{"id":"tolvaptan-oral-tablet","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Thirst"},{"rate":"15-25","effect":"Dry mouth"},{"rate":"10-20","effect":"Polyuria (increased urination)"},{"rate":"5-15","effect":"Hypernatremia (elevated serum sodium)"},{"rate":"5-10","effect":"Fatigue"},{"rate":"1-2","effect":"Hepatotoxicity"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"By antagonizing the V2 vasopressin receptor on the collecting duct principal cells, tolvaptan prevents aquaporin-2 water channel insertion and reduces water reabsorption. This leads to increased free water excretion and correction of hyponatremia (low serum sodium) in conditions characterized by inappropriate antidiuretic hormone (ADH) secretion or excessive vasopressin activity. The drug is selective for V2 receptors, minimizing off-target effects on V1a receptors.","oneSentence":"Tolvaptan is a selective vasopressin V2-receptor antagonist that blocks water reabsorption in the kidney's collecting duct, promoting aquaresis (water excretion) without significant electrolyte loss.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:39:21.231Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hyponatremia associated with syndrome of inappropriate antidiuretic hormone secretion (SIADH)"},{"name":"Hyponatremia in heart failure"},{"name":"Autosomal dominant polycystic kidney disease (ADPKD)"}]},"trialDetails":[{"nctId":"NCT04782258","phase":"PHASE3","title":"A Study to See Iftolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old withAutosomal Recessive Polycystic Kidney Disease (ARPKD)","status":"RECRUITING","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2023-01-23","conditions":"Autosomal Recessive Polycystic Kidney (ARPKD)","enrollment":20},{"nctId":"NCT07282821","phase":"PHASE2","title":"Bempedoic Acid Therapy for Polycystic Kidney Disease","status":"NOT_YET_RECRUITING","sponsor":"Kenneth Hallows","startDate":"2026-02-01","conditions":"ADPKD (Autosomal Dominant Polycystic Kidney Disease)","enrollment":120},{"nctId":"NCT06506994","phase":"PHASE1","title":"A Study of HRS-9057 in Patients With Heart Failure and Volume Overload","status":"COMPLETED","sponsor":"Fujian Shengdi Pharmaceutical Co., Ltd.","startDate":"2024-08-16","conditions":"Heart Failure With Volume Overload","enrollment":25},{"nctId":"NCT07166783","phase":"PHASE1","title":"Single Dose of 7.5mg Tolvaptan Phase I Clinical Trial Protocol","status":"COMPLETED","sponsor":"Otsuka Beijing Research Institute","startDate":"2011-06-16","conditions":"Health Subjects","enrollment":10},{"nctId":"NCT07166796","phase":"PHASE1","title":"a Phase I PK Study in Healthy Male Subjects. 2 Groups of Healthy Male Subjects","status":"COMPLETED","sponsor":"Otsuka Beijing Research Institute","startDate":"2006-10-01","conditions":"Health Subjects","enrollment":64},{"nctId":"NCT00664014","phase":"PHASE2","title":"A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia","status":"COMPLETED","sponsor":"Otsuka Beijing Research Institute","startDate":"2008-05","conditions":"Hypovolemic Hyponatremia","enrollment":241},{"nctId":"NCT02964273","phase":"PHASE3","title":"Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2016-09-23","conditions":"Autosomal Dominant Polycystic Kidney Disease (ADPKD)","enrollment":91},{"nctId":"NCT05060523","phase":"NA","title":"To Study Effect of the Combination of Midodrine and Tolvaptan Versus Tolvaptan Alone in Patients With Severe Hyponatremia in Cirrhosis(TOLMINA Trial)","status":"UNKNOWN","sponsor":"Institute of Liver and Biliary Sciences, India","startDate":"2021-09-19","conditions":"Liver Cirrhosis","enrollment":220},{"nctId":"NCT01214421","phase":"PHASE3","title":"Tolvaptan Extension Study in Participants With ADPKD","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2010-05-26","conditions":"Autosomal Dominant Polycystic Kidney Disease (ADPKD)","enrollment":1083},{"nctId":"NCT03772041","phase":"PHASE3","title":"Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2019-01-16","conditions":"Congestive Heart Failure","enrollment":294},{"nctId":"NCT03254108","phase":"NA","title":"Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2017-11-06","conditions":"Congestive Heart Failure","enrollment":61},{"nctId":"NCT02994394","phase":"PHASE1","title":"A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2017-01-06","conditions":"Healthy Adult Male","enrollment":84},{"nctId":"NCT03048747","phase":"PHASE3","title":"A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2017-03-02","conditions":"Syndrome of Inappropriate Antidiuretic Hormone Secretion","enrollment":16},{"nctId":"NCT02020278","phase":"PHASE3","title":"An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia","status":"TERMINATED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2016-04-22","conditions":"Hyponatremia","enrollment":3},{"nctId":"NCT02251275","phase":"PHASE3","title":"Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2014-10-17","conditions":"Polycystic Kidney, Autosomal Dominant","enrollment":1803},{"nctId":"NCT02606253","phase":"PHASE4","title":"Comparison of Oral or Intravenous Thiazides vs Tolvaptan in Diuretic Resistant Decompensated Heart Failure","status":"COMPLETED","sponsor":"Vanderbilt University","startDate":"2016-02","conditions":"Heart Failure","enrollment":60},{"nctId":"NCT02331680","phase":"PHASE2","title":"A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2014-12","conditions":"Chronic Renal Failure","enrollment":124},{"nctId":"NCT01439009","phase":"PHASE4","title":"Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2011-09","conditions":"Heart Failure","enrollment":100},{"nctId":"NCT03910231","phase":"PHASE1","title":"The Role of Vasopressin Antagonism on Renal Sodium Handling","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2012-02-01","conditions":"Healthy","enrollment":30},{"nctId":"NCT01336972","phase":"PHASE2","title":"Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2010-10","conditions":"Autosomal Dominant Polycystic Kidney Disease","enrollment":29},{"nctId":"NCT02160145","phase":"PHASE3","title":"Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2014-05","conditions":"Chronic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease","enrollment":1370},{"nctId":"NCT02442674","phase":"PHASE3","title":"A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia","status":"WITHDRAWN","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2015-11","conditions":"Hyponatremia","enrollment":""},{"nctId":"NCT00413777","phase":"PHASE2","title":"Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2005-12","conditions":"Polycystic Kidney, Autosomal Dominant","enrollment":46},{"nctId":"NCT00428948","phase":"PHASE3","title":"Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2007-01","conditions":"Polycystic Kidney Disease, Autosomal Dominant","enrollment":1445},{"nctId":"NCT02352285","phase":"PHASE4","title":"Outcome and Treatment Quality Study of Tolvaptan to Treat Hyponatremia in Patients With Heart Failure","status":"TERMINATED","sponsor":"Korea Otsuka Pharmaceutical Co., Ltd.","startDate":"2012-12","conditions":"Heart Failure With Hyponatremia","enrollment":58},{"nctId":"NCT02078973","phase":"PHASE2","title":"Effect of the Aquaretic Tolvaptan on Nitric Oxide System. A Dose-response Study (DOVA)","status":"COMPLETED","sponsor":"Regional Hospital Holstebro","startDate":"2014-03-01","conditions":"Nephropathy","enrollment":15},{"nctId":"NCT02527863","phase":"PHASE2","title":"Effect of the Aquaretic Tolvaptan on Nitric Oxide System","status":"COMPLETED","sponsor":"Regional Hospital Holstebro","startDate":"2015-02","conditions":"Autosomal Dominant Polycystic Kidney Disease","enrollment":18},{"nctId":"NCT01973140","phase":"PHASE4","title":"Effects of Tolvaptan in Healthy Adults","status":"COMPLETED","sponsor":"Northwestern University","startDate":"2013-11","conditions":"Healthy","enrollment":17},{"nctId":"NCT02009878","phase":"PHASE1, PHASE2","title":"A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2013-11","conditions":"Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)","enrollment":30},{"nctId":"NCT01048788","phase":"PHASE3","title":"A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2009-12","conditions":"Cirrhosis","enrollment":51},{"nctId":"NCT02449044","phase":"PHASE3","title":"International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2004-05","conditions":"Hyponatremia","enrollment":111},{"nctId":"NCT01292304","phase":"PHASE4","title":"Tolvaptan for Ascites in Cirrhotic Patients","status":"COMPLETED","sponsor":"University of Florida","startDate":"2012-03","conditions":"Ascites, Cirrhosis","enrollment":10},{"nctId":"NCT01227512","phase":"PHASE3","title":"Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia","status":"TERMINATED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2010-10","conditions":"Hyponatremia, Dilutional Hyponatremia, Inappropriate ADH Syndrome","enrollment":124},{"nctId":"NCT01638663","phase":"PHASE2","title":"Effect of the Aquaretic Tolvaptan on Nitric Oxide System (TORA)","status":"COMPLETED","sponsor":"Regional Hospital Holstebro","startDate":"2012-05","conditions":"Cardiovascular Diseases, Nephropathy","enrollment":20},{"nctId":"NCT01651156","phase":"PHASE3","title":"Efficacy and Safety Study of Tolvaptan to Treat Patients With Cardiac Edema","status":"COMPLETED","sponsor":"Otsuka Beijing Research Institute","startDate":"2012-07","conditions":"Cardiac Edema","enrollment":244},{"nctId":"NCT01261481","phase":"PHASE1","title":"Bioavailability Study Comparing Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact","status":"COMPLETED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2011-01","conditions":"Healthy","enrollment":29},{"nctId":"NCT00071331","phase":"PHASE3","title":"EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2003-09","conditions":"Congestive Heart Failure","enrollment":3600},{"nctId":"NCT00201994","phase":"PHASE3","title":"\"SALT-2 Trial\" Study of Ascending Levels of Tolvaptan in Hyponatremia","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2003-11","conditions":"Hyponatremia, Water Intoxication, Inappropriate ADH Syndrome","enrollment":243},{"nctId":"NCT00132886","phase":"PHASE2","title":"Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2004-12","conditions":"Heart Failure, Congestive","enrollment":140},{"nctId":"NCT01507727","phase":"PHASE2, PHASE3","title":"Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia","status":"UNKNOWN","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2012-01","conditions":"Non-hypovolemic Non-acute Hyponatremia","enrollment":240},{"nctId":"NCT01359462","phase":"PHASE1","title":"Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis","status":"COMPLETED","sponsor":"Otsuka Beijing Research Institute","startDate":"2009-04","conditions":"Hepatic Cirrhosis, Ascites","enrollment":11},{"nctId":"NCT00550459","phase":"PHASE3","title":"Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2007-08","conditions":"Hyponatremia","enrollment":57},{"nctId":"NCT00072683","phase":"PHASE3","title":"\"SALT Trial\" Study of Ascending Levels of Tolvaptan in Hyponatremia","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2003-04","conditions":"Hyponatremias, Water Intoxication, Inappropriate ADH Syndrome","enrollment":240}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Tolvaptan Oral Tablet","genericName":"Tolvaptan Oral Tablet","companyName":"Otsuka Pharmaceutical Co., Ltd.","companyId":"otsuka","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tolvaptan is a selective vasopressin V2-receptor antagonist that blocks water reabsorption in the kidney's collecting duct, promoting aquaresis (water excretion) without significant electrolyte loss. Used for Hyponatremia associated with syndrome of inappropriate antidiuretic hormone secretion (SIADH), Hyponatremia in heart failure, Autosomal dominant polycystic kidney disease (ADPKD).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}