Tolvaptan

Generic Name: Tolvaptan

Brand Names: Jinarc, Jynarque 45/15 Carton, Samsca, Tolvaptan Accord, Xeljanz

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₅ClN_₂O_₃

CAS Number: 150683-30-0

Unique Ingredient Identifier: 1E2497LPNY

Background: Tolvaptan is used to treat low blood sodium levels (hyponatremia) associated with various conditions like congestive heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormones (SIADH). FDA approved on May 19, 2009.

Indication: Treatment of symptomatic and resistant to fluid restriction euvolemic or hypervolemic hyponatremia associated with congestive heart failure, SIADH, and cirrhosis.

Associated Conditions: Autosomal Dominant Polycystic Kidney Disease （ADPKD), Symptomatic euvolemic Hyponatremia, Symptomatic hypervolemic Hyponatremia

Associated Therapies: -

Clinical Trials

Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia

Phase 2

Conditions: Non-hypovolemic Non-acute Hyponatremia

Interventions: Drug: Placebo
Drug: Tolvaptan

First Posted Date: 2012-01-11

Last Posted Date: 2012-01-11

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 240

Registration Number: NCT01507727

Locations: 🇨🇳
Cardiology, Beijing An Zhen Hospital Affiliated to Capital University of Medical Science, Beijing, China
🇨🇳
Hepatology, No. 302 Hospital, Beijing, China
🇨🇳
Endocrinology, Beijing Friendship Hospital, Beijing, China

Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis

Phase 2

Active, not recruiting

Conditions: Juvenile Idiopathic Arthritis

Interventions: Drug: Tofacitinib

First Posted Date: 2011-12-28

Last Posted Date: 2024-10-07

Lead Sponsor: Pfizer

Target Recruit Count: 281

Registration Number: NCT01500551

Locations: 🇺🇸
UNC Children's Raleigh, Raleigh, North Carolina, United States
🇺🇸
Loma Linda University Eye Institute, Loma Linda, California, United States
🇺🇸
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

and more 154 locations

A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis

Phase 3

Completed

Conditions: Ulcerative Colitis

Interventions: Drug: Placebo
Drug: tofacitinib

First Posted Date: 2011-11-06

Last Posted Date: 2016-06-07

Lead Sponsor: Pfizer

Target Recruit Count: 614

Registration Number: NCT01465763

Locations: 🇺🇸
Shafran Gastroenterology Center, Winter Park, Florida, United States
🇺🇸
Icahn School of Medicine at Mount Sinai, Marietta, Georgia, United States
🇺🇸
GI Consultants (Colonoscopy only), Atlanta, Georgia, United States

and more 174 locations

A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis

Phase 3

Completed

Conditions: Ulcerative Colitis

Interventions: Drug: Placebo
Drug: tofacitinib

First Posted Date: 2011-10-25

Last Posted Date: 2016-06-01

Lead Sponsor: Pfizer

Target Recruit Count: 547

Registration Number: NCT01458951

Locations: 🇵🇱
Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych,, Bydgoszcz, Kujawsko-pomorskie, Poland
🇵🇱
H-T Centrum Medyczne sp. z o.o. sp. komandytowa, Tychy, Slaskie, Poland
🇺🇸
Atlanta Center for Gastroenterology, P.C., Decatur, Georgia, United States

and more 178 locations

Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients

Phase 4

Completed

Conditions: Heart Failure

Interventions: Drug: Placebo of tolvaptan
Drug: Tolvaptan

First Posted Date: 2011-09-22

Last Posted Date: 2019-10-22

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Target Recruit Count: 100

Registration Number: NCT01439009

Tolvaptan for In-hospital Hyponatremia

Phase 2

Terminated

Conditions: Hyponatremia

Interventions: Other: Standard therapy
Drug: Tolvaptan

First Posted Date: 2011-07-01

Last Posted Date: 2016-12-15

Lead Sponsor: Mario Negri Institute for Pharmacological Research

Target Recruit Count: 3

Registration Number: NCT01386372

Locations: 🇮🇹
OO.RR., Bergamo - Unit of Nephrology and Dialisis, Bergamo, Italy

Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients

Completed

Conditions: Kidney Transplantation

Interventions: Drug: Tofacitinib

First Posted Date: 2011-06-17

Last Posted Date: 2013-10-29

Lead Sponsor: Pfizer

Target Recruit Count: 83

Registration Number: NCT01375127

Locations: 🇪🇸
Pfizer Investigational Site, Barcelona, Spain

Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis

Phase 1

Completed

Conditions: Hepatic Cirrhosis
Ascites

Interventions: Drug: tolvaptan

First Posted Date: 2011-05-24

Last Posted Date: 2011-05-24

Lead Sponsor: Otsuka Beijing Research Institute

Target Recruit Count: 11

Registration Number: NCT01359462

Locations: 🇨🇳
Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites

Phase 3

Completed

Conditions: Ascites
Hepatic Cirrhosis

Interventions: Drug: placebo
Drug: Tolvaptan

First Posted Date: 2011-05-06

Last Posted Date: 2012-10-12

Lead Sponsor: Otsuka Beijing Research Institute

Target Recruit Count: 535

Registration Number: NCT01349348

Locations: 🇨🇳
Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China

Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites

Phase 2

Completed

Conditions: Ascites
Hepatic Cirrhosis

Interventions: Drug: placebo
Drug: Tolvaptan

First Posted Date: 2011-05-06

Last Posted Date: 2012-10-12

Lead Sponsor: Otsuka Beijing Research Institute

Target Recruit Count: 180

Registration Number: NCT01349335

Locations: 🇨🇳
Renji hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2024. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy