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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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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
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 5 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
cardeneNew Drug Application2016-08-06
cardene ivNew Drug Application2024-09-27
nicardipine hydrochlorideANDA2024-11-04
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
58 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I101153616
Ischemic strokeD000083242————2114
Covid-19D000086382—————123
Intracranial vasospasmD020301EFO_1000994G45.9—1—113
Coronary artery diseaseD003324—I25.11——113
EmergenciesD004630—————213
Hypertensive crisisD000096003—————213
HypotensionD007022EFO_0005251I95———213
Coronavirus infectionsD018352EFO_0007224B34.2———112
Angle class iii malocclusionD008313HP_0000303M26.213———1—1
Show 5 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HemorrhageD006470MP_0001914R58111—912
StrokeD020521EFO_0000712I63.9112—48
Cerebral hemorrhageD002543——1—1—57
Pre-eclampsiaD011225EFO_0000668O14——2—13
Heart failureD006333HP_0001635I50——1—12
IschemiaD007511EFO_0000556———2——2
Muscle crampD009120HP_0003394———1——1
SpasmD013035—M62.83——1——1
VasodilationD014664————1——1
EclampsiaD004461HP_0100601O15——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Subarachnoid hemorrhageD013345EFO_0000713I60—1——34
ThrombectomyD017131———1———1
AneurysmD000783HP_0002617I72.9—1———1
Thoracic aortic aneurysmD017545EFO_0004282——1———1
Aortic aneurysmD001014EFO_0001666I71.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PainD010146EFO_0003843R521———12
Cardiovascular diseasesD002318HP_0001626—1————1
Drug-related side effects and adverse reactionsD064420—T88.71————1
Brain neoplasmsD001932EFO_0003833C711————1
Coronary diseaseD003327——1————1
Myocardial ischemiaD017202EFO_1001375I20-I251————1
BurnsD002056—T30.01————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypoxiaD000860HP_0012418R09.02————22
InfectionsD007239EFO_0000544—————11
MenorrhagiaD008595EFO_0003945N92.0————11
Hemophilia aD006467EFO_0007267D66————11
Down syndromeD004314EFO_0001064Q90————11
PneumoniaD011014EFO_0003106—————11
Blood coagulation disordersD001778EFO_0009314D68.9————11
Mucocutaneous lymph node syndromeD009080EFO_0004246M30.3————11
HyperaldosteronismD006929HP_0011736E26————11
Pulmonary arterial hypertensionD000081029——————11
Show 31 more
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
Image (chem structure or protein)Loading
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
KCNA4
KCNA4
ADORA3
ADORA3
Organism
Homo sapiens
Gene name
KCNA4
Gene synonyms
KCNA4L
NCBI Gene ID
Protein name
potassium voltage-gated channel subfamily A member 4
Protein synonyms
cardiac potassium channel, fetal skeletal muscle potassium channel, HPCN2, potassium channel 2, potassium channel, voltage gated shaker related subfamily A, member 4, rapidly inactivating potassium channel, shaker-related potassium channel Kv1.4, type A potassium channel, Voltage-gated K(+) channel HuKII, Voltage-gated potassium channel HBK4, Voltage-gated potassium channel HK1, Voltage-gated potassium channel subunit Kv1.4
Uniprot ID
Mouse ortholog
Kcna4 (16492)
potassium voltage-gated channel subfamily A member 4 (Q8CBF8)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Nicardipine
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,954 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,003 adverse events reported
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