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.
Background
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
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/11/02 | Phase 4 | Completed | |||
2016/08/23 | Phase 4 | Completed | |||
2016/02/15 | Phase 4 | Completed | |||
2015/12/22 | Phase 2 | Completed | |||
2015/12/11 | Phase 3 | Completed | |||
2015/12/02 | Phase 2 | Terminated | |||
2014/04/11 | Phase 4 | Completed | |||
2014/01/30 | Phase 4 | Completed | University Hospital, Gentofte, Copenhagen | ||
2014/01/09 | Phase 2 | Completed | |||
2013/09/23 | Not Applicable | UNKNOWN |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Daiichi Sankyo Inc. | 65597-903 | ORAL | 1.875 g in 1 1 | 10/26/2021 | |
| Bryant Ranch Prepack | 63629-8767 | ORAL | 625 mg in 1 1 | 11/26/2021 | |
| A-S Medication Solutions | 50090-4371 | ORAL | 625 mg in 1 1 | 11/26/2021 | |
| A-S Medication Solutions | 50090-6995 | ORAL | 625 mg in 1 1 | 9/12/2022 | |
| Bionpharma Inc. | 69452-158 | ORAL | 625 mg in 1 1 | 2/14/2023 | |
| Bryant Ranch Prepack | 72162-1847 | ORAL | 3.75 g in 1 1 | 3/12/2024 | |
| Bryant Ranch Prepack | 63629-8860 | ORAL | 3.75 g in 1 1 | 12/13/2022 | |
| Tris Pharma Inc | 27808-190 | ORAL | 625 mg in 1 1 | 6/30/2022 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1864 | ORAL | 3.75 g in 1 1 | 10/18/2022 | |
| Cosette Pharmaceuticals, Inc. | 0713-0879 | ORAL | 625 mg in 1 1 | 9/7/2022 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||