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Carafate (sucralfate)
Sucralfate (Carafate) is a locally-acting mucosal protectant that forms a protective barrier over ulcer craters. Approved in 1981. Very safe due to minimal systemic absorption. Available generically.
At a glance
| Generic name | sucralfate |
|---|---|
| Also known as | Carafate |
| Sponsor | Generic (originally Marion Merrell Dow) |
| Drug class | Aluminum Complex [EPC] |
| Target | Pepsin A-5 |
| Modality | Complex sugar-metal salt |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 1981-10-30 (United States) |
Approved indications
- Duodenal ulcer disease
- Maintenance of Healing Duodenal Ulcer
Common side effects
- Constipation
Key clinical trials
- A Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy of a Multi-strain Synbiotic (SH-DS01) to Restore Gut Barrier Integrity and Gut Microbiota Composition After Antibiotic Ad (NA)
- Treatment and Prevention of Oral and Alimentary Mucositis Using Polymerized Cross-Linked High Potency Sucralfate as a Single Agent Therapy (N/A)
- A Phase III Study of Magic Mouthwash Plus Sucralfate Versus Benzydamine HCl for Treatment of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients. (Phase 3)
- Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation (Phase 2)
- Alginate vs Sucralfate for GERD Symptomatic Relief in Combination With PPIS (Phase 2)
- A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia: a Randomized Prospective Study (Phase 4)
- Prevention of Delayed Post-polypectomy Bleeding by Endoscopic Sucralfate Spray in High-risk Patients: A Randomized Controlled Trial (Phase 4)
- Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection (CENERDD) (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Carafate CI brief — competitive landscape report
- Carafate updates RSS · CI watch RSS
- Generic (originally Marion Merrell Dow) portfolio CI