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.
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 |
|---|---|---|---|---|---|
2025/02/05 | Phase 1 | Completed | |||
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| BROZIL CAPSULES 300MG | N/A | 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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| DOM-GEMFIBROZIL | dominion pharmacal | 02241608 | Capsule - Oral | 300 MG | 3/10/2000 |
| DOM-GEMFIBROZIL | dominion pharmacal | 02230580 | Tablet - Oral | 600 MG | 10/22/1998 |
| PHL-GEMFIBROZIL | pharmel inc | 02254859 | Capsule - Oral | 300 MG | 8/4/2004 |
| GEMFIBROZIL CAP 300MG | omni laboratories division, warner-lambert canada inc. | 00851922 | Capsule - Oral | 300 MG / CAP | 12/31/1990 |
| GEMFIBROZIL TAB 600MG | omni laboratories division, warner-lambert canada inc. | 00851930 | Tablet - Oral | 600 MG | 12/31/1991 |
| APO-GEMFIBROZIL CAP 300MG USP | 01979574 | Capsule - Oral | 300 MG | 12/31/1993 | |
| PMS-GEMFIBROZIL | 02239951 | Capsule - Oral | 300 MG | 5/4/1999 | |
| PHL-GEMFIBROZIL | pharmel inc | 02254867 | Tablet - Oral | 600 MG | 8/4/2004 |
| LOPID CAP 300MG | 00599026 | Capsule - Oral | 300 MG | 12/31/1984 | |
| GEMFIBROZIL-600 - TAB 600MG | PRO DOC LIMITEE | 02136058 | Tablet - Oral | 600 MG | 12/31/1995 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| LOPID 600 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Pfizer S.L. | 58832 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| TRIALMIN 900 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Laboratorios Menarini S.A. | 61051 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| GEMFIBROZILO STADA 600 mg COMPRIMIDOS EFG | Laboratorio Stada S.L. | 61830 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| GEMFIBROZILO STADA 900 mg COMPRIMIDOS EFG | Laboratorio Stada S.L. | 61831 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| TRIALMIN 600 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Laboratorios Menarini S.A. | 58839 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| GEMFIBROZILO TARBIS 600 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tarbis Farma S.L. | 62503 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| LOPID 900 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Pfizer S.L. | 61026 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| GEMFIBROZILO TARBIS 900 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tarbis Farma S.L. | 64264 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| GEMFIBROZILO ARISTO 600 mg COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Aristo Pharma Iberia S.L. | 63763 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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