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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR VONOPRAZAN FUMARATE


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All Clinical Trials for Vonoprazan Fumarate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04901117 ↗ Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days Not yet recruiting Heze Municipal 3rd people's hospital Phase 4 2021-06-01 The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.
NCT04901117 ↗ Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days Not yet recruiting Jining No.2 People's Hospital Phase 4 2021-06-01 The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.
NCT04901117 ↗ Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days Not yet recruiting Maternity and Child Care Health Center of Dezhou Phase 4 2021-06-01 The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.
NCT04901117 ↗ Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days Not yet recruiting PKUcare luzhong hospital Phase 4 2021-06-01 The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.
NCT04901117 ↗ Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days Not yet recruiting Qihe County City Hospital Phase 4 2021-06-01 The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.
NCT04901117 ↗ Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days Not yet recruiting Qilu Hospital of Shandong University Phase 4 2021-06-01 The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.
NCT04901117 ↗ Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days Not yet recruiting Shandong Electric Power Central Hospital Phase 4 2021-06-01 The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Vonoprazan Fumarate

Condition Name

Condition Name for Vonoprazan Fumarate
Intervention Trials
Helicobacter Pylori Infection 4
Helicobacter Pylori Eradication Rate 2
Helicobacter Pylori 1
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Condition MeSH

Condition MeSH for Vonoprazan Fumarate
Intervention Trials
Infections 1
Helicobacter Infections 1
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Clinical Trial Locations for Vonoprazan Fumarate

Trials by Country

Trials by Country for Vonoprazan Fumarate
Location Trials
China 5
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Clinical Trial Progress for Vonoprazan Fumarate

Clinical Trial Phase

Clinical Trial Phase for Vonoprazan Fumarate
Clinical Trial Phase Trials
Phase 4 5
Phase 3 1
N/A 1
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Clinical Trial Status

Clinical Trial Status for Vonoprazan Fumarate
Clinical Trial Phase Trials
Not yet recruiting 5
Recruiting 2
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Clinical Trial Sponsors for Vonoprazan Fumarate

Sponsor Name

Sponsor Name for Vonoprazan Fumarate
Sponsor Trials
Maternity and Child Care Health Center of Dezhou 2
PKUcare luzhong hospital 2
Shandong University 2
[disabled in preview] 7
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Sponsor Type

Sponsor Type for Vonoprazan Fumarate
Sponsor Trials
Other 36
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Vonoprazan Fumarate: Clinical Trials, Market Analysis, and Projections

Introduction

Vonoprazan fumarate, a novel potassium-competitive acid blocker (P-CAB), is gaining significant attention in the pharmaceutical industry for its potential in treating various gastrointestinal disorders. This article provides an update on the clinical trials, market analysis, and projections for vonoprazan fumarate.

Clinical Trials Update

Current Phase and Indications

Vonoprazan fumarate is currently in Phase I clinical trials for the treatment of Reflux Esophagitis (Gastroesophageal Reflux Disease) under the development of Phathom Pharmaceuticals[1].

Phase Transition Success Rate

According to GlobalData, Phase I drugs for Reflux Esophagitis have a 78% phase transition success rate (PTSR) benchmark for progressing into Phase II. This indicates a relatively high likelihood of vonoprazan fumarate advancing to the next phase of clinical trials[1].

Ongoing and Planned Studies

Several clinical trials are ongoing or planned to evaluate the efficacy and safety of vonoprazan fumarate. For instance, studies are being conducted to assess its pharmacokinetics and safety in pediatric patients with erosive esophagitis and GERD. Additionally, trials are planned to evaluate its efficacy in healing endoscopically confirmed erosive esophagitis and relieving heartburn symptoms[4].

Market Analysis

Market Size and Growth Potential

The vonoprazan fumarate API market is expected to grow significantly from 2024 to 2031, driven by the increasing prevalence of gastrointestinal disorders such as GERD and peptic ulcers. The market is anticipated to expand due to rising healthcare expenditure, favorable regulatory approvals, and advancements in pharmaceutical research[2].

Market Drivers

  • Rising Incidence of Gastrointestinal Disorders: The growing prevalence of GERD, peptic ulcers, and other acid-related disorders is driving the demand for effective treatments like vonoprazan fumarate[2].
  • Advancements in Pharmaceutical Research: Ongoing research and development in pharmaceuticals are enhancing the efficacy and application of vonoprazan fumarate in clinical settings[2].
  • Increasing Healthcare Expenditure: Growing healthcare spending, particularly in emerging economies, is supporting the development and accessibility of advanced treatments like vonoprazan fumarate[2].
  • Favorable Regulatory Approvals: Regulatory approvals from health authorities such as the FDA and EMA are validating the safety and efficacy of vonoprazan fumarate, promoting its adoption in clinical practice[2].

Market Restraints

  • Potential Adverse Effects: Safety concerns and potential adverse effects associated with vonoprazan fumarate can limit its adoption. Patients and healthcare providers may prefer established medications with well-known safety profiles[2].
  • Limited Awareness in Developing Regions: In developing regions, limited awareness and understanding of advanced gastrointestinal treatments can restrict the market for vonoprazan fumarate API[2].
  • Competition from Alternative Therapies: The availability of alternative therapies, such as other PPIs and H2 receptor antagonists, presents competition for vonoprazan fumarate[2].

Market Projections

Growth Forecast

The vonoprazan fumarate API market is projected to grow at a moderate pace over the next several years. The market size is expected to increase significantly due to the expanding global pharmaceutical industry, increased production capacities, and technological advancements[2].

Key Markets

Emerging economies in Asia-Pacific, Latin America, and the Middle East present significant growth opportunities for the vonoprazan fumarate API market. Improving healthcare infrastructure, rising disposable incomes, and greater access to medical care in these regions are driving market expansion[2].

Therapeutic Applications

Vonoprazan fumarate is being developed for various therapeutic applications, including:

  • Gastroesophageal Reflux Disease (GERD)
  • Peptic Ulcer Disease
  • Helicobacter pylori Infection
  • Non-Erosive Reflux Disease (NERD)
  • Erosive Esophagitis
  • Eosinophilic Esophagitis (EoE)
  • Duodenal Ulcer Adjunct to Helicobacter pylori Eradication[1][3][5].

High Efficacy and Patient Compliance

Vonoprazan fumarate offers several advantages over traditional proton pump inhibitors (PPIs), including a rapid onset of action and a prolonged duration of effect. These characteristics make it a preferred choice for treating acid-related disorders, driving its demand and market growth[2].

Strategic Collaborations and Partnerships

Collaborations between pharmaceutical companies, research institutions, and healthcare providers are enhancing the development and commercialization of vonoprazan fumarate API. These partnerships facilitate knowledge sharing, innovation, and market penetration, contributing to market growth[2].

Regulatory Environment

Favorable regulatory approvals by health authorities such as the FDA and EMA are crucial for the market growth of vonoprazan fumarate. These approvals validate the safety and efficacy of the drug, promoting its use in clinical practice[2].

Market Opportunities

  • Expanding Global Pharmaceutical Industry: The overall expansion of the global pharmaceutical industry supports the production and distribution of vonoprazan fumarate API.
  • Enhancing Eco-Friendly Packaging: Initiatives to develop eco-friendly packaging can appeal to environmentally conscious consumers and organizations.
  • Telehealth Integration: Integrating telehealth platforms can facilitate virtual consultations and seamless patient prescribing processes[5].

Market Challenges

  • Diverse Patient Needs: Understanding the diverse needs of patients and healthcare practitioners in various geographical markets is essential for successful market penetration.
  • Economic Instability: Economic instability can impact healthcare spending and the adoption of new treatments like vonoprazan fumarate[2].
"Vonoprazan fumarate offers higher efficacy and better patient compliance compared to traditional proton pump inhibitors (PPIs). Its rapid onset of action and prolonged duration of effect make it a preferred choice for treating acid-related disorders, driving its demand." - Verified Market Research[2]

Key Takeaways

  • Clinical Trials: Vonoprazan fumarate is in Phase I clinical trials for Reflux Esophagitis with a high phase transition success rate.
  • Market Growth: The market is expected to grow significantly due to rising incidence of gastrointestinal disorders, advancements in pharmaceutical research, and favorable regulatory approvals.
  • Therapeutic Applications: Vonoprazan fumarate is being developed for various gastrointestinal disorders, including GERD, peptic ulcers, and Helicobacter pylori infections.
  • High Efficacy: The drug offers higher efficacy and better patient compliance compared to traditional PPIs.
  • Market Opportunities: Expanding global pharmaceutical industry, eco-friendly packaging initiatives, and telehealth integration are key opportunities for market growth.

FAQs

What is vonoprazan fumarate and how does it work?

Vonoprazan fumarate is a potassium-competitive acid blocker (P-CAB) that works by inhibiting the proton pump in the stomach, reducing acid production. It is formulated as capsules and tablets for oral administration.

What are the current clinical trial phases for vonoprazan fumarate?

Vonoprazan fumarate is currently in Phase I clinical trials for the treatment of Reflux Esophagitis (Gastroesophageal Reflux Disease).

What are the key market drivers for vonoprazan fumarate?

Key market drivers include the rising incidence of gastrointestinal disorders, advancements in pharmaceutical research, increasing healthcare expenditure, and favorable regulatory approvals.

What are the potential market restraints for vonoprazan fumarate?

Potential restraints include safety concerns, limited awareness in developing regions, competition from alternative therapies, and economic instability.

What are the therapeutic applications of vonoprazan fumarate?

Vonoprazan fumarate is being developed for various therapeutic applications, including GERD, peptic ulcer disease, Helicobacter pylori infection, non-erosive reflux disease, erosive esophagitis, and eosinophilic esophagitis.

Sources

  1. Pharmaceutical Technology: "Vonoprazan fumarate by Phathom Pharmaceuticals for Reflux Esophagitis (Gastroesophageal Reflux Disease)".
  2. Verified Market Research: "Vonoprazan Fumarate API Market Size & Forecast".
  3. GlobalData: "Likelihood of Approval and Phase Transition Success Rate Model – Vonoprazan Fumarate in Reflux Esophagitis (Gastroesophageal Reflux Disease)".
  4. FDA: "215151Orig1s000 INTEGRATED REVIEW - accessdata.fda.gov".
  5. 360 Research Reports: "Vonoprazan Fumarate Tablets Market Size & Share 2025-2030".

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