bismuth subsalicylate
Trade name: Pepto-Bismol
Approved
Aug 15, 1996
Bismuth subsalicylate, sold generically as pink bismuth and under brand names including Pepto-Bismol, Pepti-Calm, and BisBacter, is a medication used to treat temporary discomfort of the stomach and gastrointestinal tract. This includes an upset stomach, heartburn, or other similar symptoms. — Wikipedia
Clinical trial activity
11 trials · 15 clinical orgs · 3 marketing orgs
Earliest trial started Aug 1, 1995 (NCT00002682)
Timeline
1990s
- Jan 1, 1995
Earliest Phase 2 Sponsor(trial)
- Aug 15, 1996
Casper Pharma LLC — Earliest FDA Approval
- Aug 15, 1996
Casper Pharma LLC — NDA Secondary Org
- Aug 15, 1996
Casper Pharma LLC — NDA Organization
2010s
- Jan 1, 2013
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2018
Earliest Phase 3 Sponsor(trial)
- Nov 30, 2018
Ailex Pharmaceuticals — Marketing Organization
- Nov 30, 2018
Nostrum Laboratories — Marketing Organization
Indications
Mechanism of action
- CyclooxygenaseINHIBITOR
Cyclooxygenase inhibitor
Combination products
helidac
with metronidazole, tetracycline
Approval history
- approvedAug 15, 1996
Chemistry & pharmacology
- Mol. weight
- 362.09 g/mol
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaBismuth subsalicylate ↗
- ChEMBLCHEMBL1120 ↗
Also known as
- 2-hydroxy-benzo[1,3,2]dioxabismin-4-one
- 2-hydroxy-benzo[1,3,2]dioxabismin-4-one
- basic bismuth salicylate
- basic bismuth salicylate
- bismogenol
- bismukote
- bismuth oxide salicylate
- bismuth oxide salicylate
- bismuth oxysalicylate
- bismuth oxysalicylate
- bismuth oxysalicylate
- bismuth subsalicylate
- bismuth subsalicylate
- bismuth subsalicylate
- bismuth subsalicylate
- bismuth subsalicylate
- bismuth subsalicylate
- bismuth subsalicylate
- bismuth subsalicylate
- bismuth subsalicylate
- bismuth subsalicylate
- corrective suspension
- gastro-cote
- helidac
- kaopectate
- pepto-bismol
- pepto-bismol
- pepto-bismol
- pink bismuth
- pink bismuth
- subsalicylate bismuth
- trigastronol
- wismutsubsalicylat
- wismutsubsalicylat
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05930197 | Phase 1 | Aug 31, 2023 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT04811339 | Phase 4 | Oct 27, 2020 | Procter and Gamble, University of Cincinnati |
| NCT03757650 | Phase 4 | Oct 1, 2018 | Government of Turkey |
| NCT03535272 | Phase 3 | May 20, 2018 | Centers for Disease Control and Prevention (CDC), Procter and Gamble |
| NCT03592082 | Phase 4 | Mar 1, 2018 | Bassett Healthcare |
| NCT02400476 | Phase 2 | Feb 1, 2015 | Puma Biotechnology, Inc. |
| NCT02047162 | N/A | May 1, 2014 | Centers for Disease Control and Prevention (CDC), Procter and Gamble |
| NCT01915901 | Phase 1 | Aug 1, 2013 | Biogen |
| NCT01742429 | Phase 4 | Nov 1, 2012 | Jiao Tong University |
| NCT01967329 | Phase 4 | Nov 1, 2008 | Alberta Innovates Health Solutions, ArcticNet, Canadian Institutes of Health Research (CIHR), University of Alberta |
| NCT00002682 | Phase 2 | Aug 1, 1995 | National Cancer Institute (NCI), University of Texas at Houston |
Organizations
Research & Development (15)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Procter and Gamble | For profit | 3 | 0 | 3 | 2014 |
| Centers for Disease Control and Prevention (CDC) | Government | 2 | 2 | 2 | 2014 |
| Alberta Innovates Health Solutions | Academic/Hospital | 1 | 0 | 1 | 2008 |
| ArcticNet | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Bassett Healthcare | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Biogen | For profit | 1 | 1 | 1 | 2013 |
| Canadian Institutes of Health Research (CIHR) | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Government of Turkey | Government | 1 | 1 | 1 | 2018 |
| Jiao Tong University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 1995 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 1 | 1 | 1 | 2023 |
| Puma Biotechnology, Inc. | For profit | 1 | 1 | 1 | 2015 |
| University of Alberta | Academic/Hospital | 1 | 1 | 1 | 2008 |
| University of Cincinnati | Academic/Hospital | 1 | 1 | 1 | 2020 |
| University of Texas at Houston | Academic/Hospital | 1 | 1 | 1 | 1995 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Ailex Pharmaceuticals | For profit | MKTG | Nov 30, 2018 |
| Casper Pharma LLC | For profit | NDA2 | Aug 15, 1996 |
| Casper Pharma LLC | For profit | NDA | Aug 15, 1996 |
| Nostrum Laboratories | For profit | MKTG | Nov 30, 2018 |