{"id":"colestilan","rwe":[{"pmid":"39910709","year":"2025","title":"Cholestyramine in hemodialysis: a new approach for hyperphosphatemia management.","finding":"","journal":"The Korean journal of physiology & pharmacology : official journal of the Korean Physiological Society and the Korean Society of Pharmacology","studyType":"Clinical Study"},{"pmid":"37367171","year":"2023","title":"Bile Acid Sequestrants Based on Natural and Synthetic Gels.","finding":"","journal":"Gels (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"34137362","year":"2021","title":"The Rising Risk of Chronic Kidney Disease (CKD) and How it is Dealt with: A Review of Current and Potential Phosphate Binders (PB).","finding":"","journal":"Mini reviews in medicinal chemistry","studyType":"Clinical Study"},{"pmid":"31865608","year":"2020","title":"Phosphate binders in chronic kidney disease: an updated narrative review of recent data.","finding":"","journal":"Journal of nephrology","studyType":"Clinical Study"},{"pmid":"30132304","year":"2018","title":"Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD).","finding":"","journal":"The Cochrane database of systematic reviews","studyType":"Clinical Study"}],"tags":[{"label":"colestilan","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"V03AE06","category":"atc"},{"label":"Active","category":"status"},{"label":"Hyperlipidemia","category":"indication"},{"label":"Hyperphosphatemia","category":"indication"},{"label":"Tanabe Pharma Corporation","category":"company"}],"phase":"discontinued","safety":{},"trials":[],"aliases":["BindRen"],"company":"Tanabe Pharma Corporation","patents":[],"pricing":[],"allNames":"colestimide","offLabel":[],"synonyms":["colestilan","colestimide","colestilan chloride","MCI-196"],"timeline":[],"approvals":[],"brandName":"Colestimide","ecosystem":[{"indication":"Hyperlipidemia","otherDrugs":[{"name":"cholestyramine","slug":"cholestyramine","company":"Bristol Myers"},{"name":"choline fenofibrate","slug":"choline-fenofibrate","company":"Abbvie"},{"name":"clofibrate","slug":"clofibrate","company":""},{"name":"colestipol","slug":"colestipol","company":"Pharmacia And Upjohn"}],"globalPrevalence":390000000},{"indication":"Hyperphosphatemia","otherDrugs":[{"name":"ferric citrate","slug":"ferric-citrate","company":"Keryx Biopharms"},{"name":"sucroferric oxyhydroxide","slug":"sucroferric-oxyhydroxide","company":"Vifor Fresenius"}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"colestilan","explanation":"Think of it like a sponge that soaks up extra cholesterol and phosphorus from the food you eat, preventing it from entering your bloodstream and causing problems. This can help lower levels of cholesterol and phosphorus in your blood, which can reduce your risk of heart disease and other health issues. By reducing the amount of cholesterol and phosphorus in your blood, Colestimide can help improve your overall health and well-being.","oneSentence":"Colestimide works by inhibiting the absorption of cholesterol and/or phosphorus in the intestines.","technicalDetail":"Colestimide is a small molecule that likely acts as a competitive inhibitor of the sodium-dependent phosphate cotransporter 2 (NaPi2) and/or the Niemann-Pick C1-like 1 (NPC1L1) protein, which are involved in the intestinal absorption of phosphorus and cholesterol, respectively."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Colestilan","title":"Colestilan","extract":"Colestilan is a medication that acts as a phosphate binder and bile acid sequestrant. It is an ion-exchange resin, is an orally administered bile acid sequestrant that is being developed by Mitsubishi Tanabe Pharma Corporation for the treatment of hypercholesterolaemia and hyperphosphataemia. It has been launched in Japan for hypercholesterolaemia. For the treatment of hyperphosphataemia, it is launched in Austria, Germany, the Czech Republic, Portugal and the United Kingdom, is registered in the EU. Phase III development in paediatric patients with hyperphosphataemia associated with chronic kidney disease was underway in the UK and Germany. However, the company discontinued the development. In addition, the phase II development in type-2 diabetes mellitus and phase I development in hyperphosphataemia, in Japan, was also discontinued by the company."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4851","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=colestilan","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=colestilan","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Colestilan","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T10:16:47.731694","biosimilars":[],"competitors":[{"drugName":"sodium polystyrene sulfonate","drugSlug":"sodium-polystyrene-sulfonate","fdaApproval":"1958-06-05","genericCount":14,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"sevelamer","drugSlug":"sevelamer","fdaApproval":"1998-10-30","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"lanthanum carbonate","drugSlug":"lanthanum-carbonate","fdaApproval":"2004-10-26","patentExpiry":"Dec 1, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"sucroferric oxyhydroxide","drugSlug":"sucroferric-oxyhydroxide","fdaApproval":"2013-11-27","relationship":"same-class"},{"drugName":"calcium acetate","drugSlug":"calcium-acetate","fdaApproval":"1982-05-06","patentExpiry":"Jul 20, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ferric citrate","drugSlug":"ferric-citrate","fdaApproval":"2014-09-05","patentExpiry":"Jul 21, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"patiromer calcium","drugSlug":"patiromer-calcium","fdaApproval":"2015-10-21","relationship":"same-class"},{"drugName":"sodium zirconium cyclosilicate","drugSlug":"sodium-zirconium-cyclosilicate","fdaApproval":"2018-05-18","patentExpiry":"Oct 22, 2033","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"colestilan","indications":{"approved":[{"name":"Hyperlipidemia","source":"DrugCentral","snomedId":55822004,"regulator":"FDA","usPrevalence":null,"globalPrevalence":390000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Hyperphosphatemia","source":"DrugCentral","snomedId":20165001,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"sodium-polystyrene-sulfonate","brandName":"sodium polystyrene sulfonate","genericName":"sodium polystyrene sulfonate","approvalYear":"1958","relationship":"same-class"},{"drugId":"sevelamer","brandName":"sevelamer","genericName":"sevelamer","approvalYear":"1998","relationship":"same-class"},{"drugId":"lanthanum-carbonate","brandName":"lanthanum carbonate","genericName":"lanthanum carbonate","approvalYear":"2004","relationship":"same-class"},{"drugId":"sucroferric-oxyhydroxide","brandName":"sucroferric oxyhydroxide","genericName":"sucroferric oxyhydroxide","approvalYear":"2013","relationship":"same-class"},{"drugId":"calcium-acetate","brandName":"calcium acetate","genericName":"calcium acetate","approvalYear":"1982","relationship":"same-class"},{"drugId":"ferric-citrate","brandName":"ferric citrate","genericName":"ferric citrate","approvalYear":"2014","relationship":"same-class"},{"drugId":"patiromer-calcium","brandName":"patiromer calcium","genericName":"patiromer calcium","approvalYear":"2015","relationship":"same-class"},{"drugId":"sodium-zirconium-cyclosilicate","brandName":"sodium zirconium cyclosilicate","genericName":"sodium zirconium cyclosilicate","approvalYear":"2018","relationship":"same-class"}],"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","Dyslipidemia"],"enrollment":642,"completionDate":"2009-11"},{"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,"completionDate":"2010-08"},{"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,"completionDate":"2009-09"},{"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,"completionDate":"2009-11"},{"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,"completionDate":"2014-01"},{"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,"completionDate":"2010-03"},{"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,"completionDate":"2010-08"},{"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,"completionDate":"2007-09"},{"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","Paediatric"],"enrollment":6,"completionDate":"2014-12"},{"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","Paediatric"],"enrollment":10,"completionDate":"2015-01"},{"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","Paediatric"],"enrollment":4,"completionDate":"2014-12"},{"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,"completionDate":"2011-01"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"VSI302RYSR","CHEBI":"CHEBI:31428","INN_ID":"7213","UMLSCUI":"C0540213","ChEMBL_ID":"CHEMBL2103800","KEGG_DRUG":"D01934","DRUGBANK_ID":"DB11634","PUBCHEM_CID":"65840","MESH_SUPPLEMENTAL_RECORD_UI":"C417427"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"Tanabe Pharma Corporation","relationship":"Current Owner"}],"publicationCount":34,"therapeuticAreas":["Metabolic"],"atcClassification":{"source":"DrugCentral","atcCode":"V03AE06","allCodes":["V03AE06"]},"biosimilarFilings":[],"recentPublications":[{"date":"2025 Jul 1","pmid":"39910709","title":"Cholestyramine in hemodialysis: a new approach for hyperphosphatemia management.","journal":"The Korean journal of physiology & pharmacology : official journal of the Korean Physiological Society and the Korean Society of Pharmacology"},{"date":"2023 Jun 19","pmid":"37367171","title":"Bile Acid Sequestrants Based on Natural and Synthetic Gels.","journal":"Gels (Basel, Switzerland)"},{"date":"2021","pmid":"34137362","title":"The Rising Risk of Chronic Kidney Disease (CKD) and How it is Dealt with: A Review of Current and Potential Phosphate Binders (PB).","journal":"Mini reviews in medicinal chemistry"},{"date":"2020 Jun","pmid":"31865608","title":"Phosphate binders in chronic kidney disease: an updated narrative review of recent data.","journal":"Journal of nephrology"},{"date":"2018 Aug 22","pmid":"30132304","title":"Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD).","journal":"The Cochrane database of systematic reviews"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"discontinued","companyName":"Tanabe Pharma Corporation","companyId":"tanabe-pharma-corporation","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Colestimide, also known as colestilan, is a small molecule drug developed by Tanabe Pharma Corporation. It is used to treat hyperlipidemia and hyperphosphatemia, and its exact mechanism of action is not well-documented. As a colestilan, it is likely involved in the inhibition of intestinal absorption of cholesterol and/or phosphorus. The commercial status of Colestimide is unclear, and it may be patented or available as a generic. Further research is needed to fully understand its safety and efficacy.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"withdrawn","approval_date":null,"mah":null,"brand_name_local":"BindRen","application_number":"EMEA/H/C/002377"},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"BindRen","application_number":null}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}