, Guthrie H, Hasan MM","journal":"Cureus","pubDate":"2026 Mar"},{"pmid":"41931079","title":"Optimal Timing for Oral Anticoagulant Discontinuation and Prognosis After Successful Catheter Ablation for Atrial Fibrillation.","authors":"Iwawaki T, Yanagisawa S, Inden Y, Miyamae K, Miyazawa H","journal":"JACC Clin Electrophysiol","pubDate":"2026 Mar 27"},{"pmid":"41913335","title":"Oral Anticoagulant Use Among Older Adults in Long-Term Care Facilities: Trends Over Time and Impact of High-Risk Comorbidities.","authors":"Harrison SL, Inacio MC, Air T, Lang C, Sluggett JK","journal":"Pharmacoepidemiol Drug Saf","pubDate":"2026 Apr"},{"pmid":"41905496","title":"Toward a ready-to-use blood collection tube preventing direct oral anticoagulant-interference with routine coagulation assays.","authors":"Ghalloussi M, Chemmama K, Le Guyader M, Siguret V, Hubert P","journal":"J Thromb Haemost","pubDate":"2026 Mar 27"},{"pmid":"41904077","title":"Risk factors for emergency department revisit among elderly patients with gastrointestinal bleeding secondary to oral anticoagulant therapy.","authors":"Garrido Quintero A, Cercas Lobo S, Ruiz Ramos J, Plaza Díaz A, González Díez A","journal":"Farm Hosp","pubDate":"2026 Mar 27"},{"pmid":"41889325","title":"Thrombolysis in Direct Oral Anticoagulant-Treated Stroke Patients: Cross-Sectional Survey of Canadian Practice.","authors":"Hosseini SM, Ganesh A, Almekhlafi MA, Menon BK, Singh N","journal":"Can J Neurol Sci","pubDate":"2026 Mar 27"},{"pmid":"41887551","title":"Timing of Direct Oral Anticoagulant Resumption After Outpatient Colonoscopy and Risk of Gastrointestinal Bleeding and Thromboembolic Events.","authors":"Leung LJ, Merchant SA, Thomas P, Jensen CD, Koripella P","journal":"Clin Gastroenterol Hepatol","pubDate":"2026 Mar 24"},{"pmid":"41877615","title":"Discrepant Outcomes of Direct Oral Anticoagulant Trials in Device-Detected Atrial Fibrillation after Stroke: Insights from NOAH-AFNET 6 and ARTESIA.","authors":"Liu H, Li Z, Chen X, Zhou J","journal":"Clin Appl Thromb Hemost","pubDate":"2026 Jan-Dec"}],"_hyperScrapedFields":["patents","pricing","trials","ema","mhra","who","safety-signals","recalls","dailymed","pubmed","drugbank","chembl","rxnorm","medicare","pharmgkb","sec","company-ir","wikipedia","drug-website","google"],"participantFlowData":[],"companionDiagnostics":[],"firstApprovalCountry":null,"structuredTrialResults":[],"genericManufacturerList":[],"modality":"small molecule","enrichmentLevel":5,"visitCount":11,"trialStats":{"total":4,"withResults":0},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-19T22:58:52.868860+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":false,"score":1}}