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
Radiation Proctopathy	1
Bleeding	1

Condition MeSH

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

Clinical Trial Locations for SUCRALFATE

Trials by Country

Trials by Country for SUCRALFATE
Location	Trials
United States	10
China	8
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
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

Sucralfate Clinical Trials Update, Market Analysis, and Forecast: Pipeline Readouts, Competitive Dynamics, and Commercial Projections

Last updated: July 28, 2026

Sucralfate is a long-established gastrointestinal (GI) drug with limited late-stage pipeline activity tied to true “new-to-market” development. Commercial outlook is driven by (1) patent and exclusivity status of branded and generic formulations in the US and select EU markets, (2) penetration of generic suspensions and tablets, and (3) the competitive position of newer acid-suppression regimens (PPIs, H2 blockers) for overlapping indications. Near-term market growth is expected to track incremental demand for ulcer healing and stress ulcer prophylaxis, with volume gains offset by steady generic price compression.

What is the latest clinical trials update for sucralfate in 2024–2026?

Answer: Publicly visible late-stage clinical trial activity for sucralfate is sparse. Most activity in recent years is linked to (a) formulation or bioequivalence studies, (b) comparative safety/tolerability in GI indications, or (c) niche regimens in settings where sucralfate remains standard of care in some care pathways. The practical signal for investors is that trial inflow is not dominated by Phase 3 “registrational” programs likely to reset exclusivity.

Which sucralfate indications dominate recent study activity?

High-intent searches for sucralfate trials typically cluster around:

• Peptic ulcer disease (gastric and duodenal ulcers)
• Gastroesophageal reflux disease (GERD) and symptom control (often as adjunct therapy rather than primary therapy)
• Erosive esophagitis (adjunct in some protocols)
• Stress ulcer prophylaxis in hospital settings (historically important; today often compared with or overshadowed by PPIs)
• Mucositis/chemoradiation-related injury (reported in smaller studies and niche settings)

What trial phases and endpoints are most common?

When sucralfate is studied, programs most commonly aim at:

• Endpoints: endoscopic healing rates, symptom scores, recurrence rates, time to symptom relief
• Design: randomized comparative trials vs placebo or active comparators; or bioequivalence/PK studies for reformulated products
• Regulatory posture: supplementing existing labeling rather than broad label expansion

Why is pipeline visibility low for sucralfate?

Sucralfate’s clinical profile is well characterized and generic competition is widespread. That reduces sponsor incentives for large Phase 3 registrational trials unless there is a differentiation claim (new delivery system, new combination regimen, or a new geographic regulatory gap).

What is the sucralfate market size and who are the key competitors?

Answer: Sucralfate is a mature GI product with a competitive base dominated by generic tablets and oral suspensions plus a smaller branded footprint depending on country. The competitive set includes both direct generic sucralfate products and indirect substitutes from the broader acid-suppression class.

Direct competitors (sucralfate products)

Competition is primarily within:

• Oral tablets (e.g., generic equivalents of branded tablets where present)
• Oral suspensions (market share is often tied to dosing convenience and formulary inclusion)
• Institutional supply contracts for hospital prophylaxis indications

Indirect substitutes (therapeutic competition)

Sucralfate faces substitution pressure from:

• PPIs (omeprazole, pantoprazole, esomeprazole, etc.)
• H2 receptor antagonists (famotidine, etc.)
• Proton-potassium competitive agents (where used)
• Mucosal protectants used in overlapping settings

How does formularies affect demand?

GI prophylaxis and ulcer healing volume are influenced by:

• hospital formulary preferences (PPIs frequently dominate prophylaxis)
• outpatient guideline adherence
• payer policies that favor lowest acquisition cost generics
• switching behavior among therapeutic classes

How do sucralfate prices and revenue typically behave under generic competition?

Answer: Sucralfate is exposed to the typical post-patent generics pattern: rapid price erosion in oral dosage forms, limited pricing power, and margin compression unless differentiated by supply-chain reliability, formulation convenience, or contract awards.

What are the revenue drivers for sucralfate sellers?

• Volume retention in long-tail GI use cases where sucralfate is still prescribed
• Institutional procurement for stress ulcer prophylaxis where adopted
• Payer step edits that keep sucralfate viable after other therapies are attempted or where guideline positioning supports it

What are the headwinds?

• ongoing PPI substitution
• competitive pressure from other mucosal protectants and banded formularies
• manufacturing cost pressure in low-margin generics

When does sucralfate lose exclusivity and what does that imply for market share?

Answer: For sucralfate itself, exclusivity is generally not a growth lever in the way it is for modern branded drugs. Market share is instead shaped by the timing of generic entries for specific formulations in specific markets and by changes to labeling or clinical positioning.

What patent categories matter for sucralfate commercialization?

Even if overall sucralfate chemistry is old, commercial differentiation can come from:

• formulation patents (specific excipients, coatings, stability)
• process/manufacturing patents
• combinations (if a product is co-formulated with other actives)
• use patents (less common for such a mature drug)

What generic entry risks exist for sucralfate in the US?

Answer: Generic entry risk is usually low for any already-generic-heavy segment because most sucralfate oral products are already generic. The practical “risk” is not whether generics can enter, but whether a manufacturer can maintain supply, pricing, and contract position after competition.

How do Paragraph IV and Hatch-Waxman dynamics typically map to sucralfate?

For mature, extensively genericized drugs, the number of fresh Hatch-Waxman events is usually limited. Any new litigation is more likely tied to:

• reformulated product exclusivity
• specific strengths or dosage forms
• manufacturing process or formulation patents

What formulations are protected for sucralfate and how do they affect competition?

Answer: If formulation IP exists for a particular product line, it affects competition by creating barriers to immediate “drop-in” substitution for certain dosage forms or release profiles. In the absence of active, enforceable formulation IP, competition defaults to price and supply chain efficiency.

Key formulation segments to map for competitive risk

• tablets (immediate release vs modified release where applicable)
• oral suspension (viscosity, stability, flavoring)
• extemporaneous or hospital-ready packaged forms
• any liquid preparations with special handling claims

What sucralfate patent litigation has affected commercialization?

Answer: For sucralfate, litigation visibility is usually lower than in newer therapeutics. When disputes occur, they are most plausibly linked to formulation/process patents for specific product lines rather than core active ingredient IP.

What to watch in litigation for market impact

• injunction risk affecting supply
• settlement terms that delay or carve out certain generic strengths/dosage forms
• consent judgments that define “design around” boundaries

What is the Orange Book status of sucralfate?

Answer: Sucralfate is widely marketed in the US in generic forms, and Orange Book activity is typically concentrated in older branded listings and any surviving formulation/process patents tied to specific NDA/ANDA entries. Market impact comes from the current listed patent expiration and any remaining exclusivities for particular products rather than for the drug substance broadly.

What is the regulatory status of sucralfate outside the US?

Answer: Sucralfate remains approved in multiple jurisdictions as an oral GI protectant. Competitive dynamics in the EU and other regions generally mirror the US: generic penetration is high, with demand tied to local prescribing patterns and formulary inclusion.

How do regulatory pathways influence competition?

• generics (ANDA/abbreviated routes where available)
• national variations in interchangeability and substitution rules
• labeling and packaging changes that impact procurement and switching

How does sucralfate compare with PPIs and H2 blockers for clinical and commercial positioning?

Answer: Sucralfate competes primarily as an alternative or adjunct in ulcer-related indications rather than as the preferred first-line acid suppression class. That position limits growth versus PPIs, but maintains a stable role in certain patient segments, care settings, or guideline-adherent pathways.

What does this mean for uptake?

• growth is likely modest and incremental
• share shifts are driven by physician habits, payer policies, and hospital protocols
• price competition drives margins rather than differentiation

Market projection for sucralfate (2026–2030): base case and scenarios

Answer: The base case is low-to-mid single-digit value growth driven by continued demand stability and modest volume expansion in certain institutional and outpatient cohorts, offset by pricing compression. Any upside scenario requires a clear differentiation event (new formulation with meaningful adherence or stability advantages, or successful clinical positioning change). A downside scenario is dominated by further PPI dominance in prophylaxis and continued generic price erosion.

Projection structure (how revenue is likely to evolve)

• Unit volume: stable to low growth, anchored by persistent indication use
• Net price: downward trend with periodic volatility from supply/contracting cycles
• Mix: shifts between tablets and suspensions based on institutional procurement
• Geography: limited incremental expansion unless formulary access improves

What outcomes would change the forecast?

• sustained adoption in hospital stress ulcer protocols where sucralfate maintains a role
• successful differentiation around formulation stability, dosing convenience, or tolerability
• litigation/settlement outcomes that restrict certain competitors in specific strengths or dosage forms
• adverse safety signals would be material, but none are implied by the competitive landscape overview

Key data points to build an actionable business view

Competitive landscape mapping checklist

• US product lineup: branded vs generic tablets and suspensions by strength
• procurement footprint: major IDNs and pharmacy benefit managers’ preferred products
• channel split: hospital vs retail
• formulary positioning: “preferred” vs “second-line/step” in ulcer-related pathways
• substitute share: PPI/H2 utilization trends by indication

Risk register (commercial)

• continued price compression from generic entrants
• formulary switching to PPIs in prophylaxis
• margin volatility due to contract-based pricing
• IP/design-around disputes around formulation/process claims for specific SKUs

Key Takeaways

• Sucralfate is a mature GI drug; recent clinical trial activity is unlikely to drive a registrational resurgence.
• Commercial performance depends on generic competition dynamics, formulary inclusion, and substitution by PPIs.
• Market growth is likely incremental, with value gains constrained by net price erosion.
• Forecast upside requires formulation differentiation or protocol shifts; downside is driven by ongoing PPI dominance and pricing pressure.

FAQs

1) Are there any ongoing Phase 3 sucralfate trials for ulcer healing?

Public late-stage registrational activity is limited; most visible activity is formulation, comparative, or PK-focused.

2) Does sucralfate remain used for stress ulcer prophylaxis in hospitals?

Yes, in some institutional protocols, but adoption is increasingly shaped by PPI-led prophylaxis pathways.

3) What are the most competitive sucralfate dosage forms in the US market?

Oral tablets and oral suspensions, where generic penetration is high and procurement determines mix.

4) Can a new sucralfate formulation materially change market share?

Only if it delivers measurable differentiation tied to stability, dosing convenience, or an enforceable formulation IP moat that affects substitutability.

5) How do payer policies influence sucralfate uptake versus PPIs?

Payer step edits and preferred drug lists commonly favor PPIs, which constrains sucralfate growth to patients or pathways where alternatives are limited or adjunctive.

References

No sources were provided in the prompt, and no verifiable, citable dataset (e.g., ClinicalTrials.gov query results, FDA Orange Book listings, company financials, or sales estimates) is available within this exchange to support a factual clinical and market update.