Drugs / Sucralfate
Sucralfate
also known as
Aluminum sucrose octasulfate · Antepsin · Carafate · Carafate (sucralfate) · Citogel · Emoflon · Hexagastron · Kéal · +13 more
targets PGA5 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | CARAFATE | — | 1990-05-11 | fda.gov ↗ |
| Approved | US (FDA) | CARAFATE | — | 1981-10-30 | fda.gov ↗ |
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02353078 | Jan 2015 → Dec 2016 | eosinophilic esophagitis | Mayo Clinic | Completed | No outcome recorded |
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT05817656 | May 2023 → Apr 2024 | hemorrhagic disease | National Cheng-Kung University Hospital | Unknown | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06617026 | Aug → Oct 2024 | ulcer of anus and rectum | Suez Canal University | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT05659576 | Dec 2022 → Dec 2026 expected | radiation-induced disorder | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03241030 | Sep 2017 → Jul 2018 | hand, foot and mouth disease, herpangina, stomatitis | University of Texas at Austin | Completed | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT00814359 | May 2009 → Sep 2010 | head and neck cancer, mucositis | Juravinski Cancer Centre Foundation | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07312370 | Apr → Dec 2026 expected | active peptic ulcer disease, gastric carcinoma, gastric ulcer | LanZhou University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07257926 | Dec 2025 → Dec 2027 expected | — | National Cheng-Kung University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03635372 | Jun → Oct 2017 | dyspepsia | Pamukkale University | Completed | No outcome recorded |
| Phase 4 | NCT02570529 | Oct 2015 → Oct 2017 | pancreatic ductal adenocarcinoma | Yonsei University | Withdrawn | No outcome recorded |
| Phase 4 | NCT01613534 | Jun 2003 → Jun 2007 | radiation proctitis | Maria Sklodowska-Curie National Research Institute of Oncology | Completed | No outcome recorded |
| Phase not applicable8 trials · 2 met primary | ||||||
| — | NCT07679139 | Jul 2026 → Dec 2027 expected | — | National Cheng-Kung University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07679191 | Jul 2026 → Dec 2027 expected | ulcer disease | National Cheng-Kung University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07540026 | May 2026 → Dec 2027 expected | upper digestive tract disorder | National Cheng-Kung University Hospital | Recruiting | No outcome recorded |
| — | NCT06421389 | Aug 2024 → Jun 2025 | active peptic ulcer disease | National Cheng-Kung University Hospital | Completed | Met primary |
| — | NCT06107504 | Jan 2024 → Feb 2025 overdue | — | National Cheng-Kung University Hospital | Recruiting | Met primary |
| — | NCT04918758 | Jul 2021 → Dec 2024 | radiation proctitis | Manchester University NHS Foundation Trust | Completed | No outcome recorded |
| — | NCT02788591 | Aug 2015 → Jun 2021 | gastroesophageal reflux disease | LCMC Health | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02039869 | ? → Dec 2015 | dyspepsia, gastroesophageal reflux disease | Virginia Commonwealth University | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy5 trials | ||||||
| Phase 2/3 | NCT07310927 Comparator | Apr 2025 → Apr 2026 | gastroesophageal reflux disease | CMH Lahore Medical College and Institute of Dentistry | Completed | No outcome recorded |
| Phase 3 | NCT05369234 Background | Jan 2022 → Jan 2024 | esophageal cancer, larynx cancer, mediastinal cancer, mucositis +3 | Covenant Health Cancer Center | Completed | No outcome recorded |
| Phase 4 | NCT07611162 Comparator | May 2026 → May 2030 expected | gastroesophageal reflux disease | University of Mons | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT01284647 Comparator | Feb 2011 → Oct 2012 | chronic erosive gastritis | Changhai Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00702871 Comparator | Mar 2005 → Apr 2006 | — | Maulana Azad Medical College | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-05-22 | Halcygen Pharmaceuticals Limited | Regulatory Strides receives USFDA approval for Sucralfate Oral Suspension, 1gm/10 mL strides.com ↗
Strides receives USFDA approval for Sucralfate Oral Suspension, 1gm/10 mL |
| 2023-05-04 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Sucralfate Tablets USP, 1 gram zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Sucralfate Tablets USP, 1 gram (USRLD: Carafate Tablets, 1 gram). |
| 2019-12-03 | Impax Laboratories, LLC | Regulatory Amneal Announces the Approval and Launch of Generic Carafate® amneal.com ↗
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received final U.S. Food and Drug Administration approval on its Abbreviated New Drug Application for a generic version of Carafate® (sucralfate) Oral Suspension, 1 g/10 ml. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-05-22 | Halcygen Pharmaceuticals Limited | Strides receives USFDA approval for Sucralfate Oral Suspension, 1gm/10 mL strides.com ↗ |
| 2023-05-04 | Zydus Lifesciences Limited | Zydus receives final approval from the USFDA for Sucralfate Tablets USP, 1 gram zyduslife.com ↗ |
| 2019-12-03 | Impax Laboratories, LLC | Amneal Announces the Approval and Launch of Generic Carafate® amneal.com ↗ |
Evidence & citations 25 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sucralfate | “Sucralfate enemas 2g twice daily for 8 weeks, this is standard care in patients with haemorrhagic radiation proctopathy in the short term” NCT04918758 ↗22“Sucralfate, a complex of aluminum hydroxide and sucrose octa sulfate, can bind to the wound base.” NCT06421389 ↗ “Albis® is a newly developed drug comprised of ranitidine, bismuth and sucralfate.” NCT02570529 ↗ |
| Known as | Aluminum sucrose octasulfate | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Antepsin | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Carafate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05369234 ↗ |
| Known as | Carafate (sucralfate) | “Carafate (sucralfate)” NCT02039869 ↗ |
| Known as | Citogel | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Emoflon | “Sucralfate (Emoflon®)” NCT06617026 ↗ |
| Known as | Hexagastron | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Kéal | “use of Kéal sucralfate” NCT07611162 ↗ |
| Known as | Succosa | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Sucralfate hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Sucralfato | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Sucralfin | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Sucrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Sugast | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Sulcrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Ulcar | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Ulcermin | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Ulcogant | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Ulsanic | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Urbal | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Known as | Venter | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067980 ↗ |
| Action | Inhibit | “Pepsin A inhibitor” CHEMBL6067980 ↗ |
| Route | Other | “Sucralfate was given in dose of 1gm via nasogastric tube” NCT00702871 ↗ |
| Target | PGA5 | “Pepsin A inhibitor” CHEMBL6067980 ↗ |