Gemfibrozil

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
A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081	2025/02/05	NCT06809608	Phase 1	Completed	Hoffmann-La Roche
A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults	2024/04/30	NCT06392659	Phase 1	Completed	Vertex Pharmaceuticals Incorporated
Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects	2023/10/03	NCT06064539	Phase 1	Completed	Sanofi
Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant	2023/07/25	NCT05959447	Phase 1	Completed	Bellus Health Inc. - a GSK company
A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants	2023/07/06	NCT05932303	Phase 1	Completed	Bristol-Myers Squibb
Study to Evaluate the Safety, Tolerability, Efficacy, and PK of FHL-301 in Parkinson's Disease Patients.	2023/07/05	NCT05931484	Phase 2	Not yet recruiting	Forest Hills Lab
A Study to Investigate the Drug-drug Interactions (DDIs) of SKLB1028 With Itraconazole, Gemfibrozil or Rifampicin in Healthy Subjects	2021/10/06	NCT05069870	Phase 1	UNKNOWN	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants	2021/07/09	NCT04956627	Phase 1	Completed	Bristol-Myers Squibb
Safety, Tolerability, and Efficacy of PLX-200 in Patients With CLN3	2020/11/19	NCT04637282	Phase 3	Not yet recruiting	Polaryx Therapeutics, Inc.
A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone	2019/07/05	NCT04008186	Phase 1	Completed	Biogen

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Gemfibrozil	Aidarex Pharmaceuticals LLC	33261-146	ORAL	600 mg in 1 1	1/3/2014
GEMFIBROZIL	PD-Rx Pharmaceuticals, Inc.	43063-921	ORAL	600 mg in 1 1	5/1/2023
Gemfibrozil	Contract Pharmacy Services-PA	67046-233	ORAL	600 mg in 1 1	9/20/2017
Gemfibrozil	NuCare Pharmaceuticals, Inc.	66267-436	ORAL	600 mg in 1 1	1/11/2021
GEMFIBROZIL	Camber Pharmaceuticals, Inc.	31722-128	ORAL	600 mg in 1 1	8/26/2021
Gemfibrozil	Blenheim Pharmacal, Inc.	10544-569	ORAL	600 mg in 1 1	2/24/2015
Gemfibrozil	NuCare Pharmaceuticals,Inc.	68071-2422	ORAL	600 mg in 1 1	5/27/2021
Gemfibrozil	REMEDYREPACK INC.	70518-1563	ORAL	600 mg in 1 1	2/21/2024
Gemfibrozil	RPK Pharmaceuticals, Inc.	53002-2068	ORAL	600 mg in 1 1	1/19/2021
Gemfibrozil	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	MEDOCHEMIE LTD - Factory AZ	SIN04902P	CAPSULE	300 mg	7/4/1990
BROZIL CAPSULE 300 mg	Y S P INDUSTRIES (M) SDN BHD	SIN08467P	CAPSULE	300 mg	12/9/1995
LIPISTOROL CAPSULE 300 mg	HOVID BHD	SIN09167P	CAPSULE	300 mg	1/25/1997
GEMFIBROZIL CAPSULE 300 mg	PT INDOFARMA	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	PT. YUNG SHIN PHARMACEUTICAL INDONESIA	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	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	12/16/1997
PHARMACOR GEMFIBROZIL 600 gemfibrozil 600mg tablet bottle	130604	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/4/2007
LIPIGEM gemfibrozil 600mg tablet bottle	61430	Alphapharm Pty Ltd	Medicine	A	9/19/1997
GEMFITRIL gemfibrozil 600mg tablet bottle	147593	Strides Pharma Science Pty Ltd	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	Apotex Inc	01979574	Capsule - Oral	300 MG	12/31/1993
PMS-GEMFIBROZIL	Pharmascience Inc	02239951	Capsule - Oral	300 MG	5/4/1999
PHL-GEMFIBROZIL	pharmel inc	02254867	Tablet - Oral	600 MG	8/4/2004
LOPID CAP 300MG	Pfizer Canada Ulc	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
No CIMA AEMPS (Spain) approvals found for this drug.

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.

AI-Powered Research

Premium Access