Drugs / Sucralfate

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02353078 Jan 2015 → Dec 2016 eosinophilic esophagitis Mayo Clinic Completed No outcome recorded
Phase 11 trial
Phase 1 NCT05817656 May 2023 → Apr 2024 hemorrhagic disease National Cheng-Kung University Hospital Unknown No outcome recorded
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
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 No outcome recorded
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Phase 4 NCT02570529 Oct 2015 → Oct 2017 pancreatic ductal adenocarcinoma Yonsei University Withdrawn No outcome recorded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
NCT07679191 Jul 2026 → Dec 2027 expected ulcer disease National Cheng-Kung University Hospital Not yet recruiting No outcome recorded
NCT07679139 Jul 2026 → Dec 2027 expected 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 No outcome recorded
NCT06107504 Jan 2024 → Feb 2025 overdue National Cheng-Kung University Hospital Recruiting No outcome recorded
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
NCT02039869 ? → Dec 2015 dyspepsia, gastroesophageal reflux disease Virginia Commonwealth University Withdrawn No outcome recorded
Also used as a comparator or background therapy in 5 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2/31 trial
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 31 trial
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 43 trials
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

Evidence & citations 25 cited values

Every value below carries the sentence it was read from. 25 sources stand behind the page.

FieldValueCited 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

NCT07312370

NCT03635372

NCT00702871

NCT05659576

NCT05817656

NCT07310927

NCT06617026

NCT07679139

NCT02039869

NCT07611162

NCT06107504

NCT07679191

NCT02788591

NCT03241030

NCT07257926

NCT01284647

NCT02353078

NCT00814359

NCT01613534

NCT07540026

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