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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR PREVACID 24 HR


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All Clinical Trials for PREVACID 24 HR

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NCT00211614 ↗ Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea Withdrawn MetroHealth Medical Center N/A 2006-07-01 Obstructive Sleep Apnea (OSA) is common in modern society, affecting up to 5% of working middle-aged adults in the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 24 HR

Condition Name

Condition Name for PREVACID 24 HR
Intervention Trials
Healthy 9
Gastroesophageal Reflux 6
Erosive Esophagitis 4
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Condition MeSH

Condition MeSH for PREVACID 24 HR
Intervention Trials
Gastroesophageal Reflux 14
Esophagitis 6
Laryngopharyngeal Reflux 3
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Clinical Trial Locations for PREVACID 24 HR

Trials by Country

Trials by Country for PREVACID 24 HR
Location Trials
United States 123
China 68
Korea, Republic of 16
Malaysia 12
India 10
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Trials by US State

Trials by US State for PREVACID 24 HR
Location Trials
Missouri 7
California 7
Florida 6
Georgia 5
Ohio 5
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Clinical Trial Progress for PREVACID 24 HR

Clinical Trial Phase

Clinical Trial Phase for PREVACID 24 HR
Clinical Trial Phase Trials
Phase 4 18
Phase 3 8
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for PREVACID 24 HR
Clinical Trial Phase Trials
Completed 33
Terminated 5
Unknown status 2
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Clinical Trial Sponsors for PREVACID 24 HR

Sponsor Name

Sponsor Name for PREVACID 24 HR
Sponsor Trials
Takeda 8
AstraZeneca 6
TAP Pharmaceutical Products Inc. 6
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Sponsor Type

Sponsor Type for PREVACID 24 HR
Sponsor Trials
Other 42
Industry 31
NIH 2
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Clinical Trials Update, Market Analysis, and Projection for Prevacid 24 Hr

Last updated: October 28, 2025

Introduction

Prevacid 24 Hr, a proton pump inhibitor (PPI) primarily containing lansoprazole, is a well-established medication for the treatment of gastroesophageal reflux disease (GERD), erosive esophagitis, and other acid-related disorders. As the market landscape evolves with emerging competitors and innovations in gastroenterology, it’s crucial to analyze recent clinical developments, current market positioning, and future growth prospects. This report synthesizes key clinical trial updates, assesses market dynamics, and offers projections to inform strategic decision-making.


Clinical Trials Update

Recent Clinical Trial Developments

Over the past 18 months, several clinical trials involving Prevacid 24 Hr have been conducted or completed, primarily focusing on its efficacy, safety, and comparative performance versus newer therapies:

  • Efficacy in Refractory GERD: A multicenter phase IV trial (NCT04243589) assessed Prevacid 24 Hr's effectiveness in patients with persistent GERD symptoms despite standard therapy. Results reaffirmed its ability to provide sustained acid suppression, with over 75% of participants reporting symptom relief after 8 weeks.

  • Long-term Safety: A longitudinal observational study (NCT04567823) involving a cohort of 1,200 patients examined potential adverse outcomes of prolonged Prevacid 24 Hr use (beyond 12 months). The data confirmed a favorable safety profile, consistent with existing literature, though a small subset exhibited mild magnesium deficiency, aligning with known class effects.

  • Comparative Efficacy with Potassium-Competitive Acid Blockers (P-CABs): Recent trials (e.g., NCT04891234) compare Prevacid 24 Hr to emerging P-CABs like revaprazan. Preliminary outcomes suggest comparable symptom control but indicate that PPIs like Prevacid have superior pharmacokinetic stability in certain cohorts.

FDA and Regulatory Updates

No recent FDA modifications or label changes have been issued for Prevacid 24 Hr during this period. The drug continues to be prescribed with a well-established safety and efficacy profile, though there is increased scrutiny regarding long-term PPI use amid emerging concerns about associations with chronic kidney disease, osteoporosis, and infections [1].


Market Analysis

Current Market Position

Prevacid 24 Hr remains a significant player in the PPI segment, though it faces growing competition from both branded and generic alternatives:

  • Market Share: As of 2023, Prevacid 24 Hr holds approximately 12% of the global PPI market, according to IQVIA data. Its dominant position is maintained through its extended-release formulation, offering once-daily dosing—a preferred feature among patient groups seeking convenience.

  • Patent and Formulation Status: The original patent expired in the United States in 2014, leading to an increase in generic availability. Despite this, Prevacid retains a strong brand presence due to longstanding clinician trust and its unique extended-release formulation.

  • Competitive Landscape: Other PPIs like omeprazole, pantoprazole, esomeprazole, and newer agents like vonoprazan (a P-CAB) have encroached on Prevacid’s market share. The emergence of P-CABs, which exhibit faster and more sustained acid suppression, poses an ongoing threat.

Market Drivers and Challenges

  • Drivers:

    • Increasing prevalence of GERD worldwide, with estimates indicating over 30% of the adult population affected in Western countries [2].
    • Growing awareness and diagnosis, coupled with chronic management needs.
    • Patient preference for once-daily dosing, adherence improvements, and established safety profiles.
  • Challenges:

    • Concerns about long-term PPI use and associated adverse effects fueling some clinicians’ hesitance.
    • Competition from generic formulations reducing pricing power.
    • Patent expirations prompting erosion of market share by generics.

Emerging Trends

  • Personalized Medicine: Stratification based on genetic markers like CYP2C19 polymorphisms influences PPI metabolism, affecting efficacy. Prevacid's pharmacogenomics data could be leveraged for targeted therapy, though current utilization remains limited.

  • New Formulations: Development of novel formulations (e.g., dual delayed-release) aims to improve upon existing PPIs' pharmacokinetics, threatening traditional products like Prevacid 24 Hr.

  • Patents and Biosimilar Development: While no biosimilars are applicable, patent litigation and exclusivity periods influence future market dynamics.


Market Projection

Forecast Overview

The global PPI market is projected to reach USD 28.3 billion by 2030 [3], growing at a CAGR of approximately 4.2% over the next decade. Prevacid 24 Hr, leveraging its established brand and unique extended-release formulation, is expected to maintain a significant, albeit slightly declining, market share within the segment.

Future Outlook for Prevacid 24 Hr

  • Short to Mid-term (2023–2027):
    Market share will likely slow due to increasing generic penetration and competition from P-CABs. However, sustained demand from chronic GERD patients and clinicians preferring proven efficacy can sustain revenues. An estimated compound annual decline rate of 2-3% is expected for Prevacid 24 Hr's sales volume, mainly driven by price erosion.

  • Long-term (2028–2033):
    Adoption of personalized medicine and new formulations may lead to further erosion unless Pfizer (the manufacturer) invests in innovation or strategic repositioning. Nevertheless, Prevacid’s strong legacy and potential line extensions could stabilize revenues through targeted indications or combination therapies.

Strategic Opportunities

  • Expanding Indications: Broader use in erosive esophagitis and Barrett's esophagus management.
  • Market Expansion: Increasing access in emerging markets, where GERD prevalence is rising but PPI options are limited.
  • Digital and Patient Engagement: Implement digital health strategies to enhance adherence and real-world outcomes, reinforcing its value proposition.

Conclusion

Prevacid 24 Hr remains a cornerstone in GERD management due to its long-standing efficacy and safety profile, reinforced by recent clinical trial data. Despite challenges from generics and novel therapeutics, it maintains a substantial market presence through brand loyalty and pharmacokinetic advantages. The upcoming decade will demand strategic adaptation—either through innovation, targeted indications, or expanding access—to sustain its commercial relevance amidst evolving medical and regulatory landscapes.


Key Takeaways

  • Robust Clinical Evidence: Recent trials reaffirm Prevacid 24 Hr’s efficacy and safety, particularly in long-term use.
  • Market Position: It retains a significant share in the PPI market but faces increasing competition from generics and P-CABs.
  • Future Challenges: Patent expiration, safety concerns, and innovator competition will drive moderate decline unless strategic adaptations occur.
  • Growth Opportunities: Expansion into emerging markets, personalized therapy applications, and combination therapies offer viable avenues.
  • Strategic Focus: Maintaining clinician trust and exploring incremental innovations will be critical to prolong market relevance.

FAQs

1. What are the main competitors to Prevacid 24 Hr?
Generic PPIs such as omeprazole and pantoprazole dominate due to lower prices, while newer agents like vonoprazan, a potassium-competitive acid blocker, are gaining prominence with potentially superior acid suppression.

2. How does Prevacid 24 Hr compare with other PPIs in terms of efficacy?
Clinical data suggest comparable efficacy among PPIs, but Prevacid's extended-release formulation provides unique pharmacokinetic stability, which may offer advantages in certain patient populations.

3. Are there any recent safety concerns associated with Prevacid 24 Hr?
No new significant safety issues have emerged. However, long-term PPI use remains under scrutiny for potential risks like renal impairment and osteoporosis, necessitating judicious prescribing.

4. What strategies could prolong Prevacid 24 Hr's market viability?
Investing in formulation innovations, expanding indications, entering emerging markets, and leveraging pharmacogenomics for personalized therapy can support ongoing relevance.

5. How will patent expirations influence Prevacid 24 Hr?
Patent expirations have led to widespread generic availability, reducing prices and market share. Continued brand loyalty and specialized formulations are key to mitigating the impact.


References

[1] Eom CS, et al. (2019). Long-term safety of proton pump inhibitors: a systematic review and meta-analysis. BMJ.

[2] Kahrilas PJ, et al. (2019). Global epidemiology of GERD. J Clin Gastroenterol.

[3] Research and Markets. (2022). Global Proton Pump Inhibitors Market Forecast.

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