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Lopid (Gemfibrozil)
Gemfibrozil is a lipid regulating agent indicated for treatment of very high serum triglyceride elevations (Types IV and V hyperlipidemia) at risk of pancreatitis and for reducing coronary heart disease risk in Type IIb patients with inadequate response to other therapies. The drug decreases triglycerides and VLDL cholesterol while increasing HDL cholesterol, with the Helsinki Heart Study demonstrating a 34% relative reduction in serious coronary events over five years. Contraindications include hepatic/severe renal dysfunction, gallbladder disease, and concurrent use with simvastatin, repaglinide, dasabuvir, and selexipag. Potential toxicity concerns including malignancy, gallbladder disease, and increased non-coronary mortality observed with related drug clofibrate warrant careful patient selection and monitoring.
At a glance
| Generic name | Gemfibrozil |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Peroxisome Proliferator Receptor alpha Agonist [EPC] |
| Target | PPAR-alpha (Peroxisome Proliferator-Activated Receptor Alpha) |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
Approved indications
- Treatment of adult patients with Type IV hyperlipidemia with very high serum triglyceride elevations (>2,000 mg/dL) presenting risk of pancreatitis unresponsive to diet
- Treatment of adult patients with Type V hyperlipidemia with very high serum triglyceride elevations (>2,000 mg/dL) presenting risk of pancreatitis unresponsive to diet
- Treatment of adult patients with triglyceride elevations between 1,000-2,000 mg/dL and history of pancreatitis or recurrent abdominal pain typical of pancreatitis
- Reducing risk of developing coronary heart disease in Type IIb patients without history or symptoms of existing coronary heart disease with low HDL-cholesterol, elevated LDL-cholesterol, and elevated triglycerides unresponsive to weight loss, diet, exercise, and other pharmacologic agents
Common side effects
- Constipation
- Palpitations
- Abdominal pain upper
- Thyroxine free decreased
- Dysgeusia
- Headache
- Affect lability
- Abdominal pain
- Aphthous ulcer
- Faeces soft
- Flatulence
- Gastrointestinal sounds abnormal
Drug interactions
- CYP2C19 Substrates
- CYP2C8 Substrates
- CYP2C9 Substrates
- lovastatin
- pioglitazone
- pravastatin
- repaglinide
- simvastatin
- warfarin
Key clinical trials
- Study to Evaluate the Safety, Tolerability, Efficacy, and PK of FHL-301 in Parkinson's Disease Patients. (PHASE2)
- Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects (PHASE1)
- A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081 (PHASE1)
- A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone (PHASE1)
- Safety, Tolerability, and Efficacy of PLX-200 in Patients With CLN3 (PHASE3)
- Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant (PHASE1)
- A Clinical Study to Investigate the Effect of Gemfibrozil or Rifampicin on Blood Concentrations of Selexipag in Healthy Subjects (PHASE1)
- A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults (PHASE1)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |