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 | Completed | |||
2018/06/19 | Phase 3 | Terminated | |||
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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