NDAORALCAPSULE
Approved
May 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
4/8 — Partial
WELCHOL (colesevelam hydrochloride) by Ichnos Glenmark Innovation is hyperlipidemia: colesevelam hydrochloride, the active pharmaceutical ingredient in colesevelam hydrochloride tablets, is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption. First approved in 2000.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WELCHOL (colesevelam hydrochloride) is an oral, non-absorbed bile acid sequestrant polymer approved in 2000 for hyperlipidemia and type 2 diabetes mellitus. It reduces LDL cholesterol by binding bile acids in the intestine, triggering compensatory upregulation of hepatic LDL receptors and cholesterol clearance. The mechanism for glycemic benefit remains incompletely understood.
$9MPart D
LOE ApproachingMature product approaching loss of exclusivity with modest Medicare utilization, signaling reduced commercial expansion and potential team downsizing or focus on cost management.
Mechanism of Action
Hyperlipidemia: Colesevelam hydrochloride, the active pharmaceutical ingredient in colesevelam hydrochloride tablets, is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption. As the bile acid pool becomes depleted, the hepatic enzyme,…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes
Started Sep 2009
21 enrolled
Type 2 Diabetes
The Effect of Welchol on Glucose Metabolism in Type 2 Diabetics
Started Aug 2009
38 enrolled
Type 2 Diabetes
Welchol as Monotherapy for Type 2 Diabetes Mellitus
Started Jan 2009
357 enrolled
Type 2 Diabetes Mellitus
Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus
Started May 2006
35 enrolled
Type 2 Diabetes Mellitus
Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes
Started Dec 2004
780 enrolled
Type 2 Diabetes
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.