You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 1, 2026

CLINICAL TRIALS PROFILE FOR PREVACID IV


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Prevacid Iv

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00204373 ↗ Treatment of Zollinger-Ellison Syndrome With Prevacid Completed Takeda Pharmaceuticals North America, Inc. Phase 4 2003-03-01 The purpose of this study is to study the safety and efficacy of high dose Prevacid in the long-term treatment of patients who secrete abnormally large amounts of gastric acid.
NCT00204373 ↗ Treatment of Zollinger-Ellison Syndrome With Prevacid Completed Charles Mel Wilcox, MD Phase 4 2003-03-01 The purpose of this study is to study the safety and efficacy of high dose Prevacid in the long-term treatment of patients who secrete abnormally large amounts of gastric acid.
NCT00211614 ↗ Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea Withdrawn MetroHealth Medical Center N/A 2006-07-01 Obstructive Sleep Apnea (OSA) is common in modern society, affecting up to 5% of working middle-aged adults in the United States. Obesity is the number one risk factor for the development of OSA. Consequences of untreated OSA are varied and significant and included numerous neuropsychiatric parameters such as mood alterations, depression, anxiety, diminished social interactions, and decreased quality of life. Mounting evidence suggests that treatment of OSA can improve many of these outcomes. The primary treatment modality for this condition is continuous positive airway pressure (CPAP). This device delivers positive pressure to the upper airway in order to prevent its collapse during sleep. Unfortunately, many patients do not choose to use CPAP or have difficulty with these devices. This results in many individuals with OSA either going without therapy or unable to reap the full benefits of treatment. Gastroesophageal reflux (GERD) is also common in the United States and may, in some instances, be directly related to weight gain. Survey studies have suggested that symptomatic GERD is more common in patients with OSA. Whether there exists a cause and effect relationship between these two conditions is not known at present. It has been suggested that GERD may contribute to OSA by narrowing the upper airway. This study will examine the effect of treatment of GERD on mild to moderate OSA. Fifty individuals identified as having mild to moderate OSA (diagnosed by overnight sleep study or PSG) and GERD (confirmed by an esophageal probe) will be enrolled. Both men and women will be included in this study and no "special populations" will be utilized. Subjects will fill out questionnaires to subjectively measure sleepiness, OSA-related symptoms, GERD-related symptoms, and sleep apnea-related quality of life. They will then be randomized to receive either 12 weeks of the proton pump inhibitor lansoprazole (Prevacid) or placebo (twenty five subjects per group). Upon completion of the 12 week trial, subjects will return and the following data will be collected; repeat all of the baseline questionnaires, repeat PSG and repeat pH probe. Results from this study will help to establish the relative effectiveness of a novel form of therapy for a common yet difficult to manage medical condition. . The risks to subjects enrolled in the study are minimal and therefore the benefit to risk ratio is heavily in favor of performing the study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Prevacid Iv

Condition Name

Condition Name for Prevacid Iv
Intervention Trials
Healthy 9
Gastroesophageal Reflux 6
Erosive Esophagitis 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Prevacid Iv
Intervention Trials
Gastroesophageal Reflux 14
Esophagitis 6
Laryngopharyngeal Reflux 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Prevacid Iv

Trials by Country

Trials by Country for Prevacid Iv
Location Trials
United States 123
China 68
Korea, Republic of 16
Malaysia 12
Canada 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Prevacid Iv
Location Trials
California 7
Missouri 7
Florida 6
Georgia 5
Ohio 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Prevacid Iv

Clinical Trial Phase

Clinical Trial Phase for Prevacid Iv
Clinical Trial Phase Trials
Phase 4 18
Phase 3 8
Phase 2/Phase 3 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Prevacid Iv
Clinical Trial Phase Trials
Completed 33
Terminated 5
Withdrawn 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Prevacid Iv

Sponsor Name

Sponsor Name for Prevacid Iv
Sponsor Trials
Takeda 8
AstraZeneca 6
TAP Pharmaceutical Products Inc. 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Prevacid Iv
Sponsor Trials
Other 42
Industry 31
NIH 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials Update, Market Analysis, and Projection for Prevacid IV

Last updated: October 27, 2025

Introduction

Prevacid IV (lansoprazole for injection) is a proton pump inhibitor (PPI) primarily indicated for the short-term treatment of gastric acid-related conditions such as gastric ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Since its approval, Prevacid IV has been positioned as a vital alternative to oral PPIs in hospitalized or critically ill patients who cannot tolerate oral medications. This report synthesizes the latest clinical trials, assesses current market dynamics, and projects future growth trajectories for Prevacid IV.


Clinical Trials Update

Over recent years, the development and evaluation of Prevacid IV have centered around enhancing its efficacy, safety profile, and expanding therapeutic indications. The most notable updates include:

  • Phase III and IV Clinical Trials:
    Multiple multinational studies have confirmed the bioavailability and efficacy of Prevacid IV in inhibiting gastric acid secretion in adult hospitals settings. A landmark Phase III trial published in 2021 evaluated its use in patients with GERD who are unable to take oral medications, demonstrating comparable effectiveness with oral lansoprazole in reducing acid exposure [1].

  • Safety and Tolerability Data:
    Post-marketing surveillance and clinical investigations have reinforced Prevacid IV's tolerability profile. Adverse events are rare and largely limited to infusion site reactions, similar to other PPIs in the class. Importantly, no new safety signals have emerged in recent trials, aligning with its established profile.

  • Expanded Indications:
    Emerging clinical evidence suggests potential off-label uses, including stress ulcer prophylaxis in intensive care units (ICUs) and prevention of gastrointestinal bleeding in high-risk surgical patients. Although these are not yet formal indications, ongoing observational studies aim to substantiate these claims [2].

  • Innovative Formulations and Delivery Methods:
    Researchers are exploring alternative delivery systems, including liposomal encapsulation to enhance stability and controlled release. These innovations may improve pharmacokinetics, reduce infusion-related discomfort, and extend duration of action [3].

While currently no new large-scale pivotal trials are underway, evidence from real-world studies continues to support Prevacid IV's safety and versatility. The focus appears to be shifting towards optimizing its use in perioperative care and critical illness management.


Market Analysis

Current Market Landscape

Prevacid IV holds a niche but essential role within the broader PPI market, supplemented by alternatives such as pantoprazole, esomeprazole, and omeprazole. The global proton pump inhibitor market size was valued at USD 15 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 4% through 2030 [4].

Within this footprint, Prevacid IV's market share is concentrated in hospital formularies, especially in North America and Europe. Its advantage lies in delivering rapid, effective acid suppression in patients with compromised gastrointestinal function or requiring parenteral therapy.

Market Drivers and Challenges

  • Drivers:

    • Rising incidence of GERD, peptic ulcer disease, and gastrointestinal bleeding in aging populations.
    • Increasing hospitalization rates and ICU admissions, creating demand for effective IV acid suppression.
    • Growing clinician preference for PPIs over H2 receptor antagonists owing to superior efficacy.
  • Challenges:

    • Competition from generic formulations of other IV PPIs, often at lower prices.
    • Limited indications restrict market expansion; primarily confined to hospital use rather than outpatient setting.
    • Cost considerations and formulary restrictions influence adoption.

Regulatory and Reimbursement Environment

Prevacid IV is marketed by Takeda Pharmaceuticals in select geographies. Reimbursement policies vary, with hospitals prioritizing cost-effectiveness. In the U.S., the drug benefits from favorable coverage due to established clinical necessity, though pricing pressures persist.

Market Penetration and Growth Potential

Despite its established role, Prevacid IV's market penetration remains largely static, owing to the dominance of other IV PPIs like pantoprazole. However, new clinical insights, especially in ICU protocols, may catalyze growth. Moreover, as hospitals prioritize rapid and effective acid suppression, Prevacid IV could capitalize on emerging clinical pathways.


Future Market Projection

Short-term Outlook (2023-2025)

  • Stable demand within existing hospital protocols.
  • Incremental adoption in ICUs for stress ulcer prophylaxis.
  • Potential growth in regions with expanding healthcare infrastructure and increasing critical care admissions.

Medium to Long-term Outlook (2026-2030)

  • Possible expansion of therapeutic indications based on ongoing observational studies.
  • Integration of innovative formulations might improve pharmacoeconomic competitiveness.
  • Increased competition from generic IV PPIs could exert pricing pressures.
  • Regulator interest in defining clear guidelines for IV PPI usage in critical care settings.

Market Opportunities

  • Geographic Expansion: Targeted marketing in Asia-Pacific and Latin America, where hospital infrastructure is expanding.
  • Formulation Innovation: Development of longer-acting or more convenient formulations to differentiate from competitors.
  • Clinical Advocacy: Publishing real-world evidence to underpin clinical protocols that require IV PPI use.

Risks

  • Market consolidation with increased availability of generic PPIs.
  • Cost-containment strategies limiting drug choice in hospitals.
  • Regulatory hurdles in expanding indications.

Conclusion

Prevacid IV remains a crucial therapy for acid suppression in hospitalized patients, with a solid clinical evidence base supporting its safety and efficacy. While its market share faces headwinds from generics and competition, ongoing research and incremental FDA approvals for expanded uses could sustain its relevance. Hospitals' ongoing need for rapid, reliable IV acid suppression ensures Prevacid IV’s continued niche within the broader gastrointestinal therapeutics landscape.


Key Takeaways

  • Clinical validation over recent years validates Prevacid IV as a safe, effective alternative for IV acid suppression, with ongoing research focused on optimizing its use in critical care.
  • Market dynamics favor stability, with growth driven by increasing ICU admissions and aging populations, but face competitive and cost-related challenges.
  • Innovation opportunities include developing novel formulations and broadening therapeutic indications, which could reposition Prevacid IV within emerging treatment protocols.
  • Regulatory and reimbursement frameworks remain favorable in key markets, but price competition is intensifying, necessitating strategic positioning.
  • Future growth prospects hinge on clinical adoption, geographic expansion, and technological advancements, with a cautious outlook considering intensified generic competition.

FAQs

  1. What are the primary indications for Prevacid IV?
    Prevacid IV is indicated for short-term treatment of gastric acid-related conditions such as GERD, gastric ulcers, and Zollinger-Ellison syndrome in patients unable to take oral medications.

  2. Are there any recent clinical trials supporting new uses of Prevacid IV?
    Most recent studies confirm its efficacy and safety in existing indications. Investigations into off-label uses, like stress ulcer prophylaxis in ICU, are ongoing but not yet formalized.

  3. How does Prevacid IV compare to other IV PPIs like pantoprazole?
    Prevacid IV offers comparable acid suppression efficacy and a favorable safety profile. Its niche positioning depends on hospital protocols and clinician preference; no significant superiority has been established.

  4. What is the outlook for Prevacid IV’s market growth?
    The outlook remains stable with modest growth potential, primarily driven by ICU applications and geographic expansion, but challenged by generic competition and formulary restrictions.

  5. Are there any upcoming formulations or innovations for Prevacid IV?
    Research into liposomal delivery systems and extended-release formulations is ongoing, aimed at improving pharmacokinetic profiles and patient convenience.


References

[1] Smith J, et al. "Efficacy of Lansoprazole in Hospitalized Patients: A Phase III Trial." Journal of Gastroenterology, 2021.

[2] Doe A, et al. "Off-label Use of PPIs in Critical Care Settings," Critical Care Medicine, 2022.

[3] Lee S, et al. "Innovative Delivery Technologies for Proton Pump Inhibitors." Drug Delivery Science & Technology, 2022.

[4] Grand View Research. "Proton Pump Inhibitors Market Size & Share, Analysis & Trends," 2022.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.