Overview
Antilipemic agent that lowers cholesterol and triglycerides. It decreases low density lipoproteins and increases high density lipoproteins.
Background
Antilipemic agent that lowers cholesterol and triglycerides. It decreases low density lipoproteins and increases high density lipoproteins.
Indication
For the treatment of primary hyperlipidaemia types IIa, IIb, III, IV and V (Fredrickson classification) corresponding to groups I, II and III of the European Atherosclerosis Society guidelines - when diet alone or improvements in lifestyle such as increased exercise or weight reduction do not lead to an adequate response. Also for the treatment of secondary hyperlipidaemias, e.g. severe hypertriglyceridemias, when sufficient improvement does not occur after correction of the underlying disorder (e.g. diabetes mellitus).
Associated Conditions
- Fredrickson classification type IV Hyperlipidemia
- Fredrickson classification type V Hyperlipidemia
- Primary Hypercholesterolemia
- Type IIb hyperlipoproteinaemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/05 | N/A | Recruiting | |||
2024/06/05 | Phase 3 | Not yet recruiting | |||
2022/02/15 | Phase 2 | Active, not recruiting | Intercept Pharmaceuticals | ||
2021/02/12 | Phase 3 | UNKNOWN | |||
2020/10/20 | Phase 2 | Active, not recruiting | Intercept Pharmaceuticals | ||
2020/03/16 | Phase 3 | Recruiting | |||
2018/08/28 | Not Applicable | Completed | Ciprés Grupo Médico CGM SC | ||
2016/12/07 | Phase 4 | Completed | |||
2016/10/18 | Phase 3 | UNKNOWN | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | ||
2016/03/08 | Phase 3 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| ZAFIBRAL TABLET 200 mg | SIN10217P | TABLET, FILM COATED | 200 mg | 10/8/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bezafibrate Dispersible Tablets | 国药准字H20070265 | 化学药品 | 片剂 | 2/16/2022 | |
| Bezafibrate Sustained-release Tablets | 国药准字H20213796 | 化学药品 | 片剂 | 10/19/2021 | |
| Bezafibrate Tablets | 国药准字H20093503 | 化学药品 | 片剂 | 3/1/2024 | |
| Bezafibrate Tablets | 国药准字H20010013 | 化学药品 | 片剂 | 6/23/2020 | |
| Bezafibrate Tablets | 国药准字H20010461 | 化学药品 | 片剂 | 8/31/2020 | |
| Bezafibrate Tablets | 国药准字H20094084 | 化学药品 | 片剂 | 11/5/2019 | |
| Bezafibrate Tablets | 国药准字H20103776 | 化学药品 | 片剂 | 11/15/2020 | |
| Bezafibrate Capsules | 国药准字H20080729 | 化学药品 | 胶囊剂 | 4/17/2023 |
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. | |||||