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Welchol

(Colesevelam)

ApprovedSmall molecule

CCosette Pharmaceuticals, Inc.

Colesevelam is used to lower cholesterol levels in the blood and to help control blood sugar in people with diabetes. It works by binding to cholesterol in the digestive system so your body removes it instead of absorbing it.[2] Welchol is currently approved and in use across 9 indications[4].[1]

Welchol is one of 190 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

9

Indications

26

Total Trials

4

Active Trials

189

Competitors

4

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Type 2 Diabetes MellitusActive, not recruiting

Fecal IncontinenceActive, not recruiting

Breast CancerActive, not recruiting

Multiple MyelomaActive, not recruiting

Type 2 DiabetesActive, not recruiting

Irritable Bowel SyndromeActive, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Type 2 Diabetes MellitusPhase 3

Active, not recruiting

Fecal IncontinencePhase 3

Active, not recruiting

Breast CancerPhase 2

Active, not recruiting

Multiple MyelomaPhase 2

Active, not recruiting

Type 2 DiabetesPhase 2

Active, not recruiting

Irritable Bowel SyndromePhase 2

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Welchol

CCosette Pharmaceuticals, Inc.

Trodelvy

Tykerb

Adriamycin

GGynecologic Oncology Group

Avastin

BBio-Thera Solutions

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Prolia

Gemzar

GGynecologic Oncology Group

Lexiscan

Adenocard

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

Timeline

Expected Milestones

Q4 2028

Phase 1Recruiting

Gastric Bypass Surgery

NCT06925997

Phase 1/2Recruiting

Gastrointestinal

NCT07226440

Q1 2030

Phase 2Active, not recruiting

Breast Cancer

NCT05252988

Clinical

Trials by Indication[1]

Treatment2 trials

Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy

Completed·RRadiant Research·Phase 4·NCT01239004·140 enrolled

Impact of Therapy Using Colesevelam Treatment Reducing Bile Acids in Patients With Fontan Circulation.

Not yet recruiting·—·Phase 1/2·NCT06197763·50 enrolled

Gastric2 trials

Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass

Completed·HHvidovre University Hospital·Phase 4·NCT02952963·8 enrolled

Effects of Bile Acids and Bile Acid Sequestrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass

Completed·HHvidovre University Hospital·Phase 4·NCT02876484·12 enrolled

Bile Acid Malabsorption2 trials

Treatment of Bile Acid Malabsorption With Liraglutide

Completed·FFilip Krag Knop·Phase 4·NCT03955575·52 enrolled

Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease

Terminated·FFlorian Beigel·Phase 4·NCT01203254·34 enrolled

GLP-12 trials

The Impact of Gall Bladder Emptying and Bile Acids on the Human GLP-1-secretion

Completed·FFilip Krag Knop·N/A·NCT01656057·10 enrolled

Effect of Bile Acids on GLP-1 Secretion

Completed·UUniversity Hospital, Gentofte, Copenhagen·N/A·NCT01666223·20 enrolled

Type 2 Diabetes Mellitus2 trials

Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT00789750·562 enrolled

Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT00570739·502 enrolled

16 more indications

Diarrhea1 trial

Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption

Completed·MMayo Clinic·Phase 2·NCT03270085·30 enrolled

Fecal Incontinence1 trial

A Study of Colesevelam in Fecal Incontinence

Completed·MMayo Clinic·Phase 3·NCT02628626·88 enrolled

Randomized1 trial

Randomized Trial Comparing Colesevelam vs. Ezetimibe

Completed·LLMC Diabetes & Endocrinology Ltd.·Phase 4·NCT02682680·200 enrolled

Insulin Sensitivity1 trial

Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)

Completed·SSeattle Institute for Biomedical and Clinical Research·Phase 3·NCT00990184·21 enrolled

Magnetic Resonance Imaging1 trial

Evaluate Carotid Artery Plaque Composition by Magnetic Resonance Imaging in People Receiving Cholesterol Medication

Completed·UUniversity of Washington·Phase 4·NCT00715273·217 enrolled

Metformin1 trial

The Role of Metformin and Colesevelam in Human GLP-1 Secretion

Completed·UUniversity Hospital, Gentofte, Copenhagen·Phase 4·NCT02050074·12 enrolled

Pruritus1 trial

Colesevelam Versus Placebo in Cholestatic Pruritus

Completed·FFoundation for Liver Research·Phase 2/3·NCT00756171·38 enrolled

LAM1 trial

Effects of Fish Oil and Colesevelam (STAIR7007)

Unknown status·UUniversity of Manitoba·N/A·NCT01948648·13 enrolled

Multiple Myeloma1 trial

Manage Diarrhea in Patients With Multiple Myeloma While Receiving Conditioning Chemotherapy for Autologous SCT

Terminated·MMayo Clinic·Phase 2·NCT02619812·4 enrolled

Gastric Bypass Surgery1 trial

Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery

Recruiting·HHvidovre University Hospital·Phase 1·NCT06925997·18 enrolled

Gastrointestinal1 trial

Examining a Novel Gastrointestinal Intervention to Negate Environmental Toxicants (ENGINE)

Recruiting·UUniversity of California, San Francisco·Phase 1/2·NCT07226440·40 enrolled

Metabolism1 trial

The Effect of Welchol on Glucose Metabolism in Type 2 Diabetics

Completed·MMayo Clinic·Phase 4·NCT00951899·38 enrolled

Breast Cancer1 trial

Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib

Active, not recruiting·SSpanish Breast Cancer Research Group·Phase 2·NCT05252988·177 enrolled

Irritable Bowel Syndrome1 trial

Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)?

Completed·MMayo Clinic·Phase 2·NCT00911612·24 enrolled

Type 2 Diabetes1 trial

Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 2·NCT00147745·36 enrolled

Unspecified1 trial

Ability of Mayo Clinic High-performance Liquid Chromatography (HPLC) Method to Measure Fecal Bile Acids

Completed·MMayo Clinic·Phase 4·NCT02111603·13 enrolled

Regulatory

FDA Approval Timeline[5]

May 26, 2000

WELCHOL

NDA NDA021141

May 26, 2000

WELCHOL

NDA NDA021176

Oct 2, 2009

WELCHOL

NDA NDA022362

Apr 3, 2019

WELCHOL

NDA NDA210895

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Colesevelam. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Welchol drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Colesevelam compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Colesevelam. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210895). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Cosette Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CCosette Pharmaceuticals, Inc.

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