Vonoprazan

Generic Name
Vonoprazan
Brand Names
Voquezna 14 Day Dualpak 20;500, Voquezna 14 Day Triplepak 20;500;500
Drug Type
Small Molecule
Chemical Formula
C17H16FN3O2S
CAS Number
881681-00-1
Unique Ingredient Identifier
1R5L3J156G
Background

Vonoprazan is a potassium-competitive acid blocker (PCAB) that inhibits H, K-ATPase-mediated gastric acid secretion. PCABs represent an alternative to proton-pump inhibitors for the treatment of acid-related disorders. Unlike proton-pump inhibitors, PCABs are not affected by CYP2C19 genetic polymorphisms and do not require acid-resistant formulations. Furthe...

Indication

Vonoprazan, in combination with amoxicillin and clarithromycin in a co-packaged product, is indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults. Another co-packaged product with only vonoprazan and amoxicillin is also indicated for the treatment of H. pylori infection in adults.

Associated Conditions
Duodenal Ulcer, Gastric Ulcer, Gastric or Duodenal Ulcers Caused by Low-dose Aspirin, Helicobacter Pylori Infection, Reflux Esophagitis (RE), Develop NSAID-induced gastric ulcers
Associated Therapies
-

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2021-01-28
Last Posted Date
2023-03-31
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Target Recruit Count
44
Registration Number
NCT04729101
Locations
🇺🇸

Celerion, 2420 W Baseline Rd,, Tempe, Arizona, United States

The Need of Revisiting to an Outpatient Clinic After the Prescription of Vonoprazan or Esomeprazole

Not Applicable
Recruiting
Conditions
Interventions
First Posted Date
2021-01-22
Last Posted Date
2024-02-23
Lead Sponsor
Showa Inan General Hospital
Target Recruit Count
300
Registration Number
NCT04720781
Locations
🇯🇵

Showa Inan General hospital, Komagane, Nagano, Japan

Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants

Phase 1
Withdrawn
Conditions
Interventions
First Posted Date
2020-09-22
Last Posted Date
2022-03-02
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Registration Number
NCT04558216
Locations
🇺🇸

PPD Development, LP, 7551 Metro Center Drive, Suite 200, Austin, Texas, United States

Evaluation of Effect of Vonoprazan on Midazolam Pharmacokinetics in Healthy Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2020-09-11
Last Posted Date
2023-03-17
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Target Recruit Count
20
Registration Number
NCT04545944
Locations
🇺🇸

PPD Development, LP, Austin, Texas, United States

A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

First Posted Date
2019-12-13
Last Posted Date
2023-09-07
Lead Sponsor
Takeda
Target Recruit Count
510
Registration Number
NCT04198363
Locations
🇨🇳

The First People's Hospital of Foshan, Foshan, Guangdong, China

🇨🇳

Friendship Hospital, Capital Medical University, Beijing, Beijing, China

🇨🇳

Peking University Third Hospital, Beijing, Beijing, China

and more 26 locations

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection

First Posted Date
2019-11-19
Last Posted Date
2022-04-05
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Target Recruit Count
1046
Registration Number
NCT04167670
Locations
🇺🇸

Carolina Research, Greenville, North Carolina, United States

🇺🇸

Synexus Clinical Research US, Inc. - Anderson, Anderson, South Carolina, United States

🇺🇸

Anaheim Clinical Trials LLC, Anaheim, California, United States

and more 147 locations

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2019-10-14
Last Posted Date
2022-07-29
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Target Recruit Count
1027
Registration Number
NCT04124926
Locations
🇺🇸

Carolina Research, Greenville, North Carolina, United States

🇺🇸

Central Sooner Research, Norman, Oklahoma, United States

🇺🇸

Biopharma Informatic, LLC, Houston, Texas, United States

and more 149 locations

Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2019-07-22
Last Posted Date
2023-11-22
Lead Sponsor
St. Luke's Medical Center, Philippines
Target Recruit Count
82
Registration Number
NCT04028466
Locations
🇵🇭

St. Luke's Medical Center, Quezon City, National Capital Region, Philippines

A RCT of Triple Therapy With Proton Pump Inhibitor vs Vonoprazan for Helicobacter Pylori Gastritis

First Posted Date
2019-04-09
Last Posted Date
2020-10-08
Lead Sponsor
Changi General Hospital
Target Recruit Count
252
Registration Number
NCT03908619
Locations
🇸🇬

Clinical Trials & Research Unit, Singapore, Singapore

Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"

First Posted Date
2017-07-17
Last Posted Date
2019-03-22
Lead Sponsor
Takeda
Target Recruit Count
560
Registration Number
NCT03219723
Locations
🇯🇵

Takeda Selected Site, Tokyo, Japan

© Copyright 2024. All Rights Reserved by MedPath