Drugs / Bismuth subsalicylate
Bismuth subsalicylate
also known as
BSS · Pepto-Bismol · Bismatrol · Bismukote · Bismuth salicylate · Bismuth subsalicylate component of helidac · Corrective suspension · Diotame · +5 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | HELIDAC | — | 1996-08-15 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 missed | ||||||
| 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 | Missed primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT00002682 | Aug 1995 → Oct 2001 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 45 trials · 1 met primary · 1 missed | ||||||
| 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 | Met primary |
| 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 | Missed primary |
| Phase 4 | NCT03592082 | Mar → Jul 2018 | Clostridium difficile colitis | Bassett Healthcare | Withdrawn | No outcome recorded |
| Phase not applicable3 trials · 1 met primary | ||||||
| — | 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 | Met primary |
| Comparator or background therapy5 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 | Met primary |
| 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. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bismuth Subsalicylate | “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 ↗15“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 ↗ |
| 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 ↗ |