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Vonoprazan Tablets
Vonoprazan is a potassium-competitive acid blocker that reversibly inhibits the H+/K+-ATPase pump in gastric parietal cells to reduce gastric acid secretion.
Vonoprazan is a potassium-competitive acid blocker that reversibly inhibits the H+/K+-ATPase pump in gastric parietal cells to reduce gastric acid secretion. Used for Gastroesophageal reflux disease (GERD), Peptic ulcer disease, Helicobacter pylori eradication (as part of combination therapy).
At a glance
| Generic name | Vonoprazan Tablets |
|---|---|
| Sponsor | Humanis Saglık Anonim Sirketi |
| Drug class | Potassium-competitive acid blocker (P-CAB) |
| Target | H+/K+-ATPase (proton pump) |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Unlike proton pump inhibitors (PPIs) that irreversibly bind to the H+/K+-ATPase, vonoprazan competitively blocks potassium binding to the pump, allowing for faster onset and offset of acid suppression. This mechanism provides more rapid and sustained acid suppression, making it effective for conditions requiring strong gastric acid reduction. It is particularly useful in treating acid-related disorders and has shown efficacy in Helicobacter pylori eradication regimens.
Approved indications
- Gastroesophageal reflux disease (GERD)
- Peptic ulcer disease
- Helicobacter pylori eradication (as part of combination therapy)
Common side effects
- Headache
- Diarrhea
- Abdominal pain
- Nausea
Key clinical trials
- A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks (PHASE2)
- Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication (PHASE3)
- Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1 (PHASE4)
- 7-day High-Dose Vonoprazan-amoxicillin Dual Therapy Versus 14-day Vonoprazan-amoxicillin Dual Therapy for H. Pylori (NA)
- Eradication of Helicobacter Pylori Improves Metabolic Syndrome Through Modulation of Gut Microbiota. (PHASE4)
- Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial (PHASE2)
- A Study to Evaluate Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Participants (PHASE1)
- Bioequivalence Study to Compare Vonoprazan 20 mg Film Coated Tablets Versus Voquezna® 20 mg (Vonoprazan) Tablets (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vonoprazan Tablets CI brief — competitive landscape report
- Vonoprazan Tablets updates RSS · CI watch RSS
- Humanis Saglık Anonim Sirketi portfolio CI