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 of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi.

Phase 3

Completed

Conditions: Alopecia Universalis
Alopecia Totalis
Alopecia Areata

Interventions: Drug: Tofacitinib

First Posted Date: 2024-02-26

Last Posted Date: 2024-02-26

Lead Sponsor: Jinnah Hospital

Target Recruit Count: 30

Registration Number: NCT06278402

Locations: 🇵🇰
Misbah Zari Qadir, Karachi, Sindh, Pakistan

Low-dose Tolvaptan for Inpatient Hyponatraemia.

Recruiting

Conditions: Hyponatremia
SIADH

Interventions: Drug: Tolvaptan

First Posted Date: 2023-12-14

Last Posted Date: 2024-03-08

Lead Sponsor: King's College Hospital NHS Trust

Target Recruit Count: 180

Registration Number: NCT06171100

Locations: 🇬🇧
King's College Hospital NHS Foundation Trust, London, United Kingdom

Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis

Early Phase 1

Recruiting

Conditions: Toxic Epidermal Necrolysis

Interventions: Drug: Abrocitinib
Drug: Tofacitinib

First Posted Date: 2023-11-07

Last Posted Date: 2023-11-28

Lead Sponsor: Peng Zhang

Target Recruit Count: 30

Registration Number: NCT06119490

Locations: 🇨🇳
Department of Dermatology, the First Affiliated Hospital of Fujian Medical University., Fuzhou, Fujian, China

A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

Phase 4

Recruiting

Conditions: Ulcerative Colitis

Interventions: Drug: Vedolizumab
Drug: Tofacitinib

First Posted Date: 2023-10-23

Last Posted Date: 2024-11-15

Lead Sponsor: Takeda

Target Recruit Count: 65

Registration Number: NCT06095128

Locations: 🇺🇸
Digestive Health Specialsits, Dothan, Alabama, United States
🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Hoag Hospital Newport Beach, Newport Beach, California, United States

and more 46 locations

Effectiveness of Tofacitinib in Systemic Sclerosis

Phase 2

Recruiting

Conditions: Efficacy of Tofacitinib in the Systemic Sclerosis

Interventions: Drug: Tofacitinib

First Posted Date: 2023-09-21

Last Posted Date: 2023-09-21

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

Target Recruit Count: 44

Registration Number: NCT06044844

Locations: 🇧🇩
Nabil Amin Khan, Dhaka, Shahbag, Bangladesh

A Phase 3 Study Comparing TLL-018 to Tofacitinib in RA Subjects With Inadequate Response or Intolerance to bDMARDs

Phase 3

Recruiting

Conditions: Rheumatoid Arthritis

Interventions: Drug: TLL-018
Drug: Tofacitinib

First Posted Date: 2023-08-31

Last Posted Date: 2023-11-18

Lead Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd

Target Recruit Count: 450

Registration Number: NCT06020144

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China

Tocilizumab and Tofacitinib in the Treatment of Vascular Behçet's Syndrome

Phase 2

Recruiting

Conditions: Aneurysm
Behcet Syndrome, Vascular Type

Interventions: Drug: tocilizumab
Drug: tofacitinib
Drug: cyclophosphamide

First Posted Date: 2023-05-06

Last Posted Date: 2024-08-19

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 81

Registration Number: NCT05845723

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China

Retrospective Observational Comparison Study Between Ustekinumab and Tofacitinib as Third Line Therapy in a Multicenter Cohort of Patients With Refractory Ulcerative Colitis.

Completed

Conditions: Ulcerative Colitis

Interventions: Drug: Ustekinumab
Drug: Tofacitinib

First Posted Date: 2023-02-14

Last Posted Date: 2023-02-14

Lead Sponsor: IRCCS San Raffaele

Target Recruit Count: 100

Registration Number: NCT05728008

Locations: 🇮🇹
Mariangela Allocca, Milano, Italy

Therapies for Down Syndrome Regression Disorder

Phase 2

Recruiting

Conditions: Down Syndrome
Regression

Interventions: Drug: Lorazepam
Drug: Intravenous immunoglobulin (IVIG)
Drug: Tofacitinib

First Posted Date: 2022-12-22

Last Posted Date: 2024-03-21

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 66

Registration Number: NCT05662228

Locations: 🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Children's Hospital Colorado, Aurora, Colorado, United States

Tofatib Treatment for IgG4-related Disease

Recruiting

Conditions: IgG4-related Disease

Interventions: Drug: tofacitinib

First Posted Date: 2022-11-23

Last Posted Date: 2022-11-23

Lead Sponsor: Changhai Hospital

Target Recruit Count: 40

Registration Number: NCT05625581

Locations: 🇨🇳
Shanghai Changhai Hospital, Shanghai, Shanghai, China

Drug Development Updates

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