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

Effective Treatment of Jak1/3 Inhibitor in Blau Syndrome

Conditions: Blau Syndrome

Interventions: Drug: Tofacitinib

First Posted Date: 2024-11-14

Last Posted Date: 2024-11-14

Lead Sponsor: Tongji Hospital

Target Recruit Count: 24

Registration Number: NCT06688838

Locations: 🇨🇳
Yikai YU, Wuhan, Hubei, China

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

Phase 3

Not yet recruiting

Conditions: Polyarticular Course Juvenile Idiopathic Arthritis (JIA)

Interventions: Drug: Abatacept
Drug: TNFi (Tumor Necrosis Factor inhibitor) medication
Drug: Tocilizumab
Drug: Tofacitinib

First Posted Date: 2024-10-23

Last Posted Date: 2024-10-23

Lead Sponsor: Duke University

Target Recruit Count: 400

Registration Number: NCT06654882

TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS

Phase 4

Not yet recruiting

Conditions: Ulcerative Colitis

Interventions: Drug: Tofacitinib
Drug: Tofacitinib plus mesalamine

First Posted Date: 2024-10-03

Last Posted Date: 2024-10-03

Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Target Recruit Count: 75

Registration Number: NCT06625450

Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study

Recruiting

Conditions: Janus Kinase Inhibitors
Alopecia Areata

Interventions: Drug: Baricitinib
Drug: Tofacitinib
Drug: Ruxolitinib
Drug: Upadacitinib
Drug: Ritlecitinib
Drug: Abrocitinib

First Posted Date: 2024-08-27

Last Posted Date: 2024-08-27

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Target Recruit Count: 150

Registration Number: NCT06573593

Locations: 🇨🇳
Second Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, China

A Study of HRS-9057 in Patients With Heart Failure and Volume Overload

Phase 1

Not yet recruiting

Conditions: Heart Failure With Volume Overload

Interventions: Drug: HRS-9057
Drug: Tolvaptan

First Posted Date: 2024-07-18

Last Posted Date: 2024-07-18

Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Target Recruit Count: 24

Registration Number: NCT06506994

Locations: 🇨🇳
The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasu's Arteritis

Phase 4

Recruiting

Conditions: Takayasu Arteritis

Interventions: Drug: Prednisone
Drug: Methotrexate
Drug: Tocilizumab
Drug: Tofacitinib
Drug: Adalimumab

First Posted Date: 2024-07-12

Last Posted Date: 2024-10-17

Lead Sponsor: Shanghai Zhongshan Hospital

Target Recruit Count: 124

Registration Number: NCT06498089

Locations: 🇨🇳
Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China

Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN

Not Applicable

Recruiting

Conditions: Toxic Epidermal Necrolysis
Stevens-Johnson Syndrome

Interventions: Drug: Tofacitinib

First Posted Date: 2024-06-25

Last Posted Date: 2024-06-26

Lead Sponsor: Chang Gung Memorial Hospital

Target Recruit Count: 20

Registration Number: NCT06474078

Locations: 🇨🇳
Chang Gung Memorial Hospital, Taoyuan, Taiwan

Efficacy and Safety of Dupilumab in Combination With Tofacitinib in Moderate to Severe Adult AD Patients

Phase 4

Not yet recruiting

Conditions: Atopic Dermatitis

Interventions: Drug: Dupilumab
Drug: Tofacitinib

First Posted Date: 2024-06-20

Last Posted Date: 2024-06-20

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Target Recruit Count: 220

Registration Number: NCT06465732

A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis

Active, not recruiting

Conditions: Rheumatoid Arthritis

Interventions: Drug: tofacitinib
Drug: tumor necrosis factor inhibitors (TNFi)
Drug: abatacept
Drug: tocilizumab or sarilumab

First Posted Date: 2024-05-17

Last Posted Date: 2024-10-07

Lead Sponsor: Pfizer

Target Recruit Count: 20000

Registration Number: NCT06418529

Locations: 🇺🇸
Pfizer, New York, New York, United States

Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study

Phase 4

Completed

Conditions: Axial Spondyloarthritis

Interventions: Drug: Tofacitinib

First Posted Date: 2024-03-13

Last Posted Date: 2024-03-13

Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Target Recruit Count: 92

Registration Number: NCT06310057

Locations: 🇧🇩
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Drug Development Updates

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