Overview
Gemfibrozil is a fibric acid agent, similar to clofibrate, used to treat Type IIb, IV, and V hyperlipidemias. Gemfibrozil is not a first line treatment and is prescribed to patients who have not responded adequately to weight loss, diet, exercise, and other medications. Gemfibrozil was granted FDA approval on 21 December 1981.
Background
Gemfibrozil is a fibric acid agent, similar to clofibrate, used to treat Type IIb, IV, and V hyperlipidemias. Gemfibrozil is not a first line treatment and is prescribed to patients who have not responded adequately to weight loss, diet, exercise, and other medications. Gemfibrozil was granted FDA approval on 21 December 1981.
Indication
Gemfibrozil is indicated to treat patients with Types IV and V hyperlipidemia who have elevated serum triglycerides (usually above 2000mg/dL), elevated VLDL cholesterol, fasting chylomicrons, are at risk of developing pancreatitis, and do not adequately respond to dietary restrictions. Gemfibrozil is also indicated to reduce the risk of developing coronary heart disease in patients with Type IIb hyperlipidemia without history or symptoms of coronary heart disease; who do not adequately respond to weight loss, diet, exercise, and other medications; and have low HDL, raised LDL, and raised triglycerides.
Associated Conditions
- Coronary Heart Disease (CHD)
- Fredrickson classification type IV Hyperlipidemia
- Fredrickson classification type V Hyperlipidemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/25 | Phase 1 | Active, not recruiting | |||
2024/04/30 | Phase 1 | Completed | |||
2023/10/03 | Phase 1 | Completed | |||
2023/07/25 | Phase 1 | Completed | Bellus Health Inc. - a GSK company | ||
2023/07/06 | Phase 1 | Completed | |||
2023/07/05 | Phase 2 | Not yet recruiting | Forest Hills Lab | ||
2021/10/06 | Phase 1 | UNKNOWN | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||
2021/07/09 | Phase 1 | Completed | |||
2020/11/19 | Phase 3 | Not yet recruiting | |||
2019/07/05 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aidarex Pharmaceuticals LLC | 33261-146 | ORAL | 600 mg in 1 1 | 1/3/2014 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-921 | ORAL | 600 mg in 1 1 | 5/1/2023 | |
| Contract Pharmacy Services-PA | 67046-233 | ORAL | 600 mg in 1 1 | 9/20/2017 | |
| NuCare Pharmaceuticals, Inc. | 66267-436 | ORAL | 600 mg in 1 1 | 1/11/2021 | |
| Camber Pharmaceuticals, Inc. | 31722-128 | ORAL | 600 mg in 1 1 | 8/26/2021 | |
| Blenheim Pharmacal, Inc. | 10544-569 | ORAL | 600 mg in 1 1 | 2/24/2015 | |
| NuCare Pharmaceuticals,Inc. | 68071-2422 | ORAL | 600 mg in 1 1 | 5/27/2021 | |
| REMEDYREPACK INC. | 70518-1563 | ORAL | 600 mg in 1 1 | 2/21/2024 | |
| RPK Pharmaceuticals, Inc. | 53002-2068 | ORAL | 600 mg in 1 1 | 1/19/2021 | |
| Aidarex Pharmaceuticals LLC | 53217-251 | ORAL | 600 mg in 1 1 | 12/6/2016 |
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 |
|---|---|---|---|---|---|
| IPOLIPID CAPSULE 300 mg | SIN04902P | CAPSULE | 300 mg | 7/4/1990 | |
| BROZIL CAPSULE 300 mg | SIN08467P | CAPSULE | 300 mg | 12/9/1995 | |
| LIPISTOROL CAPSULE 300 mg | SIN09167P | CAPSULE | 300 mg | 1/25/1997 | |
| GEMFIBROZIL CAPSULE 300 mg | SIN09798P | CAPSULE | 300 mg | 6/4/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Gemfibrozil Tablets | 国药准字H10970143 | 化学药品 | 片剂 | 10/22/2022 | |
| Gemfibrozil Capsules | 国药准字H19999165 | 化学药品 | 胶囊剂 | 10/26/2020 | |
| Gemfibrozil Capsules | 国药准字H20003044 | 化学药品 | 胶囊剂 | 6/25/2020 | |
| Gemfibrozil Capsules | 国药准字H20093140 | 化学药品 | 胶囊剂 | 4/20/2023 | |
| Gemfibrozil Capsules | 国药准字H20066192 | 化学药品 | 胶囊剂 | 3/1/2021 | |
| Gemfibrozil Capsules | 国药准字H19994095 | 化学药品 | 胶囊剂 | 8/13/2020 | |
| Gemfibrozil Capsules | 国药准字H20033518 | 化学药品 | 胶囊剂 | 4/18/2024 | |
| Gemfibrozil Capsules | 国药准字H20055225 | 化学药品 | 胶囊剂 | 6/15/2021 | |
| Gemfibrozil Capsules | 国药准字H44020877 | 化学药品 | 胶囊剂 | 1/16/2020 | |
| Gemfibrozil Capsules | 国药准字H37022279 | 化学药品 | 胶囊剂 | 9/10/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| BROZIL CAPSULES 300MG | N/A | yung shin co ltd | N/A | N/A | 12/9/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| AUSGEM Gemfibrozil 600mg tablet bottle | 62099 | Medicine | A | 12/16/1997 | |
| PHARMACOR GEMFIBROZIL 600 gemfibrozil 600mg tablet bottle | 130604 | Medicine | A | 9/4/2007 | |
| LIPIGEM gemfibrozil 600mg tablet bottle | 61430 | Medicine | A | 9/19/1997 | |
| GEMFITRIL gemfibrozil 600mg tablet bottle | 147593 | Medicine | A | 4/23/2008 |