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: *
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: GSK
Company Location: Europe
Company Founding Year: 2000
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, China, Poland
Active Clinical Trial Count: 6
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Polaryx Therapeutics presented P0 Leukodystrophy, Globoid Cell results on 2026-02-06 for Gemfibrozil
Highest Development Phases
Phase 3: Neuronal Ceroid-Lipofuscinosis
Phase 2: Parkinson's Disease
Phase 1: Adrenoleukodystrophy|Atypical Hemolytic Uremic Syndrome|Cold Agglutinin Disease|Healthy Volunteers|Idiopathic Pulmonary Fibrosis|Paroxysmal Hemoglobinuria|Paroxysmal Nocturnal Hemoglobinuria|Purpura, Thrombocytopenic, Idiopathic
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2025-521508-23-00 |
MT-1-02 | P1 |
Not yet recruiting |
Adrenoleukodystrophy |
2025-12-29 |
|||
CTR20252409 |
CTR20252409 | P1 |
Completed |
Purpura, Thrombocytopenic, Idiopathic|Paroxysmal Hemoglobinuria|Atypical Hemolytic Uremic Syndrome|Paroxysmal Nocturnal Hemoglobinuria|Cold Agglutinin Disease |
2025-09-09 |
2025-12-06 |
Patient Enrollment|Start Date|Treatments |
|
NCT05932303 |
IM027-1007 | P1 |
Completed |
Idiopathic Pulmonary Fibrosis |
2023-10-23 |
23% |
2023-10-31 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05931484 |
FHL-301-001 | P2 |
Not yet recruiting |
Parkinson's Disease |
2028-11-01 |
12% |
2025-02-12 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
NCT04637282 |
PLX-200-002 | P3 |
Not yet recruiting |
Neuronal Ceroid-Lipofuscinosis |
2026-03-31 |
36% |
2025-05-31 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
NCT05959447 |
BUS-P1-12 | P1 |
Completed |
Healthy Volunteers |
2023-10-13 |
23% |
2025-03-27 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
02/10/2026 |
News Article |
Polaryx Announces Key Pre-Clinical Data Related to SOTERIA at the 22nd Annual WORLDSymposium™ |
|
02/05/2026 |
News Article |
Polaryx Therapeutics Welcomes New Members of the Board of Directors |
|
02/03/2026 |
News Article |
Polaryx to Present Late-Breaker Data Related to SOTERIA at the 22nd Annual WORLDSymposium™ as Company Prepares for SOTERIA Trial Launch |
|
02/02/2026 |
News Article |
Polaryx Therapeutics Announces Direct Listing on Nasdaq; Shares to Begin Trading Under the Symbol "PLYX" |