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colesevelam HCl
Colesevelam is a bile acid sequestrant that binds bile acids in the intestine, preventing their reabsorption and increasing their fecal excretion.
Colesevelam is a bile acid sequestrant that binds bile acids in the intestine, preventing their reabsorption and increasing their fecal excretion. Used for Hypercholesterolemia (elevated LDL cholesterol), Type 2 diabetes mellitus (as adjunctive therapy for glycemic control).
At a glance
| Generic name | colesevelam HCl |
|---|---|
| Also known as | Welchol, WELCHOL (colesevelam hydrochloride), Initial U.S. Approval: 2000, WelChol |
| Sponsor | HealthPartners Institute |
| Drug class | Bile acid sequestrant |
| Target | Bile acids |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular; Endocrinology |
| Phase | FDA-approved |
Mechanism of action
By binding bile acids in the gastrointestinal tract, colesevelam prevents their enterohepatic circulation and increases their elimination in feces. This stimulates the liver to convert more cholesterol into bile acids to replace those lost, thereby reducing serum LDL cholesterol levels. The drug may also improve glycemic control through effects on glucose metabolism and GLP-1 signaling.
Approved indications
- Hypercholesterolemia (elevated LDL cholesterol)
- Type 2 diabetes mellitus (as adjunctive therapy for glycemic control)
Common side effects
- Constipation
- Dyspepsia
- Nausea
- Abdominal pain
- Flatulence
Key clinical trials
- Examining a Novel Gastrointestinal Intervention to Negate Environmental Toxicants (ENGINE) (PHASE1, PHASE2)
- A Study of Colesevelam for Lenalidomide-Associated Diarrhea (PHASE2)
- Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry
- Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery (EARLY_PHASE1)
- Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib (PHASE2)
- Impact of Therapy Using Colesevelam Treatment Reducing Bile Acids in Patients With Fontan Circulation. (PHASE1, PHASE2)
- A Study of Colesevelam in Fecal Incontinence (PHASE3)
- Effect of the Sequestrant Colesevelam in Bile Acid Diarrhoea (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 |
|---|---|
| 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:
- colesevelam HCl CI brief — competitive landscape report
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- HealthPartners Institute portfolio CI