Product Description
Gemfibrozil is used with diet changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol and triglycerides (other fatty substances) in the blood in certain people with very high triglycerides who are at risk of pancreatic disease (conditions affecting the pancreas, a gland that produces fluid to break down food and hormones to control blood sugar). Gemfibrozil is also used in people with a combination of low high-density lipoprotein (HDL; 'good cholesterol') levels and high low-density lipoprotein (LDL; 'bad cholesterol') and triglyceride levels to reduce the risk of heart disease. Gemfibrozil is in a class of lipid-regulating medications called fibrates. It works by reducing the production of triglycerides in the liver. (Sourced from: https://medlineplus.gov/druginfo/meds/a686002.html)
Mechanisms of Action: PPAR-a Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Brazil | Canada | Chile | Colombia | Cyprus | Denmark | Dominican Republic | Ecuador | Egypt | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Italy | Jordan | Korea | Lebanon | Malaysia | Mexico | Netherlands | New Zealand | Pakistan | Peru | Philippines | Portugal | Saudi Arabia | Singapore | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Turkey | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: GlaxoSmithKline
Company Location: BRENTFORD MIDDLESEX X0 TW8 9GS
Company CEO: Emma Walmsley
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, United States
Active Clinical Trial Count: 5
Highest Development Phases
Phase 3: Neuronal Ceroid-Lipofuscinosis
Phase 2: Parkinson's Disease
Phase 1: Healthy Volunteers|Idiopathic Pulmonary Fibrosis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| PLX-200-002 | P3 |
Not yet recruiting |
Neuronal Ceroid-Lipofuscinosis |
2025-12-31 |
95% |
| FHL-301-001 | P2 |
Not yet recruiting |
Parkinson's Disease |
2024-12-01 |
|
| IM027-1007 | P1 |
Completed |
Idiopathic Pulmonary Fibrosis |
2023-10-23 |
53% |
| BUS-P1-12 | P1 |
Completed |
Healthy Volunteers |
2023-10-13 |
|
| BUS-P1-12 | P1 |
Completed |
Healthy Volunteers |
2023-10-13 |