Drugs / Nicardipine
Nicardipine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CARDENE | — | 1988-12-21 | fda.gov ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03184155 | Dec 2025 → Dec 2026 | coronary artery disorder | Thomas Jefferson University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 12 trials | ||||||
| Phase 1 | NCT03098680 | Apr 2017 → Feb 2020 | cardiovascular disorder | Cambridge University Hospitals NHS Foundation Trust | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00415610 | Jul 2005 → Sep 2007 | hypertensive disorder, intracerebral hemorrhage | University of Minnesota | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT04269408 | Apr 2020 → May 2022 | acquired aneurysmal subarachnoid hemorrhage | BIT Pharma GmbH | Completed | Met primary |
| Phase 2 | NCT01810302 | Aug 2013 → Jan 2014 | intracranial vasospasm | University of Florida | Terminated | No outcome recorded |
| Phase 2 | NCT00508118 | Jan → Apr 2008 | thoracic aortic aneurysm | Duke University | Terminated | No outcome recorded |
| Phase 2 | NCT00528827 | Sep 2007 → Dec 2008 | hypertensive disorder | Facet Biotech | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07302919 | Feb 2026 → Jun 2028 expected | hepatocellular carcinoma | University Hospital, Basel, Switzerland | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04538534 | Nov 2020 → Feb 2022 | — | Pr. Semir Nouira | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT07246629 | Jan 2027 → Mar 2028 expected | acquired aneurysmal subarachnoid hemorrhage | Wake Forest University Health Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07044232 | Oct 2025 → Sep 2026 overdue | intracerebral hemorrhage | Aarhus University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06093893 | Mar 2025 → Jan 2026 | — | Boston Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT04330300 | Apr 2020 → Jul 2021 | COVID-19, essential hypertension | National University of Ireland, Galway, Ireland | Suspended | No outcome recorded Stop: Business |
| Phase 4 | NCT01872039 | Mar 2013 → Jan 2014 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT01171911 | Oct → Dec 2010 | acute coronary syndrome, coronary stenosis | Nanjing Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT00325793 | Jan 2004 → ? | hypertensive disorder | OSF Healthcare System | Unknown | No outcome recorded |
| Phase not applicable11 trials · 1 met primary | ||||||
| — | NCT07603037 | Jul 2026 → Jul 2027 expected | acute respiratory failure, aortic disorder, hypertensive disorder | First Affiliated Hospital of Wannan Medical College | Not yet recruiting | No outcome recorded |
| — | NCT07659496 | Jun → Aug 2026 overdue | otorhinolaryngologic disease | Dicle University | Not yet recruiting | No outcome recorded |
| — | NCT07660562 | Jun → Jul 2026 overdue | nasal disorder | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07364201 | Nov 2025 → Jan 2026 | hemorrhagic stroke, hypertensive disorder | Universitas Sumatera Utara | Completed | No outcome recorded |
| — | NCT06329635 | May 2024 → May 2026 overdue | acquired aneurysmal subarachnoid hemorrhage, intracranial vasospasm | The Affiliated Hospital Of Guizhou Medical University | Recruiting | No outcome recorded |
| — | NCT05920538 | Mar → Dec 2023 | — | Mahidol University | Unknown | No outcome recorded |
| — | NCT05586347 | Apr → Sep 2022 | — | Nanjing First Hospital, Nanjing Medical University | Completed | No outcome recorded |
| — | NCT03497351 | Apr 2018 → Jan 2019 | — | Chinese PLA General Hospital | Completed | No outcome recorded |
| — | NCT03207100 | Dec 2017 → Feb 2021 | — | Hong Yang | Completed | No outcome recorded |
| — | NCT02116868 | Mar 2014 → Mar 2018 | — | Central Hospital, Nancy, France | Completed | Met primary |
| — | NCT01175746 | Aug 2010 → Jun 2011 | — | Yonsei University | Completed | No outcome recorded |
| Comparator or background therapy20 trials | ||||||
| Phase 0 | NCT05625503 Comparator | Dec 2022 → Dec 2023 | vascular disorder | University of Illinois at Chicago | Completed | No outcome recorded |
| Phase 1 | NCT01951950 Comparator | Sep 2013 → May 2014 | brain neoplasm | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT04116112 Background | Jan 2020 → Jul 2022 | stroke disorder | University of Cincinnati | Completed | No outcome recorded |
| Phase 3 | NCT06677970 Comparator | Oct 2024 → Dec 2029 expected | ischemic stroke | Yonsei University | Recruiting | No outcome recorded |
| Phase 3 | NCT04670809 Comparator | Jul 2020 → Aug 2021 | hypertensive disorder | Nanjing Yoko Biomedical Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT03622060 Comparator | Jun 2018 → May 2019 | arterial occlusion, isoproterenol-mediated vasodilatation, radial neuropathy | Hermina Heart Center Kemayoran | Completed | No outcome recorded |
| Phase 3 | NCT02558023 Comparator | Sep 2015 → Aug 2020 | preeclampsia | University Hospital, Strasbourg, France | Terminated | No outcome recorded |
| Phase 3 | NCT01176565 Comparator | May 2011 → Dec 2015 | intracerebral hemorrhage | University of Minnesota | Terminated | No outcome recorded |
| Phase 3 | NCT00803634 Comparator | Dec 2008 → Feb 2012 | heart failure, hypertensive disorder | The Medicines Company | Completed | No outcome recorded |
| Phase 3 | NCT00409253 Comparator | Jun 2007 → Jun 2010 | preeclampsia | University Hospital, Strasbourg, France | Unknown | No outcome recorded |
| Phase 3 | NCT00093925 Comparator | May 2004 → Jul 2006 | hypertensive disorder | The Medicines Company | Completed | No outcome recorded |
| Phase 4 | NCT07277283 Comparator | Feb → Jul 2025 | hypertensive disorder, ischemic stroke | Haseki Training and Research Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04205305 Comparator | Jun 2020 → Jul 2023 | ischemic stroke | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT01996436 Comparator | Aug 2016 → Apr 2024 | intracranial vasospasm | Peng Roc Chen, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01634594 Comparator | Jun 2012 → Feb 2013 | autosomal dominant prognathism | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT02271191 Comparator | May 2012 → Jan 2013 | spinal stenosis | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT00765648 Comparator | Oct 2008 → Jan 2010 | hypertensive urgency | The Cleveland Clinic | Completed | No outcome recorded |
| — | NCT01041066 Comparator | Sep → Dec 2009 | — | Seoul National University Bundang Hospital | Unknown | No outcome recorded |
| — | NCT00226096 Background | Nov 2005 → Sep 2007 | intracerebral hemorrhage | The George Institute | Completed | No outcome recorded |
| — | NCT00684489 Comparator | Sep 2003 → Mar 2005 | essential hypertension | Medical University of South Carolina | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2022-12-19 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules, 20 mg and 30 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules, 20 mg and 30 mg |
| 2009-11-18 | Wockhardt | Regulatory Wockhardt launches anti – hypertensive drug Nicardipine injections in USA wockhardt.com ↗
Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing the 25mg/10 ml injection of Nicardipine HCl, which is used for short-term management of hypertension or increased blood pressure. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-12-19 | Glenmark Pharmaceuticals Ltd. India | Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules, 20 mg and 30 mg glenmarkpharma.com ↗ |
| 2009-11-18 | Wockhardt | Wockhardt launches anti – hypertensive drug Nicardipine injections in USA wockhardt.com ↗ |
| 2008-09-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Introduces Nicardipine HCL Injection in The United States; First Alternative to Cardene® I.V. tevapharm.com ↗ |
Evidence & citations 40 cited values
Every value below carries the sentence it was read from. 50 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nicardipine | “METHODS: This is a multicenter, randomized, single-blind, parallel, positive-controlled, noninferiority phase III clinical trial comparing the efficacy and safety of...” PMID 41231022 ↗ Oct 202544“Amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nimodipine, nitrendipine, verapamil” NCT04330300 ↗ “Continuous infusion of nicardipine at 1 ~ 7 mcg/kg/min with sevoflurane concentration of 1 MAC” NCT01634594 ↗ “Urapidil, nicardipine, and labetalol will be used in this group.” NCT03207100 ↗ “felodipine, isradipine, nicardipine, nifedipine, nisoldipine” NCT00684489 ↗ “the active ingredient nicardipine in the tumor” NCT07302919 ↗ “200 microgram intraraterial Nicardipine” NCT03622060 ↗ “nicardipine” NCT00803634 ↗ “Nicardipine” NCT02116868 ↗ |
| Known as | Barizin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Cardene | “Intravenous infusion of nicardipine (Cardene) for control of hypertension is FDA approved.” NCT00325793 ↗ |
| Known as | Cardene sr | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Cardepine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Dacarel | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Lecibra | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Lecibral | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Lescodil | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Loxen | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Ncardipine Hydrochloride Injection | “Dilute the Ncardipine Hydrochloride Injection to 0.1mg/ml. Initiate the intravenous infusion at 0.5μg/(kg•min).” NCT04670809 ↗ |
| Known as | Nerdipina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | NIC | “Clevidipine is a novel, rapidly acting dihydropyridine L-type calcium channel blocker with an ultrashort half-life that decreases arterial blood pressure (BP). The Evaluation...” PMID 18806012 ↗ Oct 20081“loaded with 33mg/ml doxorubicin (Dox) and 0.3mg/mL nicardipine (Nic)” NCT07302919 ↗ |
| Known as | Nicant | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | NicaPlant | “NicaPlant®” NCT04269408 ↗ |
| Known as | Nicapress | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Nicardal | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Nicardipine (stn) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Nicardipine hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | NICARDIPINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Nicardipino | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Nicarpin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Nicodel | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Nimicor | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | NSC-757855 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Perdipina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Perdipine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01872039 ↗ |
| Known as | Perpidine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Ranvil | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Ridene | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | RS-69216 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | RS-69216-XX-07-0 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Rycarden | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Rydene | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Vasodin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | Vasonase | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Known as | YC-93 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1484 ↗ |
| Action | Inhibit | “Nicardipine, one calcium channel blocker” NCT01171911 ↗ |
| Modality | Small molecule | — CHEMBL1484 ↗ |
| Route | Intravenous | “was administered intravenously as per institutional practice” NCT00093925 ↗ |