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

Tofacitinib Combined With Chidamide in R/R ENKTCL

Phase 2

Conditions: Extranodal NK/T-cell Lymphoma

Interventions: Drug: tofacitinib
Drug: chidamide

First Posted Date: 2018-07-26

Last Posted Date: 2018-07-26

Lead Sponsor: Sichuan University

Target Recruit Count: 20

Registration Number: NCT03598959

Locations: 🇨🇳
West China Hospital of Sichuan University, Chengdu, Sichuan, China

Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease

Phase 4

Conditions: Autosomal Dominant Polycystic Kidney

Interventions: Drug: Tolvaptan

First Posted Date: 2018-07-24

Last Posted Date: 2018-11-26

Lead Sponsor: Lisbet Brandi

Target Recruit Count: 90

Registration Number: NCT03596957

Locations: 🇩🇰
Sjællands University Hospital Roskilde, Roskilde, Denmark
🇩🇰
Rigshospitalet - Site 42, Copenhagen, Denmark
🇩🇰
Aarhus University Hospital - Site 43, Skejby, Aarhus N, Denmark

and more 3 locations

Tofacitinib for Inflammatory Eye Disease

Phase 2

Conditions: Uveitis
Scleritis

Interventions: Drug: tofacitinib

First Posted Date: 2018-07-09

Last Posted Date: 2021-02-01

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 5

Registration Number: NCT03580343

Locations: 🇺🇸
Washington University in Saint Louis, Saint Louis, Missouri, United States

Tolvaptan-Octreotide LAR Combination in ADPKD

Phase 2

Completed

Conditions: Autosomal Dominant Polycystic Kidney Disease

Interventions: Drug: Tolvaptan
Drug: Octreotide LAR
Other: Placebo

First Posted Date: 2018-05-30

Last Posted Date: 2022-11-03

Lead Sponsor: Mario Negri Institute for Pharmacological Research

Target Recruit Count: 20

Registration Number: NCT03541447

Locations: 🇮🇹
CRC per le Malattie Rare Aldo e Cele Daccò, Ranica, Bergamo, Italy

Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

Phase 3

Completed

Conditions: Ankylosing Spondylitis

Interventions: Drug: Tofacitinib

First Posted Date: 2018-04-18

Last Posted Date: 2021-09-17

Lead Sponsor: Pfizer

Target Recruit Count: 270

Registration Number: NCT03502616

Locations: 🇨🇦
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc., Quebec, Canada
🇨🇳
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
🇨🇳
The Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China

and more 96 locations

Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis

Phase 3

Completed

Conditions: Psoriatic Arthritis

Interventions: Other: Placebo
Drug: Tofacitinib

First Posted Date: 2018-04-03

Last Posted Date: 2024-02-08

Lead Sponsor: Pfizer

Target Recruit Count: 204

Registration Number: NCT03486457

Locations: 🇨🇳
The Third Hospital of Hebei Medical University, Rheumatology and Immunology Department, Shijiazhuang, Hebei, China
🇨🇳
Xiangya Hospital Central South University, Changsha, Hunan, China
🇨🇳
The Second Xiangya Hospital of Central South University, Changsha, Hunan, China

and more 35 locations

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Phase 3

Recruiting

Conditions: Rheumatoid Arthritis

Interventions: Drug: Rituximab
Drug: Sulfasalazine
Drug: Methotrexate
Drug: Abatacept
Drug: Adalimumab
Drug: Golimumab
Drug: Azathioprine
Drug: Baricitinib
Drug: Certolizumab
Drug: Etanercept
Drug: Hydroxychloroquine
Drug: Infliximab
Drug: Leflunomide
Drug: Minocycline
Drug: Sarilumab
Drug: Tofacitinib

First Posted Date: 2018-01-30

Last Posted Date: 2024-06-24

Lead Sponsor: University of Nebraska

Target Recruit Count: 400

Registration Number: NCT03414502

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

Samsca PMS in ADPKD Patients

Recruiting

Conditions: Safety

First Posted Date: 2018-01-23

Last Posted Date: 2023-09-28

Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Target Recruit Count: 600

Registration Number: NCT03406286

Locations: 🇰🇷
Kim Med Clinic, Ulsan, Gyeongsangnam-do, Korea, Republic of

Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis

Completed

Conditions: Arthritis, Rheumatoid

First Posted Date: 2018-01-02

Last Posted Date: 2024-10-21

Lead Sponsor: Pfizer

Target Recruit Count: 1459

Registration Number: NCT03387423

Locations: 🇩🇪
Private Practice Richter, Rostock, Germany
🇩🇪
Private Practice, Templin, Germany
🇩🇪
Private Praxis, Duesseldorf, Nordrhein-westfalen, Germany

and more 84 locations

Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus

Phase 1

Completed

Conditions: Systemic Lupus Erythematosus
Cutaneous Lupus

Interventions: Drug: Tofacitinib

First Posted Date: 2017-09-20

Last Posted Date: 2024-07-30

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Target Recruit Count: 13

Registration Number: NCT03288324

Locations: 🇺🇸
Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, United States
🇺🇸
MetroHealth Medical Center, Cleveland, Ohio, United States

Drug Development Updates

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