{"id":"prx302","safety":{"commonSideEffects":[{"rate":null,"effect":"Dysuria / urinary discomfort"},{"rate":null,"effect":"Hematuria"},{"rate":null,"effect":"Urinary retention"},{"rate":null,"effect":"Prostatitis / urinary tract infection"},{"rate":null,"effect":"Pelvic pain"}]},"_chembl":{"chemblId":"CHEMBL2364656","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PRX302 is a genetically engineered protease designed to target and activate PAR1 specifically in prostate tissue, leading to localized cell death and recruitment of immune cells. This mechanism aims to trigger an anti-tumor immune response while minimizing systemic toxicity by concentrating activity in the prostate. The drug is administered via transurethral injection directly into the prostate gland.","oneSentence":"PRX302 is a serine protease that selectively activates protease-activated receptor 1 (PAR1) in the prostate to induce localized tissue destruction and immune activation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:51:59.560Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Benign prostatic hyperplasia (BPH)"},{"name":"Prostate cancer (early-stage)"}]},"trialDetails":[{"nctId":"NCT06900348","phase":"","title":"Prostate Specific Antigen Levels of Individuals Living in Rural Areas","status":"NOT_YET_RECRUITING","sponsor":"Suleyman Demirel University","startDate":"2025-03-25","conditions":"Prostate Carcinoma","enrollment":308},{"nctId":"NCT03081481","phase":"PHASE2","title":"Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer","status":"COMPLETED","sponsor":"Sophiris Bio Corp","startDate":"2017-06-07","conditions":"Prostate Cancer","enrollment":38},{"nctId":"NCT00889707","phase":"PHASE2","title":"Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia","status":"COMPLETED","sponsor":"Sophiris Bio Corp","startDate":"2009-01","conditions":"Benign Prostatic Hyperplasia","enrollment":92},{"nctId":"NCT00379561","phase":"PHASE1","title":"PSA-Activated PSA-PAH1 for Locally Recurrent Prostate Cancer","status":"COMPLETED","sponsor":"Sophiris Bio Corp","startDate":"2006-03","conditions":"Prostate Cancer","enrollment":24},{"nctId":"NCT01966614","phase":"PHASE3","title":"Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH","status":"COMPLETED","sponsor":"Sophiris Bio Corp","startDate":"2013-10","conditions":"Benign Prostatic Hyperplasia","enrollment":479},{"nctId":"NCT02499848","phase":"PHASE2","title":"Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate Cancer","status":"COMPLETED","sponsor":"Sophiris Bio Corp","startDate":"2015-07","conditions":"Prostate Cancer","enrollment":18},{"nctId":"NCT01454349","phase":"PHASE1, PHASE2","title":"Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)","status":"COMPLETED","sponsor":"Sophiris Bio Corp","startDate":"2011-09","conditions":"Benign Prostatic Hyperplasia","enrollment":40},{"nctId":"NCT00686088","phase":"PHASE2","title":"An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy","status":"COMPLETED","sponsor":"Sophiris Bio Corp","startDate":"2008-02","conditions":"Locally Recurrent Prostate Cancer","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":24,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["topsalysin","Topsalysin"],"phase":"phase_3","status":"active","brandName":"PRX302","genericName":"PRX302","companyName":"Sophiris Bio Corp","companyId":"sophiris-bio-corp","modality":"Small molecule","firstApprovalDate":"","aiSummary":"PRX302 is a serine protease that selectively activates protease-activated receptor 1 (PAR1) in the prostate to induce localized tissue destruction and immune activation. Used for Benign prostatic hyperplasia (BPH), Prostate cancer (early-stage).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}