Explore

Companies

Drugs

About·Data Management·Terms·Privacy

Stay informed

© 2026 VivoSeq. All rights reserved.

Cardene

(Nicardipine)

ApprovedSmall molecule

Nicardipine is used to lower high blood pressure and to help prevent chest pain caused by heart disease. It works by relaxing blood vessels to improve blood flow and reduce the workload on your heart.[2] Cardene is currently approved and in use across 13 indications[4].[1]

Cardene is one of 332 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

13

Indications

27

Total Trials

4

Active Trials

331

Competitors

5

FDA Applications

NDA/BLA/ANDA regulatory filings

6

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Acute Respiratory FailureNot yet recruiting

StrokeActive, not recruiting

HemorrhageActive, not recruiting

AneurysmActive, not recruiting

Thoracic Aortic AneurysmApproved

HypertensionActive, not recruiting

Brain NeoplasmApproved

Muscle CrampApproved

PreeclampsiaApproved

Cardiovascular DiseaseApproved

Active, not recruiting

Acute Respiratory FailurePreclinical

Not yet recruiting

StrokePhase 2

Active, not recruiting

HemorrhagePhase 1

Active, not recruiting

AneurysmPhase 2

Active, not recruiting

Thoracic Aortic AneurysmApproved

Approved

HypertensionPhase 3

Active, not recruiting

Brain NeoplasmApproved

Approved

Muscle CrampApproved

Approved

PreeclampsiaApproved

Approved

Showing 10 of 13 indications

Competition

Competitive Landscape

566 competitors in Hypertension

#DrugCompanyPhaseTrials

Cardene

Edarbi

Apresoline

Benicar

Zebeta

Edarbi

Aceon

Institut de Recherches Internationales Servier

Winrevair

Alphagan

Deltavit

HHyundai Pharmaceutical Co., LTD.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

PreclinicalNot yet recruiting

Surgery

NCT07660562

Q1 2027

Post-ApprovalNot yet recruiting

Subarachnoid Hemorrhage

NCT07246629

Q3 2027

PreclinicalNot yet recruiting

Acute Respiratory Failure

NCT07603037

Clinical

Trials by Indication[1]

CAR3 trials

Nicardipine Versus Labetalol During Intubation

Unknown status·SSeoul National University Bundang Hospital·N/A·NCT01041066·70 enrolled

Nicardipine vs. Labetalol

Completed·HHaseki Training and Research Hospital·Phase 4·NCT07277283·34 enrolled

Effects of Subcutaneously Infiltrated Nicardipine on the Success Rate of Radial Artety Cannulation

Unknown status·MMahidol University·N/A·NCT05920538·190 enrolled

Stroke3 trials

IV Double and Triple Concentrated Nicardipine for Stroke and ICH

Unknown status·OOSF Healthcare System·Phase 4·NCT00325793·50 enrolled

Blood Pressure After Endovascular Stroke Therapy-II

Completed·UUniversity of Cincinnati·Phase 2·NCT04116112·120 enrolled

A Comparison of Nicardipine and Labetalol for Blood Pressure Control in Intensive Care Patients After Hemorrhagic Stroke Brain Surgery

Completed·UUniversitas Sumatera Utara·N/A·NCT07364201·30 enrolled

Hypertension3 trials

The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine

Terminated·UUniversity Hospital, Strasbourg, France·Phase 3·NCT02558023·14 enrolled

Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine

Unknown status·UUniversity Hospital, Strasbourg, France·Phase 3·NCT00409253·72 enrolled

Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)

Completed· Novartis logo

Novartis·Phase 3·NCT00093925·739 enrolled

Hypotensive Anesthesia2 trials

Hypotensive Anesthesia for Orthognathic Surgery

Active, not recruiting·—·Phase 4·NCT06093893·90 enrolled

The Effect of Nicardipine on Kidney Function During Orthognathic Surgery Under Hypotensive Anesthesia

Completed·YYonsei University·N/A·NCT01175746·46 enrolled

Surgery2 trials

NICardipine Neuroprotection in AortiC Surgery (NICNACS)

Terminated·—·Phase 2·NCT00508118·7 enrolled

Comparison of Remifentanil and Nicardipine Infusions for Controlled Hypotension in Elective Nasal Surgery Where Bleeding Control is Critical: A Randomized Controlled Trial

Not yet recruiting·SSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital·Preclinical·NCT07660562·44 enrolled

14 more indications

Trial1 trial

The Intra-arterial Vasospasm Trial

Terminated·PPeng Roc Chen, MD·Phase 4·NCT01996436·92 enrolled

Percutaneous Coronary Intervention1 trial

Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention

Completed·PPr. Semir Nouira·Phase 3·NCT04538534·1,500 enrolled

Hypotension1 trial

Effect of Nicardipine on Renal Function in Deliberate Hypotension

Completed·YYonsei University·Phase 4·NCT02271191·64 enrolled

ART1 trial

Dilution of Verapamil During Intraarterial Administration

Completed·UUniversity of Illinois at Chicago·Phase 1·NCT05625503·55 enrolled

Craniotomy1 trial

Nicardipine vs Esmolol Craniotomy Emergence

Completed·NNorthwestern University·Phase 1·NCT01951950·40 enrolled

Subarachnoid Hemorrhage1 trial

Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage

Not yet recruiting·WWake Forest University Health Sciences·Phase 4·NCT07246629·214 enrolled

Cardiac Surgery1 trial

Relationship Between Perioperative Carotid Blood Flow Monitoring and Cerebral Function Protection in Cardiac Surgery

Completed·NNanjing First Hospital, Nanjing Medical University·N/A·NCT05586347·64 enrolled

Aneurysm1 trial

A Safety and Efficacy Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping

Completed·BBIT Pharma GmbH·Phase 2·NCT04269408·41 enrolled

Coronary Microvascular Dysfunction1 trial

Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

Withdrawn·TThomas Jefferson University·Phase 1·NCT03184155

Intravenous1 trial

Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department

Completed·TThe Cleveland Clinic·Phase 4·NCT00765648·226 enrolled

Hemorrhage1 trial

Antihypertensive Treatment in Acute Cerebral Hemorrhage

Completed·UUniversity of Minnesota·Phase 1·NCT00415610·60 enrolled

Blood Pressure1 trial

Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

Completed·TThe George Institute·N/A·NCT00226096·404 enrolled

Hemodynamic1 trial

Effects of Different Kinds of Hypotensive Drugs on Dynamic Hemodynamic Changing in Patients Under Surgeries

Completed·—·N/A·NCT03497351·59 enrolled

Acute Respiratory Failure1 trial

Effect of Nicardipine and Nitroglycerin on the Ventilation-Perfusion Ratio in Patients With Acute Respiratory Failure Using Electrical Impedance Tomography: A Prospective Pilot Study

Not yet recruiting·FFirst Affiliated Hospital of Wannan Medical College·Preclinical·NCT07603037·12 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 21, 1988

CARDENE

NDA NDA019488

Jan 30, 1992

CARDENE

NDA NDA019734

Feb 21, 1992

CARDENE SR

NDA NDA020005

Jul 24, 2008

NICARDIPINE HYDROCHLORIDE

NDA NDA022276

Nov 17, 2009

NICARDIPINE HYDROCHLORIDE

NDA NDA078405

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Nicardipine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cardene drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nicardipine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nicardipine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA078405). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cardene. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Sun Pharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Voltage-Gated L-Type Calcium Channel Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Sun Pharma

Patent Landscape[6]

Patent Cliff

Apr 18, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8455524Apr 18, 2027

7659291Apr 18, 2027

11547758Apr 18, 2027

10758616Apr 18, 2027

9364564Dec 26, 2027

1 more patents

7612102Dec 26, 2027

Related News