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NCT00211614 ↗	Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea	Withdrawn	MetroHealth Medical Center	N/A	2006-07-01	Obstructive Sleep Apnea (OSA) is common in modern society, affecting up to 5% of working middle-aged adults in the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

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
Laryngopharyngeal Reflux	3
Ulcer	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
Canada	10

Trials by US State

Trials by US State for Prevacid
Location	Trials
California	7
Missouri	7
Florida	6
Georgia	5
Ohio	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 (lansoprazole): Clinical Trials Update, Market Analysis and Projection

Last updated: April 25, 2026

What is Prevacid and how is it positioned in the US market?

Prevacid is the brand of lansoprazole, a proton pump inhibitor (PPI) used for acid-related disorders including GERD and peptic ulcer disease. In the US, Prevacid’s brand exclusivity has long expired, and the product is marketed alongside multiple generic lansoprazole products. Prevacid therefore competes primarily on formulation, contracting, and managed-care positioning, not on novel clinical development.

What clinical trial activity matters for Prevacid today?

No active, sponsor-level late-stage “brand-defining” clinical program is apparent in the public trial record that would indicate a new pivotal NDA/BLA pathway for Prevacid (lansoprazole). The dominant publicly observable clinical evidence for lansoprazole continues to be older efficacy and safety studies, plus smaller studies tied to:

• dosing schedules and patient subgroups,
• comparative studies versus other PPIs,
• real-world effectiveness evaluations,
• formulation and bioequivalence work that typically supports generic or supplemental approvals rather than new clinical endpoints.

A usable, business-relevant bottom line is that Prevacid is not currently driven by ongoing Phase 3 registrational trials in the public record; market dynamics are instead governed by generic penetration and competitive PPI switching.

Key public trial record used for surveillance

• Clinical trials involving lansoprazole exist across the historical landscape and continue to appear periodically, but they do not read like new pivotal programs for a new Prevacid indication or dosing breakthrough. Trial oversight is centralized through ClinicalTrials.gov records. [1]

What does the market look like for lansoprazole/Prevacid?

Because Prevacid is the brand of a generic-active molecule (lansoprazole), market value is shaped by:

• generic substitution intensity,
• payer formularies and step edits among PPIs,
• wholesale acquisition cost (WAC) compression and contract pricing,
• conversion of patients from prescription to OTC PPIs in some markets (class-level effect),
• and channel mix (hospital vs retail).

Market structure

Prevacid sits inside a PPI class where:

• omeprazole and esomeprazole often dominate formulary share in many channels through contracting and brand/generic mix,
• lansoprazole competes as a lower-cost alternative once generics scale,
• and the brand’s revenue is largely a function of contract positioning and specific formulations where payer preferences or patient response history maintains share.

Pricing and share implications

For brand PPIs with generic penetration, the recurring pattern is:

• brand sales erode as generic share expands,
• residual brand revenue persists if contracting favors the brand or if certain delayed-release or dose strengths remain more favorable in a payer’s preferred list.

In practice, Prevacid behaves like a legacy PPI with limited upside tied to small changes in share and contracting, not to clinical expansion.

How should you project Prevacid revenue and volume over the next 3 to 5 years?

A reliable projection for a generic-major PPI brand must be built on generic penetration, class competition, and formulary churn, not on “pipeline optionality.” Without a live, registrational pipeline, forecast ranges should be interpreted as share drift rather than indication expansion.

Projection framework (share-drift model)

Use three inputs that are observable from market practice and payer behavior:

1. Generic substitution rate within lansoprazole
2. Class switching among PPIs (omeprazole/esomeprazole/pantoprazole favored by formulary)
3. Channel mix (retail vs institutional)

Directional forecast

• Total PPI demand tends to be stable to modestly declining over time in many markets because GERD and ulcer indications are chronic, but PPI utilization may soften with guideline-based optimization and shifts to step-down therapy.
• Prevacid brand share typically continues to drift downward as payer formularies simplify to preferred generic PPIs and as patient-level switches occur.

3-to-5-year outlook (directional)

• Revenue: slow, continuing decline or flat-to-down depending on contract capture; upside is limited.
• Volume: mostly stable to modestly down as patients switch within class and as OTC availability (where applicable) pulls low-acuity use away from prescription channels.
• Market volatility: driven by contracting cycles, interchange rules, and occasional supply or pricing events, not by new clinical evidence.

Which regulatory and clinical facts define the Prevacid lifecycle risk?

For legacy PPIs, the regulatory risk profile is dominated by:

• loss of exclusivity (already occurred for the brand),
• ongoing bioequivalence-based generic entry,
• and class-wide safety monitoring (rare long-term risks associated with chronic PPI use).

Clinical and safety labeling for lansoprazole has been updated over time through routine postmarketing updates and class safety updates tracked via FDA communications and prescribing information revisions. [2]

Clinical differentiation: does Prevacid have a durable evidence edge?

Prevacid’s clinical position rests on established efficacy for acid suppression and symptom control in GERD and related acid disorders. The modern market does not price differentiation from a legacy PPI molecule unless:

• a payer has a specific clinical preference,
• there is a formulation advantage that improves adherence, or
• a patient subgroup responds better (rarely codified as a payer-mandated distinction at class scale).

The evidence base for lansoprazole remains broad but not new-driving. The actionable business reality is that differentiation now happens through contracting and managed-care design, not via new Phase 3 outcomes.

What competitive landscape should be assumed for forecasting?

PPI competition drivers

Prevacid competes within the PPI class on:

• formulary tier placement,
• pharmacy benefit manager (PBM) rebates and preferred-list rules,
• and tablet/capsule regimen preferences.

Switching dynamics

• Switch incentives favor patients to move from “non-preferred” PPIs to preferred generic PPIs.
• Once a preferred generic is chosen, prescribers tend to follow payer protocols, particularly in large systems with standardized order sets.

Clinical trial surveillance priorities (what to monitor next)

Even for legacy PPIs, monitors should track:

• any new clinical trials that aim at new endpoints (for example, outcomes beyond symptom control),
• any label expansion that changes patient selection or duration (rare for this class),
• any major formulation or dosing change trials that could alter market access.

The operational feed for this monitoring is ClinicalTrials.gov. [1]

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Key Takeaways

• Prevacid (lansoprazole) is a legacy PPI brand with ongoing generic competition; market outcomes are dominated by contracting and class switching.
• Public clinical trial activity does not show a brand-defining, ongoing late-stage registrational program that would materially shift the forecast via new indications or pivotal outcomes. [1]
• 3-to-5-year projection should be modeled as share drift within the PPI class: slow erosion or flat-to-down for brand revenue, with limited upside absent a new label or formulation advantage that payers formalize.
• Forecast sensitivity is highest to PBM/formulary rules and preferred generic dynamics, not to new clinical efficacy breakthroughs.

FAQs

1. Is Prevacid currently in late-stage clinical trials for a new indication?
   Public trial records show ongoing lansoprazole-related studies, but no clear sign of a new brand-defining late-stage registrational program that would drive a new NDA/BLA path. [1]

2. What is the biggest risk to a Prevacid brand revenue forecast?
   Continued generic substitution and formulary preference drift toward other preferred PPIs through PBM contracting cycles.

3. What is the most important driver of Prevacid market share?
   Payer formulary placement and contracting within the PPI class, which governs prescribing patterns and patient switching.

4. Does new clinical evidence typically move Prevacid’s market position?
   Not at class scale. For legacy PPIs, market share typically moves through access design, not through incremental efficacy publications.

5. Where do you track Prevacid and lansoprazole clinical trial updates?
   ClinicalTrials.gov trial listings for lansoprazole and related entries. [1]

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References (APA)

[1] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. (n.d.). Prescribing information and drug safety communications for lansoprazole/PPIs. https://www.fda.gov/