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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR DEXLANSOPRAZOLE


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All Clinical Trials for Dexlansoprazole

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).
NCT00251758 ↗ Safety and Efficacy 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).
NCT00255151 ↗ Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis Completed Takeda Phase 3 2006-01-01 The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dexlansoprazole

Condition Name

Condition Name for Dexlansoprazole
Intervention Trials
Gastroesophageal Reflux Disease 13
Esophagitis, Reflux 5
Gastroesophageal Reflux 5
Esophagitis, Peptic 5
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Condition MeSH

Condition MeSH for Dexlansoprazole
Intervention Trials
Gastroesophageal Reflux 26
Esophagitis, Peptic 17
Esophagitis 12
Heartburn 6
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Clinical Trial Locations for Dexlansoprazole

Trials by Country

Trials by Country for Dexlansoprazole
Location Trials
United States 461
China 33
Mexico 18
Canada 12
Brazil 9
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Trials by US State

Trials by US State for Dexlansoprazole
Location Trials
California 19
Arizona 18
Texas 17
Ohio 17
Illinois 17
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Clinical Trial Progress for Dexlansoprazole

Clinical Trial Phase

Clinical Trial Phase for Dexlansoprazole
Clinical Trial Phase Trials
Phase 4 10
Phase 3 13
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Dexlansoprazole
Clinical Trial Phase Trials
Completed 34
Unknown status 5
Withdrawn 5
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Clinical Trial Sponsors for Dexlansoprazole

Sponsor Name

Sponsor Name for Dexlansoprazole
Sponsor Trials
Takeda 31
Mayo Clinic 2
TAP Pharmaceutical Products Inc. 1
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Sponsor Type

Sponsor Type for Dexlansoprazole
Sponsor Trials
Industry 35
Other 29
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Dexlansoprazole: Clinical Trials, Market Analysis, and Projections

Introduction to Dexlansoprazole

Dexlansoprazole, a proton pump inhibitor (PPI), is widely used for the treatment of gastroesophageal reflux disease (GERD), including symptomatic non-erosive GERD and erosive esophagitis (EE). Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Pediatric Studies

Several clinical trials are ongoing to evaluate the safety and efficacy of dexlansoprazole in pediatric patients. For instance:

  • Study TAK-390MR_207: This study focuses on adolescents aged 12 to 17 years, assessing the safety and effectiveness of dexlansoprazole for the relief of heartburn associated with symptomatic non-erosive GERD and the healing and maintenance of healing of EE[1].
  • NCT02615184: This interventional study is designed to evaluate the safety and efficacy of dexlansoprazole in pediatric participants aged 2 to 11 years. It involves two periods: a Healing of EE Period and a Maintenance of Healed EE Period, with participants receiving either 60 mg or 30 mg of dexlansoprazole[4].

Dosing Based on Body Weight

Another study, TAK-390MR_204, aims to determine if dexlansoprazole doses based on body weight help children with symptomatic nonerosive GERD feel better. This study is enrolling 70 participants and is scheduled to run from February 2023 to October 2027[3].

Safety and Efficacy

The FDA has reviewed several studies and concluded that dexlansoprazole is well-tolerated in pediatric patients, with no new information altering the risk-benefit assessment that supported its initial approval in adults. Studies such as 1788-1, 1788-2, and 1788-3 under the Pediatric Research Equity Act (PREA) have been designed to evaluate the pharmacokinetics, healing, maintenance of healing, and safety profiles of dexlansoprazole in various age groups of pediatric patients[1].

Market Analysis

Global Market Size and Growth

The global dexlansoprazole market is experiencing significant growth driven by several factors:

  • Global Market Size: The market was estimated to be worth USD 298 million in 2023 and is forecasted to reach USD 428.1 million by 2030, with a compound annual growth rate (CAGR) of 5.3% during the forecast period 2024-2030[5].
  • Regional Growth: North America holds a major share of the global market, with a CAGR of 4.2% from 2024 to 2031. The Asia Pacific region is growing at a higher CAGR of 8%, driven by rising rates of GERD and an aging population[2].

Key Drivers

  • Increasing GERD Prevalence: The growing awareness and prevalence of GERD are significant drivers of the dexlansoprazole market. This is particularly evident in regions like North America and the Asia Pacific, where lifestyle changes and an aging population contribute to higher GERD rates[2].
  • Extended-Release Formulations: The availability of extended-release formulations of dexlansoprazole provides long-lasting symptom relief, making it an attractive option for patients requiring chronic treatment[2].
  • Healthcare Infrastructure: Improvements in healthcare infrastructure and increasing healthcare spending in regions like the Asia Pacific and Latin America are also fueling market growth[2].

Market Segmentation

The market is segmented by product type, application, and region. Key players in the dexlansoprazole market include Takeda Pharmaceuticals, Par Pharmaceutical, and TWi Pharmaceuticals[5].

Market Projections

Forecasted Growth

  • Global Forecast: The global dexlansoprazole market is expected to grow at a CAGR of 5.3% from 2024 to 2030, reaching a market size of USD 428.1 million by 2030[5].
  • Regional Projections: North America is expected to grow at a CAGR of 4.2%, while the Asia Pacific region is projected to grow at a CAGR of 8% during the same period. Latin America and the Middle East and Africa are also expected to see significant growth, with CAGRs of 5.4% and 5.7%, respectively[2].

Emerging Trends

  • Increasing Demand for Efficient Treatments: The demand for efficient and long-lasting treatments for GERD is on the rise, driven by patient preferences and the need for chronic management of the condition.
  • Aging Population: The aging population, particularly in regions like North America and the Asia Pacific, is a significant factor driving the growth of the dexlansoprazole market.
  • Improving Healthcare Infrastructure: Continuous improvements in healthcare infrastructure and increasing healthcare spending are expected to support market growth in various regions.

Key Takeaways

  • Dexlansoprazole is undergoing extensive clinical trials to establish its safety and efficacy in pediatric patients.
  • The global market for dexlansoprazole is growing steadily, driven by increasing GERD prevalence, the availability of extended-release formulations, and improvements in healthcare infrastructure.
  • Key regions such as North America and the Asia Pacific are expected to drive significant market growth.
  • The market is forecasted to reach USD 428.1 million by 2030, with a CAGR of 5.3% during the forecast period.

FAQs

What is dexlansoprazole used for?

Dexlansoprazole is used for the treatment of gastroesophageal reflux disease (GERD), including symptomatic non-erosive GERD and erosive esophagitis (EE).

What are the current clinical trials focusing on for dexlansoprazole?

Current clinical trials are focusing on the safety and efficacy of dexlansoprazole in pediatric patients, including studies on adolescents and younger children with GERD and EE.

What is the global market size of dexlansoprazole projected to be by 2030?

The global market size of dexlansoprazole is projected to reach USD 428.1 million by 2030, growing at a CAGR of 5.3% from 2024 to 2030.

Which regions are driving the growth of the dexlansoprazole market?

North America and the Asia Pacific are significant drivers of the dexlansoprazole market, with the Asia Pacific region showing the highest growth rate at a CAGR of 8%.

What are the key factors driving the growth of the dexlansoprazole market?

Key factors include the increasing prevalence of GERD, the availability of extended-release formulations, and improvements in healthcare infrastructure and spending.

Sources

  1. FDA Clinical Review for Dexlansoprazole - FDA
  2. Dexlansoprazole Market Report - Cognitive Market Research
  3. TAK-390MR_204 Clinical Trial Summary - Clinical Trials by Takeda
  4. NCT02615184 Clinical Trial Details - Clinical Trials by UCSF
  5. Dexlansoprazole Sustained Release Capsule Market - Valuates Reports

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