CARAFATE (sucralfate)
CARAFATE is indicated for the treatment of Duodenal Ulcer.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1981-10-30
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, TABLET
CARAFATE Approval History
What CARAFATE Treats
1 indicationsCARAFATE is approved for 1 conditions since its original approval in 1981. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Duodenal Ulcer
CARAFATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to CARAFATE
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07310927 | 580/2024 | Ph 2, Ph 3 | completed | Alginate vs Sucralfate for GERD Symptomatic Relief |
| NCT05659576 | 22-307 | Ph 2 | active not recruiting | Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation |
| NCT07257926 | A-BR-114-027 | Ph 4 | not yet recruiting | Prevention of Delayed Post-polypectomy Bleeding by Endoscopic Sucralfate Spray in High-risk Patients: A Randomized Controlled Trial |
| NCT06617026 | #5787 | Ph 1, Ph 2 | completed | Short-Term Outcome of Medical Vs. Surgical Management Of Chronic Anal Fissure |
| NCT05369234 | 2022-404 INV Aloe_Oncology | Ph 3 | completed | Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis |
| NCT03241030 results posted | 2017-06-0024 | Ph 2 | completed | Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial |
| NCT03635372 | 2016TPF001 | Ph 4 | completed | A Comparison of Effectiveness of Oral Sucrolfate, Alginate and Hydrotalcide in Dispeptic Pain Treatment |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CARAFATE FDA Label Details
Indications & Usage
FDA Label (PDF)CARAFATE is indicated for the treatment of Duodenal Ulcer.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment