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Lopid (GEMFIBROZIL)
GEMFIBROZIL (Lopid), marketed by Pfizer, is a well-established treatment for hypertriglyceridemia, facing competition from off-patent generics like clofibrate and choline fenofibrate, as well as the patent-protected fenofibrate. Its key strength lies in its mechanism of action through the activation of peroxisome proliferator receptor alpha, effectively reducing triglyceride levels. The primary risk is the key composition patent expiry in 2028, which could lead to increased generic competition and revenue erosion.
At a glance
| Generic name | GEMFIBROZIL |
|---|---|
| Sponsor | Pfizer |
| Drug class | Peroxisome Proliferator Receptor alpha Agonist [EPC] |
| Target | Transthyretin |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1981 |
Approved indications
- Hypertriglyceridemia
- Primary Prevention of Coronary Heart Disease
Common side effects
- Gastrointestinal reactions
- Dyspepsia
- Abdominal pain
- Diarrhea
- Fatigue
- Nausea/Vomiting
- Eczema
- Rash
- Vertigo
- Constipation
- Headache
- Atrial fibrillation
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
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lopid CI brief — competitive landscape report
- Lopid updates RSS · CI watch RSS
- Pfizer portfolio CI