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sucralfate

Trade name: carafate

Small moleculeapproved

Approved

Oct 30, 1981

Sucralfate (trade name CARAFATE) is a medication primarily taken to treat active duodenal ulcers. Sucralfate is also used for the treatment of gastroesophageal reflux disease (GERD) and stress ulcers. Sucralfate is a sucrose sulfate-aluminium complex that binds to the ulcer, creating a physical barrier that protects the gastrointestinal tract from stomach acid and prevents the degradation of mucus. Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine. — NCATS

Clinical trial activity

17 trials · 17 clinical orgs · 9 marketing orgs

Phase 1
3
Phase 2
5
Phase 3
3
Phase 4
6

Earliest trial started Jun 1, 2003 (NCT01613534)

Timeline

1980s

  1. Oct 30, 1981

    Merrell Dow — Earliest FDA Approval

  2. Oct 30, 1981

    Allergan — NDA Secondary Org

  3. Oct 30, 1981

    Merrell Dow — NDA Organization

  4. Oct 30, 1981

    Allergan — Marketing Organization

  5. Oct 30, 1981

    AbbVie — Marketing Organization

  6. Oct 30, 1981

    AbbVie — NDA Secondary Org

1990s

  1. Mar 29, 1996

    Teva — Marketing Organization

  2. Jun 8, 1998

    Nostrum Laboratories — Marketing Organization

  3. Jun 8, 1998

    Mylan — Marketing Organization

2000s

  1. Jan 1, 2009

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2015

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2017

    Earliest Phase 2 Sponsor(trial)

  3. Dec 2, 2019

    Amneal Pharmaceuticals — Marketing Organization

2020s

  1. Mar 15, 2022

    VistaPharm, Inc. — Marketing Organization

  2. May 3, 2023

    Zydus Discovery DMCC — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewOct 30, 1981

Chemistry & pharmacology

Loading structure…

SMILES

O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O=S(=O)(OC[C@H]1O[C@@H](O[C@]2(COS(=O)(=O)O[Al](O)O)O[C@H](OS(=O)(=O)O[Al](O)O)[C@@H](OS(=O)(=O)O[Al](O)O)[C@@H]2OS(=O)(=O)O[Al](O)O)[C@H](OS(=O)(=O)O[Al](O)O)[C@@H](OS(=O)(=O)O[Al](O)O)[C@@H]1OS(=O)(=O)O[Al](O)O)O[Al](O)O.O[Al](O)O.O[Al](O)O.O[Al](O)O.O[Al](O)O.O[Al](O)O.O[Al](O)O.O[Al](O)O.O[Al](O)O
Mol. weight
2469.04 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • antepsin
  • antepsin
  • antepsin
  • carafate
  • carafate
  • carafate
  • carafate
  • hexadeca-μ-hydroxytetracosahydroxy[μ8-[1,3,4,6-tetra-o-sulfo-β-dfructofuranosyl-α-d-glucopyranoside tetrakis(hydrogen sulfato)8-)]]hexadecaaluminum
  • hexadeca-μ-hydroxytetracosahydroxy[μ8-[1,3,4,6-tetra-o-sulfo-β-dfructofuranosyl-α-d-glucopyranoside tetrakis(hydrogen sulfato)8-)]]hexadecaaluminum
  • sucralate
  • sucralfat
  • sucralfat
  • sucralfate
  • sucralfate
  • sucralfate
  • sucralfate
  • sucralfate
  • sucralfate
  • sucralfate
  • sucralfate
  • sucralfate
  • sucralfato
  • sucralfato
  • sucralfatum
  • sucralfatum
  • sucralfin
  • sucrate
  • sulcrate
  • ulcerlmin
  • ulcerlmin
  • ulcogant

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07312370Phase 4Jan 20, 2026LanZhou University
NCT07257926Phase 4Dec 15, 2025National Cheng Kung University
NCT07310927Phase 2/Phase 3 (Phase 3)Apr 1, 2025CMH Lahore Medical College
NCT06617026Phase 1/Phase 2 (Phase 2)Aug 30, 2024Suez Canal University
NCT06107504N/ANov 1, 2023National Cheng Kung University
NCT05817656Phase 1May 15, 2023National Cheng Kung University
NCT05659576Phase 2Dec 13, 2022Memorial Sloan-Kettering Cancer Center
NCT05369234Phase 3Jan 20, 2022Thompson Cancer Survival Center
NCT03241030Phase 2Sep 12, 2017University of Texas, Austin
NCT03635372Phase 4Jun 20, 2017Pamukkale University
NCT02788591N/AAug 1, 2015Ochsner Health System
NCT02353078Early Phase 1 (Phase 1)Jan 1, 2015Mayo Clinic
NCT02039869N/ADec 20, 2013Medical University of South Carolina, Ochsner Health System, Virginia Commonwealth University
NCT01284647Phase 4Feb 1, 2011Changhai Hospital, Eisai
NCT00814359Phase 3May 1, 2009McMaster University
NCT00702871Phase 4Mar 1, 2005Azad University
NCT01613534Phase 4Jun 1, 2003Maria Sklodowska Curie Children's Hospital
Showing 17 of 17 trials
Page 1 / 1

Organizations

Research & Development (17)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cheng Kung UniversityAcademic/Hospital3332023
Ochsner Health SystemAcademic/Hospital2112013
Azad UniversityAcademic/Hospital1112005
Changhai HospitalAcademic/Hospital1112011
CMH Lahore Medical CollegeAcademic/Hospital1112025
EisaiFor profit1012011
LanZhou UniversityAcademic/Hospital1112026
Maria Sklodowska Curie Children's HospitalAcademic/Hospital1112003
Mayo ClinicAcademic/Hospital1112015
McMaster UniversityAcademic/Hospital1112009
Medical University of South CarolinaAcademic/Hospital1012013
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital1112022
Pamukkale UniversityAcademic/Hospital1112017
Suez Canal UniversityAcademic/Hospital1112024
Thompson Cancer Survival CenterAcademic/Hospital1112022
University of Texas, AustinAcademic/Hospital1112017
Virginia Commonwealth UniversityAcademic/Hospital1112013
17 organizations
Page 1 / 1

Marketing (14)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGOct 30, 1981
AbbVieFor profitNDA2Oct 30, 1981
AllerganFor profitNDA2Oct 30, 1981
AllerganFor profitMKTGOct 30, 1981
Amneal PharmaceuticalsFor profitSYNApr 15, 2022
Amneal PharmaceuticalsFor profitMKTGDec 2, 2019
Amneal PharmaceuticalsFor profitSYNDec 2, 2019
Merrell DowFor profitNDAOct 30, 1981
MylanFor profitSYNSep 12, 2022
MylanFor profitMKTGJun 8, 1998
Nostrum LaboratoriesFor profitMKTGJun 8, 1998
TevaFor profitMKTGMar 29, 1996
VistaPharm, Inc.For profitMKTGMar 15, 2022
Zydus Discovery DMCCFor profitMKTGMay 3, 2023