Cholestyramine
- Generic Name
- Cholestyramine
- Brand Names
- Prevalite, Questran
- Drug Type
- Small Molecule
- CAS Number
- 11041-12-6
- Unique Ingredient Identifier
- 4B33BGI082
- Background
Cholestyramine or colestyramine is a bile acid sequestrant. Bile acid sequestrants are polymeric compounds which serve as ion exchange resins. Cholestyramine resin is quite hydrophilic, but insoluble in water.
- Indication
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. Also for the relief of pruritus associated with partial biliary obstruction.
- Associated Conditions
- Atherosclerosis, Primary Hypercholesterolemia, Pruritus
FDA-Approved Kidney Drug Sevelamer Shows Promise in Fighting Antibiotic Resistance
• Penn State researchers have demonstrated that sevelamer, an FDA-approved dialysis drug, can capture "off-target" antibiotics in the gut, potentially preventing bacteria from developing resistance.
• The drug successfully bound vancomycin and daptomycin—two commonly prescribed antibiotics—in mouse models, blocking antibiotic activity and preventing resistance evolution in gut bacteria.
• As 5-10% of intravenously administered antibiotics end up in the gastrointestinal tract where bacteria can develop resistance, this "anti-antibiotic" approach offers a novel strategy to preserve antibiotic effectiveness.
FDA Grants Breakthrough Therapy Status to Radiprodil for GRIN-Related Seizure Treatment
• GRIN Therapeutics' radiprodil receives FDA Breakthrough Therapy designation for treating seizures in patients with GRIN-related neurodevelopmental disorder, showing 86% median reduction in seizure frequency during Phase 1b trials.
• The investigational drug demonstrated significant efficacy in Phase 1b Honeycomb study, with 71% of patients achieving over 50% reduction in countable motor seizures and most patients showing behavioral improvements.
• The company plans to initiate Phase 3 pivotal trials in mid-2025, backed by a $200M capital commitment from Blackstone Life Sciences, to evaluate radiprodil's impact on seizures and behavioral outcomes.
Phase 3 Clinical Trial Enrolling to Test Maralixibat for Cholestasis-Related Itch
A Phase 3 clinical trial, EXPAND, is currently enrolling participants to evaluate the effectiveness of maralixibat in treating treatment-resistant itching associated with rare cholestatic conditions. The trial aims to enroll up to 90 participants aged 6 months and older across multiple global sites, with results expected by 2026.
Comprehensive Treatment Options Expand for Non-Familial Hypercholesterolemia Management
• Statins remain the cornerstone of lipid management, offering 30-50% LDL cholesterol reduction and corresponding decrease in cardiovascular risk through HMG-CoA reductase inhibition.
• Novel therapies including PCSK9 inhibitors and bempedoic acid provide additional options, with PCSK9 inhibitors showing 43-46% LDL reduction when combined with statins.
• Treatment decisions are guided by cardiovascular risk factors, with specific LDL targets and risk enhancers helping clinicians determine appropriate therapeutic interventions.
Clinical Trial Shows Promise for Maralixibat in Treating ALGS-Related Cholestatic Pruritus
A phase IIb clinical trial, ICONIC, evaluated the safety and efficacy of maralixibat in children with Alagille Syndrome (ALGS), showing significant improvements in serum bile acid (sBA) levels and pruritus severity. The study, involving 31 patients aged 1 to 18 years, demonstrated maralixibat's potential as a treatment for cholestatic pruritus in ALGS patients, with notable reductions in sBA and improvements in quality of life measures.
Intercept's Ocaliva Faces Setback as FDA Advisory Committee Recommends Against Full Approval for PBC
• The FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) has voted against full approval of Intercept's Ocaliva for primary biliary cholangitis (PBC).
• The vote raises concerns about Ocaliva's clinical benefit as a second-line therapy for PBC patients, despite eight years of real-world patient experience.
• Intercept remains committed to working with the FDA to address concerns and seek full approval for Ocaliva, with a PDUFA date set for October 15, 2024.
• Ocaliva, a farnesoid X receptor (FXR) agonist, is currently approved under accelerated approval based on reduction in alkaline phosphatase (ALP).
Drug Development Updates
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