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 diseases | D002318 |
| signs and symptoms pathological conditions | D013568 |
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 | Chiesi Farmaceutici | N-019734 RX | 1992-01-30 | 1 products, RLD |
| CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | Chiesi Farmaceutici | N-019734 RX | 2008-07-31 | 1 products, RLD, RS |
| CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | Chiesi Farmaceutici | N-019734 RX | 2008-07-31 | 1 products, RLD, RS |
| CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | Chiesi Farmaceutici | N-019734 RX | 2008-11-07 | 1 products, RLD, RS |
| NICARDIPINE HYDROCHLORIDE | Hikma Pharmaceuticals | N-022276 RX | 2008-07-24 | 1 products, RLD, RS |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | Hikma Pharmaceuticals | N-022276 RX | 2016-04-07 | 2 products, RLD, RS |
Show 4 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cardene | New Drug Application | 2016-08-06 |
| cardene iv | New Drug Application | 2026-04-13 |
| nicardipine hydrochloride | ANDA | 2026-04-24 |
| nicardipine hydrochloride in sodium chloride | ANDA | 2025-06-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hypertension | EFO_0000537 | D006973 | I10 |
| stable angina | — | D060050 | I20.89 |
| variant angina pectoris | — | D000788 | I20.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE, SENORES PHARMS | |||
| 2024-03-20 | CGT | ||
HCPCS
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Clinical
Clinical Trials
67 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 | 1 | 5 | 3 | 7 | 17 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | 1 | 1 | 1 | 5 | 9 |
| Ischemic stroke | D000083242 | — | — | — | — | 2 | 2 | 2 | 6 |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | 2 | — | 1 | 3 | 6 |
| Hypertensive crisis | D000096003 | — | I16 | — | — | — | 3 | 1 | 4 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | 1 | 2 | 3 |
| Intracranial vasospasm | D020301 | EFO_1000994 | G45.9 | — | 1 | — | 1 | 1 | 3 |
| Coronary artery disease | D003324 | — | I25.1 | 1 | — | — | 1 | 1 | 3 |
| Emergencies | D004630 | — | — | — | — | — | 2 | 1 | 3 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | 1 | 1 | 2 |
Show 8 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cerebral hemorrhage | D002543 | — | — | 1 | — | 1 | — | 5 | 7 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | 2 | — | 1 | 3 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | — | 1 | 2 |
| Muscle cramp | D009120 | — | — | — | — | 1 | — | — | 1 |
| Spasm | D013035 | — | M62.83 | — | — | 1 | — | — | 1 |
| Vasodilation | D014664 | — | — | — | — | 1 | — | — | 1 |
| Eclampsia | D004461 | — | O15 | — | — | 1 | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | 1 | — | — | 4 | 6 |
| Thrombectomy | D017131 | — | — | — | 1 | — | — | 1 | 2 |
| Aneurysm | D000783 | — | I72.9 | — | 1 | — | — | — | 1 |
| Thoracic aortic aneurysm | D017545 | EFO_0004282 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | 1 | — | — | — | 1 | 2 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | — | — | — | 1 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | — | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Coronary disease | D003327 | — | — | 1 | — | — | — | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 1 | — | — | — | — | 1 |
| Burns | D002056 | — | T30.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| General anesthesia | D000768 | — | — | — | — | — | — | 2 | 2 |
| Hypoxia | D000860 | — | R09.02 | — | — | — | — | 2 | 2 |
| Aortic dissection | D000784 | — | I71.0 | — | — | — | — | 2 | 2 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
| Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | — | — | — | — | 1 | 1 |
| Hyperaldosteronism | D006929 | — | E26 | — | — | — | — | 1 | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | — | — | — | — | 1 | 1 |
Show 28 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nicardipine |
| INN | nicardipine |
| 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 class | phenylpyridine vasodilators; tricyclic compounds |
| Image (chem structure or protein) |  |
| 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-ID | 55985-32-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1484 |
| ChEBI ID | 7550 |
| PubChem CID | 4474 |
| DrugBank | DB00622 |
| UNII ID | CZ5312222S (ChemIDplus, GSRS) |
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Nicardipine
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Trends
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Safety
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Adverse Events
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3,395 adverse events reported
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