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Drug ReportsGemfibrozil
Gemfibrozil
Gemfibrozil, Lopid (gemfibrozil) is a small molecule pharmaceutical. Gemfibrozil was first approved as Lopid on 1982-01-01. It is used to treat coronary artery disease, hypercholesterolemia, hyperlipoproteinemias, and hypertriglyceridemia in the USA. The pharmaceutical is active against peroxisome proliferator-activated receptor alpha. In addition, it is known to target solute carrier organic anion transporter family member 2B1, solute carrier organic anion transporter family member 1B1, and solute carrier organic anion transporter family member 1B3.
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Variants
Financial
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YTD
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FDA approval date
EMA approval date
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Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Lopid (generic drugs available since 1993-09-27)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gemfibrozil
Tradename
Company
Number
Date
Products
LOPIDPfizerN-018422 RX1986-11-20
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
gemfibrozilANDA2024-09-05
lopidNew Drug Application2024-07-16
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AB: Fibrates, lipid modifying drugs, plain
— C10AB04: Gemfibrozil
HCPCS
Code
Description
G9507
Documentation that the patient is on a statin medication or has documentation of a valid contraindication or exception to statin medications; contraindications/exceptions that can be defined by diagnosis codes include pregnancy during the measurement period, active liver disease, rhabdomyolysis, end stage renal disease on dialysis and heart failure; provider documented contraindications/exceptions include breastfeeding during the measurement period, woman of child-bearing age not actively taking birth control, allergy to statin, drug interaction (hiv protease inhibitors, nefazodone, cyclosporine, gemfibrozil, and danazol) and intolerance (with supporting documentation of trying a statin at least once within the last 5 years or diagnosis codes for myostitis or toxic myopathy related to drugs)
Clinical
Clinical Trials
41 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———14——1116
AtherosclerosisD050197EFO_0003914I25.1———1—1
Atherosclerotic plaqueD058226HP_0031678I70———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Coronary diseaseD003327———11——2
Myocardial ischemiaD017202EFO_1001375I20-I25—11——2
Heart diseasesD006331EFO_0003777I51.9—11——2
Diabetic nephropathiesD003928EFO_0000401———1——1
Kidney diseasesD007674EFO_0003086N08——1——1
Coronary artery diseaseD003324—I25.1——1——1
Neuronal ceroid-lipofuscinosesD009472—E75.4——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471—C6111———2
Insulin resistanceD007333HP_0000855—11———2
Smoking cessationD016540EFO_0004319——1———1
Tobacco use disorderD014029—F17—1———1
Cardiovascular diseasesD002318HP_0001626——1———1
AlcoholismD000437EFO_0003829F10.1—1———1
Alcohol drinkingD000428EFO_0004329——1———1
Parkinson diseaseD010300EFO_0002508G20—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 2 diabetes mellitusD003924EFO_0001360E112———24
Diabetes mellitusD003920HP_0000819E08-E131———23
Drug interactionsD004347——3————3
NeoplasmsD009369—C801————1
PharmacokineticsD010599——1————1
Hiv infectionsD015658EFO_0000764B201————1
Alzheimer diseaseD000544EFO_0000249F031————1
AnemiaD000740HP_0001903D64.91————1
Biological availabilityD001682——1————1
HypertriglyceridemiaD015228EFO_0004211—1————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes complicationsD048909——————11
ObesityD009765EFO_0001073E66.9————11
Mitochondrial diseasesD028361EFO_0000591—————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGemfibrozil
INNgemfibrozil
Description
Gemfibrozil is an aromatic ether. It has a role as an antilipemic drug. It is functionally related to a valeric acid.
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
Cc1ccc(C)c(OCCCC(C)(C)C(=O)O)c1
Identifiers
PDB—
CAS-ID25812-30-0
RxCUI—
ChEMBL IDCHEMBL457
ChEBI ID5296
PubChem CID3463
DrugBankDB01241
UNII IDQ8X02027X3 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
SLCO2B1
SLCO2B1
ALB
ALB
Organism
Homo sapiens
Gene name
SLCO2B1
Gene synonyms
KIAA0880, OATP2B1, OATPB, SLC21A9
NCBI Gene ID
Protein name
solute carrier organic anion transporter family member 2B1
Protein synonyms
OATP-B, OATP-RP2, OATP2B1, OATPRP2, Organic anion transporter B, Organic anion transporter polypeptide-related protein 2, Organic anion transporting polypeptide 2B1, solute carrier family 21 (organic anion transporter), member 9, Solute carrier family 21 member 9
Uniprot ID
Mouse ortholog
Slco2b1 (101488)
solute carrier organic anion transporter family member 2B1 (Q8BXB6)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Gemfibrozil
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,828 documents
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Safety
Black-box Warning
Black-box warning for: Gemfibrozil
Adverse Events
Top Adverse Reactions
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55,188 adverse events reported
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