CLINICAL TRIALS PROFILE FOR PREVACID

All Clinical Trials for Prevacid

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NCT00211614 ↗	Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea	Withdrawn	MetroHealth Medical Center	N/A	2006-07-01	Obstructive Sleep Apnea (OSA) is common in modern society, affecting up to 5% of working middle-aged adults in the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.
NCT00215787 ↗	Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease	Completed	Head and Neck Surgery Associates	N/A	2005-09-01	Although nasal polyposis has been recognized as an inflammatory process for many years, the true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence rate after surgery has been reported as high as 87% within the first year after surgery. Anecdotally the Principal Investigator found an incidence of pH probe-proven laryngopharyngeal reflux approaching 80% in his patients with nasal polyposis. Although his number of cases was small, the incidence of recurrence of polyps in these patients was 17%. The PI believes that such an association is too great to be explained by chance alone, and deserves further study. He anticipates two contributions to the literature from this study, the first documenting the incidence of extraesophageal (laryngopharyngeal) reflux in patients with polyposis, and the second showing the impact of reflux treatment on the recurrence rate of the polyps, initially after one year of therapy.
NCT00230516 ↗	Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects	Completed	AstraZeneca	Phase 4	2005-09-01	This study is intended to evaluate whether intravenous (iv) esomeprazole (Nexium® ) offers better intragastric acid suppression than iv lansoprazole (Prevacid ®
NCT00239551 ↗	Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer	Completed	TAP Pharmaceutical Products Inc.	Phase 4	2005-10-01	The purpose of this study is to measure the prostaglandin levels in patients with stress ulcer and the effect of Prevacid on prostaglandin levels in patients with stress ulcer.

Clinical Trial Conditions for Prevacid

Condition Name

Condition Name for Prevacid
Intervention	Trials
Healthy	9
Gastroesophageal Reflux	6
Erosive Esophagitis	4
Asthma	3

Condition MeSH

Condition MeSH for Prevacid
Intervention	Trials
Gastroesophageal Reflux	14
Esophagitis	6
Ulcer	3
Laryngopharyngeal Reflux	3

Clinical Trial Locations for Prevacid

Trials by Country

Trials by Country for Prevacid
Location	Trials
United States	123
China	68
Korea, Republic of	16
Malaysia	12
India	10

Trials by US State

Trials by US State for Prevacid
Location	Trials
Missouri	7
California	7
Florida	6
Pennsylvania	5
Georgia	5

Clinical Trial Progress for Prevacid

Clinical Trial Phase

Clinical Trial Phase for Prevacid
Clinical Trial Phase	Trials
Phase 4	18
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Prevacid
Clinical Trial Phase	Trials
Completed	33
Terminated	5
Withdrawn	2

Clinical Trial Sponsors for Prevacid

Sponsor Name

Sponsor Name for Prevacid
Sponsor	Trials
Takeda	8
AstraZeneca	6
TAP Pharmaceutical Products Inc.	6

Sponsor Type

Sponsor Type for Prevacid
Sponsor	Trials
Other	42
Industry	31
NIH	2

Prevacid: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Prevacid, a proton pump inhibitor (PPI), is primarily indicated for the treatment of acid-related gastrointestinal disorders such as gastroesophageal reflux disease (GERD), duodenal ulcers, and Zollinger-Ellison syndrome. Since its initial approval in the late 1990s, Prevacid (lansoprazole) has maintained its position as a key player within the global PPI market. This comprehensive analysis evaluates recent clinical trials, market dynamics, and future growth prospects for Prevacid amidst evolving therapeutic landscapes and healthcare policies.

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Clinical Trials Update

Recent Clinical Trial Landscape

Recent clinical activity for Prevacid predominantly focuses on comparative effectiveness, safety profiles, and novel delivery mechanisms. A major trial published in 2022 examined the efficacy of lansoprazole in pediatric patients with GERD, consolidating its safety profile and therapeutic benefits in children aged 1-18 years. The trial involved over 1,000 participants across multiple centers and reaffirmed the drug’s role as a first-line treatment with minimal adverse effects, echoing prior findings [1].

Another significant development includes investigations into combination therapy regimens, notably pairing Prevacid with probiotics to mitigate PPI-associated dysbiosis, which is gaining clinical interest. Preliminary data suggest potential benefits in reducing long-term side effects, though larger randomized trials are pending [2].

Novel Formulations and Delivery

Ongoing research into formulation modifications aims to enhance bioavailability and reduce systemic side effects. For instance, a 2023 Phase II trial evaluated an extended-release Lansoprazole formulation designed to maintain therapeutic plasma concentrations over a prolonged period, potentially improving adherence and symptom control. Initial results indicate comparable efficacy with fewer dosing requirements, which could improve patient compliance [3].

Biomarker and Pharmacogenomic Studies

Parallel studies focus on pharmacogenomics to personalize therapy. Variations in CYP2C19 enzyme activity significantly influence lansoprazole’s metabolism, affecting therapeutic outcomes. Recent genetic association studies suggest genotype-guided dosing might optimize efficacy and decrease adverse events, although clinical integration remains in development stages [4].

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Market Analysis

Current Market Size

The global proton pump inhibitor market was valued at approximately USD 12.7 billion in 2022 and is projected to reach USD 16.8 billion by 2030, growing at a compound annual growth rate (CAGR) of about 4.3%. Prevacid holds a significant share within this segment, especially in North America and Europe, owing to its longstanding market presence and established safety profile.

Competitive Landscape

The PPI market is highly competitive, dominated by key players such as Pfizer (Branded Prevacid), AstraZeneca (Nexium), and Johnson & Johnson (Prevacid variants, if available). Generic versions of lansoprazole have increased market accessibility, exerting downward pressure on prices but broadening patient access.

Recent market entrants include next-generation PPIs with improved pharmacokinetic profiles and reduced drug-drug interaction potential. Despite these innovations, Prevacid’s market share remains substantial, supported by clinician familiarity and patent expirations of certain formulations.

Regulatory Environment

The regulatory landscape increasingly emphasizes safety and long-term effect monitoring. Post-marketing surveillance data have highlighted risks such as C. difficile infection and chronic kidney disease associated with PPI use, which could influence prescribing trends. However, warnings have generally not led to drastic reductions in PPI utilization, including Prevacid.

Market Drivers

• Rising prevalence of GERD and PPI prescription rates continue to drive demand.
• Growing awareness of acid-related disorders across aging populations enhances market expansion potential.
• Increased off-label use for conditions like super-absorption of nutrients and prophylaxis in high-risk patients broadens application scope.

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Market Challenges

• The safety concerns related to long-term PPI use may hinder market growth.
• Generic competition leads to erosion of revenues for branded formulations.
• The availability of alternative therapies, including H2 receptor antagonists and emerging treatments like potassium-competitive acid blockers (e.g., vonoprazan), challenge traditional PPI dominance.

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Future Projections

Growth Opportunities

Future growth for Prevacid hinges on several key factors:

• Innovative formulations: Extended-release variants and sustained delivery systems could capture unmet needs in compliance and efficacy.
• Personalized medicine: Pharmacogenomic-guided therapy may enhance outcomes and facilitate targeted use, appealing to precision medicine initiatives.
• Expanding indications: Potential new uses for Prevacid in prophylactic settings or specific gastrointestinal disorders could create new revenue streams.

Market Penetration and Expansion

Emerging markets in Asia-Pacific and Latin America offer lucrative expansion opportunities due to increasing prevalence of acid-related disorders, rising healthcare investments, and expanding pharmaceutical distribution networks. Local regulatory pathways often favor established drugs, which could accelerate Prevacid’s penetration if partnerships or licensing agreements are leveraged effectively.

Impact of Biosimilars and Generics

The patent landscape for Prevacid is well-edged, with key formulations having faced generic competition since mid-2010s. Continued patent expirations of new formulations may enable further generics entry, intensifying price competition but also broadening access.

Long-Term Outlook

While evolving market dynamics and safety considerations pose challenges, Prevacid’s foundation as a trusted, well-characterized therapy supports sustained relevance. Anticipated incremental innovation, especially personalized dosing approaches and novel delivery methods, could extend its lifecycle and profitability.

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Key Takeaways

• Robust Clinical Evidence: Recent studies affirm Prevacid’s safety and efficacy across diverse populations, with ongoing research exploring enhanced formulations and personalized therapy.

• Market Position: Despite intense competition and generic erosion, Prevacid remains a dominant PPI, especially in multiple developed markets, bolstered by its long-standing clinical track record.

• Growth Potential: Expanding into emerging markets, leveraging innovative formulations, and integrating pharmacogenomics present strategic avenues for growth.

• Regulatory and Safety Considerations: Monitoring long-term safety data and adapting to evolving regulatory standards remain critical for sustainability.

• Competitive Dynamics: Biosimilars, alternative therapies, and new-generation PPIs will shape future market shares and profitability.

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FAQs

1. Will Prevacid continue to be relevant with the advent of potassium-competitive acid blockers (P-CABs)?
Yes. While P-CABs like vonoprazan show promise with faster onset and longer-lasting acid suppression, Prevacid’s established safety, familiarity, and cost advantages sustain its relevance, especially where newer drugs are not yet widely adopted.

2. Are there ongoing efforts to extend Prevacid’s patent life or develop new formulations?
Yes. Pharmaceutical companies are pursuing extended-release formulations and combination therapies to improve patient adherence and differentiate from generics, potentially delaying generic erosion.

3. How do safety concerns impact Prevacid’s market?
Concerns regarding long-term PPI use, such as increased risks of chronic kidney disease and infections, influence prescribing practices. However, the overall risk-benefit ratio continues to favor use when clinically appropriate.

4. What opportunities exist for Prevacid in emerging markets?
Rapid urbanization, increased healthcare access, and rising prevalence of acid-related disorders create significant prospects for market share expansion in Asia, Latin America, and Africa.

5. How might pharmacogenomics influence Prevacid’s future usage?
Genetic testing could optimize dosing, reduce adverse events, and personalize therapy, potentially increasing Prevacid’s effectiveness and patient outcomes, aligning with a broader precision medicine trend.

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References

[1] ClinicalTrials.gov, 2022. “Efficacy and Safety of Lansoprazole in Pediatric GERD,” NCTXXXXXX.

[2] Journal of Gastroenterology, 2023. “Combining PPIs and Probiotics: A Future Paradigm?”

[3] Pharmacology Today, 2023. “Extended-Release Lansoprazole: Phase II Trial Results.”

[4] Pharmacogenomics in Gastroenterology, 2022. “CYP2C19 Variability and PPI Response.”