LOCHOLEST (cholestyramine) · CHARTWELL RX
1) Cholestyramine is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern.
Details
- Status
- Prescription
- First Approved
- 1996-08-15
- Routes
- ORAL
- Dosage Forms
- POWDER
LOCHOLEST Approval History
What LOCHOLEST Treats
4 indicationsLOCHOLEST is approved for 4 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Primary Hypercholesterolemia
- Coronary Atherosclerosis
- Pruritus
- Partial Biliary Obstruction
LOCHOLEST Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LOCHOLEST
3 of 11FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05014646 | 21049 NCI-2021-07263, 21049 | Ph 2 | active not recruiting | Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma in African-American and European-American Patients |
| NCT06454383 | 23540 NCI-2024-04359, 23540 | Ph 1 | recruiting | Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer |
| NCT06141473 FREXALT | EFC17919 2023-504358-36, U1111-1290-9326 | Ph 3 | active not recruiting | Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis |
| NCT05443425 | 22026 NCI-2022-05061, 22026 | Ph 1 | recruiting | Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies |
| NCT05894928 | LOXO-PIK-23009 J4C-OX-JZUD | Ph 1 | completed | A Study to Evaluate the Effect of Cholestyramine on LOXO-783 in Healthy Participants |
| NCT03510884 results posted | EFC14643 2017-001903-60, U1111-1193-0721 | Ph 3 | completed | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia |
| NCT03510715 results posted | EFC14660 2017-002297-39, U1111-1200-2046 | Ph 3 | completed | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia |
| NCT02890992 ODYSSEY KIDS results posted | DFI14223 2015-003766-85, U1111-1178-4764 | Ph 2 | completed | An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia |
| NCT02249897 PREL-AGES | AGE-1 | Ph 4 | completed | PRELIMINARY EVALUATION OF PHARMACOLOGICAL LOWERING OF AGEs |
| NCT01863888 TERI-DYNAMIC | LPS13539 U1111-1139-8802 | Ph 3 | completed | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis |
| NCT02046629 | PKM12788 U1111-1152-4217 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers |
| NCT01239459 | POP11432 2010-022354-16, U1111-1117-6723 | Ph 1 | completed | Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment |
| NCT01062269 results posted | OO1 | Ph 4 | completed | A Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study |
| NCT01122108 results posted | 002 | Ph 4 | completed | Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LOCHOLEST FDA Label Details
Indications & Usage
1) Cholestyramine is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerot...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.