VOQUEZNA (vonoprazan fumarate)
Voquezna helps adults manage various acid-related conditions, including the healing and maintenance of all grades of erosive esophagitis. It also provides relief for patients suffering from heartburn associated with both erosive and non-erosive gastroesophageal reflux disease. Additionally, this medication is used in combination with specific antibiotics to help clear *Helicobacter pylori* infections.
How VOQUEZNA Works
This medication works by inhibiting the H+, K+-ATPase enzyme system, often called the proton pump, at the surface of gastric parietal cells. By binding to these pumps in a potassium-competitive and reversible manner, it blocks the final step of gastric acid production. Unlike some other treatments, it does not require acid to become active and can concentrate in the cells during both resting and active states.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-11-01
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- TABLET
VOQUEZNA Approval History
What VOQUEZNA Treats
4 indicationsVOQUEZNA is approved for 4 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Erosive Esophagitis
- Heartburn
- Non-Erosive Gastroesophageal Reflux Disease
- Helicobacter Pylori Infection
VOQUEZNA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VOQUEZNA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
40 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06851559 | EoE-201 | Ph 2 | recruiting | 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 |
| NCT06561711 | rjhy20240816 | Ph 4 | completed | Optimization of Minocycline for Helicobacter Pylori Rescue Treatment |
| NCT05582174 | PPI vs VPZ study | Ph 4 | recruiting | PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers |
| NCT06340724 | KY20240123-08 | Ph 3 | completed | Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication |
| NCT07275632 | ZZ2025-945-01 | Ph 1, Ph 2 | recruiting | The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients |
| NCT07242456 TV-HP | TV-HP-2024-01 BCF-LX-XH-20221014-26 | Ph 2, Ph 3 | recruiting | Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for H. Pylori Eradication |
| NCT05874544 | rjhy20230001 | Ph 4 | completed | Rescue Therapy for Helicobacter Pylori Infection |
| NCT07068607 | KY20252096-F-1 | Ph 4 | recruiting | Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial |
| NCT06514274 | KY20242226-C-1 | Ph 4 | completed | Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication |
| NCT06168084 | KY20232236-F-2 | Ph 4 | completed | Helicobacter Rescue Therapy With Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy |
| NCT05343364 results posted | VPED-102 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease |
| NCT06391177 results posted | VONO-401 | Ph 1 | completed | A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily or Vonoprazan 20 mg Twice Daily |
| NCT06576882 VOTE-HP | 0306630 | Ph 3 | completed | 7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication |
| NCT05901051 | rjyy20210815 | Ph 4 | completed | High-dose Dual Therapy with Different Administration Frequencies |
| NCT06561698 | rjhy20240814 | Ph 4 | recruiting | High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection |
| NCT06106022 results posted | VPED-103 2022-003228-42 | Ph 1 | completed | A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease |
| NCT05649540 | KY20221124-07 | Ph 4 | completed | Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori |
| NCT06162949 | 0306381 | Ph 3 | completed | Vonoprazan for Helicobacter Pylori Eradication in Adolescents |
| NCT06526455 | PJKT2024-109 | Ph 4 | not yet recruiting | Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection |
| NCT05469685 | KY20220701-06 | Ph 4 | completed | Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication |
| NCT05366738 results posted | VPED-101 | Ph 1 | completed | A Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants |
| NCT05195528 results posted | NERD-301 | Ph 3 | completed | 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) |
| NCT02679508 results posted | Vonoprazan-4003 U1111-1178-8948, JapicCTI-163153 | Ph 4 | completed | Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety |
| NCT04028466 | RP 19-007 | Ph 4 | terminated | Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features |
| NCT06101420 P-CABs | 111954 | Ph 3 | completed | Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication |
| NCT04198363 results posted | Vonoprazan-3002 | Ph 3 | completed | 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 |
| NCT04753437 results posted | Vonoprazan-1001 U1111-1257-0258 | Ph 1 | completed | A Study of Vonoprazan in Adults With Helicobacter Pylori |
| NCT05049902 | 2021-SDU-QILU-G001-2 | Ph 4 | completed | Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication |
| NCT04729101 results posted | VONO-103 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants |
| NCT04545944 results posted | VONO-101 | Ph 1 | completed | Evaluation of Effect of Vonoprazan on Midazolam Pharmacokinetics in Healthy Participants |
| NCT05014334 | KY20212155-C-1 | Ph 4 | completed | Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication |
| NCT04799158 results posted | NERD-201 | Ph 2 | completed | A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease |
| NCT04124926 results posted | EE-301 2019-002579-33 | Ph 3 | completed | Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis |
| NCT04167670 results posted | HP-301 2019-002668-28 | Ph 3 | completed | Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection |
| NCT04558216 | VONO-102 | Ph 1 | withdrawn | Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants |
| NCT02388737 results posted | TAK-438_305 U1111-1136-5706, CTR20150039 | Ph 3 | completed | Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis |
| NCT02743949 results posted | Vonoprazan-2001 U1111-1172-2373, 2015-001154-14 | Ph 2 | completed | Comparison of Vonoprazan to Esomeprazole in Participants With Symptomatic GERD Who Responded Partially to a High Dose of Proton Pump Inhibitor (PPI) |
| NCT02388724 results posted | TAK-438_303 U1111-1138-4788, CTR20150040 | Ph 3 | completed | Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis |
| NCT03116841 VISTAEXE results posted | Vonoprazan-4006 U1111-1192-9760, JapicCTI-173538 | Ph 4 | completed | Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation |
| NCT02037477 results posted | TAK-438/CPH-010 U1111-1152-3926, NCT02037477 | Ph 3 | completed | Phase 3 Study to Evaluate the Acid-Inhibitory Effect of Multiple Oral Doses of Vonoprazan (TAK-438) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VOQUEZNA FDA Label Details
Indications & Usage
FDA Label (PDF)VOQUEZNA is indicated for the treatment of Erosive Esophagitis; Heartburn; Non-Erosive Gastroesophageal Reflux Disease; Helicobacter Pylori Infection.
VOQUEZNA Patents & Exclusivity
Exclusivity
Pro Intelligence Preview
Deep insights for VOQUEZNA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 8 active patents
Trial Analysis
- • 41 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment