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 10 indications[4].[1]

Lopid is one of 297 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

296

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Nicotine DependenceApproved

Familial HyperlipidemiaActive, not recruiting

Type 2 Diabetes MellitusApproved

Parkinson DiseaseApproved

Anemia (phenotype)Approved

Abdominal PainActive, not recruiting

Alcohol DependenceApproved

HypertriglyceridemiaApproved

Coronary Artery DiseaseApproved

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Nicotine DependenceApproved

Approved

Familial HyperlipidemiaApproved

Active, not recruiting

Type 2 Diabetes MellitusApproved

Approved

Parkinson DiseaseApproved

Approved

Anemia (phenotype)Approved

Approved

Abdominal PainApproved

Active, not recruiting

Alcohol DependenceApproved

Approved

HypertriglyceridemiaApproved

Approved

Competition

Competitive Landscape

147 competitors in Cardiovascular Disease

#DrugCompanyPhaseTrials

Lopid

Pfizer

Approved

33 2

Trexall

Plavix

Pletal

1 5

Bystolic

VVitae Pharmaceuticals Inc., an Allergan affiliate

Coumadin

Samsca

Colcrys

1 9

Pelacarsen

Novartis

Phase 3

1 10

Cagrilintide

Novo Nordisk

Phase 3

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

Clinical

Trials by Indication[1]

Interaction8 trials

Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

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

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

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

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

Completed· Astellas logo

Astellas·Phase 1·NCT01913379·41 enrolled

Show 5 more trials

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

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

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

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

Treatment2 trials

Exploration of Gemfibrozil as a Treatment for AUD

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

Initial Screening of Gemfibrozil as a Novel Treatment for Tobacco Addiction

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

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

17 more indications

Oral1 trial

Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets

Completed·BBlu Caribe·Phase 1·NCT00800475·40 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

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

Alzheimer disease1 trial

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

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

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

Atherosclerotic Plaque1 trial

Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques

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

Lip1 trial

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

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

ART1 trial

A Study of Evacetrapib in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01736254·24 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

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

Smoking Cessation1 trial

Gemfibrozil for Nicotine Smoking Cessation

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

Parkinson disease1 trial

A Phase 2, Double-Blind, Multi-Center, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of FHL-301 in Adult Patients With Parkinson's Disease

Withdrawn·FForest Hills Lab·Phase 2·NCT05931484

Unspecified2 trials

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

An Open-Label, Fixed Sequence Study to Investigate the Effect of Multiple Oral Doses of Itraconazole, Multiple Oral Doses of Gemfibrozil, and Single Oral Dose of Cyclosporine, on the Pharmacokinetics of a Single Oral Dose of RO7795081 in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT06809608·36 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 21, 1981

LOPID

NDA NDA018422

Jan 1, 1982

LOPID

NDA NDA018422

Jun 1, 1982

LOPID

NDA NDA018422

Sep 26, 1983

LOPID

NDA NDA018422

Aug 22, 1984

LOPID

NDA NDA018422

Dec 10, 1985

LOPID

NDA NDA018422

Dec 20, 1985

LOPID

NDA NDA018422

Apr 4, 1986

LOPID

NDA NDA018422

Nov 20, 1986

LOPID

NDA NDA018422

Aug 26, 1987

LOPID

NDA NDA018422

Nov 3, 1987

LOPID

NDA NDA018422

Nov 3, 1987

LOPID

NDA NDA018422

Jan 28, 1988

LOPID

NDA NDA018422

Feb 3, 1988

LOPID

NDA NDA018422

Feb 3, 1988

LOPID

NDA NDA018422

May 25, 1988

LOPID

NDA NDA018422

Nov 15, 1988

LOPID

NDA NDA018422

Dec 1, 1988

LOPID

NDA NDA018422

Jan 17, 1989

LOPID

NDA NDA018422

May 30, 1989

LOPID

NDA NDA018422

May 30, 1989

LOPID

NDA NDA018422

Jan 3, 1990

LOPID

NDA NDA018422

Jan 29, 1990

LOPID

NDA NDA018422

Jun 4, 1990

LOPID

NDA NDA018422

Mar 16, 1992

LOPID

NDA NDA018422

Dec 2, 1992

LOPID

NDA NDA018422

Mar 24, 1995

LOPID

NDA NDA018422

Mar 24, 1995

LOPID

NDA NDA018422

Mar 24, 1995

LOPID

NDA NDA018422

Jul 18, 1997

LOPID

NDA NDA018422

Dec 3, 1998

LOPID

NDA NDA018422

Aug 7, 2001

LOPID

NDA NDA018422

Aug 7, 2001

LOPID

NDA NDA018422

Sep 26, 2002

LOPID

NDA NDA018422

Jan 15, 2003

LOPID

NDA NDA018422

Mar 30, 2004

LOPID

NDA NDA018422

Jul 14, 2009

LOPID

NDA NDA018422

Sep 27, 2010

LOPID

NDA NDA018422

Oct 31, 2013

LOPID

NDA NDA018422

Nov 5, 2014

LOPID

NDA NDA018422

Apr 6, 2016

LOPID

NDA NDA018422

Apr 18, 2017

LOPID

NDA NDA018422

Apr 25, 2018

LOPID

NDA NDA018422

Dec 10, 2020

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

Trials by Indication[1]

Interaction8 trials

Single Dose2 trials

Treatment2 trials

Drug Interactions2 trials

Endothelial Dysfunction1 trial

Oral1 trial

Drug1 trial

Heart Disease1 trial

Atherosclerosis1 trial

Adult Subject1 trial

Empagliflozin1 trial

Alzheimer disease1 trial

Concentration1 trial

CAR1 trial

Atherosclerotic Plaque1 trial

Lip1 trial

ART1 trial

Solid Tumors1 trial

Tics1 trial

Smoking Cessation1 trial

Parkinson disease1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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