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Questran

(Cholestyramine)

ApprovedSmall molecule

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Cholestyramine is used to lower cholesterol levels in the blood and can also help relieve itching caused by certain liver conditions. It works by binding to cholesterol in your digestive system so your body removes it instead of absorbing it.[2] Questran is currently approved and in use across 19 indications[4].[1]

Questran is one of 386 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

19

Indications

23

Total Trials

5

Active Trials

385

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Asymptomatic MyelomaApproved

HypothyroidismActive, not recruiting

HyperlipidemiaActive, not recruiting

HyperthyroidismActive, not recruiting

Familial HypercholesterolemiaActive, not recruiting

AtherosclerosisActive, not recruiting

Graves DiseaseApproved

Kidney DiseaseApproved

Acute Graft Versus Host DiseaseRecruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Asymptomatic MyelomaApproved

Approved

HypothyroidismApproved

Active, not recruiting

HyperlipidemiaPreclinical

Active, not recruiting

HyperthyroidismPhase 3

Active, not recruiting

Familial HypercholesterolemiaPhase 3

Active, not recruiting

AtherosclerosisPhase 2

Active, not recruiting

Graves DiseaseApproved

Approved

Kidney DiseaseApproved

Approved

Acute Graft Versus Host DiseasePhase 1

Recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

1135 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Questran

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Ninlaro

Prolia

Eliquis

Bristol-Myers Squibb

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Adriamycin

GGynecologic Oncology Group

Nolvadex

Oncovin

EEastern Cooperative Oncology Group

Intron a

Systemic Therapy

Bristol-Myers Squibb

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Pancreatic Cancer

NCT06454383

Q1 2027

Phase 1Recruiting

Acute Graft Versus Host Disease

NCT05443425

Phase 2Active, not recruiting

Multiple Myeloma

NCT05014646

Q2 2027

Phase 3Recruiting

Multiple Sclerosis

NCT06141473

Clinical

Trials by Indication[1]

Hyperthyroidism2 trials

Low Doses of Cholestyramine in the Treatment of Hyperthyroidism

Completed·SShiraz University of Medical Sciences·N/A·NCT00677469·45 enrolled

Efficacy and Safety of Cholestyramine and Prednisolone as Adjunctive Therapy in Treatment of Overt Hyperthyroidism

Unknown status·—·Phase 3·NCT03303053·135 enrolled

Familial Hypercholesterolemia2 trials

An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 2·NCT02890992·42 enrolled

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 3·NCT03510884·153 enrolled

Multiple Sclerosis2 trials

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT06141473·1,600 enrolled

Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 3·NCT01863888·70 enrolled

Acceptability2 trials

A Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study

Completed·LLouisville Metabolic and Atherosclerosis Research Center·Phase 4·NCT01062269·42 enrolled

Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale

Completed·LLouisville Metabolic and Atherosclerosis Research Center·Phase 4·NCT01122108·42 enrolled

NHL1 trial

NHLBI Type II Coronary Intervention Study

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000594

14 more indications

Atherosclerosis1 trial

Harvard Atherosclerosis Reversibility Project (HARP)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00000461

Pancreatic Cancer1 trial

Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer

Recruiting·—·Phase 1·NCT06454383·19 enrolled

Homozygous Familial Hypercholesterolemia1 trial

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 3·NCT03510715·18 enrolled

Multiple Myeloma1 trial

Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma in African-American and European-American Patients

Active, not recruiting·—·Phase 2·NCT05014646·27 enrolled

Age1 trial

PRELIMINARY EVALUATION OF PHARMACOLOGICAL LOWERING OF AGEs

Completed·UUniversity of Chile·Phase 4·NCT02249897·7 enrolled

ART1 trial

A Study to Evaluate the Effect of Cholestyramine on LOXO-783 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05894928·21 enrolled

Renal Impairment1 trial

Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment

Completed· Sanofi logo

Sanofi·Phase 1·NCT01239459·16 enrolled

Prevention1 trial

Lipid Research Clinics Coronary Primary Prevention Trial (CPPT)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000488

Coronary Artery Bypass1 trial

Post Coronary Artery Bypass Graft (CABG) Study

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000463

Short Bowel Syndrome1 trial

Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome

Terminated·PPharmascience Inc.·Phase 2·NCT04046328·13 enrolled

Female1 trial

Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of POPs in Obese Female Patients

Recruiting·—·N/A·NCT05966727·20 enrolled

Hyperlipidemia1 trial

Effect of Lipid Modifying Drugs on HDL Function in Patients With Hyperlipidemia

Completed·YYonsei University·N/A·NCT02942602·58 enrolled

Acute Graft Versus Host Disease1 trial

Pilot Trial of Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies

Recruiting·CCity of Hope Medical Center·Phase 1·NCT05443425·18 enrolled

Unspecified1 trial

A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers

Completed· Sanofi logo

Sanofi·Phase 1·NCT02046629·12 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

QUESTRAN

NDA NDA016640

Dec 5, 1988

QUESTRAN LIGHT

NDA NDA019669

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for Cholestyramine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Questran drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Cholestyramine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Cholestyramine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA019669). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Karuna Therapeutics, Inc., a Bristol Myers Squibb company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

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