{"id":"rthrombin","safety":{"commonSideEffects":[{"rate":null,"effect":"Thrombosis"},{"rate":null,"effect":"Allergic reaction"},{"rate":null,"effect":"Fever"}]},"_chembl":null,"_fixedAt":"2026-03-30T17:36:00.872899","_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"rThrombin is a recombinant version of the natural coagulation enzyme thrombin, which catalyzes the final step of the coagulation cascade by cleaving fibrinogen into fibrin monomers that polymerize to form stable clots. It is used topically or systemically to achieve rapid hemostasis in surgical and bleeding situations where conventional methods are insufficient or contraindicated. By bypassing upstream coagulation defects, it can be effective in patients with factor deficiencies or inhibitors.","oneSentence":"rThrombin is a recombinant human thrombin that directly converts fibrinogen to fibrin to promote blood clotting and hemostasis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:52:40.021Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Control of bleeding in patients with Factor V deficiency"},{"name":"Hemostasis in surgical patients with coagulation disorders"}]},"_fixedFields":["pubmed(9)"],"trialDetails":[{"nctId":"NCT04814433","phase":"PHASE4","title":"Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation","status":"TERMINATED","sponsor":"NYU Langone Health","startDate":"2021-03-24","conditions":"Opioid Pain Medication","enrollment":46},{"nctId":"NCT02803905","phase":"PHASE2","title":"Islet Transplant Alone in OMENtum","status":"UNKNOWN","sponsor":"Lorenzo Piemonti","startDate":"2016-04","conditions":"Islets of Langerhans Transplantation, Diabetes Mellitus, Type 1","enrollment":12},{"nctId":"NCT04459871","phase":"PHASE3","title":"Safety and Efficacy of Topical Recombinant Human Thrombin(rhThrombin) for Surgical Hemostasis","status":"COMPLETED","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","startDate":"2019-11-11","conditions":"Surgical Hemostasis","enrollment":348},{"nctId":"NCT03611426","phase":"PHASE1, PHASE2","title":"Topical rhThrombin as an Adjunct to Hemostasis During Segmental Hepatectomy","status":"COMPLETED","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","startDate":"2017-11-29","conditions":"Hepatectomy","enrollment":84},{"nctId":"NCT00859547","phase":"PHASE4","title":"Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants","status":"COMPLETED","sponsor":"ZymoGenetics","startDate":"2009-03","conditions":"Blood Loss, Surgical","enrollment":30},{"nctId":"NCT00491608","phase":"PHASE3","title":"Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis","status":"COMPLETED","sponsor":"ZymoGenetics","startDate":"2007-06","conditions":"Spinal Surgery, Vascular Surgery","enrollment":234},{"nctId":"NCT00813904","phase":"PHASE4","title":"Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis","status":"COMPLETED","sponsor":"ZymoGenetics","startDate":"2009-01","conditions":"Blood Loss, Surgical","enrollment":31},{"nctId":"NCT00371215","phase":"PHASE2","title":"Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting","status":"COMPLETED","sponsor":"ZymoGenetics","startDate":"2006-08","conditions":"Surgical Hemostasis","enrollment":72},{"nctId":"NCT00245336","phase":"PHASE3","title":"Study of Recombinant Human Thrombin for Bleeding During Surgery","status":"COMPLETED","sponsor":"ZymoGenetics","startDate":"2005-10","conditions":"Surgical Hemostasis","enrollment":401}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":9,"recentPublications":[{"date":"2012 Nov","pmid":"23108631","title":"Safety and immunogenicity of recombinant human thrombin: a pooled analysis of results from 10 clinical trials.","journal":"Pharmacotherapy"},{"date":"2011 Oct","pmid":"22008340","title":"Recombinant human thrombin: safety and immunogenicity in pediatric burn wound excision.","journal":"Journal of pediatric surgery"},{"date":"2011 Dec","pmid":"21958507","title":"Immunogenicity and safety of re-exposure to recombinant human thrombin in surgical hemostasis.","journal":"Journal of the American College of Surgeons"},{"date":"2010 Feb","pmid":"20113940","title":"Safety and immunogenicity observations pooled from eight clinical trials of recombinant human thrombin.","journal":"Journal of the American College of Surgeons"},{"date":"2009 Nov 19","pmid":"19925675","title":"Topical recombinant thrombin at a concentration of 1000 IU/mL reliably shortens in vivo TTH and delivers durable hemostasis in the presence of heparin anticoagulation and clopidogrel platelet inhibition in a rabbit model of vascular bleeding.","journal":"Annals of surgical innovation and research"}],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"rThrombin","genericName":"rThrombin","companyName":"ZymoGenetics","companyId":"zymogenetics","modality":"Biologic","firstApprovalDate":"","aiSummary":"rThrombin is a recombinant human thrombin that directly converts fibrinogen to fibrin to promote blood clotting and hemostasis. Used for Control of bleeding in patients with Factor V deficiency, Hemostasis in surgical patients with coagulation disorders.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}