Lopid

(Gemfibrozil)

ApprovedSmall molecule

Gemfibrozil is used to lower cholesterol and triglycerides (a type of fat) in the blood to help reduce the risk of heart disease and stroke.[2] Lopid is currently approved and in use across 15 indications[4].[1]

Lopid is one of 457 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

456

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Endothelial DysfunctionActive, not recruiting

Nicotine DependenceApproved

Familial HyperlipidemiaActive, not recruiting

Type 2 Diabetes MellitusApproved

Alzheimer DiseaseActive, not recruiting

Parkinson DiseaseApproved

AtherosclerosisActive, not recruiting

Anemia (phenotype)Approved

Coronary Artery DiseaseApproved

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Endothelial DysfunctionPhase 1

Active, not recruiting

Nicotine DependenceApproved

Approved

Familial HyperlipidemiaApproved

Active, not recruiting

Type 2 Diabetes MellitusApproved

Approved

Alzheimer DiseasePhase 1

Active, not recruiting

Parkinson DiseaseApproved

Approved

AtherosclerosisPhase 2

Active, not recruiting

Anemia (phenotype)Approved

Approved

Showing 10 of 15 indications

Competition

Competitive Landscape

676 competitors in Type 2 Diabetes Mellitus

#DrugCompanyPhaseTrials

Lopid

Pfizer

Approved

33 2

Byetta

AstraZeneca

Preclinical

20 3

Tanzeum

GSK

Preclinical

10 4

Insulin 320

Novo Nordisk

Preclinical

43 5

NOVOLIN R

Novo Nordisk

Preclinical

1 6

Dostinex

Golytely

Cipro

Myrbetriq

Lantus

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Phase 2Not yet recruiting

Parkinson's Disease

NCT05931484

Clinical

Trials by Indication[1]

Interaction8 trials

Drug-drug Interaction Study With MDV3100 (ASP9785) and Gemfibrozil and Itraconazole

Completed· Astellas logo

Astellas·Phase 1·NCT01913379·41 enrolled

Study to Assess Drug-Drug Interaction Between Itraconazole or Gemfibrozil and JNJ-56021927

Completed·AAragon Pharmaceuticals, Inc.·Phase 1·NCT02230033·45 enrolled

A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT06392659·42 enrolled

Show 5 more trials

A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone

Completed· Biogen logo

Biogen·Phase 1·NCT04008186·61 enrolled

A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib

Completed· Pfizer logo

Pfizer·Phase 1·NCT03723395·116 enrolled

Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

Completed·EElixir Pharmaceuticals·Phase 1·NCT00566865·14 enrolled

Drug Interaction Study of Lopinavir/Ritonavir and Gemfibrozil

Completed·NNational Institutes of Health Clinical Center (CC)·N/A·NCT00474201·15 enrolled

Drug-drug Interaction Study of Ozanimod With Inhibitor or Inducer of CYP2C8 and/or CYP3A

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03624959·100 enrolled

Drug Interactions2 trials

A Study to Investigate the Drug-drug Interactions (DDIs) of SKLB1028 With Itraconazole, Gemfibrozil or Rifampicin in Healthy Subjects

Unknown status· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 1·NCT05069870·42 enrolled

Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant

Completed·—·Phase 1·NCT05959447·45 enrolled

Treatment2 trials

Initial Screening of Gemfibrozil as a Novel Treatment for Tobacco Addiction

Completed·CCentre for Addiction and Mental Health·Phase 2·NCT01876810·28 enrolled

Exploration of Gemfibrozil as a Treatment for AUD

Terminated·TThe Mind Research Network·Phase 2·NCT03539432·3 enrolled

Single Dose2 trials

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

Completed· Astellas logo

Astellas·Phase 1·NCT01797198·48 enrolled

To Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01083212·19 enrolled

Endothelial Dysfunction1 trial

Endothelial Dysfunction as a Risk Factor in HIV Study

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT00039663·75 enrolled

18 more indications

Concentration1 trial

A Clinical Study to Investigate the Effect of Gemfibrozil or Rifampicin on Blood Concentrations of Selexipag in Healthy Subjects

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02770222·40 enrolled

CAR1 trial

A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05932303·47 enrolled

Alzheimer disease1 trial

Modulation of Micro-RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease

Completed·GGregory Jicha, 323-5550·Phase 1·NCT02045056·72 enrolled

Medication1 trial

A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081

Completed· Roche logo

Roche·Phase 1·NCT06809608·36 enrolled

Parkinson's Disease1 trial

Study to Evaluate the Safety, Tolerability, Efficacy, and PK of FHL-301 in Parkinson's Disease Patients.

Not yet recruiting·FForest Hills Lab·Phase 2·NCT05931484·32 enrolled

Smoking Cessation1 trial

Gemfibrozil for Nicotine Smoking Cessation

Completed·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT02638597·16 enrolled

Drug1 trial

A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04956627·15 enrolled

Tics1 trial

Study to Assess the Pharmacokinetics of GSK1278863A Coadministered With a High Fat Meal or an Inhibitor of CYP2C8 (Gemfibrozil)

Completed· GSK logo

GSK·Phase 1·NCT01376232·23 enrolled

Oral1 trial

Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets

Completed·BBlu Caribe·Phase 1·NCT00800475·40 enrolled

Heart Disease1 trial

The VA HDL Intervention Trial (HIT): Secondary Prevention of Coronary Heart Disease in Men With Low HDL-Cholesterol and Desirable LDL-Cholesterol

Completed·VVA Office of Research and Development·Phase 3·NCT00283335·2,531 enrolled

Atherosclerosis1 trial

Harvard Atherosclerosis Reversibility Project (HARP)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00000461

Adult Subject1 trial

Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT06064539·30 enrolled

Empagliflozin1 trial

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

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01301742·18 enrolled

ART1 trial

A Study of Evacetrapib in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01736254·24 enrolled

Atherosclerotic Plaque1 trial

Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques

Withdrawn·UUniversity Hospital Muenster·Phase 4·NCT00243672·100 enrolled

Solid Tumors1 trial

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

Completed· GSK logo

GSK·Phase 1·NCT01340846·48 enrolled

Lip1 trial

Effect of Gemfibrozil on Serum Glycosylphosphatidylinositol (GPI) Phospholipase D and Triglycerides

Completed·UUS Department of Veterans Affairs·Phase 1·NCT00108511

Unspecified1 trial

The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01836198·30 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

LOPID

NDA NDA018422

Sources

References

[1]
ClinicalTrials.gov — 33 trial records for Gemfibrozil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lopid drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Gemfibrozil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Gemfibrozil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA018422). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Peroxisome Proliferator-Activated Receptor Alpha Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Lopid

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2028

Trials by Indication[1]

Interaction8 trials

Drug Interactions2 trials

Treatment2 trials

Single Dose2 trials

Endothelial Dysfunction1 trial

Concentration1 trial

CAR1 trial

Alzheimer disease1 trial

Medication1 trial

Parkinson's Disease1 trial

Smoking Cessation1 trial

Drug1 trial

Tics1 trial

Oral1 trial

Heart Disease1 trial

Atherosclerosis1 trial

Adult Subject1 trial

Empagliflozin1 trial

ART1 trial

Atherosclerotic Plaque1 trial

Solid Tumors1 trial

Lip1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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