CLINICAL TRIALS PROFILE FOR LANSOPRAZOLE

All Clinical Trials for Lansoprazole

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00149084 ↗	Tailored Treatment of H. Pylori Infection Based Polymorphisms of CYP2C19 and 23S rRNA of H. Pylori	Unknown status	Yokoyama Foundation for Clinical Pharmacology	Phase 3	2003-04-01	The eradication rate of the standard H. pylori eradication therapy (such as the triple therapy with a proton pump inhibitor [PPI], amoxicillin and clarithromycin) depends on bacterial susceptibility to clarithromycin and genotypes of CYP2C19 in patients. The investigators intend to investigate whether the tailored therapy based on the two above-mentioned factors increases the cure rate of the initial eradication therapy.
NCT00149084 ↗	Tailored Treatment of H. Pylori Infection Based Polymorphisms of CYP2C19 and 23S rRNA of H. Pylori	Unknown status	Hamamatsu University	Phase 3	2003-04-01	The eradication rate of the standard H. pylori eradication therapy (such as the triple therapy with a proton pump inhibitor [PPI], amoxicillin and clarithromycin) depends on bacterial susceptibility to clarithromycin and genotypes of CYP2C19 in patients. The investigators intend to investigate whether the tailored therapy based on the two above-mentioned factors increases the cure rate of the initial eradication therapy.
NCT00174928 ↗	A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease	Completed	Takeda	Phase 1	2005-05-01	The purpose of this study is to understand how quickly lansoprazole, once daily (QD), improves feeding in premature babies or babies less than 28 days of age.
NCT00175032 ↗	A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin	Completed	Takeda	Phase 3	2003-07-01	The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in participants with osteoarthritis taking low dose aspirin.
NCT00175045 ↗	Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis	Completed	Takeda	Phase 2	2003-06-01	The purpose of this study was to compare the pharmacodynamics of intravenous (IV) lansoprazole to oral lansoprazole capsules, once daily (QD), in participants with erosive esophagitis.
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.

Clinical Trial Conditions for Lansoprazole

Condition Name

Condition Name for Lansoprazole
Intervention	Trials
Helicobacter Pylori Infection	14
Healthy	14
Erosive Esophagitis	12
Gastroesophageal Reflux	10

Condition MeSH

Condition MeSH for Lansoprazole
Intervention	Trials
Gastroesophageal Reflux	37
Esophagitis	23
Ulcer	23
Helicobacter Infections	18

Clinical Trial Locations for Lansoprazole

Trials by Country

Trials by Country for Lansoprazole
Location	Trials
United States	358
Japan	341
China	107
Korea, Republic of	34
Taiwan	19

Trials by US State

Trials by US State for Lansoprazole
Location	Trials
Texas	17
Florida	17
California	17
Missouri	16
North Carolina	14

Clinical Trial Progress for Lansoprazole

Clinical Trial Phase

Clinical Trial Phase for Lansoprazole
Clinical Trial Phase	Trials
Phase 4	65
Phase 3	51
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Lansoprazole
Clinical Trial Phase	Trials
Completed	119
Unknown status	18
Recruiting	14

Clinical Trial Sponsors for Lansoprazole

Sponsor Name

Sponsor Name for Lansoprazole
Sponsor	Trials
Takeda	37
AstraZeneca	10
National Taiwan University Hospital	6

Sponsor Type

Sponsor Type for Lansoprazole
Sponsor	Trials
Other	155
Industry	106
NIH	3

Lansoprazole: Clinical Trials, Market Analysis, and Projections

Introduction to Lansoprazole

Lansoprazole, commonly known by the brand name Prevacid, is a proton pump inhibitor (PPI) widely used to treat gastroesophageal reflux disease (GERD), gastric ulcers, and duodenal ulcers. The drug has been a staple in gastrointestinal medicine for decades, but recent studies and market trends reveal new and intriguing aspects of its use and market performance.

Clinical Trials: Exploring New Uses

Idiopathic Pulmonary Fibrosis (IPF)

One of the most significant ongoing clinical trials involving lansoprazole is the TIPAL Study. This Phase 3 clinical trial aims to determine whether the addition of lansoprazole to current treatments can slow down the decline of lung function in patients with idiopathic pulmonary fibrosis (IPF). The study involves patients receiving either lansoprazole or a placebo in addition to their current treatment for 12 months. The primary objectives are to assess the impact of lansoprazole on cough, breathlessness, and quality of life in IPF patients[1].

Preterm Birth

Another area of clinical interest is the potential of lansoprazole to reduce preterm birth. A computational drug repurposing study identified lansoprazole as a promising candidate due to its anti-inflammatory properties. The study, conducted at UC San Francisco, found that lansoprazole affected biological pathways implicated in preterm birth, particularly those related to immune response and inflammation. While the study showed promising results in mice, further human trials are necessary to confirm its efficacy in pregnant women at risk of preterm birth[4].

Market Analysis

Current Market Size and Growth

The global lansoprazole market has been experiencing significant growth. As of 2023, the market was valued at approximately USD 2.4 billion and is projected to reach USD 5.2 billion by 2032, with a compound annual growth rate (CAGR) of around 8.98% during the forecast period from 2025 to 2032[2].

Segment Analysis

The market is segmented by type, application, and region. The oral segment dominates the global market, driven by the high incidence of GERD, gastric ulcers, and duodenal ulcers. The demand for proton pump inhibitors, such as lansoprazole, remains strong due to their effectiveness in treating these conditions[3].

Key Players

The lansoprazole market is competitive, with several major pharmaceutical companies involved. Key players include Takeda Pharmaceutical, Teva Pharmaceuticals, Sandoz, GlaxoSmithKline (GSK), Dr. Reddy's, Pfizer, and others. These companies are focusing on strategic research methodologies, innovative formulations, and targeted marketing strategies to capture market share[5].

Market Projections

Forecasted Market Size

By 2030, the global lansoprazole market is forecasted to reach a readjusted size of USD 541.2 million, growing at a CAGR of 6.4% during the period from 2024 to 2030. This growth is driven by increasing demand for effective treatments for gastrointestinal diseases and the ongoing development of new formulations and delivery models[5].

Regional Growth

The market growth is expected to be robust across various regions, with emerging markets in developing countries showing significant potential. The rise in healthcare spending and increasing awareness of gastrointestinal diseases are key factors driving this growth[3].

Challenges and Opportunities

Competition from New Drug Classes

Despite the strong market position of lansoprazole, the introduction of new drug classes such as H2 blockers and antacids poses a competitive challenge. Patient preference for immediate relief from GERD symptoms may shift towards these newer drug classes, potentially restraining the growth of the lansoprazole market[3].

Ongoing Clinical Trials and Repurposing

The ongoing clinical trials, particularly those exploring new uses like IPF and preterm birth, present significant opportunities for lansoprazole. Successful outcomes from these trials could expand the drug's indications and further boost its market presence.

Key Takeaways

• Clinical Trials: Lansoprazole is being investigated for new uses, including treating IPF and reducing preterm birth.
• Market Growth: The global lansoprazole market is projected to grow significantly, driven by increasing demand for treatments for gastrointestinal diseases.
• Segment Analysis: The oral segment dominates the market, with key players focusing on innovative formulations and targeted marketing.
• Challenges: The market faces competition from new drug classes, but ongoing clinical trials offer opportunities for expansion.

FAQs

What is the TIPAL Study?

The TIPAL Study is a Phase 3 clinical trial investigating whether the addition of lansoprazole to current treatments can slow down the decline of lung function in patients with idiopathic pulmonary fibrosis (IPF).

How is lansoprazole being explored for preterm birth?

Lansoprazole has been identified as a potential candidate to reduce preterm birth due to its anti-inflammatory properties. A computational drug repurposing study showed promising results in mice, but further human trials are needed.

What is the projected growth rate of the lansoprazole market?

The global lansoprazole market is expected to grow at a CAGR of around 8.98% from 2025 to 2032.

Who are the key players in the lansoprazole market?

Key players include Takeda Pharmaceutical, Teva Pharmaceuticals, Sandoz, GlaxoSmithKline (GSK), Dr. Reddy's, Pfizer, and others.

What are the main challenges facing the lansoprazole market?

The main challenges include competition from new drug classes such as H2 blockers and antacids, and shifts in patient preference towards immediate relief from GERD symptoms.

Sources

1. ActionPF: Research Opportunity: A clinical trial treating people with idiopathic pulmonary fibrosis with the anti-acid drug lansoprazole.
2. OpenPR: Lansoprazole API Market Growth: Projected CAGR Of 8.98 % Through 2032.
3. BioSpace: Lansoprazole Market: The oral segment dominated the global market.
4. UCSF: Acid Reflux Drug Is a Surprising Candidate to Curb Preterm Birth.
5. Valuates Reports: Lansoprazole - Market Size.