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Colloidal Bismuth Subcitrate
Colloidal bismuth subcitrate forms a protective coating over gastric and duodenal ulcers while also exhibiting antimicrobial activity against Helicobacter pylori.
Colloidal bismuth subcitrate forms a protective coating over gastric and duodenal ulcers while also exhibiting antimicrobial activity against Helicobacter pylori. Used for Peptic ulcer disease (gastric and duodenal ulcers), Helicobacter pylori eradication as part of combination therapy, Functional dyspepsia.
At a glance
| Generic name | Colloidal Bismuth Subcitrate |
|---|---|
| Also known as | PIDI |
| Sponsor | Sir Run Run Shaw Hospital |
| Drug class | Bismuth-containing antiulcer agent |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
The bismuth component binds to ulcer bases and damaged mucosa, creating a physical barrier that protects against acid and pepsin while promoting healing. Additionally, bismuth has direct bactericidal effects against H. pylori, making it effective in eradication regimens. The subcitrate formulation enhances bioavailability and reduces systemic bismuth absorption.
Approved indications
- Peptic ulcer disease (gastric and duodenal ulcers)
- Helicobacter pylori eradication as part of combination therapy
- Functional dyspepsia
Common side effects
- Darkening of stool/tongue (bismuth discoloration)
- Nausea
- Constipation
- Abdominal discomfort
Key clinical trials
- Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection (NA)
- Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer (PHASE2)
- Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans (PHASE3)
- Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease (NA)
- Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection (PHASE4)
- Clinical Evaluation of a 14day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in a High Clarithromycin and Metronidazole Resistance Area Regarding Patients With Peptic Ulcer and Non Ulcer Dyspepsia (PHASE4)
- Efficacies of HDDT With or Without Bismuth vs Amoxicillin-metronidazole BQT for First-line H Pylori Eradication (PHASE4)
- A Comparison of Four Different Treatment Regimens of Helicobacter Pylori in Chinese Children (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Colloidal Bismuth Subcitrate CI brief — competitive landscape report
- Colloidal Bismuth Subcitrate updates RSS · CI watch RSS
- Sir Run Run Shaw Hospital portfolio CI