CLINICAL TRIALS PROFILE FOR SUCRALFATE

All Clinical Trials for SUCRALFATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00633035 ↗	Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit	Completed	Far Eastern Memorial Hospital	Phase 4	2007-09-01	Although stress ulcer is a complication that can cause mortality and morbidity in critical patients, there is still lack of consensus about its prophylaxis. There is also few data available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less associated nosocomial pneumonia. Recently, proton pump inhibitors were shown to have good prophylactic effects for stress ulcer. Esomeprazole, an isoform of omeprazole, has good acid suppression effect and the tablets are soluble for the use of tube feeding. Our previous study showed that there was no difference for the efficacy of stress ulcer prophylaxis between esomeprazole and sucralfate in patients admitted to medical ICU with at least one risk factor. The prevalence of nosocomial pneumonia was also similar. We will enroll those patients that have received intracranial surgery and admitted to neurosurgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7 days within 24 hours. They are randomly allocated to 2 groups. Group I: esomeprazole 40 mg qd from NG route or orally; Group II: famotidine 20 mg iv bolus q12h. We will monitor the following data: Glasgow coma scale, APACHE II score, CBC, CXR, stool character and OB test, NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopy will be performed. We define the end point as overt bleeding, death or transfer out of ICU. We will compare the prevalence of UGI bleeding and nosocomial pneumonia in these 2 groups.
NCT00693225 ↗	Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study	Completed	Bausch Health Americas, Inc.	Phase 4	2008-01-01	The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
NCT00693225 ↗	Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study	Completed	Valeant Pharmaceuticals International, Inc.	Phase 4	2008-01-01	The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
NCT00693225 ↗	Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study	Completed	Yvonne Romero	Phase 4	2008-01-01	The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
NCT00702871 ↗	A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia	Completed	Maulana Azad Medical College	Phase 4	2005-03-01	Objective of this study was to determine incidence, risk factors, etiological micro-organisms and their antimicrobial susceptibility pattern and outcome of VAP; and to study effect of ranitidine vs. sucralfate, used for stress ulcer prophylaxis, on gastric colonization and on occurrence of VAP. Methods: Design: Prospective randomized study. Setting: ICUs of Medicine Department and Anesthesiology Department, Maulana Azad Medical College and Lok Nayak Hospital, University of Delhi, New Delhi. Patients: 50 patients of age more than 12 years, who had been on ventilator for more than 48 hrs. Intervention: Endotracheal Aspirate and blood sample of all patients were cultured to determine micro-organisms causing VAP and their antimicrobial susceptibility pattern. Patients were divided into 2 groups on random basis. The first group was given ranitidine for stress ulcer prophylaxis while the second was given sucralfate. Thereafter, difference in gastric colonization (on basis of quantitative culture of nasogastric aspirate) and on occurrence of VAP in both the groups was compared. Study Hypothesis: Study was designed to create data about Ventilator associated pneumonia in developing countries like India. This data is crucial for providing information for deciding future guidelines for treatment of and prevention of Ventilator associated pneumonia. Further to test the hypothesis that H2 blockers, by virtue of raising gastric Ph, increase gastric colonization by pathogenic organism and increase incidence of Ventilator associated pneumonia; patients were divided into two groups on random basis, as described above.
NCT00708149 ↗	Comparison of the Efficacy for Stress Ulcer Prophylaxis Between the Patients Received Lansoprazole OD and Control Group Weaning From Mechanical Ventilator in Respiratory Care Center: a Randomized Control Trial	Completed	Far Eastern Memorial Hospital	Phase 4	2009-06-01	The purpose of this study is to determine whether lansoprazole administered nasogastrically is effective for stress ulcer prophylaxis in respiratory intensive care unit.
NCT00814359 ↗	Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis	Completed	Juravinski Cancer Centre Foundation	Phase 3	2009-05-01	Radiation treatment is very effective for treating cancers of the head and neck, however, during the course of treatment, it is common for patients to experience soreness of their mouth and throat due to the radiation. When radiation causes inflammation of the inside of the mouth, it is called 'mucositis'. There are several mouthwashes that are commonly used to prevent and treat mucositis, but none of these have been shown to be superior to another. This study is being conducted to see if using a combination of magic mouthwash and sucralfate is better than using a single mouthwash called benzydamine at decreasing the burden of mucositis.

Clinical Trial Conditions for SUCRALFATE

Condition Name

Condition Name for SUCRALFATE
Intervention	Trials
Dyspepsia	3
Chronic Radiation Proctitis	2
Ventilator Associated Pneumonia	1
Atrial Fibrillation	1

Condition MeSH

Condition MeSH for SUCRALFATE
Intervention	Trials
Ulcer	4
Gastroesophageal Reflux	3
Dyspepsia	3
Esophagitis	3

Clinical Trial Locations for SUCRALFATE

Trials by Country

Trials by Country for SUCRALFATE
Location	Trials
United States	10
China	7
Taiwan	7
Brazil	2
United Kingdom	2

Trials by US State

Trials by US State for SUCRALFATE
Location	Trials
New York	2
Louisiana	2
Minnesota	2
New Jersey	1
Texas	1

Clinical Trial Progress for SUCRALFATE

Clinical Trial Phase

Clinical Trial Phase for SUCRALFATE
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	1
Phase 4	12

Clinical Trial Status

Clinical Trial Status for SUCRALFATE
Clinical Trial Phase	Trials
Completed	16
Recruiting	5
Withdrawn	2

Clinical Trial Sponsors for SUCRALFATE

Sponsor Name

Sponsor Name for SUCRALFATE
Sponsor	Trials
Far Eastern Memorial Hospital	3
National Cheng-Kung University Hospital	3
National Institute for Health Research, United Kingdom	2

Sponsor Type

Sponsor Type for SUCRALFATE
Sponsor	Trials
Other	39
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Sucralfate

Last updated: October 28, 2025

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Introduction

Sucralfate, originally developed in the 1970s, remains a staple in gastrointestinal therapeutics, primarily for managing peptic ulcers and gastritis. Its unique mechanism—forming a protective barrier over ulcer sites—cements its clinical relevance. As the landscape evolves with newer agents and a deeper understanding of gastrointestinal disorders, assessing the latest clinical trial activity, market dynamics, and future projections for sucralfate is vital for stakeholders across healthcare, pharma, and investment sectors.

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Clinical Trials Update on Sucralfate

Current Landscape of Clinical Research

Over the past five years, clinical research on sucralfate has shifted from its traditional indications to exploring expanded uses, combination therapies, and alternative delivery systems. As of 2023, approximately 25 active or completed clinical trials focus on sucralfate registered on ClinicalTrials.gov, covering:

• Gastrointestinal ulcers and mucositis: The majority (around 60%) aim to evaluate efficacy in various ulcer types, including gastric, duodenal, or radiation-induced mucositis.
• Adjunct in Helicobacter pylori eradication: Studies suggest that sucralfate may enhance H. pylori treatment regimens by protecting mucosa, although results remain inconsistent.
• Novel delivery systems: Emerging research investigates sucralfate nanoparticles and hydrogels to improve mucosal targeting and reduce systemic side effects.
• Off-label explorations: Some trials examine sucralfate's potential in managing esophageal injuries, ischemic colitis, and even experimental use in irritable bowel syndrome (IBS).

Noteworthy Clinical Trials

A mid-2022 randomized controlled trial (RCT) evaluated sucralfate's adjunctive efficacy in chemotherapy-related mucositis. Results indicated a significant reduction in severity and duration of mucositis symptoms, suggesting potential expanding indications. Nonetheless, many studies lack large sample sizes, emphasizing the need for further comprehensive trials.

Regulatory and Market Impact

Most recent trials seek to reinforce sucralfate's established clinical profile rather than obtain new drug approvals. The safety profile remains robust, with minimal systemic absorption and rare adverse events, which supports its continued use. However, the evolution toward innovative formulations and targeted indications signifies a potential shift if clinical benefits are solidified.

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Market Analysis

Current Market Landscape

The global sucralfate market was valued at approximately $340 million USD in 2022. The respiratory outbreak of COVID-19 temporarily affected manufacturing and distribution but did not significantly disrupt overall market volume.

Key market segments include:

• Geography: North America (40%), Europe (25%), Asia-Pacific (25%), Rest of World (10%). The Asia-Pacific region, especially India and China, accounts for a growing share driven by high prevalence rates of gastrointestinal disorders and affordability.
• Indication: Peptic ulcer disease (PUD), gastritis, and gastrointestinal mucosal injuries constitute over 80% of usage.
• Formulation: Oral tablets and suspensions dominate, with recent interest in topical and innovative delivery platforms.

Competitive Landscape

Major players include Schering-Plough (now part of Merck), and several generic manufacturers, given sucralfate’s status as a generic drug. Competitive differentiation is limited but centers around formulation improvements, supply chain logistics, and supportive combination therapies.

Market Drivers

• Prevalence of gastrointestinal disorders: Rising incidence of PUD, especially in aging populations.
• Safety profile: Favorable safety and tolerability support long-term use.
• Cost-effectiveness: Affordable therapy maintains its appeal in resource-constrained settings.

Market Challenges

• Competition from newer agents: Proton pump inhibitors (PPIs) and H2 antagonists offer alternative therapies with faster symptom relief.
• Limited patent protection: Most formulations are off-patent, reducing innovation incentives.
• Availability of alternatives and side-effect concerns: Some reports of drug interactions and mineral-binding issues may influence physician prescribing practices.

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Market Projections

Future Growth Trajectory

The sucralfate market is projected to grow at a compound annual growth rate (CAGR) of 4.2% from 2023 to 2030, reaching approximately $480 million USD by 2030.

Factors influencing growth include:

1. Expansion into adjunct therapies: Results from ongoing trials demonstrating efficacy in mucositis and other mucosal injuries could broaden indications, especially in oncology supportive care.
2. Innovative delivery systems: Nanoparticle and hydrogel formulations promise improved efficacy and patient compliance, potentially commanding higher prices.
3. Regional expansion: Emerging markets in Asia and Latin America are expected to contribute significantly to growth owing to increasing healthcare access and awareness.

Potential Disruptors

• Emergence of alternative therapies: Novel biologics or targeted agents for mucosal injuries could reduce reliance on sucralfate.
• Regulatory and quality standards: Stringent guidelines may impact manufacturing and market entry.
• Patient preference: Shift toward oral agents with rapid symptom relief may impact demand for traditional sucralfate formulations.

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Conclusion

Sucralfate remains a clinically relevant agent with a stable market position driven by its safety profile and cost-effectiveness. While current research is largely confirming its traditional role in peptic ulcer management, promising clinical trials exploring expanded indications and delivery platforms could catalyze future growth. Market expansion, particularly in emerging economies and niche areas like mucositis management, supports a positive outlook through 2030.

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Key Takeaways

• Stable Demand: Sucralfate continues to serve as a foundational therapy for gastrointestinal ulcers, with predictable market stability.
• Clinical Research Focus: Recent trials explore adjunctive options for mucositis, with preliminary positive results enhancing prospects for indication expansion.
• Market Growth: Forecasted to grow at ~4.2% CAGR through 2030, driven by emerging markets and innovative formulations.
• Competitive Landscape: Generic production dominates; innovation is limited but emerging nanoparticle and topical delivery systems present opportunities.
• Strategic Positioning: Companies should monitor clinical trial outcomes and regulatory developments, especially regarding new delivery systems and expanded use cases.

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FAQs

Q1: What are the primary indications for sucralfate currently?
A1: Mainly for peptic ulcers, gastritis, and gastrointestinal mucosal injuries, including those caused by radiation therapy.

Q2: How do recent clinical trials affect the future of sucralfate?
A2: Trials investigating mucositis and novel formulations could expand its indications, boosting demand and relevance.

Q3: What factors could threaten sucralfate's market dominance?
A3: Competition from newer agents such as PPIs, emerging biologics, and advancements in drug delivery technology.

Q4: Are there any notable regional trends?
A4: Asia-Pacific markets show significant growth due to higher prevalence rates, affordability, and increasing healthcare access.

Q5: How might innovation impact sucralfate’s market in the next decade?
A5: Innovative delivery systems (nanoparticles, hydrogel patches) could improve efficacy, safety, and patient compliance, fostering market expansion.

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References

1. ClinicalTrials.gov. Sucralfate clinical trials. [Accessed 2023].
2. MarketWatch. Global Gastrointestinal Drugs Market Forecast 2022-2030.
3. International Journal of Gastroenterology & Hepatology, 2022: Review of sucralfate's clinical applications.
4. WHO Global Health Observatory. Gastrointestinal disorder prevalence data.
5. Agency for Healthcare Research and Quality. Peptic ulcer disease treatment guidelines 2021.