Overview
Sucralfate is a medication that is widely used to prevent and treat a number of diseases in the gastrointestinal tract such as duodenal ulcers , gastro-esophageal reflux disease (GERD), gastritis, peptic ulcer disease, stress ulcer, in addition to dyspepsia . It is considered a cytoprotective agent, protecting cells in the gastrointestinal tract from damage caused by agents such as gastric acid, bile salts, alcohol, and acetylsalicylic acid (aspirin), among other substances . Sucralfate has been shown to be a well-tolerated and safe drug. It is sold under many brands and is available in both tablet and suspension forms. It was approved by the FDA 1982 in tablet form, and in 1994 for the suspension form .
Background
Sucralfate is a medication that is widely used to prevent and treat a number of diseases in the gastrointestinal tract such as duodenal ulcers , gastro-esophageal reflux disease (GERD), gastritis, peptic ulcer disease, stress ulcer, in addition to dyspepsia . It is considered a cytoprotective agent, protecting cells in the gastrointestinal tract from damage caused by agents such as gastric acid, bile salts, alcohol, and acetylsalicylic acid (aspirin), among other substances . Sucralfate has been shown to be a well-tolerated and safe drug. It is sold under many brands and is available in both tablet and suspension forms. It was approved by the FDA 1982 in tablet form, and in 1994 for the suspension form .
Indication
The sucralfate suspension and tablet are used for the treatment of active duodenal ulcer for up to 8 weeks. The tablet form may be used at a lower dose for healed duodenal ulcers, for the purpose of maintaining healing and preventing recurrence . Sucralfate is also used in the prevention and/or treatment of gastro-esophageal reflux disease (GERD), gastritis, peptic ulcer disease, stress ulcer, in addition to dyspepsia .
Associated Conditions
- Dyspepsia
- Gastric Ulcer
- Gastritis
- Gastro-esophageal Reflux Disease (GERD)
- Healing
- Mucositis
- Peptic Ulcer
- Stress Ulcers
- Active Duodenal ulcer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/27 | Phase 1 | Completed | |||
2023/10/30 | Not Applicable | Recruiting | |||
2023/04/18 | Phase 1 | Recruiting | |||
2022/12/21 | Phase 2 | Recruiting | |||
2022/05/11 | Phase 3 | Completed | |||
2018/08/17 | Phase 4 | Completed | |||
2017/08/07 | Phase 2 | Completed | |||
2016/06/02 | Not Applicable | Terminated | |||
2015/02/02 | Early Phase 1 | Completed | |||
2014/01/20 | Not Applicable | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0188 | ORAL | 1 g in 1 1 | 11/11/2022 | |
| Chartwell RX, LLC | 62135-436 | ORAL | 1 g in 1 1 | 3/16/2023 | |
| Bryant Ranch Prepack | 63629-1307 | ORAL | 1 g in 1 1 | 5/24/2023 | |
| Preferred Pharmaceuticals Inc. | 68788-8316 | ORAL | 1 g in 1 1 | 9/25/2023 | |
| Viona Pharmaceuticals Inc | 72578-081 | ORAL | 1 g in 1 1 | 3/8/2024 | |
| Richmond Pharmaceuticals, Inc. | 54738-005 | ORAL | 1 g in 10 mL | 5/23/2025 | |
| NuCare Pharmaceuticals, Inc. | 66267-596 | ORAL | 1 g in 1 1 | 1/11/2021 | |
| Greenstone LLC | 59762-0401 | ORAL | 1 g in 1 1 | 11/20/2023 | |
| State of Florida DOH Central Pharmacy | 53808-0593 | ORAL | 1 g in 1 1 | 6/8/2010 | |
| A-S Medication Solutions | 50090-6455 | ORAL | 1 g in 1 1 | 2/26/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| APO-SUCRALFATE TABLET 1 g | SIN08585P | TABLET | 1 g | 2/27/1996 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Sucralfate Granules | 国药准字H10960212 | 化学药品 | 颗粒剂 | 3/4/2020 | |
| Sucralfate Dispersible Tablets | 国药准字H20040473 | 化学药品 | 片剂 | 4/9/2020 | |
| Sucralfate Dispersible Tablets | 国药准字H20010342 | 化学药品 | 片剂 | 4/8/2020 | |
| Sucralfate Tablets | 国药准字H22023267 | 化学药品 | 片剂 | 4/28/2021 | |
| Sucralfate Tablets | 国药准字H11020043 | 化学药品 | 片剂 | 1/28/2021 | |
| Sucralfate Tablets | 国药准字H53020174 | 化学药品 | 片剂 | 6/30/2020 | |
| Sucralfate Tablets | 国药准字H44021223 | 化学药品 | 片剂 | 6/28/2019 | |
| Sucralfate Chewable Tablets | 国药准字H42020447 | 化学药品 | 片剂 | 7/30/2020 | |
| Sucralfate Chewable Tablets | 国药准字H34020565 | 化学药品 | 片剂 | 4/13/2020 | |
| Sucralfate Chewable Tablets | 国药准字H34021240 | 化学药品 | 片剂 | 6/15/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CARAFATE | 40742 | Medicine | A | 8/6/1992 | |
| CARAFATE sucralfate 1g uncoated tablet bottle | 14930 | Medicine | A | 9/9/1991 |