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Drug ReportsNicardipine
Nicardipine
Cardene, Nicardipine (nicardipine) is a small molecule pharmaceutical. Nicardipine was first approved as Cardene on 1988-12-21. It is used to treat hypertension, stable angina, and variant angina pectoris in the USA. It is known to target potassium voltage-gated channel subfamily A member 4 and adenosine receptor A3.
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Cardene, Nicardipine (discontinued: Cardene, Nicardipine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nicardipine hydrochloride
Tradename
Company
Number
Date
Products
CARDENEChiesi FarmaceuticiN-019734 RX1992-01-30
1 products, RLD
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINERChiesi FarmaceuticiN-019734 RX2008-07-31
1 products, RLD, RS
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINERChiesi FarmaceuticiN-019734 RX2008-07-31
1 products, RLD, RS
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINERChiesi FarmaceuticiN-019734 RX2008-11-07
1 products, RLD, RS
NICARDIPINE HYDROCHLORIDEHikma PharmaceuticalsN-022276 RX2008-07-24
1 products, RLD, RS
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEHikma PharmaceuticalsN-022276 RX2016-04-07
2 products, RLD, RS
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
cardeneNew Drug Application2016-08-06
cardene ivNew Drug Application2025-12-29
nicardipine hydrochlorideANDA2026-01-29
nicardipine hydrochloride in sodium chlorideANDA2025-06-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypertensionEFO_0000537D006973I10
stable angina—D060050I20.89
variant angina pectoris—D000788I20.1
Agency Specific
FDA
EMA
Expiration
Code
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE, SENORES PHARMS
2024-03-20CGT
Patent Expiration
Patent
Expires
Flag
FDA Information
Nicardipine Hydrochloride, Cardene, Chiesi
76121022027-12-26DP
93645642027-12-26DP
76592912027-04-18U-1029
84555242027-04-18U-1029
107586162027-04-18DP
115477582027-04-18U-1029
ATC Codes
C: Cardiovascular system drugs
— C08: Calcium channel blockers
— C08C: Selective calcium channel blockers with mainly vascular effects
— C08CA: Dihydropyridine derivative selective calcium channel blockers with mainly vascular effects
— C08CA04: Nicardipine
HCPCS
No data
Clinical
Clinical Trials
66 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10————11
StrokeD020521EFO_0000712I63.9————11
Cerebral hemorrhageD002543——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNicardipine
INNnicardipine
Description
Nicardipine is a racemate comprising equimolar amounts of (R)- and (S)-nicardipine. It is a calcium channel blocker which is used to treat hypertension. It has a role as an antihypertensive agent, a calcium channel blocker, a vasodilator agent and an autophagy inhibitor. It contains a (S)-nicardipine and a (R)-nicardipine.
Classification
Small molecule
Drug classphenylpyridine vasodilators; tricyclic compounds
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Structure (InChI/SMILES or Protein Sequence)
COC(=O)C1=C(C)NC(C)=C(C(=O)OCCN(C)Cc2ccccc2)C1c1cccc([N+](=O)[O-])c1
Identifiers
PDB—
CAS-ID55985-32-5
RxCUI—
ChEMBL IDCHEMBL1484
ChEBI ID7550
PubChem CID4474
DrugBankDB00622
UNII IDCZ5312222S (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
ADORA3
ADORA3
Organism
Homo sapiens
Gene name
ADORA3
Gene synonyms
NCBI Gene ID
140
Protein name
adenosine receptor A3
Protein synonyms
Uniprot ID
Q9BYZ1
Mouse ortholog
—
—
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Nicardipine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,180 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,297 adverse events reported
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