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Pylera (BISMUTH SUBCITRATE)
Pylera (Bismuth Subcitrate) is a small molecule drug in the bismuth subcitrate class, originally developed by Salix Pharmaceuticals and currently owned by Salix Pharmaceuticals (acquired by Valeant Pharmaceuticals in 2015). It is FDA-approved for the treatment of duodenal ulcers caused by H. pylori. Pylera works by inhibiting the growth of H. pylori bacteria, which can cause ulcers in the stomach and duodenum. The commercial status of Pylera is patented, but it is likely to become available as a generic medication once the patent expires. Key safety considerations include potential gastrointestinal side effects such as diarrhea and nausea.
At a glance
| Generic name | BISMUTH SUBCITRATE |
|---|---|
| Drug class | Nitroimidazole Antimicrobial [EPC] |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2006 |
Approved indications
- Duodenal Ulcer due to H. Pylori
Boxed warnings
- WARNING: POTENTIAL FOR CARCINOGENICITY Metronidazole has been shown to be carcinogenic in mice and rats. It is unknown whether metronidazole is associated with carcinogenicity in humans [see Warning and Precautions ( 5.1 ) ] . WARNING: POTENTIAL FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Metronidazole has been shown to be carcinogenic in mice and rats. It is unknown whether metronidazole is associated with carcinogenicity in humans ( 5.1 ).
Common side effects
- Drug eruption
Key clinical trials
- Prevalence of Asymptomatic H Pylori Infection Among Patients Undergoing PCI and Impact of Its Eradication on Occurrence of GIT Symptoms and Bleeding" (PHASE3)
- Eradication of Helicobacter Pylori Subtypes at High Gastric Cancer Risk: a Cluster-randomized Controlled Trial (NA)
- 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)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Pylera CI brief — competitive landscape report
- Pylera updates RSS · CI watch RSS