Tolvaptan

Generic Name
Tolvaptan
Brand Names
Jinarc, Jynarque 45/15 Carton, Samsca, Tolvaptan Accord, Xeljanz
Drug Type
Small Molecule
Chemical Formula
C26H25ClN2O3
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
Related News

Comparison of Oral or Intravenous Thiazides vs Tolvaptan in Diuretic Resistant Decompensated Heart Failure

First Posted Date
2015-11-17
Last Posted Date
2019-11-08
Lead Sponsor
Vanderbilt University
Target Recruit Count
60
Registration Number
NCT02606253
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve Low Disease Activity (LDA) or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: tofacitinib
First Posted Date
2015-10-02
Last Posted Date
2019-07-05
Lead Sponsor
Norman B. Gaylis, MD
Target Recruit Count
20
Registration Number
NCT02566967
Locations
🇺🇸

AARDS Research, Inc., Aventura, Florida, United States

Tolvaptan for Patients With Acute Neurological Injuries

Not Applicable
Terminated
Conditions
SIADH
Hyponatremia
Interventions
Drug: Tolvaptan
First Posted Date
2015-09-09
Last Posted Date
2018-09-24
Lead Sponsor
Polderman, Kees, H., MD, PhD
Target Recruit Count
25
Registration Number
NCT02545114
Locations
🇺🇸

Mercy Hospital, Pittsburgh, Pennsylvania, United States

🇺🇸

UPMC Presbyterian, Pittsburgh, Pennsylvania, United States

TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study

Not Applicable
Completed
Conditions
Cystinuria
Interventions
Drug: Tolvaptan
First Posted Date
2015-09-02
Last Posted Date
2020-07-10
Lead Sponsor
Caleb Nelson
Target Recruit Count
4
Registration Number
NCT02538016
Locations
🇺🇸

Boston Children's Hospital, Boston, Massachusetts, United States

Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus

Phase 1
Completed
Conditions
Systemic Lupus Erythematosus
Interventions
Drug: Placebo
Drug: Tofacitinib
First Posted Date
2015-08-31
Last Posted Date
2018-08-09
Lead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Target Recruit Count
34
Registration Number
NCT02535689
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Effect of the Aquaretic Tolvaptan on Nitric Oxide System

First Posted Date
2015-08-19
Last Posted Date
2017-03-01
Lead Sponsor
Regional Hospital Holstebro
Target Recruit Count
18
Registration Number
NCT02527863
Locations
🇩🇰

Department of Medical Research and Medicine, Holstebro Regional Hospital, Holstebro, Denmark

Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders

Phase 4
Completed
Conditions
Congestive Heart Failure
Interventions
Other: Placebo
Drug: tolvaptan
First Posted Date
2015-06-19
Last Posted Date
2022-05-05
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
40
Registration Number
NCT02476409
Locations
🇺🇸

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia

Phase 3
Completed
Conditions
Hyponatremia
Interventions
Drug: Tolvaptan
First Posted Date
2015-05-20
Last Posted Date
2016-01-21
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
111
Registration Number
NCT02449044

A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia

Phase 3
Withdrawn
Conditions
Hyponatremia
Interventions
Other: Placebo
Drug: Tolvaptan
First Posted Date
2015-05-13
Last Posted Date
2017-07-31
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Registration Number
NCT02442674

Outcome and Treatment Quality Study of Tolvaptan to Treat Hyponatremia in Patients With Heart Failure

Phase 4
Terminated
Conditions
Heart Failure With Hyponatremia
Interventions
Drug: Placebo
Drug: Tolvaptan
First Posted Date
2015-02-02
Last Posted Date
2017-06-14
Lead Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
58
Registration Number
NCT02352285
Locations
🇰🇷

Seoul National University Bundang Hospital, Seoul, Korea, Republic of

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