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

Clinical Trials

Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM

Not Applicable

Not yet recruiting

Conditions: GERD

Interventions: Drug: Vonoprazan
Drug: Esomeprazole 40mg

First Posted Date: 2025-05-02

Last Posted Date: 2025-05-07

Lead Sponsor: Asian Institute of Gastroenterology, India

Target Recruit Count: 300

Registration Number: NCT06955520

A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks

Not Applicable

Not yet recruiting

Conditions: GERD

Interventions: Drug: Vonoprazan
Drug: Esomeprazole 40mg

First Posted Date: 2025-05-01

Last Posted Date: 2025-05-07

Lead Sponsor: Asian Institute of Gastroenterology, India

Target Recruit Count: 414

Registration Number: NCT06953986

Locations: 🇮🇳
Asian Institute of Gastroenterology /Aig Hospitals, Hyderabad, Telangana, India

Zuojin Wan Combined with Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication

Early Phase 1

Not yet recruiting

Conditions: Helicobacter Pylori Infection

Interventions: Drug: Vonoprazan
Drug: Amoxicillin
Drug: Zuojin Wan

First Posted Date: 2025-03-28

Last Posted Date: 2025-03-28

Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Target Recruit Count: 136

Registration Number: NCT06901375

Locations: 🇨🇳
Nanjing First Hospitai, Nanjing, Jiangsu, China

A Study in Adult and Adolescent Participants With EoE to Evaluate Vonoprazan 10 mg and 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 10 mg and 20 mg Up to 52 Weeks

Phase 2

Not yet recruiting

Conditions: Eosinophilic Esophagitis

Interventions: Drug: Vonoprazan
Drug: Placebo

First Posted Date: 2025-02-28

Last Posted Date: 2025-02-28

Lead Sponsor: Phathom Pharmaceuticals, Inc.

Target Recruit Count: 150

Registration Number: NCT06851559

Comparison of the Efficacies of Two Novel Dose Dual Therapies in the First-line Helicobacter Pylori Eradication

Phase 3

Conditions: HELICOBACTER PYLORI INFECTIONS

Interventions: Drug: Vonoprazan
Drug: Esomeprazole 40mg
Drug: Amoxicillin

First Posted Date: 2025-02-06

Last Posted Date: 2025-02-12

Lead Sponsor: Chang Gung Memorial Hospital

Target Recruit Count: 300

Registration Number: NCT06811207

Locations: 🇨🇳
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Others, Taiwan

Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease

Phase 4

Completed

Conditions: Vonoprazan
Proton Pump Inhibitor
Gastroesophageal Reflux Disease

Interventions: Drug: Dexlansoprazole 60 mg
Drug: Vonoprazan 20 mg bid

First Posted Date: 2025-01-16

Last Posted Date: 2025-02-27

Lead Sponsor: Ayman Magd Eldin Mohammad Sadek

Target Recruit Count: 136

Registration Number: NCT06778395

Locations: 🇪🇬
Zagazig University Hospital, Zagazig, Sharkia, Egypt

Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study

Not yet recruiting

Conditions: HELICOBACTER PYLORI INFECTIONS

Interventions: Drug: Bismuth
Drug: Vonoprazan
Drug: Amoxicillin
Drug: Rifabutin
Drug: Metronidazole
Drug: Other antibiotics

First Posted Date: 2024-12-12

Last Posted Date: 2024-12-19

Lead Sponsor: Xiuli Zuo

Target Recruit Count: 30

Registration Number: NCT06731023

Locations: 🇨🇳
Qilu Hospital of Shandong University, Jinan, Shandong, China

Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis

Phase 4

Not yet recruiting

Conditions: Erosive Esophagitis

Interventions: Drug: Vonoprazan 20 mg
Drug: Esomeprazole

First Posted Date: 2024-12-06

Last Posted Date: 2024-12-17

Lead Sponsor: Indonesia University

Target Recruit Count: 216

Registration Number: NCT06720610

Locations: 🇮🇩
Cipto Mangunkusumo Hospital, Jakarta Pusat, DKI Jakarta, Indonesia
🇮🇩
Hermina Kemayoran Hospital, Jakarta Pusat, DKI Jakarta, Indonesia
🇮🇩
Hermina Bekasi Hospital, Bekasi, Jawa Barat, Indonesia

and more 2 locations