{"id":"physioneal-35","safety":{"commonSideEffects":[{"rate":null,"effect":"Peritonitis"},{"rate":null,"effect":"Hyperglycemia"},{"rate":null,"effect":"Electrolyte imbalances"},{"rate":null,"effect":"Abdominal discomfort"}]},"_chembl":{"chemblId":"CHEMBL4802179","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Physioneal 35 is a bicarbonate-buffered peritoneal dialysis solution designed to improve biocompatibility compared to conventional lactate-buffered solutions. It contains a physiologic electrolyte composition and uses bicarbonate as the primary buffer, which reduces glucose degradation products and advanced glycation end products (AGEs) that can damage the peritoneal membrane. This formulation aims to preserve peritoneal function and reduce inflammation during long-term peritoneal dialysis treatment.","oneSentence":"Physioneal 35 is a peritoneal dialysis fluid formulated to optimize electrolyte balance and reduce peritoneal membrane injury during dialysate exchange.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:00:17.403Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Peritoneal dialysis in end-stage renal disease (ESRD)"}]},"trialDetails":[{"nctId":"NCT03994471","phase":"PHASE3","title":"Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.","status":"RECRUITING","sponsor":"Iperboreal Pharma Srl","startDate":"2022-12-14","conditions":"End Stage Renal Disease","enrollment":170},{"nctId":"NCT00567489","phase":"PHASE4","title":"IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients","status":"COMPLETED","sponsor":"Vantive Health LLC","startDate":"2008-01","conditions":"ESRD, Diabetes, CAPD","enrollment":137},{"nctId":"NCT00567398","phase":"PHASE3","title":"IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients","status":"COMPLETED","sponsor":"Vantive Health LLC","startDate":"2008-04","conditions":"ESRD, Diabetes","enrollment":43},{"nctId":"NCT00776191","phase":"PHASE4","title":"Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism","status":"TERMINATED","sponsor":"University of Erlangen-Nürnberg Medical School","startDate":"2008-09","conditions":"Endstage Renal Disease","enrollment":5}],"_emaApprovals":[],"_faersSignals":[{"count":33,"reaction":"DEATH"},{"count":11,"reaction":"PERITONITIS BACTERIAL"},{"count":9,"reaction":"CARDIAC FAILURE"},{"count":9,"reaction":"PERITONITIS"},{"count":6,"reaction":"SEPSIS"},{"count":5,"reaction":"CARDIAC ARREST"},{"count":5,"reaction":"PERITONEAL CLOUDY EFFLUENT"},{"count":4,"reaction":"MALAISE"},{"count":4,"reaction":"PERITONEAL DIALYSIS COMPLICATION"},{"count":3,"reaction":"ABDOMINAL PAIN"}],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Nephropaed-PD-01/B"],"phase":"marketed","status":"active","brandName":"Physioneal 35","genericName":"Physioneal 35","companyName":"University of Erlangen-Nürnberg Medical School","companyId":"university-of-erlangen-n-rnberg-medical-school","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Physioneal 35 is a peritoneal dialysis fluid formulated to optimize electrolyte balance and reduce peritoneal membrane injury during dialysate exchange. Used for Peritoneal dialysis in end-stage renal disease (ESRD).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}