MedPath

Colesevelam

Generic Name
Colesevelam
Brand Names
Cholestagel, Lodalis, Welchol
Drug Type
Small Molecule
CAS Number
182815-43-6
Unique Ingredient Identifier
1XU104G55N

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
2025/04/13
Early Phase 1
Recruiting
2024/01/09
Phase 1
Not yet recruiting
2022/02/23
Phase 2
Active, not recruiting
2019/05/20
Phase 4
Completed
Filip Krag Knop
2019/03/15
Phase 4
Completed
Lars Kristian Munck
2019/02/27
Phase 1
Completed
2018/12/06
Phase 2
Completed
2018/06/19
Phase 3
Terminated
2018/06/19
Phase 3
Completed
2017/09/01
Phase 2
Completed

FDA Drug Approvals

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