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
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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
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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 |
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| No EMA approvals found for this drug. | |||
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| No UK EMC drug information found for this drug. | |||||
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