{"id":"ugn-102","safety":{"commonSideEffects":[{"rate":null,"effect":"Dysuria"},{"rate":null,"effect":"Urinary frequency"},{"rate":null,"effect":"Hematuria"},{"rate":null,"effect":"Bladder irritation"}]},"_chembl":{"chemblId":"CHEMBL3669412","moleculeType":"Small molecule","molecularWeight":"318.38"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"UGN-102 combines mitomycin C, a DNA-crosslinking chemotherapy agent, with a reverse thermal gel carrier that allows prolonged dwell time in the bladder. The formulation enables sustained drug contact with bladder cancer cells while minimizing systemic absorption, enhancing local efficacy for upper tract urothelial carcinoma and other bladder malignancies.","oneSentence":"UGN-102 is a mitomycin C-based intravesical therapy that delivers chemotherapy directly to the bladder urothelium to treat non-muscle invasive bladder cancer.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:52:05.055Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Upper tract urothelial carcinoma"},{"name":"Non-muscle invasive bladder cancer"}]},"trialDetails":[{"nctId":"NCT06331299","phase":"PHASE3","title":"A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"UroGen Pharma Ltd.","startDate":"2024-08-29","conditions":"Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder","enrollment":99},{"nctId":"NCT05243550","phase":"PHASE3","title":"A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"UroGen Pharma Ltd.","startDate":"2022-03-01","conditions":"Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder","enrollment":240},{"nctId":"NCT05136898","phase":"PHASE3","title":"Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC)","status":"COMPLETED","sponsor":"UroGen Pharma Ltd.","startDate":"2021-11-30","conditions":"Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder","enrollment":8},{"nctId":"NCT04688931","phase":"PHASE3","title":"A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer","status":"TERMINATED","sponsor":"UroGen Pharma Ltd.","startDate":"2021-02-19","conditions":"Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder","enrollment":282},{"nctId":"NCT03558503","phase":"PHASE2","title":"A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer","status":"COMPLETED","sponsor":"UroGen Pharma Ltd.","startDate":"2018-10-15","conditions":"Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder","enrollment":63}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":15,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["UGN-102 (mitomycin) for intravesical solution"],"phase":"phase_3","status":"active","brandName":"UGN-102","genericName":"UGN-102","companyName":"UroGen Pharma Ltd.","companyId":"urogen-pharma-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"UGN-102 is a small molecule being studied as a treatment for low-grade intermediate-risk non-muscle invasive bladder cancer. It is being evaluated in a Phase 3 clinical trial (NCT05243550) as a primary chemopreventive treatment for this condition.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}