{"id":"xyntha","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"HAEMORRHAGE","source":"FDA FAERS","actionTaken":"Reported 240 times"},{"date":"","signal":"HAEMARTHROSIS","source":"FDA FAERS","actionTaken":"Reported 100 times"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"Reported 71 times"},{"date":"","signal":"JOINT SWELLING","source":"FDA FAERS","actionTaken":"Reported 54 times"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"Reported 54 times"},{"date":"","signal":"FACTOR VIII INHIBITION","source":"FDA FAERS","actionTaken":"Reported 43 times"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"Reported 36 times"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"Reported 30 times"},{"date":"","signal":"JOINT INJURY","source":"FDA FAERS","actionTaken":"Reported 29 times"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"Reported 27 times"}],"drugInteractions":[{"drug":"Aspirin","action":"Avoid","effect":"Increased risk of bleeding"},{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"NSAIDs","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Anticoagulants","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Antiplatelets","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Selective serotonin reuptake inhibitors (SSRIs)","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Serotonin-norepinephrine reuptake inhibitors (SNRIs)","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Thrombolytics","action":"Avoid","effect":"Increased risk of bleeding"},{"drug":"Heparin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Low molecular weight heparin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Fibrinolytics","action":"Avoid","effect":"Increased risk of bleeding"},{"drug":"Dipyridamole","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Clopidogrel","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Ticlopidine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Abciximab","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Eptifibatide","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Tirofiban","action":"Monitor","effect":"Increased risk of bleeding"}],"commonSideEffects":[{"effect":"Headache","drugRate":"24%","severity":"common","organSystem":""},{"effect":"Arthralgia","drugRate":"23%","severity":"common","organSystem":""},{"effect":"Pyrexia","drugRate":"23%","severity":"common","organSystem":""},{"effect":"Cough","drugRate":"12%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"8%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"8%","severity":"common","organSystem":""},{"effect":"Asthenia","drugRate":"6%","severity":"common","organSystem":""}],"contraindications":["Hypersensitivity to the active component or any of the excipients. Severe thrombotic disorders, such as disseminated intravascular coagulation (DIC), or vasculitis. History of thromboembolic events, such as stroke or myocardial infarction. Ischemic heart disease. Severe hypertension. Known bleeding disorders, such as hemophilia A or B. Pregnancy. Lactation."],"seriousAdverseEvents":[{"effect":"Factor VIII inhibitors","drugRate":"2.4%","severity":"serious"},{"effect":"Anti-FVIII antibodies","drugRate":"0.6%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=xyntha","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:52:50.574307+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Xyntha","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:52:57.810366+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:52:56.341747+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:52:50.652304+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=xyntha","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:52:56.773010+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Coagulation factor VIII exogenous protein","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:52:57.810297+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2109137/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:52:57.473655+00:00"}},"offLabel":[],"timeline":[{"date":"1937-01-01","type":"neutral","_source":"Wikipedia","milestone":"Factor VIII first discovered","regulator":"none"},{"date":"1979-01-01","type":"positive","_source":"Wikipedia","milestone":"Molecular identification of Factor VIII protein","regulator":"none"}],"_dailymed":{"setId":"25ea1c3c-14a2-ef11-302e-012bd683924f","title":"XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS LLC]","labeler":""},"aiSummary":"Xyntha is a marketed drug by Pfizer Inc. for Hemophilia A. It is a recombinant coagulation factor VIII, replacing the deficient protein in patients. This treatment helps prevent bleeding episodes and improve quality of life. Xyntha's clinical differentiation lies in its high efficacy and safety profile. Its commercial significance is substantial, with a large patient population. Pipeline developments are focused on improving treatment outcomes and reducing side effects. Xyntha's mechanism involves replacing the deficient coagulation factor VIII protein.","brandName":"Xyntha","ecosystem":[],"isGeneric":true,"mechanism":{"target":"Coagulation factor VIII","novelty":"Best-in-class","modality":"Biological","drugClass":"Recombinant protein therapy","explanation":"","oneSentence":"","technicalDetail":"Xyntha is a recombinant coagulation factor VIII protein, produced through genetic engineering. It has a similar structure and function to the native protein, but with improved stability and efficacy. Xyntha is administered intravenously, and its effects are rapid and sustained. This treatment has revolutionized the management of Hemophilia A, providing improved outcomes and quality of life for patients."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"Factor VIII","extract":"Coagulation factor VIII is an essential blood clotting protein. In humans, it is encoded by F8 gene. Defects in this gene result in hemophilia A, an X-linked bleeding disorder.","wiki_history":"== History ==\nFactor VIII  was first discovered in 1937, but it was not until 1979 that its purification by Edward Tuddenham, Frances Rotblat and coworkers led to the molecular identification of the protein."},"commercial":{"annualCostUS":"$40,000 - $60,000","genericStatus":"Biologic — patent protected","patientPopulation":"people with hemophilia A","peakSalesEstimate":"Not publicly reported"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=xyntha","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=xyntha","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://en.wikipedia.org/wiki/xyntha","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":6,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":7,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:52:59.124682+00:00","fieldsConflicting":1,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Advate","company":"Baxter","advantage":"Standard Factor VIII product with no half-life extension, effective in stopping and controlling bleeding"},{"name":"Kogenate FS","company":"Bayer","advantage":"Standard Factor VIII product with no half-life extension, effective in stopping and controlling bleeding"},{"name":"Kovaltry","company":"Bayer","advantage":"Standard Factor VIII product with no half-life extension, effective in stopping and controlling bleeding"},{"name":"Novoeight","company":"Novo Nordisk","advantage":"Factor VIII concentrate with thorough safety and effectiveness testing"},{"name":"Nuwiq","company":"Takeda","advantage":"Factor VIII concentrate with thorough safety and effectiveness testing"},{"name":"Recombinate","company":"Baxter","advantage":"Factor VIII concentrate with thorough safety and effectiveness testing"},{"name":"Adynovate","company":"Sanofi","advantage":"Extended half-life Factor VIII product, offers long-lasting protection against bleeding"},{"name":"Afstyla","company":"Bayer","advantage":"Extended half-life Factor VIII product, offers long-lasting protection against bleeding"},{"name":"Altuviiio","company":"Takeda","advantage":"Extended half-life Factor VIII product, controls bleeding well with less frequency"},{"name":"Eloctate","company":"Biogen","advantage":"Extended half-life Factor VIII product, controls bleeding well with less frequency"},{"name":"Esperoct","company":"Novo Nordisk","advantage":"Extended half-life Factor VIII product, controls bleeding well with less frequency"},{"name":"Jivi","company":"Bayer","advantage":"Extended half-life Factor VIII product for prophylactic treatment, offers flexibility in managing Hemophilia A"}],"genericName":"xyntha","indications":{"approved":[{"name":"Hemophilia A","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_drugWebsite":{"url":"https://www.xyntha.com","content":"Cookie Preferences\nSkip to main content\nHome\nImportant Safety Information\nIndication\nXYNTHA Prescribing Information\nXYNTHA SOLOFUSE Prescribing Information\nHealth Care Professionals\nEfficacy and Safety\nDevices and Kits\nResources and Support\nFree Trial Prescription Program\nSign up for Resources\nWhat Is XYNTHA?\nXYNTHA ® Antihemophilic Factor (Recombinant) is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia A. Hemophilia A is also called classic hemophilia. Your doctor might also give you XYNTHA before surgical procedures.\nXYNTHA is not used to treat von Willebrand’s disease.\nX\nNot actual patients.\nDemonstrated bleed treatment, control, and protection—\nXYNTHA SOLOFUSE helps you live actively\nXYNTHA SOLOFUSE\nPlay Video\nNot actual patients.\nProven bleed control\nand protection \nDemonstrated across clinical trials of previously treated patients (PTPs).\nAll-in-one reconstitution \nBe prepared to bring it—preparation with all-in-one reconstitution in a travel-ready kit.\nNot actual patients.\nFree trial offer* \nWhether it is your first time on XYNTHA or if you are switching to prophy, you may be eligible to receive a 1-month trial supply of up to 20,000 IU at no cost.\n*Terms and conditions apply.\nResources and support \nMore than just factor—take a look at some of the resources and support Pfizer Hemophilia has to offer.\nEnvironmentally friendly\ntravel-ready kit \nThe cardboard travel-ready kit still comes compact and loaded with everything you need to infuse on the go.\nUP NEXT\nEfficacy and Safety\nIMPORTANT SAFETY INFORMATION AND INDICATION\nEXPAND\nImportant Safety Information\nCall your health care provider or go to the emergency department right away if you have any of the following symptoms because these may be signs of a serious allergic reaction: wheezing, difficulty breathing, chest tightness, turning blue (look at lips and gums), fast heartbeat, swelling of the face, faintness, rash, low blood pressure, or hives. XYNTHA conta"},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06940830","phase":"PHASE4","title":"Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa","status":"RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2025-05-21","conditions":"Hemophilia A","enrollment":250},{"nctId":"NCT04293523","phase":"","title":"A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health","status":"ACTIVE_NOT_RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2020-03-30","conditions":"Hemophilia A","enrollment":427},{"nctId":"NCT06224907","phase":"PHASE3","title":"Phase 3 Study for Efficacy and Safety Outcomes Data in Japanese Patients With Severe Hemophilia A","status":"ACTIVE_NOT_RECRUITING","sponsor":"BioMarin Pharmaceutical","startDate":"2023-12-25","conditions":"Hemophilia A","enrollment":6},{"nctId":"NCT03588299","phase":"PHASE1, PHASE2","title":"Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a \"Shuttle\"","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bayer","startDate":"2018-11-07","conditions":"Hemophilia A","enrollment":11},{"nctId":"NCT07088458","phase":"","title":"An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A","status":"NOT_YET_RECRUITING","sponsor":"Bayer","startDate":"2026-04-30","conditions":"Hemophilia A","enrollment":40},{"nctId":"NCT06998524","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2025-06-27","conditions":"Von Willebrand Disease, Type 3","enrollment":75},{"nctId":"NCT06883240","phase":"","title":"An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2025-04-29","conditions":"Von Willebrand Disease, Type 3","enrollment":40},{"nctId":"NCT06111638","phase":"PHASE2, PHASE3","title":"Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs","status":"RECRUITING","sponsor":"Shanghai Xinzhi BioMed Co., Ltd.","startDate":"2024-01-03","conditions":"Hemophilia A","enrollment":55},{"nctId":"NCT07416526","phase":"PHASE3","title":"A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A","status":"NOT_YET_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2026-05-09","conditions":"Hemophilia A","enrollment":126},{"nctId":"NCT07032792","phase":"PHASE2","title":"Factor VIII Inhibitor Bypass Activity (FEIBA) Versus 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Patient","enrollment":18},{"nctId":"NCT05568719","phase":"PHASE3","title":"Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively","status":"RECRUITING","sponsor":"Pfizer","startDate":"2022-12-28","conditions":"Hemophilia A, Hemophilia B","enrollment":173},{"nctId":"NCT04953884","phase":"PHASE3","title":"Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age","status":"COMPLETED","sponsor":"Octapharma","startDate":"2021-09-22","conditions":"Von Willebrand Disease","enrollment":12},{"nctId":"NCT04158934","phase":"","title":"A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A","status":"ACTIVE_NOT_RECRUITING","sponsor":"Baxalta now part of Shire","startDate":"2020-07-09","conditions":"Hemophilia A","enrollment":207},{"nctId":"NCT04563520","phase":"PHASE3","title":"SAFE Study: Safety of aPCC Following Emicizumab 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Previous Trial With Efanesoctocog Alfa","status":"RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2025-03-06","conditions":"Severe Haemophilia A","enrollment":104},{"nctId":"NCT05181618","phase":"PHASE4","title":"A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2022-06-20","conditions":"Severe Hemophilia A, Moderate Hemophilia A","enrollment":136},{"nctId":"NCT04158648","phase":"PHASE3","title":"A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2020-02-10","conditions":"Mild Hereditary Factor VIII Deficiency Disease Without Inhibitor, Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor, Hemophilia A","enrollment":73},{"nctId":"NCT05147662","phase":"PHASE3","title":"A Study to Learn How Safe the Study Treatment BAY94-9027 is and How it Affects the Body in Previously Treated Children Aged 7 to Less Than 12 Years With Severe Hemophilia A, a Genetic Bleeding Disorder That is Caused by the Lack of a Protein Called Clotting Factor 8 (FVIII) in the Blood","status":"COMPLETED","sponsor":"Bayer","startDate":"2022-03-23","conditions":"Treatment of Bleeding, Prophylaxis of Bleeding, Hemophilia A","enrollment":36},{"nctId":"NCT06222697","phase":"","title":"A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A","status":"RECRUITING","sponsor":"Bayer","startDate":"2024-01-24","conditions":"Hemophilia A, Prophylaxis of Bleeding, Treatment of Bleeding","enrollment":20},{"nctId":"NCT05022459","phase":"","title":"Prevention of Bleeding in Patients With Moderate and Severe Hemophilia A Playing Sports: A Comparison Between Factor VIII and Emicizumab Prophylaxis","status":"RECRUITING","sponsor":"Wayne State University","startDate":"2023-08-16","conditions":"Hemophilia A","enrollment":72},{"nctId":"NCT05936580","phase":"PHASE4","title":"Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery","status":"RECRUITING","sponsor":"Octapharma","startDate":"2026-04","conditions":"Hemophilia A","enrollment":28},{"nctId":"NCT05768386","phase":"","title":"A Long-Term Follow-Up Study in Severe Hemophilia A Subjects Who Received BMN 270 in a Prior BioMarin Clinical Trial (270-401)","status":"ENROLLING_BY_INVITATION","sponsor":"BioMarin Pharmaceutical","startDate":"2023-01-01","conditions":"Hemophilia A","enrollment":172},{"nctId":"NCT07129343","phase":"PHASE3","title":"A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD)","status":"RECRUITING","sponsor":"Takeda","startDate":"2025-10-13","conditions":"Von Willebrand Disease (VWD)","enrollment":20},{"nctId":"NCT06738485","phase":"PHASE3","title":"Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products","status":"RECRUITING","sponsor":"CSL Behring","startDate":"2025-01-09","conditions":"Congenital Hemophilia A","enrollment":60},{"nctId":"NCT07314983","phase":"","title":"Long-term Anticoagulation in a Patient With Severe Hemophilia A","status":"RECRUITING","sponsor":"University Hospital, Strasbourg, France","startDate":"2025-09-22","conditions":"Hemophilia A","enrollment":1},{"nctId":"NCT04204408","phase":"PHASE2","title":"A Research Study Investigating Mim8 in People With Haemophilia A","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2020-01-10","conditions":"Healthy Volunteers, Haemophilia A With or Without Inhibitors","enrollment":275},{"nctId":"NCT06752850","phase":"PHASE4","title":"A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2024-12-19","conditions":"Haemophilia A (Moderate or Severe), Hemophilia, Classic, Haemophilia","enrollment":37},{"nctId":"NCT04146376","phase":"","title":"Von Willebrand Factor in Pregnancy (VIP) Study","status":"RECRUITING","sponsor":"University of Washington","startDate":"2019-10-12","conditions":"Von Willebrand Diseases","enrollment":110},{"nctId":"NCT03754790","phase":"PHASE3","title":"Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX","status":"ACTIVE_NOT_RECRUITING","sponsor":"Genzyme, a Sanofi 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