In short
Gemfibrozil is a lipid-regulating agent, a type of medicine that changes the levels of fats in the blood. It is an authorised medicine, sold in some countries as Gemfibrozilo STADA 600 mg film-coated tablets. One completed Phase 1 trial in 73 healthy male volunteers studied how gemfibrozil affects the way the body handles another medicine, leriglitazone, which is being developed for adrenoleukodystrophy.
Key points
- Gemfibrozil is a lipid-regulating agent that lowers triglycerides and raises HDL cholesterol.
- It is an authorised medicine, available as a 600 mg film-coated tablet for oral use.
- In the registered trial, gemfibrozil was used as an auxiliary medicine, not as the treatment being tested.
- The trial was a Phase 1 study in 73 male healthy subjects and is now completed.
- The study measured drug-drug interactions between gemfibrozil and oral leriglitazone.
- The condition being studied in the wider research programme is adrenoleukodystrophy.
What is gemfibrozil?
Gemfibrozil is a lipid-regulating agent, a medicine that changes the levels of fats (lipids) in the blood. Its full chemical name is 5-(2,5-dimethylphenoxy)2,2-dimethylpentanoic acid, and it is a chemically synthesised substance. Gemfibrozil is an authorised medicine: in Spain it is available as Gemfibrozilo STADA 600 mg film-coated tablets, supplied by Laboratorio STADA, S.L. It is classified under the ATC code C10AB04.
How does gemfibrozil work?
Gemfibrozil decreases serum triglycerides and very low density lipoprotein (VLDL) cholesterol, and increases high density lipoprotein (HDL) cholesterol. It may also produce modest decreases in total and low density lipoprotein (LDL) cholesterol. In the registered trial, gemfibrozil was not being tested for its own lipid-lowering effect but was used as an auxiliary medicine to see how it changes the way the body processes another medicine, leriglitazone.
Which conditions is it used or studied for?
- High blood fats (hyperlipidaemia) — gemfibrozil is used as a lipid-regulating agent to lower triglycerides and VLDL cholesterol and raise HDL cholesterol.
- Adrenoleukodystrophy — in the registered trial, gemfibrozil was used in healthy volunteers as part of research into leriglitazone, a medicine being developed for this condition.
How is gemfibrozil given?
Gemfibrozil is given by mouth as a film-coated tablet. Each tablet contains 600 mg of gemfibrozil. In the registered trial, the product used was Gemfibrozilo STADA 600 mg film-coated tablets for oral use.
What do the clinical trials show?
One completed Phase 1 trial, registered as 2025-521508-23-00, enrolled 73 male healthy subjects. The trial was open-label and single-centre. Its purpose was to evaluate drug-drug interactions: how gemfibrozil, itraconazole and carbamazepine each affect the single-dose pharmacokinetics (how the body absorbs, distributes and removes a medicine) of oral leriglitazone. Gemfibrozil was used in Part A of the study as a precipitant, meaning a medicine that may change how another medicine behaves in the body. The primary endpoints were the maximum concentration of leriglitazone in the blood (Cmax) and the total exposure over time (AUC). The trial also measured the effect of a high-fat breakfast on leriglitazone.
What side effects are known?
The sources provided do not include a list of side effects for gemfibrozil, so this section is not included.