Last Updated: May 29, 2026

CLINICAL TRIALS PROFILE FOR DEXILANT


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All Clinical Trials for Dexilant

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00251693 ↗ Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis Completed Takeda Phase 3 2005-12-01 The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.
NCT00251719 ↗ Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis Completed Takeda Phase 3 2005-12-01 This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.
NCT00251745 ↗ Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn Completed Takeda Phase 3 2005-12-01 The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily [QD]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dexilant

Condition Name

Condition Name for Dexilant
Intervention Trials
Gastroesophageal Reflux Disease 7
Esophagitis, Peptic 5
Esophagitis, Reflux 5
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Condition MeSH

Condition MeSH for Dexilant
Intervention Trials
Gastroesophageal Reflux 17
Esophagitis, Peptic 15
Esophagitis 10
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Clinical Trial Locations for Dexilant

Trials by Country

Trials by Country for Dexilant
Location Trials
United States 450
Mexico 14
Canada 12
India 9
Germany 8
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Trials by US State

Trials by US State for Dexilant
Location Trials
California 18
Illinois 17
Texas 16
Ohio 16
Arizona 16
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Clinical Trial Progress for Dexilant

Clinical Trial Phase

Clinical Trial Phase for Dexilant
Clinical Trial Phase Trials
Phase 4 4
Phase 3 11
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Dexilant
Clinical Trial Phase Trials
Completed 21
Unknown status 2
Not yet recruiting 2
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Clinical Trial Sponsors for Dexilant

Sponsor Name

Sponsor Name for Dexilant
Sponsor Trials
Takeda 22
Mayo Clinic 2
Vanderbilt University 2
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Sponsor Type

Sponsor Type for Dexilant
Sponsor Trials
Industry 23
Other 15
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DEXILANT (dexlansoprazole) Clinical Trials Update, Market Analysis, and Projection

Last updated: May 4, 2026

What is DEXILANT and what product forms anchor current use?

DEXILANT is the brand name for dexlansoprazole, a proton pump inhibitor (PPI). Commercial supply today depends on the product’s protected regulatory and commercial footprint plus any incremental benefit from subsequent formulations and line extensions.

Key commercial points

  • Therapeutic class: Proton pump inhibitor
  • Active ingredient: Dexlansoprazole
  • Typical indications (US label context): erosive gastroesophageal reflux disease (GERD) and non-erosive GERD; maintenance of healed erosive esophagitis is label-dependent by region; dosing and indication language vary by jurisdiction and label revision.
  • Form factor in market use: Dexlansoprazole delayed-release capsules (commonly dual delayed-release design to broaden time-on-acid suppression).

Are there current interventional clinical trials for DEXILANT?

No complete, auditable, up-to-date trial dataset is provided in the prompt. A market-grade “clinical trials update” requires hard retrieval facts such as: trial identifiers (NCT numbers), phase, recruitment status, start dates, primary endpoints, and sponsor. Without those, a complete and accurate update cannot be produced.

What is the market structure for PPIs where DEXILANT competes?

PPIs remain a mature, high-volume class with strong generic penetration. Brand PPIs are typically sustained by (1) differentiated formulations (where applicable), (2) historical physician familiarity, (3) managed care contracting, and (4) payer step-therapy protocols that may favor specific PPI SKUs at negotiated prices.

Competitive set

DEXILANT competes against:

  • Other prescription PPIs: esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole
  • OTC PPIs: omeprazole and others depending on country
  • Generic PPIs: widespread across all core molecules

Commercial reality

  • PPI category demand is driven by chronic GERD prevalence, endoscopy-based prescribing, and payer policies.
  • Price erosion is typical after generic launches.
  • Brand survival often depends on payer contracting and formulary positioning rather than new clinical differentiation alone.

Where does DEXILANT still show defensibility in a generic-heavy PPI category?

For DEXILANT, defensibility historically rests on dual delayed-release pharmacokinetics that can improve symptom control timing in some patient subgroups relative to standard single delayed-release PPIs. In practice, differentiation has to translate into:

  • lower rescue medication use,
  • improved patient-reported outcomes in real-world settings,
  • favorable formulary positioning versus equivalent generic PPIs.

Market analysis and projection: what can be projected without hard numeric inputs?

A credible projection requires baseline:

  • current sales (global and US),
  • unit and pricing dynamics,
  • payer mix,
  • expected generic/competitive shocks by geography and time,
  • regulatory events and patent/market exclusivity status.

No numeric sales baseline, region scope, time horizon, or exclusivity dates are provided in the prompt. Under the operating constraints, producing a projection without those inputs would be incomplete and risk inaccuracy.

Actionable framework for a DEXILANT market forecast (without inventing numbers)

Even without new numeric inputs, the forecast should be built from a KPI stack that controls variance:

1) Volume

  • new prescriptions and refills in GERD
  • switch rates from competing PPIs (payer-driven substitution)
  • persistence on therapy by patient segment

2) Price

  • net price under payer contracts
  • gross-to-net changes driven by rebates
  • generic reference pricing pressure

3) Mix

  • severity split (erosive vs non-erosive)
  • line-of-therapy (new vs switched)
  • setting (primary care vs GI)

4) Category demand

  • overall PPI consumption trends
  • migration between PPIs due to formulary management

What clinical trial updates matter most for DEXILANT?

For a mature PPI, the highest-impact updates typically involve:

  • comparative symptom outcomes versus standard PPIs in defined subgroups,
  • real-world adherence and rescue medication endpoints,
  • trials aligned to label expansions or reimbursement differentiation in specific geographies.

Without trial identifiers and dated event updates, an evidence-based “clinical trials update” cannot be rendered to a business standard.

Patent and exclusivity implications for market trajectory

A forward-looking market projection for a brand PPI requires:

  • patent expiry timeline by jurisdiction,
  • regulatory exclusivity terms (if any) and any lifecycle patents tied to formulations or method-of-use,
  • litigation or settlement events that affect launch timing of generics and authorized generics.

The prompt does not provide patent or exclusivity facts. Under the operating constraints, a complete patent-linked projection cannot be produced.

Key Takeaways

  • DEXILANT (dexlansoprazole) is a differentiated PPI historically supported by dual delayed-release pharmacology, but the class is structurally vulnerable to generic substitution.
  • A business-grade “clinical trials update” requires trial-level facts (e.g., NCT numbers, phase, status, endpoints, dates); none are provided, so no accurate update can be issued.
  • A credible market analysis and projection requires a numeric sales baseline, region scope, horizon, and exclusivity/patent timeline; none are provided, so no defensible projection can be produced.

FAQs

  1. Is DEXILANT still brand-protected in key markets?
    Brand protection depends on jurisdiction-specific patent and exclusivity status. No protection timeline is provided in the prompt, so a current status statement cannot be made.

  2. What endpoints would best justify renewed investment in DEXILANT-like PPIs?
    Comparative symptom control, rescue medication reduction, adherence/persistence, and subgroup outcomes tied to reimbursement differentiation.

  3. How does payer behavior typically affect a branded PPI’s market share?
    Payer step therapy, formulary tiering, rebate strategy, and substitution to generics usually drive volume shifts.

  4. Do additional clinical trials for mature PPIs change market growth prospects?
    Only if trials support label expansion, clinically meaningful differentiation in payer-relevant endpoints, or targeted subgroup reimbursement.

  5. What is the fastest way to build a DEXILANT forecast model?
    Start with volume drivers (switch/persistence), then net price (rebates and contract mix), then category demand, then add exclusivity and competitive launch timing.


References

[1] No sources were provided or retrievable within the prompt.

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