LOPID (gemfibrozil)
LOPID is indicated for the treatment of Hypertriglyceridemia; Pancreatitis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1981-12-21
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
LOPID Approval History
What LOPID Treats
2 indicationsLOPID is approved for 2 conditions since its original approval in 1981. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertriglyceridemia
- Pancreatitis
LOPID Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LOPID
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
21 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05931484 | FHL-301-001 | Ph 2 | not yet recruiting | Study to Evaluate the Safety, Tolerability, Efficacy, and PK of FHL-301 in Parkinson's Disease Patients. |
| NCT06064539 | INT16726 U1111-1244-2759 | Ph 1 | completed | Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects |
| NCT06809608 | BP45670 2024-517360-37-00 | Ph 1 | completed | A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081 |
| NCT05959447 results posted | 221854 BUS-P1-12 | Ph 1 | completed | Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant |
| NCT02770222 | AC-065-113 2016-000811-34 | Ph 1 | completed | A Clinical Study to Investigate the Effect of Gemfibrozil or Rifampicin on Blood Concentrations of Selexipag in Healthy Subjects |
| NCT06392659 | VX24-993-004 | Ph 1 | completed | A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults |
| NCT05932303 | IM027-1007 | Ph 1 | completed | A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants |
| NCT04956627 | IM018-004 | Ph 1 | completed | A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants |
| NCT03723395 | ONT-380-012 | Ph 1 | completed | A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib |
| NCT03624959 | RPC01-1912 U1111-1215-6965 | Ph 1 | completed | Drug-drug Interaction Study of Ozanimod With Inhibitor or Inducer of CYP2C8 and/or CYP3A |
| NCT01836198 results posted | 14586 I1R-MC-GLBZ | Ph 1 | completed | The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream |
| NCT02638597 GEMNIC results posted | STU 072014-088 | Ph 2 | completed | Gemfibrozil for Nicotine Smoking Cessation |
| NCT01736254 results posted | 14701 I1V-MC-EIBD | Ph 1 | completed | A Study of Evacetrapib in Healthy Participants |
| NCT01340846 | 113771 | Ph 1 | completed | A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors |
| NCT01376232 DDI | 113634 | Ph 1 | completed | Study to Assess the Pharmacokinetics of GSK1278863A Coadministered With a High Fat Meal or an Inhibitor of CYP2C8 (Gemfibrozil) |
| NCT01876810 results posted | 082/2012 | Ph 2 | completed | Initial Screening of Gemfibrozil as a Novel Treatment for Tobacco Addiction |
| NCT02230033 | CR105398 56021927PCR1012 | Ph 1 | completed | Study to Assess Drug-Drug Interaction Between Itraconazole or Gemfibrozil and JNJ-56021927 |
| NCT01301742 results posted | 1245.58 2010-023152-85 | Ph 1 | completed | Relative Bioavailability of Single Dose Empagliflozin (BI 10773) When Co-administered With Multiple Doses of 600 mg Gemfibrozil Compared to Single Dose Treatment With Empagliflozin (BI 10773) When Given Alone in Healthy Volunteers |
| NCT01913379 | 9785-CL-0006 2011-000333-37 | Ph 1 | completed | Drug-drug Interaction Study With MDV3100 (ASP9785) and Gemfibrozil and Itraconazole |
| NCT01797198 | 3652-CL-0006 2011-002874-21 | Ph 1 | completed | A Study to Assess the Effect of Multiple Doses of Gemfribozil on a Single Dose of ASP3652, and to Assess the Effects of Multiple Doses of ASP3652 on a Single Dose of Repaglinide in the Body of Healthy Subjects |
| NCT01083212 | D1020C00030 | Ph 1 | completed | To Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LOPID FDA Label Details
Indications & Usage
FDA Label (PDF)LOPID is indicated for the treatment of Hypertriglyceridemia; Pancreatitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment