Colesevelam

Overview

Colesevelam is a bile acid sequestrant. Colesevelam is used with exercise and diet changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol and certain fatty substances in the blood. It works by binding bile acids in the intestine. Bile acids are made when cholesterol is broken down in the body. Removing these bile acids helps to lower blood cholesterol.

Indication

用于以胆固醇升高为主的高脂血症，当饮食和锻炼不能良好达到效果者，可单独使用或与他汀类合用。

Associated Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)
Hyperlipidemias
Type 2 Diabetes Mellitus
Primary Hyperlipidemia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery	2025/04/13	NCT06925997	Early Phase 1	Recruiting	Hvidovre University Hospital
Impact of Therapy Using Colesevelam Treatment Reducing Bile Acids in Patients With Fontan Circulation.	2024/01/09	NCT06197763	Phase 1	Not yet recruiting	St. Boniface Hospital
Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib	2022/02/23	NCT05252988	Phase 2	Active, not recruiting	Spanish Breast Cancer Research Group
Treatment of Bile Acid Malabsorption With Liraglutide	2019/05/20	NCT03955575	Phase 4	Completed	Filip Krag Knop
Effect of the Sequestrant Colesevelam in Bile Acid Diarrhoea	2019/03/15	NCT03876717	Phase 4	Completed	Lars Kristian Munck
Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers	2019/02/27	NCT03856970	Phase 1	Completed	Ironwood Pharmaceuticals, Inc.
A Study of Colesevelam for Lenalidomide-Associated Diarrhea	2018/12/06	NCT03767257	Phase 2	Completed	Memorial Sloan Kettering Cancer Center
Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)	2018/06/19	NCT03561883	Phase 3	Completed	Ironwood Pharmaceuticals, Inc.
A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)	2018/06/19	NCT03561090	Phase 3	Terminated	Ironwood Pharmaceuticals, Inc.
Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption	2017/09/01	NCT03270085	Phase 2	Completed	Mayo Clinic

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
COLESEVELAM HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	0713-0935	ORAL	3.75 g in 1 1	9/12/2022
Colesevelam Hydrochloride	Dr.Reddys Laboratories Inc	43598-230	ORAL	625 mg in 1 1	6/30/2023
Colesevelam Hydrochloride	American Health Packaging	60687-385	ORAL	625 mg in 1 1	12/12/2023
Welchol	Rebel Distributors Corp	21695-779	ORAL	3.75 g in 1 1	10/6/2009
Colesevelam Hydrochloride	Amneal Pharmaceuticals of New York LLC	0115-1320	ORAL	625 mg in 1 1	12/30/2023
Welchol	Daiichi Sankyo Inc.	65597-902	ORAL	3.75 g in 1 1	10/26/2021
Welchol	Daiichi Sankyo Inc.	65597-209	ORAL	3.75 g in 1 1	10/26/2021
Welchol	Rebel Distributors Corp	21695-781	ORAL	625 mg in 1 1	10/6/2009
COLESEVELAM HYDROCHLORIDE	A-S Medication Solutions	50090-6994	ORAL	625 mg in 1 1	9/12/2022
Welchol	Daiichi Sankyo Inc.	65597-701	ORAL	625 mg in 1 1	10/26/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
LODALIS	bausch health, canada inc.	02373955	Tablet - Oral	625 MG	2/6/2012
LODALIS	bausch health, canada inc.	02432463	Powder For Suspension - Oral	3.75 G / SACHET	4/2/2015
APO-COLESEVELAM	Apotex Inc	02494051	Tablet - Oral	625 MG	7/23/2020

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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