Overview
Cholestyramine or colestyramine is a bile acid sequestrant. Bile acid sequestrants are polymeric compounds which serve as ion exchange resins. Cholestyramine resin is quite hydrophilic, but insoluble in water.
Background
Cholestyramine or colestyramine is a bile acid sequestrant. Bile acid sequestrants are polymeric compounds which serve as ion exchange resins. Cholestyramine resin is quite hydrophilic, but insoluble in water.
Indication
Indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Also for the relief of pruritus associated with partial biliary obstruction.
Associated Conditions
- Atherosclerosis
- Primary Hypercholesterolemia
- Pruritus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/27 | Early Phase 1 | Recruiting | |||
2024/11/20 | Phase 4 | Active, not recruiting | |||
2024/11/15 | Not Applicable | Active, not recruiting | Aydin Adnan Menderes University | ||
2024/06/12 | Phase 1 | Recruiting | City of Hope Medical Center | ||
2023/11/21 | Phase 3 | Recruiting | |||
2023/11/18 | Phase 4 | Not yet recruiting | |||
2023/09/25 | Phase 4 | Not yet recruiting | |||
2023/08/01 | Not Applicable | Recruiting | |||
2023/06/08 | Phase 1 | Completed | |||
2022/10/13 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ajanta Pharma USA Inc. | 27241-134 | ORAL | 4 g in 9 g | 11/23/2021 | |
| Par Pharmaceutical, Inc. | 49884-936 | ORAL | 4 g in 9 g | 9/17/2018 | |
| Zydus Lifesciences Limited | 70771-1105 | ORAL | 4 g in 9 g | 1/9/2024 | |
| EPIC PHARMA, LLC | 42806-271 | ORAL | 4 g in 5.7 g | 11/8/2023 | |
| Ascend Laboratories, LLC | 67877-422 | ORAL | 4 g in 5.718 g | 10/20/2021 | |
| EPIC PHARMA, LLC | 42806-266 | ORAL | 4 g in 9 g | 12/27/2023 | |
| EPIC PHARMA, LLC | 42806-269 | ORAL | 4 g in 5.7 g | 12/15/2021 | |
| Bryant Ranch Prepack | 72162-1834 | ORAL | 4 g in 8.780 g | 3/8/2024 | |
| Chartwell RX, LLC | 62135-937 | ORAL | 4 g in 5.7 g | 1/9/2023 | |
| Bryant Ranch Prepack | 63629-2162 | ORAL | 4 g in 5 g | 7/26/2022 |
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 |
|---|---|---|---|---|---|
| PMS-CHOLESTYRAMINE POWDER | SIN07426P | POWDER | 4.00 g | 5/12/1993 | |
| RESINCOLESTIRAMINA POWDER | SIN06583P | POWDER | 4 g/sachet | 9/27/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cholestyramine Powder | 国药准字H10940130 | 化学药品 | 散剂 | 6/30/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| RESINCOLESTIRAMINA COLESTYRAMINE POWDER FOR ORAL SUSPENSION 4G | N/A | hong kong medical supplies ltd | N/A | N/A | 5/25/2017 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| QUESTRAN LITE 4G powder sachet | 11971 | Medicine | A | 8/13/1991 |