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: C_₁₇H_₁₆FN_₃O_₂S

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. Furthermore, vonoprazan is 350-times more potent than the proton-pump inhibitor lansoprazole, thanks to its ability to accumulate in the gastric corpus mucosa, specifically in the parietal cells.

In February 2015, vonoprazan was first marketed in Japan for the treatment of acid-related disorders and as an adjunct to Helicobacter pylori (H. pylori) eradication. In May 2022, the FDA approved the use of vonoprazan in a co-packaged product containing amoxicillin and clarithromycin for the treatment of H. pylori infection. Studies have shown that the concomitant use of vonoprazan, amoxicillin, and clarithromycin leads to an H. pylori eradication rate of approximately 90%.

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: -

Clinical Trials

Vonoprazan for Helicobacter Pylori Eradication in Adolescents

Phase 3

Completed

Conditions: Treatment Effectiveness

Interventions: Drug: Vonoprazan
Drug: Amoxicillin
Drug: Clarithromycin
Drug: Esomeprazole

First Posted Date: 2023-12-08

Last Posted Date: 2024-08-28

Lead Sponsor: Alexandria University

Target Recruit Count: 242

Registration Number: NCT06162949

Locations: 🇪🇬
Faculty of Medicine, Alexandria, Egypt

A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease

Phase 1

Completed

Conditions: Gastroesophageal Reflux Disease

Interventions: Drug: Vonoprazan

First Posted Date: 2023-10-30

Last Posted Date: 2024-12-19

Lead Sponsor: Phathom Pharmaceuticals, Inc.

Target Recruit Count: 22

Registration Number: NCT06106022

Locations: 🇺🇸
Riley Hospital for Children at IU Health, Indianapolis, Indiana, United States
🇺🇸
Children's Center for Digestive Health Care, LLC, Atlanta, Georgia, United States
🇺🇸
Maspons Pediatric Gastro, El Paso, Texas, United States

and more 10 locations

Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication

Phase 3

Completed

Conditions: Helicobacter Pylori Eradication

Interventions: Drug: Vonoprazan

First Posted Date: 2023-10-26

Last Posted Date: 2023-10-26

Lead Sponsor: Ain Shams University

Target Recruit Count: 232

Registration Number: NCT06101420

Locations: 🇪🇬
Faculty of Medicine Ain Shams University, Cairo, Egypt

High-dose Dual Therapy with Different Administration Frequencies

Phase 4

Completed

Conditions: Helicobacter Pylori Infection

Interventions: Drug: vonoprazan
Drug: Amoxicillin

First Posted Date: 2023-06-13

Last Posted Date: 2024-12-30

Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Target Recruit Count: 327

Registration Number: NCT05901051

Locations: 🇨🇳
Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai, China

Rescue Therapy for Helicobacter Pylori Infection

Phase 4

Recruiting

Conditions: Helicobacter Pylori Infection

Interventions: Drug: Vonoprazan
Drug: Bismuth Potassium Citrate
Drug: Amoxicillin
Drug: Tetracycline
Drug: Rifabutin
Drug: Metronidazole

First Posted Date: 2023-05-25

Last Posted Date: 2024-12-30

Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Target Recruit Count: 360

Registration Number: NCT05874544

Locations: 🇨🇳
Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai, China
🇨🇳
Shanghai Songjiang District Central Hospital, Shanghai, Shanghai, China
🇨🇳
The Second Affiliated Hospital of Zhejiang University school of Medicine, Hangzhou, Zhejiang, China

Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial

Phase 4

Not yet recruiting

Conditions: Helicobacter Pylori Infection

Interventions: Drug: Vonoprazan
Drug: Amoxicillin, Metronidazole
Drug: Bismuth Potassium Citrate
Drug: Esomeprazole

First Posted Date: 2023-02-14

Last Posted Date: 2023-02-14

Lead Sponsor: Shanghai East Hospital

Target Recruit Count: 100

Registration Number: NCT05726734

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

The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication

Phase 4

Not yet recruiting

Conditions: Helicobacter Pylori Infection
Infections
Intestinal Bacteria Flora Disturbance

Interventions: Drug: Vonoprazan
Drug: Amoxicillin
Drug: probiotics

First Posted Date: 2022-12-20

Last Posted Date: 2023-02-08

Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Target Recruit Count: 100

Registration Number: NCT05658055

Locations: 🇨🇳
Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China

Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

Phase 4

Completed

Conditions: Helicobacter Pylori Infection

Interventions: Drug: Vonoprazan
Drug: Amoxicillin

First Posted Date: 2022-12-14

Last Posted Date: 2024-11-19

Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Target Recruit Count: 900

Registration Number: NCT05649540

Locations: 🇨🇳
Changzhou Traditional Chinese Medicine Hospital, Changzhou, Jiangsu, China
🇨🇳
Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
🇨🇳
The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, Jiangsu, China

and more 10 locations

PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers

Phase 4

Recruiting

Conditions: Upper GI Bleeding
Proton Pump Inhibitors

Interventions: Drug: esomeprazole
Drug: Vonoprazan

First Posted Date: 2022-10-17

Last Posted Date: 2023-08-30

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 594

Registration Number: NCT05582174

Locations: 🇨🇳
Nanfang Hospital Southern Medical University, Guangzhou, Guangdong, China
🇨🇳
Shenzhen Pingshan District People's Hospital, Shenzhen, Guangdong, China
🇨🇳
The Second Affiliated Hospital The Chinese University of Hong Kong, Shenzhen & Longgang District People's Hospital of Shenzhen, Shenzhen, Guangdong, China

and more 5 locations

Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication

Phase 4

Completed

Conditions: Helicobacter Pylori Infection

Interventions: Drug: Vonoprazan
Drug: Amoxicillin

First Posted Date: 2022-07-22

Last Posted Date: 2024-06-13

Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Target Recruit Count: 914

Registration Number: NCT05469685

Locations: 🇨🇳
Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China
🇨🇳
Changshu No.1 People's Hospital, Suzhou, Jiangsu, China
🇨🇳
Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

and more 7 locations

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