Delving into the Latest Updates on Nicardipine Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

NicaPlant, Nicardipine, Nicardipine Hydrochloride QR Microgranules

+ [30]

Target

Cav2.1

Action

inhibitors

Mechanism

Cav2.1 inhibitors(calcium voltage-gated channel subunit alpha1 A inhibitors)

Therapeutic Areas

Nervous System DiseasesCardiovascular Diseases

Active Indication

Angina PectorisHypertensionEssential Hypertension

Inactive Indication

Angina, Stable

Originator Organization

CHIESI Farmaceutici SpA

Active Organization

LTL Pharma Co., Ltd.

Pendopharm, Inc.

Jiangsu Desano Pharmaceutical Co. Ltd.

+ [1]

Inactive Organization

Chiesi USA, Inc

Drug Highest PhaseApproved

First Approval Date

Japan (01 May 1981),

Essential Hypertension

RegulationOrphan Drug (European Union)

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Structure/Sequence

Molecular FormulaC26H29N3O6

InChIKeyZBBHBTPTTSWHBA-UHFFFAOYSA-N

CAS Registry55985-32-5

View All Structures (2)

This is a single-center double blind, placebo controlled study of patients undergoing a cardiac catheterization where the need for a percutaneous coronary intervention (PCI) is anticipated or will be determined during the early diagnostic phase. The study will assess the use of intracoronary nicardipine vs. sterile saline injection in reducing the index measurement of microcirculatory resistance (IMR). Fifty consecutive patients presenting to the Thomas Jefferson University (TJUH) Cardiac Catheterization lab will be randomized in a 1:1 fashion to receive either intracoronary nicardipine or sterile saline injection prior to PCI. IMR values will be assessed pre and post procedure. Data on clinical outcomes and adverse events will be collected by phone at 30 days and 1 year following the procedure.

Start Date01 Dec 2025

Sponsor / Collaborator

Thomas Jefferson University

NCT06093893

/ Not yet recruitingPhase 4IIT

A Comparison of Dexmedetomidine, Nicardipine, and Labetalol to Induce Hypotensive Anesthesia and Their Effects on Surgeon Visibility, Blood Loss, Hemodynamic Parameters, Operation Time, and Adverse Events During Orthognathic Surgery

The overall objective of this double blinded, randomized controlled trial (RCT) is to compare specific outcomes of three medications (Dexmedetomidine, Nicardipine, and Labetalol) which are routinely used to lower blood pressure used during general anesthesia for orthognathic (jaw) surgery. The outcome measures for the study will be surgical field visibility, estimated blood loss, hemodynamic parameters, operation time, and adverse events.
The specific objectives of this study are to compare:
1. Dexmedetomidine, Nicardipine, and Labetalol's effect on the quality of the surgical field. (Primary Outcome)
2. Dexmedetomidine, Nicardipine, and Labetalol's effect on estimated blood loss.
3. Dexmedetomidine, Nicardipine, and Labetalol's effect on hemodynamic parameters including systolic blood pressure, mean arterial pressure, and heart rate.
4. Dexmedetomidine, Nicardipine, and Labetalol's effect on operation time.
5. Dexmedetomidine, Nicardipine, and Labetalol's effect on adverse events.
The investigators will evaluate healthy adult male and female patients who require jaw surgery at Boston Medical Center. The anticipated 90 participants will be randomized into three groups: ) A Labetalol group in which the patients receive hypotensive anesthesia with the aid of labetalol, 2) A Nicardipine group in which the patients receive hypotensive anesthesia with the aid of nicardipine, and 3) A Dexmedetomidine group in which the patients receive hypotensive anesthesia with the aid of dexmedetomidine.
The time it will take for each individual participant ranges from 1-3 months. This time includes the pre-operative visit, the surgical procedure, a 1-week post-operation visit, and then followed for 30 days post-operatively after which the patient's participation in the study will conclude.

Start Date01 Mar 2025

Sponsor / Collaborator

Boston Medical Center

ChiCTR2400085752

/ RecruitingPhase 4IIT

Clinical study of the effect of nicardipine atropine pretreatment on hemodynamic changes during the treatment of trigeminal neuralgia by percutaneous microballoon compression

Start Date20 Jun 2024

Sponsor / Collaborator

Liaoning People's Hospital

100 Clinical Results associated with Nicardipine Hydrochloride

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100 Translational Medicine associated with Nicardipine Hydrochloride

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100 Patents (Medical) associated with Nicardipine Hydrochloride

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8,605

Literatures (Medical) associated with Nicardipine Hydrochloride

01 Apr 2025·The American Journal of Emergency Medicine

Emergency medicine updates: Sympathetic crashing acute pulmonary edema

Review

Author: Long, Brit ; Gottlieb, Michael ; Brady, William J

INTRODUCTIONPatients with heart failure exacerbation can present in a variety of ways, including sympathetic crashing acute pulmonary edema (SCAPE). Emergency physicians play a key role in the diagnosis and management of this condition.OBJECTIVEThis narrative review evaluates key evidence-based updates concerning the diagnosis and management of SCAPE for the emergency clinician.DISCUSSIONSCAPE is a subset of acute heart failure, defined as a patient with sudden, severe pulmonary edema and hypertension, resulting respiratory distress, and hypoxemia. This is associated with significantly elevated afterload with fluid maldistribution into the pulmonary system. Evaluation and resuscitation should occur concurrently. Laboratory assessment, electrocardiogram, and imaging should be obtained. Point-of-care ultrasound is a rapid and reliable means of confirming pulmonary edema. Management focuses on respiratory support and vasodilator administration. Noninvasive positive pressure ventilation (NIPPV) with oxygen support is associated with reduced need for intubation, improved survival, and improved respiratory indices. If the patient does not improve or decompensates on NIPPV, endotracheal intubation is recommended. Rapid reduction in afterload is necessary, with the first-line medication including nitroglycerin. High-dose bolus nitroglycerin is safe and effective, followed by an infusion. If hypertension is refractory to NIPPV and high-dose nitroglycerin, other agents may be administered including clevidipine or nicardipine. Angiotensin-converting enzyme inhibitors such as enalaprilat are an option in those with normal renal function and resistant hypertension. Diuretics may be administered in those with evidence of systemic volume overload (e.g., cardiomegaly, peripheral edema, weight gain), but should not be routinely administered in patients with SCAPE in the absence of fluid overload. Caution is recommended in utilizing opioids and beta blockers in those with SCAPE.CONCLUSIONAn understanding of the current literature concerning SCAPE can assist emergency clinicians and improve the care of these patients.

01 Apr 2025·Journal of Pharmacy Practice

Impact of Clevidipine Versus Nicardipine on Time in Range when Lowering Blood Pressure

Article

Author: Levine, Alexander R. ; Armstrong, Kaitlin J. ; Horsfield, Michelle ; Shepard, Kelly ; O’Sullivan, David M. ; Zeiner, Abigail L.

Background: Two intravenous medications commonly used as first-line therapy for rapid blood pressure control are nicardipine and clevidipine, both of which are available as titratable infusions. Despite pharmacokinetic differences, no data clearly support a preferred agent. Objective: To evaluate efficacy and safety outcomes associated with current use of these medications across a variety of indications in a hospital system. Methods: This study was a multi-center, retrospective chart review conducted within a hospital system from June 1, 2020 to June 30, 2021. Records of patients were matched in a one-to-one fashion based on indication for blood pressure control and similar pre-intervention blood pressure. The primary outcome was time within target blood pressure range. Results: A total of 569 patients were screened, resulting in 100 matched pairs. The percent of time in blood pressure range was similar between nicardipine and clevidipine when stratified by location of care (51.5% vs 51.7%, P = 0.970 for ED; 68.1% vs 68.8%, P = 0.913 for ICU). Overall, the median (IQR) time to target blood pressure range was significantly faster with clevidipine than nicardipine [20 (7-43) min. vs 34 (14.5-57) min., resp.; P = 0.013). There were numerically higher rates of hypotension with nicardipine than clevidipine, but this finding was not significant (17% vs 10%; P = 0.093). Conclusions: This study shows a statistically significant difference in time to target blood pressure range with clevidipine compared to nicardipine. Although there was no difference in the percentage of time in blood pressure range, nicardipine was associated with a non-significant increase in the incidence of hypotension.

07 Mar 2025·American Journal of Health-System Pharmacy

Correction to: Comparison of clevidipine vs nicardipine in the treatment of hypertensive urgency and emergency in critically ill patients

1

News (Medical) associated with Nicardipine Hydrochloride

25 Sep 2023

·www.prnewswire.com

Senores Pharmaceuticals, Inc. announces the launch of Nicardipine Hydrochloride Capsules USP, 20 mg and 30 mg in the U.S. market

ATLANTA, Sept. 25, 2023 /PRNewswire/ -- Senores Pharmaceuticals, Inc. announced the launch of Nicardipine Hydrochloride Capsules USP, 20 mg and 30 mg, a bioequivalent and therapeutically equivalent to Cardene Capsules, 20 mg and 30 mg, of Chiesi USA, Inc. in the U.S. market. The product will be marketed by Burel Pharmaceuticals, LLC. Nicardipine Hydrochloride Capsules USP are indicated for the management of patients with chronic stable angina (effort-associated angina) and for the treatment of hypertension. Continue Reading Senores Pharmaceuticals, Inc. announces the launch of Nicardipine Hydrochloride Capsules USP, 20 mg and 30 mg in the U.S. market (PRNewsfoto/Senores Pharmaceuticals Inc.) Senores Pharmaceuticals, Inc. has been granted a Competitive Generic Therapy (CGT) designation for Nicardipine Hydrochloride Capsules USP, 20 mg and 30 mg. Therefore, with this approval, Senores is eligible for 180 days of CGT exclusivity upon commercial marketing. "We are pleased to announce the commercial launch of Nicardipine Hydrochloride Capsules in the U.S. through our marketing partner," stated Dhananjay Barot, Director, Senores Pharmaceuticals, Inc. "At Senores, the pursuit for better healthcare drives our actions. With this launch and an ever-expanding product portfolio, we envision a healthier tomorrow," stated S Shah, Managing Director, Senores Pharmaceuticals Limited. About Senores Pharmaceuticals, Inc. Senores Pharmaceuticals, Inc., based in Georgia, USA is one of the fastest-growing pharmaceutical companies in the U.S. market. The company has more than 20 products commercially launched or filed with the USFDA. For more information about Senores Pharmaceuticals, Inc., please visit Senores Pharmaceuticals, Inc. Georgia USA Photo: SOURCE Senores Pharmaceuticals Inc.

Drug ApprovalBreakthrough Therapy

100 Deals associated with Nicardipine Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D00617	Nicardipine Hydrochloride	C08CA04	DB00622

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Angina Pectoris	China	Jiangsu Desano Pharmaceutical Co. Ltd.	01 Jan 1988
Hypertension	China	Jiangsu Desano Pharmaceutical Co. Ltd.	01 Jan 1988
Essential Hypertension	Japan	LTL Pharma Co., Ltd.	01 May 1981

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2024	Not Applicable	-	-	Intracoronary Nicardipine	ghxzfvzkgx(qcdexpskgs) = owqvouzwhv ewtpxeceui (ampmmgmkzd, 62.1)	-	31 Aug 2024
				Intracoronary Papaverine	ghxzfvzkgx(qcdexpskgs) = uobbzeqnae ewtpxeceui (ampmmgmkzd, 14.3)
NCT04269408 (Pubmed \| JAMA Neurol) Manual	Phase 3	Aneurysm, Intracranial Berry, 1	41	Nicardipine release implants + standard of care	dosjkzqpyn(thxxpndqjq) = wmazuxgmes lahugkjstb (qpyzbggmac ) View more	Positive	19 Aug 2024
				Nicardipine (Standard of care)	dosjkzqpyn(thxxpndqjq) = ftsiayrqix lahugkjstb (qpyzbggmac ) View more
NCT04116112 (BEST-II, CTgov)	Phase 2	Thrombosis \| Stroke	120	Labetalol+Nicardipine+Hydralazine (Higher Systolic Blood Pressure (SBP) Target)	ltxywqqfxd(xiaeumvefd) = ikmposlqxg qqwungcuzc (ctpexikpjx, qcbfvtblsx - ekmftfmmre) View more	-	12 Oct 2023
				Labetalol+Nicardipine+Hydralazine (Lower SBP (<160 mmHg) Target)	ltxywqqfxd(xiaeumvefd) = kvtkpqazla qqwungcuzc (ctpexikpjx, hwwbppwyzq - fgoslvakcj) View more
P13-7.005 (AAN2023)	Not Applicable	Vasospasm, Intracranial	7	Intrathecal Nicardipine	sygeqgvqwo(uzlhxdxquh) = one patient had brief, elevated intracranial pressure spikes with ITn rzktmfsyjd (ygwpupmtvr ) View more	-	25 Apr 2023
ISC2023	Not Applicable	Cerebral Hemorrhage	370	Intravenous Nicardipine	fawlxtvngd(lhskrdwsdw) = cxlrslonhk zrkqryxqvl (uhrbbkfjze )	-	01 Feb 2023
SAT-460 (ENDO2020)	Not Applicable	Myxedema coma	1	Levothyroxine	nevpuvnqfs(yfqcqmskdp) = zokbwwemwi nxffhyrmdu (mimgvnkzin ) View more	Positive	08 May 2020
				Dopamine	(nbzjgwmvrv) = symyuceffw punucphmhk (qeecsulzpr )
ISC2020	Not Applicable	Subarachnoid Hemorrhage	-	IT Nicardipine	qldmesmpjs(woiwcxclzl) = tnxcxrknnr acumzdusng (rnwugabycn )	-	01 Feb 2020
ISC2019	Not Applicable	-	205	No antihypertensive	bygmmdcuiu(jyokhztzfh) = kcmybiqwyb fyzevfuawk (ltwggwmveb )	-	01 Feb 2019
				Labetalol	soqmqnoxaq(gcicsmnvwd) = kzyalmulck ekffkzzmeq (wyeeqjizdi ) View more
ESC2018	Not Applicable	-	-	Nicardipine	sltrwkoptd(cgustupwcg) = akejbihlwh expbqlxtbq (qkkhboogcl ) View more	-	20 Apr 2018
ISC2018	Not Applicable	Cerebral Hemorrhage	59	i.v. Nicardipine only	(lphqhpllge) = bradycardia occurred in three patients of combination treatment group xneavmpwpm (yyklcrjrpq )	-	22 Jan 2018
				Bisoprolol transdermal patch and i.v. Nicardipine