Felodipine
Felodipine, Lexxel (felodipine) is a small molecule pharmaceutical. Felodipine was first approved as Plendil on 1991-07-25. It is used to treat hypertension and variant angina pectoris in the USA. It is known to target cystic fibrosis transmembrane conductance regulator.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Enalapril maleate
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Felodipine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LEXXEL | AstraZeneca | N-020668 DISCN | 1996-12-27 | 2 products |
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Felodipine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PLENDIL | AstraZeneca | N-019834 DISCN | 1991-07-25 | 3 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| felodipine | ANDA | 2024-01-09 |
| felodipineextended-release tablets | New Drug Application | 2009-09-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hypertension | EFO_0000537 | D006973 | I10 |
| variant angina pectoris | — | D000788 | I20.1 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C07: Beta-adrenergic blocking agents
— C07F: Beta blocking agents, other combinations
— C07FB: Beta blocking agents and calcium channel blockers
— C07FB02: Metoprolol and felodipine
— C08: Calcium channel blockers
— C08C: Selective calcium channel blockers with mainly vascular effects
— C08CA: Dihydropyridine derivative selective calcium channel blockers with mainly vascular effects
— C08CA02: Felodipine
— C09: Agents acting on the renin-angiotensin system
— C09B: Ace inhibitors, combinations
— C09BB: Ace inhibitors and calcium channel blockers
— C09BB05: Ramipril and felodipine
HCPCS
No data
Clinical
Clinical Trials
25 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | 5 | 7 | 5 | 18 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | 1 | 1 | 2 |
| Left ventricular hypertrophy | D017379 | EFO_0003896 | — | — | — | 1 | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 1 | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | — | — | 1 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | — | 1 | — | — | 1 |
| Coronary disease | D003327 | — | — | — | — | 1 | — | — | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | 1 | — | — | 1 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | 1 | — | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | 1 | — | — | 1 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | 2 | 5 |
| Food-drug interactions | D018565 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | — | — | — | 1 | 1 |
| Microcirculation | D008833 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Felodipine |
| INN | felodipine |
| Description | Felodipine is the mixed (methyl, ethyl) diester of 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic acid. A calcium-channel blocker, it lowers blood pressure by reducing peripheral vascular resistance through a highly selective action on smooth muscle in arteriolar resistance vessels. It is used in the management of hypertension and angina pectoris. It has a role as a calcium channel blocker, an antihypertensive agent, a vasodilator agent and an anti-arrhythmia drug. It is a dihydropyridine, a dichlorobenzene, an ethyl ester and a methyl ester. |
| Classification | Small molecule |
| Drug class | phenylpyridine vasodilators; tricyclic compounds |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCOC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1cccc(Cl)c1Cl |
Identifiers
| PDB | — |
| CAS-ID | 72509-76-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1480 |
| ChEBI ID | 585948 |
| PubChem CID | 3333 |
| DrugBank | DB01023 |
| UNII ID | OL961R6O2C (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CYP2C8
CYP2C8
Organism
Homo sapiens
Gene name
CYP2C8
Gene synonyms
NCBI Gene ID
Protein name
cytochrome P450 2C8
Protein synonyms
CYPIIC8, Cytochrome P450 form 1, Cytochrome P450 IIC2, Cytochrome P450 MP-12, Cytochrome P450 MP-20, cytochrome P450, family 2, subfamily C, polypeptide 8, cytochrome P450, subfamily IIC (mephenytoin 4-hydroxylase), polypeptide 8, flavoprotein-linked monooxygenase, microsomal monooxygenase, P450 form 1, S-mephenytoin 4-hydroxylase, xenobiotic monooxygenase
Uniprot ID
Mouse ortholog
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Variants
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Financial
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Plendil – AstraZeneca
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Estimated US medical usage
Felodipine
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Enalapril
Total medical expenditures per year (USD, in millions)
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Number of purchases
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Felodipine
Total medical expenditures per year (USD, in millions)
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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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,868 adverse events reported
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