NDAORALFOR SUSPENSION
Approved
Oct 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
3/8 — Basic
WELCHOL (colesevelam hydrochloride) by Ichnos Glenmark Innovation is : colesevelam hydrochloride, the active pharmaceutical ingredient in welchol, is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption. First approved in 2009.
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WELCHOL (colesevelam hydrochloride) is an oral, non-absorbed polymer that binds bile acids in the intestine, triggering increased hepatic LDL receptor expression and cholesterol conversion to bile acids. It is indicated for lowering LDL cholesterol in patients with dyslipidemia and for improving glycemic control in type 2 diabetes mellitus. The dual-indication profile positions it as a cardiovascular-metabolic combination therapy.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting defensive market-maintenance strategy and potential team restructuring.
Mechanism of Action
: Colesevelam hydrochloride, the active pharmaceutical ingredient in WELCHOL, 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, cholesterol 7-α-hydroxylase, is upregulated, which…
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.