NDAORALCAPSULE
Approved
May 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
5/8 — 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. Approved for type 2 diabetes, hypercholesterolemia, familial hypercholesterolemia. First approved in 2000.
Drug data last refreshed 18h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WELCHOL (colesevelam hydrochloride) is an oral, non-absorbed polymer that lowers LDL cholesterol by binding bile acids in the intestine and increasing hepatic cholesterol clearance. It is indicated for reducing elevated LDL-C in adults with primary hyperlipidemia and in pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia, as well as for improving glycemic control in type 2 diabetes mellitus. The mechanism for glucose improvement in diabetes remains unknown. WELCHOL occupies a niche position in the lipid management and diabetes treatment landscape, competing primarily against DPP-4 inhibitors and SGLT2 inhibitors.
$0.0BPart D
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 (3)
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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.