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
Gastric Ulcer	1
Non Erosive Reflux Disease	1

Condition MeSH

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

Clinical Trial Locations for SUCRALFATE

Trials by Country

Trials by Country for SUCRALFATE
Location	Trials
United States	10
Taiwan	7
China	7
United Kingdom	2
Brazil	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
PHASE4	2
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for SUCRALFATE
Clinical Trial Phase	Trials
COMPLETED	16
Recruiting	6
NOT_YET_RECRUITING	3

Clinical Trial Sponsors for SUCRALFATE

Sponsor Name

Sponsor Name for SUCRALFATE
Sponsor	Trials
National Cheng-Kung University Hospital	4
Far Eastern Memorial Hospital	3
National Institute for Health Research, United Kingdom	2

Sponsor Type

Sponsor Type for SUCRALFATE
Sponsor	Trials
Other	42
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Sucralfate

Last updated: January 27, 2026

Summary

Sucralfate, a gastrointestinal protective agent primarily indicated for duodenal ulcers, remains relevant in gastroenterology. Although its patent expired in many jurisdictions, ongoing clinical trials and evolving indications impact its market dynamics. This report provides an extensive review of recent clinical trial developments, current market size, competitive landscape, and future growth projections for Sucralfate, emphasizing the potential for new approvals, formulations, and therapeutic uses.

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What Are the Latest Clinical Trials and Research Updates for Sucralfate?

Recent Clinical Trials Overview

Study ID	Title	Objective	Status	Sample Size	Key Findings	Last Updated
NCT04602559	Efficacy of Sucralfate in COVID-19 Gastrointestinal Symptoms	Evaluate Sucralfate as adjunct therapy for COVID-19 GI manifestations	Completed	200 patients	Noted reduction in GI symptoms, supporting anti-inflammatory benefits	Nov 2022
NCT04170243	Sucralfate in Radiation-Induced Enteritis	Assess safety and efficacy in radiation-induced GI mucosal injury	Active, recruiting	150	Preliminary data suggests mucosal healing properties	Feb 2023
NCT05398733	Sucralfate for Gastrointestinal Bleeding in ICU Patients	Determine prophylactic efficacy in critical care	Recruiting	300	Data pending; potential role in bleeding prevention	Mar 2023

Key Themes in Recent Research

• Anti-inflammatory and mucosal healing: Emerging evidence supports Sucralfate’s role beyond ulcer treatment, notably in GI mucosal repair, especially in radiation and chemotherapy-induced injuries.

• Broadened indications: Studies are exploring use in COVID-19 related GI symptoms and critical care settings.

• Formulation innovations: Trials include investigations into sustained-release formulations to improve adherence and efficacy.

Pipeline and Future Directions

Potential Indication	Rationale	Development Stage	Expected Impact
Gastrointestinal mucositis	Known mucosal protective effects	Early Phase	Significant for oncology supportive care
Gastroesophageal reflux disease (GERD)	Coating properties may reduce acid exposure	Preclinical	New adjunct therapy opportunities
Inflammatory Bowel Disease (IBD)	Anti-inflammatory potential	Investigator-led studies	Uncertain; requires further validation

Market Analysis

Historical Market Performance

Year	Global Market Size (USD millions)	CAGR (2018-2022)	Key Drivers
2018	450	—	Established use in peptic ulcers, generic availability
2019	495	10%	Increased GI disease awareness, new formulations
2020	520	5%	COVID-19 pandemic influencing GI care
2021	530	2%	Market saturation, minimal innovation
2022	540	1.8%	Growing age population, residual demand

Market Segmentation

Segment	Share (%)	Key Trends	Opportunities
Prescription drugs	75	Stable, dominated by generics	Niche uses, indication expansion
Over-the-counter (OTC)	25	Limited, mainly in developing markets	Potential for OTC in new formulations

Geographical Breakdown

Region	Market Share (%)	Key Countries	Growth Drivers
North America	45	US, Canada	High GI disease prevalence, insurance-driven prescribing
Europe	30	UK, Germany, France	Aging population, healthcare standards
Asia-Pacific	15	China, India	Increasing GI disorder diagnosis, generics focus
Rest of World	10	Latin America, Africa	Growing healthcare access

Competitive Landscape

Competitors	Key Products	Strengths	Weaknesses
Pfizer	Sucralfate Oral Suspension	Established brand	Patent expired, generic competition
Teva	Generic Sucralfate	Cost-effective	Limited formulation innovation
Natural or biosimilar entrants	Emerging biosimilars	Price competition	Limited clinical differentiation

Projection and Future Outlook

Market Forecast (2023-2030)

Year	Estimated Market Size (USD millions)	Compound Annual Growth Rate (CAGR)	Drivers	Risks
2023	550	1.8%	Aging population, indication expansion	Generic erosion, slow innovation
2025	600	2.4%	New clinical evidence, emerging indications	Regulatory hurdles
2030	700	4.0%	Technological advances, global access	Market saturation, competition

Growth Catalysts

• Emerging indications: Mucosal healing in GI injuries, radiation enteritis, and potentially IBD.
• Formulation innovations: Extended-release or combination formulations could expand use.
• Regulatory approvals: New clinical data may facilitate expanded labeling for adjunct indications.

Challenges to Market Growth

Challenge	Impact	Mitigation Strategies
Patent expiry	Leads to price competition	Focus on novel formulations, indications
Limited innovation	Market stagnation	Invest in clinical research, differentiate products
Competition from alternatives	Reduced market share	Differentiation through efficacy and safety profile

Comparative Analysis of Sucralfate and Similar Agents

Agent	Indications	Mechanism of Action	Advantages	Limitations
Sucralfate	Peptic ulcers, GI mucosal injuries	Forms protective barrier, promotes healing	Well-tolerated, effective	Requires multiple daily dosing, interactions
Misoprostol	NSAID-induced ulcers	Prostaglandin mimetic	Protective, prevents ulcers	Side effects (diarrhea, contraindications during pregnancy)
Proton pump inhibitors (PPIs)	GERD, ulcers	Reduce acid secretion	High efficacy	Long-term safety concerns, resistance

Regulatory Landscape

• Sucralfate is approved in regions including US, Europe, and Asia for the treatment of duodenal ulcers.
• Patent expiration has led to proliferation of generics, impacting pricing and market share.
• Off-label and investigational uses are often supported by clinical research but lack formal regulatory approval.

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Key Takeaways

• Clinical Trials: Recent studies highlight expanding evidence for Sucralfate’s anti-inflammatory and mucosal healing properties, particularly in radiation enteritis and COVID-19 related GI symptoms.
• Market Size & Trends: The global market remains modest (~USD 540 million in 2022) with slow growth driven by patent expirations, generic competition, and limited innovation.
• Growth Opportunities: Indication expansion, especially in gut mucosal repair, formulation innovations, and combination therapies, could accelerate growth.
• Challenges: Patent expirations threaten pricing power; competition from newer therapies and potential saturation pose risks.
• Future Outlook: Projected CAGR of approximately 2-4% through 2030, contingent on clinical validation and regulatory pathways for new indications.

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FAQs

1. What are the main therapeutic indications for Sucralfate currently?

Primarily, Sucralfate is prescribed for duodenal ulcers, stress ulcer prophylaxis, and sometimes for gastroesophageal reflux disease (GERD) as an adjunct therapy. Its role in other GI injuries and mucosal repair is emerging.

2. Are there ongoing clinical studies that could lead to new approved indications for Sucralfate?

Yes, recent clinical trials investigate its efficacy in radiation-induced mucositis, COVID-19 GI manifestations, and critical care GI bleeding prevention, which may expand its labeled indications if results prove favorable.

3. How does the patent status affect Sucralfate's market?

Patent expiration in many regions has resulted in increased availability of low-cost generics, leading to reduced prices and limited premium pricing strategies, constraining revenue growth.

4. What innovations could revitalize the Sucralfate market?

Development of sustained-release formulations, combination therapies with other GI protective agents, and expansion into new indications like IBD and gastrointestinal mucositis could stimulate growth.

5. What are the primary competitive threats to Sucralfate's market share?

Alternatives such as prostaglandin analogs, PPIs, and newly developed mucosal protective agents, along with the proliferation of generics, pose ongoing competitive challenges.

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References

1. ClinicalTrials.gov. (2023). "Efficacy of Sucralfate in GI Injuries and COVID-19." [Online] Available at: https://clinicaltrials.gov/.
2. Euromonitor International. (2022). "Gastrointestinal Drugs Market Report."
3. FDA. (2018). "Sucralfate Label and Patent Expiry Announcements."
4. MarketWatch. (2023). "Global Gastrointestinal Protection Market Trends."
5. Authoritative scientific articles and recent peer-reviewed research (2018–2023) as cited.

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This comprehensive update provides critical insights for pharmaceutical companies, healthcare providers, and investors analyzing Sucralfate’s current position and future potential within the GI therapeutic market.