Felodipine - PharmaKB

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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Clinical

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Target

Variants

Financial

Trends

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Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

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 diseases	D002318
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Felodipine (discontinued: Felodipine, Plendil)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Enalapril maleate

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	2025-11-17
felodipine felopdipine	ANDA	2023-04-04
felodipineextended-release tablets	New Drug Application	2009-09-09
felopdipine	ANDA	2024-08-07

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hypertension	EFO_0000537	D006973	I10
variant angina pectoris	—	D000788	I20.1
heart failure	EFO_0003144	D006333	I50
diabetic nephropathies	EFO_0000401	D003928	—
left ventricular dysfunction	—	D018487	—
rheumatoid arthritis	EFO_0000685	D001172	M06.9
edema	—	D004487	R60.9
malignant hypertension	EFO_1001031	D006974	—
bartter syndrome	Orphanet_112	D001477	E26.81

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

27 clinical trials

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Indications Phases 4

No data

Indications Phases 3

No data

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	—	—	—	2	—	—	—	—	2
Malnutrition	D044342	EFO_0008572	E40-E46	1	—	—	—	—	1

Indications Without Phase

No data

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

Organism

Homo sapiens

Gene name

CYP2C8

Gene synonyms

NCBI Gene ID

1558

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

Q9UCZ9

Mouse ortholog

—

Variants

No data

Financial

Revenue by drug

€

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Plendil – AstraZeneca

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Estimated US medical usage

Felodipine

Enalapril

Total medical expenditures per year (USD, in millions)

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Felodipine

Total medical expenditures per year (USD, in millions)

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 3,958 documents

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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2,768 adverse events reported

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