{"id":"engensis-vm202","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions (pain, swelling, erythema)"},{"rate":null,"effect":"Muscle pain or myalgia"},{"rate":null,"effect":"Transient elevation in liver enzymes"}]},"_chembl":{"chemblId":"CHEMBL3990043","moleculeType":"Gene"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"VM202 delivers a HGF-encoding plasmid via intramuscular injection, which is taken up by muscle cells and produces HGF protein locally. HGF stimulates new blood vessel formation (angiogenesis) and promotes tissue regeneration, improving blood flow and function in ischemic tissues. This approach aims to restore perfusion and reduce symptoms in conditions characterized by inadequate blood supply.","oneSentence":"VM202 is a plasmid DNA therapeutic that encodes hepatocyte growth factor (HGF) to promote angiogenesis and tissue repair in ischemic tissues.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:10:52.828Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Critical limb ischemia (CLI) / peripheral arterial disease"},{"name":"Diabetic foot ulcers"}]},"trialDetails":[{"nctId":"NCT02427464","phase":"PHASE3","title":"Phase 3 Gene Therapy for Painful Diabetic Neuropathy","status":"COMPLETED","sponsor":"Helixmith Co., Ltd.","startDate":"2016-04","conditions":"Painful Diabetic Neuropathy, Diabetic Neuropathy, Painful","enrollment":507},{"nctId":"NCT04055090","phase":"PHASE3","title":"Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy","status":"COMPLETED","sponsor":"Helixmith Co., Ltd.","startDate":"2019-02-04","conditions":"Painful Diabetic Neuropathy, Diabetic Neuropathy, Painful","enrollment":101},{"nctId":"NCT02563522","phase":"PHASE3","title":"Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers","status":"TERMINATED","sponsor":"Helixmith Co., Ltd.","startDate":"2017-06-27","conditions":"Foot Ulcer, Diabetic","enrollment":44},{"nctId":"NCT01475786","phase":"PHASE2","title":"Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy","status":"COMPLETED","sponsor":"Helixmith Co., Ltd.","startDate":"2012-08","conditions":"Painful Diabetic Neuropathies","enrollment":104},{"nctId":"NCT00696124","phase":"PHASE1","title":"Safety Study of Gene Therapy in Treating Critical Leg Ischemia","status":"COMPLETED","sponsor":"Helixmith Co., Ltd.","startDate":"2007-04-03","conditions":"Critical Limb Ischemia","enrollment":12},{"nctId":"NCT05361031","phase":"PHASE1, PHASE2","title":"The Safety and Tolerability of Engensis (VM202) in Patients With Charcot-Marie-Tooth Disease Subtype 1A (CMT1A)","status":"COMPLETED","sponsor":"Helixmith Co., Ltd.","startDate":"2020-09-21","conditions":"CMT","enrollment":12},{"nctId":"NCT01064440","phase":"PHASE2","title":"Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia","status":"COMPLETED","sponsor":"Helixmith Co., Ltd.","startDate":"2010-07-09","conditions":"Critical Limb Ischemia","enrollment":52},{"nctId":"NCT01002235","phase":"PHASE1, PHASE2","title":"Gene Therapy for Painful Diabetic Neuropathy","status":"COMPLETED","sponsor":"Helixmith Co., Ltd.","startDate":"2010-02","conditions":"Painful Diabetic Peripheral Neuropathy","enrollment":12},{"nctId":"NCT01422772","phase":"PHASE1, PHASE2","title":"Safety Study of Gene Therapy for Ischemic Heart Disease in Korea","status":"COMPLETED","sponsor":"Helixmith Co., Ltd.","startDate":"2007-01","conditions":"Ischemic Heart Disease","enrollment":9}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"Engensis (VM202)","genericName":"Engensis (VM202)","companyName":"Helixmith Co., Ltd.","companyId":"helixmith-co-ltd","modality":"Biologic","firstApprovalDate":"","aiSummary":"VM202 is a plasmid DNA therapeutic that encodes hepatocyte growth factor (HGF) to promote angiogenesis and tissue repair in ischemic tissues. Used for Critical limb ischemia (CLI) / peripheral arterial disease, Diabetic foot ulcers.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}