{"id":"mci-196","safety":{"commonSideEffects":[{"rate":null,"effect":"Discolored (dark) stool"},{"rate":null,"effect":"Gastrointestinal disorders"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Constipation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"MCI-196 (sucroferric oxyhydroxide) is an iron-based phosphate binder that works in the gastrointestinal lumen to bind dietary and secreted phosphate, preventing its absorption and reducing serum phosphate concentrations. This mechanism is particularly useful in patients with chronic kidney disease who have hyperphosphatemia, as elevated phosphate levels are associated with cardiovascular complications and mineral bone disease.","oneSentence":"MCI-196 is a phosphate binder that reduces serum phosphate levels by binding phosphate in the gastrointestinal tract.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:20:23.137Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hyperphosphatemia in patients with chronic kidney disease on dialysis"},{"name":"Hyperphosphatemia in patients with chronic kidney disease not on dialysis"}]},"trialDetails":[{"nctId":"NCT00542386","phase":"PHASE3","title":"A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2007-12","conditions":"Chronic Kidney Disease, Dialysis, Hyperphosphatemia","enrollment":642},{"nctId":"NCT00772382","phase":"PHASE3","title":"Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2008-12","conditions":"Chronic Kidney Disease, Dialysis, Hyperphosphatemia","enrollment":116},{"nctId":"NCT00506441","phase":"PHASE3","title":"A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2007-09","conditions":"Chronic Kidney Disease, Dialysis, Hyperphosphatemia","enrollment":245},{"nctId":"NCT00416520","phase":"PHASE3","title":"A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2007-06","conditions":"Chronic Kidney Disease, Hyperphosphatemia","enrollment":336},{"nctId":"NCT01976572","phase":"PHASE1","title":"Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2013-10","conditions":"Hyperphosphatemia, Chronic Kidney Disease","enrollment":18},{"nctId":"NCT00858637","phase":"PHASE3","title":"Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2009-03","conditions":"Chronic Kidney Disease","enrollment":260},{"nctId":"NCT00542815","phase":"PHASE3","title":"A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2007-11","conditions":"Chronic Kidney Disease, Dialysis, Hyperphosphatemia","enrollment":632},{"nctId":"NCT00497198","phase":"PHASE2","title":"Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2005-10","conditions":"Type 2 Diabetes","enrollment":183},{"nctId":"NCT01814917","phase":"PHASE3","title":"Long-term Extension Study of MCI-196","status":"TERMINATED","sponsor":"Tanabe Pharma Corporation","startDate":"2013-08","conditions":"Chronic Kidney Disease, Dialysis, Hyperphosphatemia","enrollment":6},{"nctId":"NCT01814904","phase":"PHASE3","title":"Dose-finding Study of MCI-196","status":"TERMINATED","sponsor":"Tanabe Pharma Corporation","startDate":"2014-04","conditions":"Chronic Kidney Disease, Dialysis, Hyperphosphatemia","enrollment":10},{"nctId":"NCT01818687","phase":"PHASE3","title":"Safety and Tolerability Study of MCI-196","status":"TERMINATED","sponsor":"Tanabe Pharma Corporation","startDate":"2013-08","conditions":"Chronic Kidney Disease, Not on Dialysis, Hyperphosphatemia","enrollment":4},{"nctId":"NCT00451295","phase":"PHASE3","title":"A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia","status":"TERMINATED","sponsor":"Tanabe Pharma Corporation","startDate":"2007-05","conditions":"Chronic Kidney Disease, Dialysis, Hyperphosphatemia","enrollment":6}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Colestilan(INN)","Colestimide(JAN)","CHOLEBINE®","BindRen®","Colestilan(INN),"],"phase":"phase_3","status":"active","brandName":"MCI-196","genericName":"MCI-196","companyName":"Tanabe Pharma Corporation","companyId":"tanabe-pharma-corporation","modality":"Small molecule","firstApprovalDate":"","aiSummary":"MCI-196 is a phosphate binder that reduces serum phosphate levels by binding phosphate in the gastrointestinal tract. Used for Hyperphosphatemia in patients with chronic kidney disease on dialysis, Hyperphosphatemia in patients with chronic kidney disease not on dialysis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}