Drugs / Bismuth subsalicylate

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) HELIDAC 1996-08-15 fda.gov

Trials 12 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT05930197 Aug 2023 → Dec 2024 National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT01915901 Aug → Dec 2013 Biogen Completed No outcome recorded
Phase 21 trial
Phase 2 NCT00002682 Aug 1995 → Oct 2001 lymphoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 31 trial
Phase 3 NCT07104318 Jul 2026 → Jun 2029 expected Helicobacter pylori infectious disease VA Office of Research and Development Not yet recruiting No outcome recorded
Phase 45 trials
Phase 4 NCT07312721 Jan → Dec 2024 Helicobacter pylori infectious disease, chronic gastritis, peptic ulcer disease Azfar Farogh Completed No outcome recorded
Phase 4 NCT05664685 Oct 2022 → Oct 2023 Helicobacter pylori infectious disease Pontificia Universidad Catolica de Chile Completed No outcome recorded
Phase 4 NCT04811339 Oct 2020 → Aug 2021 COVID-19, diarrheal disease University of Cincinnati Completed No outcome recorded
Phase 4 NCT04348786 Feb 2019 → Aug 2020 Helicobacter pylori infectious disease Damascus Hospital Completed No outcome recorded
Phase 4 NCT03592082 Mar → Jul 2018 Clostridium difficile colitis Bassett Healthcare Withdrawn No outcome recorded
Phase not applicable3 trials
NCT07260006 Oct 2024 → May 2026 overdue Helicobacter pylori infectious disease, peptic ulcer disease Can Tho University of Medicine and Pharmacy Recruiting No outcome recorded
NCT05449028 May 2022 → Dec 2023 Helicobacter pylori infectious disease Unidade Local de Saúde de Coimbra, EPE Unknown No outcome recorded
NCT02047162 May → Sep 2014 diarrheal disease Centers for Disease Control and Prevention Completed No outcome recorded
Also used as a comparator or background therapy in 5 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 32 trials
Phase 3 NCT03535272 Comparator May 2018 → Nov 2023 acute diarrhea, infectious disease Centers for Disease Control and Prevention Terminated No outcome recorded
Phase 3 NCT01481844 Comparator Nov 2011 → Dec 2014 Soroka University Medical Center Completed No outcome recorded
Phase 43 trials
Phase 4 NCT03757650 Comparator Oct 2018 → Nov 2020 Helicobacter pylori infectious disease, morbid obesity Fatih Sultan Mehmet Training and Research Hospital Completed No outcome recorded
Phase 4 NCT01742429 Background Nov 2012 → Apr 2013 Shanghai Jiao Tong University School of Medicine Completed No outcome recorded
Phase 4 NCT01967329 Comparator Nov 2008 → May 2019 Helicobacter pylori infectious disease University of Alberta Completed No outcome recorded

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as Bismuth Subsalicylate “BQT consists of bismuth subsalicylate 524mg QID (or bismuth subcitrate if salicylate allergy), tetracycline 500mg QID, metronidazole 500mg QID, and twice daily standard dose...” NCT07104318
16

“The intervention group will be treated with Esomeprazole 40 mg every 8 hours, Amoxicillin 1 gr every 8 hours, Metronidazole 500 mg every 8 hours, Bismuth subsalicylate 369 mg...” NCT05664685

“A 14-day regimen including proton pump inhibitor (PPI; esomeprazole \[Nexium MUPS\]), bismuth subcitrate (or bismuth subsalicylate), amoxicillin, and metronidazole.” NCT07260006

“Esomeprazole 40mg bid + bismuth subsalicylate 420mg 6/6h + metronidazole 375mg 6/6h + tetracycline 375mg 6/6h, for 10 days” NCT05449028

“Omeprazole 40 mg BID, Metronidazole 400 mg TID, Tetracycline 500 mg QID, Bismuth subsalicylate for 14 days.” NCT07312721

bismuth subsalicylate (Pepto-Bismol) (2 tablets)” NCT01967329

Bismuth subsalicylate 262 tab.2 tab q.i.d” NCT04348786

NCT04811339

NCT05930197

NCT01742429

NCT00002682

NCT01481844

NCT03757650

NCT03535272

NCT02047162

NCT01915901

NCT03592082

Known as Bismatrol “It is available in the generic form, but also under the more commonly known brands: Bismatrol; Diotame; Geri-Pectate; Kao-Tin; Peptic Relief; Pepto-Bismol; Pink Bismuth and...” NCT05930197
Known as Bismukote ChEMBL registry synonym — accepted as the source's own label CHEMBL1120
Known as Bismuth salicylate ChEMBL registry synonym — accepted as the source's own label CHEMBL1120
Known as Bismuth subsalicylate component of helidac ChEMBL registry synonym — accepted as the source's own label CHEMBL1120
Known as BSS “Bismuth subsalicylate (BSS) is an ingredient in common medicines for mild diarrhea and stomach pain.” NCT05930197
1

“addition of bismuth subsalicylate (BSS) (the active ingredient in Pepto-Bismol)” NCT03592082

Known as Corrective suspension ChEMBL registry synonym — accepted as the source's own label CHEMBL1120
Known as Diotame “It is available in the generic form, but also under the more commonly known brands: Bismatrol; Diotame; Geri-Pectate; Kao-Tin; Peptic Relief; Pepto-Bismol; Pink Bismuth and...” NCT05930197
Known as Gastro-cote ChEMBL registry synonym — accepted as the source's own label CHEMBL1120
Known as Geri-Pectate “It is available in the generic form, but also under the more commonly known brands: Bismatrol; Diotame; Geri-Pectate; Kao-Tin; Peptic Relief; Pepto-Bismol; Pink Bismuth and...” NCT05930197
Known as NSC-759117 ChEMBL registry synonym — accepted as the source's own label CHEMBL1120
Known as Peptic Relief “It is available in the generic form, but also under the more commonly known brands: Bismatrol; Diotame; Geri-Pectate; Kao-Tin; Peptic Relief; Pepto-Bismol; Pink Bismuth and...” NCT05930197
Known as Pepto bismol “bismuth subsalicylate (Pepto-Bismol) (2 tablets)” NCT01967329
1

Pepto bismol (bismuth subsalicylate)” NCT04811339

Known as Stomach Relief “It is available in the generic form, but also under the more commonly known brands: Bismatrol; Diotame; Geri-Pectate; Kao-Tin; Peptic Relief; Pepto-Bismol; Pink Bismuth and...” NCT05930197
Modality Small molecule CHEMBL1120
Route Oral “Bismuth subsalicylate administered orally as tablets” NCT03535272