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 Citrate Topical Gel 3.2% FDA BA Bridging Study

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: Tofacitinib Citrate

First Posted Date: 2020-07-13

Last Posted Date: 2021-11-29

Lead Sponsor: TWi Biotechnology, Inc.

Target Recruit Count: 14

Registration Number: NCT04468425

Locations: 🇨🇦
Syneos Health Facility, Québec, Canada

Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis

Phase 4

Conditions: Rheumatoid Arthritis

Interventions: Drug: Methotrexate
Drug: Tofacitinib

First Posted Date: 2020-07-09

Last Posted Date: 2020-07-09

Lead Sponsor: Dr. Mohammad Mamun Khan

Target Recruit Count: 110

Registration Number: NCT04464642

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

Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

Recruiting

Conditions: Ulcerative Colitis

Interventions: Drug: Tofacitinib

First Posted Date: 2020-06-09

Last Posted Date: 2024-11-05

Lead Sponsor: Pfizer

Target Recruit Count: 150

Registration Number: NCT04424303

Locations: 🇫🇷
Clinique de l Europe, Amiens, France
🇫🇷
Hopital D'Estaing, Clermont Ferrand, France
🇫🇷
Hopital Sud, Amiens, France

and more 35 locations

TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: PF-06650833
Drug: PF-06651600
Drug: Tofacitinib

First Posted Date: 2020-06-04

Last Posted Date: 2023-04-07

Lead Sponsor: Pfizer

Target Recruit Count: 460

Registration Number: NCT04413617

Locations: 🇧🇬
Independent Medical Diagnostic Laboratory Mediscan EOOD, Plovdiv, Bulgaria
🇧🇬
MHAT Plovdiv AD, Plovdiv, Bulgaria
🇧🇬
DCC Sveti Georgi EOOD, Plovdiv, Bulgaria

and more 140 locations

Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care Therapy

Phase 2

Withdrawn

Conditions: COVID-19

Interventions: Other: Placebo
Drug: Tofacitinib

First Posted Date: 2020-06-02

Last Posted Date: 2020-07-31

Lead Sponsor: Pfizer

Registration Number: NCT04412252

Locations: 🇺🇸
LSUHSC-Shreveport, Shreveport, Louisiana, United States
🇺🇸
Ochsner LSU Health Shreveport Academic Medical Center, Shreveport, Louisiana, United States
🇺🇸
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

and more 3 locations

TOFAcitinib Plus Hydroxycloroquine vs Hydroxycloroquine in Patients With COVID-19 Interstitial Pneumonia

Phase 2

Conditions: Pneumonitis, Interstitial
COVID-19

Interventions: Drug: Tofacitinib
Drug: Hydroxychloroquine

First Posted Date: 2020-05-15

Last Posted Date: 2020-05-15

Lead Sponsor: Università Politecnica delle Marche

Target Recruit Count: 116

Registration Number: NCT04390061

Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In Sweden

Recruiting

Conditions: Ulcerative Colitis

Interventions: Drug: tofacitinib

First Posted Date: 2020-04-08

Last Posted Date: 2024-10-07

Lead Sponsor: Pfizer

Target Recruit Count: 120

Registration Number: NCT04338204

Locations: 🇸🇪
Danderyds Hospital, Stockholm, Sweden
🇸🇪
Gävle Hospital, Gävle, Sweden
🇸🇪
SU/Sahlgrenska, Gastroenterologi & Hepatologi, Göteborg, Sweden

and more 15 locations

TOFAcitinib in SARS-CoV2 Pneumonia

Phase 2

Conditions: SARS-COv2 Related Interstitial Pneumonia

Interventions: Drug: Tofacitinib

First Posted Date: 2020-04-02

Last Posted Date: 2020-04-02

Lead Sponsor: Università Politecnica delle Marche

Target Recruit Count: 50

Registration Number: NCT04332042

Locations: 🇮🇹
Ospedali Riuniti di Ancona, Ancona, Marche, Italy

Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease

Phase 4

Terminated

Conditions: ILD
Rheumatoid Arthritis
Interstitial Lung Disease Due to Systemic Disease (Disorder)
RA

Interventions: Drug: Tofacitinib
Drug: Methotrexate

First Posted Date: 2020-03-17

Last Posted Date: 2024-05-23

Lead Sponsor: Vastra Gotaland Region

Target Recruit Count: 3

Registration Number: NCT04311567

Locations: 🇸🇪
Karolinska University Hospital, Department of Rheumatology, Stockholm, Sweden
🇸🇪
Skåne University Hospital, Department of Rheumatology, Lund, Skåne, Sweden
🇸🇪
Clinical Rheumatology Research Center, The Sahlgrenska University Hospital, Göteborg, Västra Götaland, Sweden

Tofacitinib for Immune Skin Conditions in Down Syndrome

Phase 2

Active, not recruiting

Conditions: Down Syndrome
Vitiligo
Hidradenitis Suppurativa
Psoriasis
Alopecia Areata
Atopic Dermatitis / Eczema

Interventions: Drug: Tofacitinib

First Posted Date: 2020-01-29

Last Posted Date: 2024-11-18

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 47

Registration Number: NCT04246372

Locations: 🇺🇸
Linda Crnic Institute for Down Syndrome, Aurora, Colorado, United States

Drug Development Updates

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