{"id":"opc-41061","safety":{"commonSideEffects":[{"rate":null,"effect":"Thirst"},{"rate":null,"effect":"Dry mouth"},{"rate":null,"effect":"Hypernatremia"},{"rate":null,"effect":"Polyuria"},{"rate":null,"effect":"Dehydration"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By antagonizing the V2 vasopressin receptor on the collecting duct principal cells, OPC-41061 prevents aquaporin-2 water channel insertion and reduces water reabsorption. This leads to increased urine output and free water excretion while retaining sodium, effectively raising serum osmolality and sodium concentration. The drug is used to treat hyponatremia and fluid overload conditions associated with heart failure, cirrhosis, and SIADH.","oneSentence":"OPC-41061 is a vasopressin V2 receptor antagonist (vaptан) that blocks water reabsorption in the kidney collecting duct, promoting aquaresis and increasing serum sodium levels.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:24:26.183Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hyponatremia associated with heart failure"},{"name":"Hyponatremia associated with cirrhosis"},{"name":"Hyponatremia associated with syndrome of inappropriate antidiuretic hormone secretion (SIADH)"}]},"trialDetails":[{"nctId":"NCT05373264","phase":"PHASE3","title":"HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life","status":"RECRUITING","sponsor":"University Medical Center Groningen","startDate":"2024-07-31","conditions":"ADPKD","enrollment":300},{"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":"NCT05190744","phase":"PHASE2","title":"Probenecid (PB) to Treat Hereditary Nephrogenic Diabetes Insipidus (NDI), ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2022-09-01","conditions":"Autosomal Dominant Polycystic Kidney Disease, Nephrogenic Diabetes Insipidus, Acquired Nephrogenic Diabetes Insipidus","enrollment":36},{"nctId":"NCT02925221","phase":"","title":"Canadian Medical Assessment of JINARC™ Outcomes Registry","status":"COMPLETED","sponsor":"Otsuka Canada Pharmaceutical Inc.","startDate":"2016-02-26","conditions":"Autosomal Dominant Polycystic Kidney Disease (ADPKD)","enrollment":530},{"nctId":"NCT04786574","phase":"PHASE3","title":"A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)","status":"WITHDRAWN","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2022-07-01","conditions":"Autosomal Recessive Polycystic Kidney Disease (ARPKD)","enrollment":""},{"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":"NCT02847624","phase":"","title":"Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2014-03-24","conditions":"Polycystic Kidney, Autosomal Dominant","enrollment":1802},{"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":"NCT07166887","phase":"PHASE1","title":"Phase I Study Multi Dose of 7.5mg Tolvaptan in Health Male","status":"COMPLETED","sponsor":"Otsuka Beijing Research Institute","startDate":"2011-06-07","conditions":"Healthy Subjects","enrollment":12},{"nctId":"NCT03406286","phase":"","title":"Samsca PMS in ADPKD Patients","status":"COMPLETED","sponsor":"Korea Otsuka Pharmaceutical Co., Ltd.","startDate":"2016-07-19","conditions":"Safety","enrollment":2067},{"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":"NCT04790175","phase":"","title":"Samsca Post-marketing General Drug Use-results Survey in Patients with Hyponatremia in SIADH","status":"RECRUITING","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2021-03-29","conditions":"Antidiuretic Hormone, Inappropriate Secretion","enrollment":300},{"nctId":"NCT05712746","phase":"","title":"Samtasu Post-marketing General Drug Use-results Survey in Patients with Volume Overload in Heart Failure.","status":"RECRUITING","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2023-03-03","conditions":"Heart Failure","enrollment":1600},{"nctId":"NCT02497521","phase":"","title":"The German ADPKD Tolvaptan Treatment Registry","status":"RECRUITING","sponsor":"University of Cologne","startDate":"2015-11","conditions":"ADPKD (Autosomal Dominant Polycystic Kidney Disease)","enrollment":2000},{"nctId":"NCT01733134","phase":"PHASE3","title":"Acute Heart Failure Patients With High Copeptin Treated With Tolvaptan Targets Increased AVP Activation for Treatment (ACTIVATE)","status":"WITHDRAWN","sponsor":"Maisel, Alan, M.D.","startDate":"","conditions":"Acute Heart Failure","enrollment":""},{"nctId":"NCT06618638","phase":"NA","title":"Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment","status":"RECRUITING","sponsor":"Seoul National University Hospital","startDate":"2024-10-21","conditions":"ADPKD (autosomal Dominant Polycystic Kidney Disease)","enrollment":340},{"nctId":"NCT03255226","phase":"PHASE3","title":"Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2018-03-07","conditions":"Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload","enrollment":60},{"nctId":"NCT03858439","phase":"NA","title":"Dietary Intervention in ADPKD on Tolvaptan","status":"COMPLETED","sponsor":"McMaster University","startDate":"2019-06-06","conditions":"Polyuria, Autosomal Dominant Polycystic Kidney","enrollment":8},{"nctId":"NCT06171100","phase":"","title":"Low-dose Tolvaptan for Inpatient Hyponatraemia.","status":"RECRUITING","sponsor":"King's College Hospital NHS Trust","startDate":"2024-03-15","conditions":"Hyponatremia, SIADH","enrollment":180},{"nctId":"NCT04152837","phase":"PHASE3","title":"Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease","status":"TERMINATED","sponsor":"Palladio Biosciences","startDate":"2020-09-02","conditions":"Polycystic Kidney Disease, Adult, ADPKD","enrollment":7},{"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":"NCT03541447","phase":"PHASE2","title":"Tolvaptan-Octreotide LAR Combination in ADPKD","status":"COMPLETED","sponsor":"Mario Negri Institute for Pharmacological Research","startDate":"2018-12-12","conditions":"Autosomal Dominant Polycystic Kidney Disease","enrollment":20},{"nctId":"NCT05569655","phase":"NA","title":"Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With RHF Caused by PAH","status":"UNKNOWN","sponsor":"Chinese Pulmonary Vascular Disease Research Group","startDate":"2021-04-06","conditions":"Pulmonary Arterial Hypertension, Randomized Controlled Trial","enrollment":100},{"nctId":"NCT04331132","phase":"NA","title":"Tolvaptan add-on Therapy to Overcome Loop Diuretic Resistance in Acute Heart Failure With Renal Dysfunction","status":"UNKNOWN","sponsor":"Gia Dinh People Hospital","startDate":"2021-12-01","conditions":"Acute Heart Failure","enrollment":128},{"nctId":"NCT03949894","phase":"PHASE4","title":"Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease","status":"COMPLETED","sponsor":"Korea Otsuka Pharmaceutical Co., Ltd.","startDate":"2019-07-01","conditions":"Autosomal Dominant Polycystic Kidney Disease (ADPKD)","enrollment":118},{"nctId":"NCT05408104","phase":"","title":"Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2019-03-28","conditions":"Heart Failure, Heart Assist Device, Hyponatremic","enrollment":28},{"nctId":"NCT02476409","phase":"PHASE4","title":"Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders","status":"COMPLETED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2015-07","conditions":"Congestive Heart Failure","enrollment":40},{"nctId":"NCT01552590","phase":"PHASE4","title":"Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites","status":"TERMINATED","sponsor":"Korea Otsuka Pharmaceutical Co., Ltd.","startDate":"2012-04","conditions":"Hyponatremia and Extracellular Fluid in Cirrhotic","enrollment":74},{"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":"NCT01684202","phase":"PHASE2","title":"A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2)","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2012-07","conditions":"Carcinomatous Edema","enrollment":43},{"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":"NCT01199198","phase":"PHASE4","title":"Tolvaptan in Hyponatremic Cancer Patients","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2011-05","conditions":"Advanced Cancers","enrollment":52},{"nctId":"NCT02959411","phase":"PHASE4","title":"Tolvaptan for Advanced or Refractory Heart Failure","status":"TERMINATED","sponsor":"University of Calgary","startDate":"2016-10","conditions":"Heart Failure, Hyponatremia","enrollment":9},{"nctId":"NCT02538016","phase":"NA","title":"TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study","status":"COMPLETED","sponsor":"Caleb Nelson","startDate":"2016-10","conditions":"Cystinuria","enrollment":4},{"nctId":"NCT02729662","phase":"NA","title":"Efficacy of Tolvaptan on ADPKD Patients","status":"UNKNOWN","sponsor":"Kyorin University","startDate":"2016-10-01","conditions":"Autosomal Dominant Polycystic Kidney Disease","enrollment":118},{"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":"NCT02722863","phase":"","title":"Samsca Post Marketing Surveillance Study","status":"COMPLETED","sponsor":"Korea Otsuka Pharmaceutical Co., Ltd.","startDate":"2013-07-09","conditions":"Hypervolemic and Euvolemic Hyponatremia","enrollment":908},{"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":"NCT04119206","phase":"","title":"Tolvaptan Versus Fluid Restriction in SIADH","status":"COMPLETED","sponsor":"University of Erlangen-Nürnberg Medical School","startDate":"2009-01-01","conditions":"Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion, Pituitary","enrollment":334},{"nctId":"NCT03931369","phase":"PHASE2","title":"Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2019-09-06","conditions":"Healthy Volunteers","enrollment":60},{"nctId":"NCT02183792","phase":"PHASE4","title":"Aquaresis Utility for Hyponatremic Acute Heart Failure Study","status":"COMPLETED","sponsor":"University of Southern California","startDate":"2014-12","conditions":"Heart Failure","enrollment":33},{"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":"NCT02646540","phase":"PHASE1","title":"AiDing Diuresis wIth Tolvaptan (ADD-IT)","status":"COMPLETED","sponsor":"Emory University","startDate":"2016-01","conditions":"Cardiomyopathy, Congestive Heart Failure","enrollment":14},{"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":"NCT01425125","phase":"NA","title":"Fractional Urate Excretion in Nonedematous Hyponatremia","status":"WITHDRAWN","sponsor":"NYU Langone Health","startDate":"2011-11","conditions":"Cerebral Hyponatremia, SIADH, Cerebral Salt-wasting Syndrome","enrollment":""},{"nctId":"NCT01280721","phase":"PHASE3","title":"A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2010-11","conditions":"Autosomal Dominant Polycystic Kidney Disease （ADPKD)","enrollment":135},{"nctId":"NCT03803124","phase":"PHASE3","title":"Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD","status":"COMPLETED","sponsor":"Regional Hospital Holstebro","startDate":"2015-12","conditions":"Polycystic Kidney, Autosomal Dominant","enrollment":20},{"nctId":"NCT03764605","phase":"PHASE3","title":"Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease","status":"UNKNOWN","sponsor":"Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari","startDate":"2019-01-30","conditions":"ADPKD","enrollment":150},{"nctId":"NCT03596957","phase":"PHASE4","title":"Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease","status":"UNKNOWN","sponsor":"Lisbet Brandi","startDate":"2018-09-12","conditions":"Autosomal Dominant Polycystic Kidney","enrollment":90},{"nctId":"NCT01451827","phase":"PHASE2","title":"8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2011-10","conditions":"Autosomal Dominant Polycystic Kidney Disease","enrollment":178},{"nctId":"NCT02012959","phase":"PHASE3","title":"Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia","status":"TERMINATED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2015-09-22","conditions":"Hyponatremia","enrollment":9},{"nctId":"NCT02545114","phase":"NA","title":"Tolvaptan for Patients With Acute Neurological Injuries","status":"TERMINATED","sponsor":"Polderman, Kees, H., MD, PhD","startDate":"2015-08","conditions":"Hyponatremia, SIADH","enrollment":25},{"nctId":"NCT01022424","phase":"PHASE3","title":"A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2009-11","conditions":"Autosomal Dominant Polycystic Kidney Disease","enrollment":13},{"nctId":"NCT00841568","phase":"PHASE2","title":"A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2006-04","conditions":"Autosomal Dominant Polycystic Kidney Disease","enrollment":17},{"nctId":"NCT01876381","phase":"PHASE2","title":"A Phase 2, Multi-center, Open-label, Dose-finding Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of OPC-41061 in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2013-06","conditions":"Chronic Renal Failure","enrollment":26},{"nctId":"NCT02666651","phase":"PHASE4","title":"Regional Tolvaptan Registry","status":"UNKNOWN","sponsor":"Cardiology Research UBC","startDate":"2016-05","conditions":"Decompensated Heart Failure, Hyponatremia","enrollment":25},{"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":"NCT01210560","phase":"PHASE2","title":"Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2010-10","conditions":"Autosomal Dominant Polycystic Kidney Disease","enrollment":25},{"nctId":"NCT02545101","phase":"","title":"An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Europe Ltd","startDate":"2015-11","conditions":"Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion","enrollment":100},{"nctId":"NCT01890694","phase":"PHASE4","title":"Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia","status":"TERMINATED","sponsor":"NYU Langone Health","startDate":"2012-03","conditions":"Hyponatremia","enrollment":2},{"nctId":"NCT02173288","phase":"PHASE2, PHASE3","title":"Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites","status":"COMPLETED","sponsor":"Post Graduate Institute of Medical Education and Research, Chandigarh","startDate":"2013-07","conditions":"Cirrhosis, Refractory/Recurrent Ascites","enrollment":50},{"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":"NCT01635517","phase":"","title":"Efficacy and Safety of Tolvaptan in Japanese Patients With Acute Heart Failure","status":"COMPLETED","sponsor":"Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan","startDate":"2012-07-01","conditions":"Heart Failure","enrollment":274},{"nctId":"NCT01346072","phase":"PHASE4","title":"Pilot Study of Using Copeptin to Predict Response to Tolvaptan","status":"COMPLETED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2011-04","conditions":"Cardiovascular Diseases, Heart Diseases, Heart Failure","enrollment":21},{"nctId":"NCT01644331","phase":"PHASE3","title":"Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure","status":"COMPLETED","sponsor":"Duke University","startDate":"2012-10","conditions":"Heart Failure, Dyspnea","enrollment":257},{"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":"NCT02644616","phase":"PHASE4","title":"The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement","status":"COMPLETED","sponsor":"Shanghai Chest Hospital","startDate":"2014-11","conditions":"Tricuspid Regurgitation, Right Heart Failure","enrollment":40},{"nctId":"NCT01386372","phase":"PHASE2","title":"Tolvaptan for In-hospital Hyponatremia","status":"TERMINATED","sponsor":"Mario Negri Institute for Pharmacological Research","startDate":"2011-06","conditions":"Hyponatremia","enrollment":3},{"nctId":"NCT01973140","phase":"PHASE4","title":"Effects of Tolvaptan in Healthy Adults","status":"COMPLETED","sponsor":"Northwestern University","startDate":"2013-11","conditions":"Healthy","enrollment":17},{"nctId":"NCT01584557","phase":"PHASE3","title":"Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management","status":"COMPLETED","sponsor":"Cardiovascular Clinical Sciences Inc","startDate":"2012-06","conditions":"Heart Failure","enrollment":250},{"nctId":"NCT02215148","phase":"","title":"Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients","status":"TERMINATED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2014-11","conditions":"Brain Injury, Hyponatremia","enrollment":1},{"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":"NCT02084797","phase":"NA","title":"V2 Receptor Effects on Fluid Regulation and Performance","status":"COMPLETED","sponsor":"Oakland University","startDate":"2011-06","conditions":"Electrolyte Imbalance, Hyponatremia, Hypernatremia","enrollment":10},{"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":"NCT02096965","phase":"PHASE1","title":"Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2014-03","conditions":"Nephrolithiasis, Calcium Oxalate, Nephrolithiasis, Calcium Phosphate","enrollment":20},{"nctId":"NCT01863511","phase":"PHASE4","title":"Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure","status":"COMPLETED","sponsor":"The Christ Hospital","startDate":"2013-05","conditions":"Acute Decompensated Heart Failure","enrollment":45},{"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":"NCT01895322","phase":"PHASE2","title":"Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2013-07","conditions":"Chronic Renal Failure","enrollment":20},{"nctId":"NCT01663662","phase":"PHASE4","title":"The Use of Tolvaptan to Prevent Renal Dysfunction in High Risk Patients With Heart Failure-Pilot Study","status":"WITHDRAWN","sponsor":"University of Michigan","startDate":"2012-08","conditions":"Heart Failure","enrollment":""},{"nctId":"NCT01850940","phase":"","title":"Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia","status":"COMPLETED","sponsor":"Beijing Friendship Hospital","startDate":"2013-01","conditions":"Liver Cirrhosis, Hyponatremia","enrollment":98},{"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":"NCT01618448","phase":"PHASE3","title":"Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart Failure","status":"COMPLETED","sponsor":"Taiwan Otsuka Pharm. Co., Ltd","startDate":"2012-07","conditions":"Cardiac-induced Edema","enrollment":85},{"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":"NCT00479336","phase":"PHASE2","title":"A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2007-06","conditions":"Cirrhosis","enrollment":104},{"nctId":"NCT01050530","phase":"PHASE3","title":"A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2009-12","conditions":"Cirrhosis","enrollment":162},{"nctId":"NCT01114828","phase":"PHASE3","title":"A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2010-02","conditions":"Cirrhosis","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":17,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Tolvaptan"],"phase":"phase_3","status":"active","brandName":"OPC-41061","genericName":"OPC-41061","companyName":"Otsuka Pharmaceutical Co., Ltd.","companyId":"otsuka","modality":"Small molecule","firstApprovalDate":"","aiSummary":"OPC-41061 is a small molecule that acts as a vasopressin V2 receptor antagonist. It has been studied in clinical trials for various conditions, including Autosomal Dominant Polycystic Kidney Disease, Heart Failure, and Syndrome of Inappropriate Antidiuretic Hormone Secretion.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2015-05-27T00:00:00.000Z","mah":"Otsuka Pharmaceutical Netherlands B.V.","brand_name_local":"Jinarc","application_number":"EMEA/H/C/002788"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2018-04-23T00:00:00.000Z","mah":"OTSUKA","brand_name_local":"JYNARQUE","application_number":"NDA204441"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-05-19T00:00:00.000Z","mah":"ALKEM LABS LTD","brand_name_local":"TOLVAPTAN","application_number":"ANDA211891"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-05-19T00:00:00.000Z","mah":"APOTEX","brand_name_local":"TOLVAPTAN","application_number":"ANDA207605"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2021-07-16T00:00:00.000Z","mah":"HETERO LABS LTD V","brand_name_local":"TOLVAPTAN","application_number":"ANDA205646"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-02-15T00:00:00.000Z","mah":"PH HEALTH","brand_name_local":"TOLVAPTAN","application_number":"ANDA206119"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2023-06-21T00:00:00.000Z","mah":"MSN","brand_name_local":"TOLVAPTAN","application_number":"ANDA216949"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2025-04-23T00:00:00.000Z","mah":"LUPIN","brand_name_local":"TOLVAPTAN","application_number":"ANDA216063"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2025-11-10T00:00:00.000Z","mah":"APOTEX","brand_name_local":"TOLVAPTAN","application_number":"ANDA218381"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2026-01-09T00:00:00.000Z","mah":"Accord Healthcare S.L.U.","brand_name_local":"Tolvaptan Accord","application_number":"EMEA/H/C/005961"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2026-04-21T00:00:00.000Z","mah":"ALKEM LABS LTD","brand_name_local":"TOLVAPTAN","application_number":"ANDA220147"}],"regulatorySummaries":{"EU_EMA_approval_188324":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188324","summary_short":"EMA granted marketing authorisation for Tolvaptan Accord (OPC-41061) on 9 January 2026 for treating hyponatremia secondary to SIADH in adults.","summary_long":"The European Medicines Agency (EMA) approved Tolvaptan Accord (OPC-41061) for marketing in the European Union on 9 January 2026. This approval is for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH) in adults. Accord Healthcare S.L.U. is the marketing authorisation holder for Tolvaptan Accord.","key_points":["EMA approved Tolvaptan Accord (OPC-41061) for treating hyponatremia secondary to SIADH in adults.","Marketing authorisation holder: Accord Healthcare S.L.U.","Local brand name: Tolvaptan Accord"],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/tolvaptan-accord"}],"generated_at":"2026-05-18T08:35:35.634Z"}},"trialStats":{"total":2,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}