{"id":"collagenase-santyl-vehicle","safety":{"commonSideEffects":[{"rate":null,"effect":"Bleeding or increased wound drainage"},{"rate":null,"effect":"Erythema at application site"},{"rate":null,"effect":"Dermatitis or skin irritation"}]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Collagenase Santyl Vehicle","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T05:25:27.234003+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T05:25:42.238357+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T05:25:34.093547+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Collagenase Santyl Vehicle","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T05:25:34.889460+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Collagen hydrolytic enzyme","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:25:35.667231+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108709/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:25:35.559168+00:00"}},"_dailymed":null,"aiSummary":"Collagenase Santyl Vehicle, marketed by Healthpoint, is a well-established product in the debridement market. A key strength is the protection provided by its composition patent, which does not expire until 2028. The primary risk is the lack of recent trial results to support ongoing efficacy and safety claims, potentially impacting market confidence.","mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Collagenase is a protease enzyme that specifically cleaves collagen, the primary structural protein in necrotic (dead) tissue. By degrading collagen in the wound bed, it selectively removes devitalized tissue while preserving healthy tissue, promoting wound healing and facilitating the natural debridement process. The Santyl vehicle formulation provides a stable delivery system for topical application.","oneSentence":"Collagenase enzymatically breaks down collagen in necrotic tissue, facilitating debridement of wounds.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:19:32.066Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T05:25:42.238409+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"name":"Debridement of necrotic tissue in chronic wounds (pressure ulcers, diabetic ulcers, venous ulcers)"},{"name":"Burn wounds"}]},"trialDetails":[{"nctId":"NCT06690177","phase":"PHASE2","title":"Clinical Study to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase, Non-surgical Standard of Care, in Patients With Venous Leg Ulcers","status":"NOT_YET_RECRUITING","sponsor":"MediWound Ltd","startDate":"2025-04-30","conditions":"Venus Leg Ulcers","enrollment":45},{"nctId":"NCT03588130","phase":"PHASE2","title":"A Study to Evaluate the Safety and the Efficacy of EscharEx (EX-02 Formulation) in Debridement of Venous Leg Ulcers","status":"COMPLETED","sponsor":"MediWound Ltd","startDate":"2019-12-02","conditions":"Venous Leg Ulcer","enrollment":120},{"nctId":"NCT02004626","phase":"PHASE3","title":"Evaluate the Noninferiority of Medicines Treating Uninfected Pressure Ulcers.","status":"WITHDRAWN","sponsor":"Cristália Produtos Químicos Farmacêuticos Ltda.","startDate":"2015-01","conditions":"Pressure Ulcer","enrollment":""},{"nctId":"NCT01197898","phase":"PHASE4","title":"Wound Edge Changes Following Treatment With Santyl","status":"COMPLETED","sponsor":"Healthpoint","startDate":"2010-12","conditions":"Diabetic Foot Ulcers, Diabetic Foot Wounds","enrollment":10},{"nctId":"NCT01143714","phase":"PHASE4","title":"A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers","status":"COMPLETED","sponsor":"Healthpoint","startDate":"2010-06","conditions":"Diabetic Foot Ulcers","enrollment":57},{"nctId":"NCT00651820","phase":"PHASE4","title":"Effect of Collagenase on Healing and Scarring","status":"COMPLETED","sponsor":"Healthpoint","startDate":"2008-04","conditions":"Scarring, Impaired Wound Healing","enrollment":28}],"_emaApprovals":[],"_faersSignals":[],"crossReferences":{"chemblId":"CHEMBL2108709"},"_approvalHistory":[],"publicationCount":917,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Collagenase Santyl Vehicle","genericName":"Collagenase Santyl Vehicle","companyName":"Healthpoint","companyId":"healthpoint","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T05:25:42.238409+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}