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
-

Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection

First Posted Date
2022-06-15
Last Posted Date
2023-02-16
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Target Recruit Count
393
Registration Number
NCT05419674
Locations
🇨🇳

Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China

A Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2022-05-09
Last Posted Date
2024-03-29
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Target Recruit Count
27
Registration Number
NCT05366738
Locations
🇺🇸

PPD Development, LP, Austin, Texas, United States

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease

Phase 1
Completed
Conditions
Interventions
First Posted Date
2022-04-25
Last Posted Date
2024-06-03
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Target Recruit Count
24
Registration Number
NCT05343364
Locations
🇺🇸

Infinite Clinical Trials, Morrow, Georgia, United States

🇺🇸

Boston Specialists, Boston, Massachusetts, United States

🇺🇸

University of South Alabama (USA) Physicians Group, Mobile, Alabama, United States

and more 7 locations

A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)

First Posted Date
2022-01-19
Last Posted Date
2023-12-29
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Target Recruit Count
776
Registration Number
NCT05195528
Locations
🇺🇸

Paragon Rx Clinical, Garden Grove, California, United States

🇺🇸

East View Medical Research, LLC, Mobile, Alabama, United States

🇺🇸

Medical Affiliated Research Center Inc, Huntsville, Alabama, United States

and more 103 locations

The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori

First Posted Date
2022-01-12
Last Posted Date
2022-03-22
Lead Sponsor
Huazhong University of Science and Technology
Target Recruit Count
672
Registration Number
NCT05189444
Locations
🇨🇳

Tongji Hospital, Tongji Medical College, HUST, Wuhan, Hubei, China

Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication

First Posted Date
2021-08-20
Last Posted Date
2023-01-31
Lead Sponsor
Xijing Hospital of Digestive Diseases
Target Recruit Count
300
Registration Number
NCT05014334
Locations
🇨🇳

Xijing Hosipital of Digestive Disease, Xi'an, Shaanxi, China

Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis

Early Phase 1
Completed
Conditions
Interventions
First Posted Date
2021-08-16
Last Posted Date
2023-10-27
Lead Sponsor
Uayporn Kaosombatwattana
Target Recruit Count
194
Registration Number
NCT05005910
Locations
🇹🇭

Faculty of internal medicine siriraj hospital, Mahidol university, Bangkok Noi, Bangkok, Thailand

Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication

First Posted Date
2021-06-01
Last Posted Date
2021-06-01
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Target Recruit Count
234
Registration Number
NCT04907747
Locations
🇨🇳

Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China

A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

First Posted Date
2021-03-16
Last Posted Date
2023-01-04
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Target Recruit Count
458
Registration Number
NCT04799158
Locations
🇺🇸

North Alabama Research Center LLC, Athens, Alabama, United States

🇺🇸

OM Research LLC, Lancaster, California, United States

🇺🇸

Medication Management LLC, Greensboro, North Carolina, United States

and more 57 locations

A Study of Vonoprazan in Adults With Helicobacter Pylori

First Posted Date
2021-02-15
Last Posted Date
2023-08-31
Lead Sponsor
Takeda
Target Recruit Count
44
Registration Number
NCT04753437
Locations
🇨🇳

West China Hospital, Sichuan University, Phase I Unit, Chengdu, Sichuan, China

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