Delving into the Latest Updates on Nicardipine Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

NicaPlant, Nicardipine, Nicardipine hydrochloride (JP17/USAN)

+ [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 FormulaC26H30ClN3O6

InChIKeyAIKVCUNQWYTVTO-UHFFFAOYSA-N

CAS Registry54527-84-3

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

/ 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 Date04 Mar 2025

Sponsor / Collaborator

Boston Medical Center

NCT06677970

/ RecruitingPhase 3IIT

Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2)

Though intravenous thrombolysis has been shown to improve symptoms in acute ischemic stroke patients, the recanalization rate remains low (22.6%) and only around 30% of patients benefit from the treatment. Recently, endovascular thrombectomy using stent retrievers or catheters has proven to be more effective, with a success rate of nearly 80%. However, only 50% of patients experience clinical improvement, highlighting the need for new treatment strategies to enhance outcomes. Current guidelines recommend maintaining systolic blood pressure (BP) below 180 mmHg after thrombectomy, but there is a lack of evidence regarding optimal blood pressure management post-reperfusion.
Four randomized clinical trials, including the OPTIMAL-BP trial, have examined blood pressure control following thrombectomy. Meta-analyses showed that intensive BP lowering did not reduce symptomatic hemorrhage and was associated with worse functional outcomes at 3 months. Specifically, lowering BP too aggressively after successful reperfusion could worsen outcomes by reducing perfusion to the ischemic penumbra. Therefore, this study will investigate whether a more targeted blood pressure elevation strategy could improve patient prognosis compared to standard BP control in those with post-thrombectomy systolic BP below 140 mmHg.
This is a prospective, randomized, open-label trial with blinded endpoint assessment (PROBE) design, aimed at comparing intensive and standard BP control strategies in acute ischemic stroke patients. Participants will be randomized 1:1 into either an intensive BP control group (targeting a 20% systolic BP increase, capped at 180 mmHg) or a standard BP control group (systolic BP below 180 mmHg).

Start Date01 Dec 2024

Sponsor / Collaborator

Yonsei University

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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8,264

Literatures (Medical) associated with Nicardipine Hydrochloride

01 May 2025·BRAIN RESEARCH BULLETIN

Remifentanil stabilizes hemodynamics with modulating subthalamic beta oscillation during deep brain stimulation

Article

Author: Chen, Shin-Yuan ; Pan, Yu-Shen ; Lin, Sheng-Huang ; Huang, Pin-Han ; Wang, Jen-Hung

General anesthesia is a promising method for advanced Parkinson's disease patients unable to tolerate awake deep brain stimulation (DBS) surgery. However, anesthetic agents must be kept at relatively low levels to preserve the quality of intraoperative microelectrode recordings, which can lead to unstable hemodynamic conditions. Remifentanil, with its sedative and analgesic properties, could offer a solution. This study retrospectively analyzed microelectrode recordings of the subthamic nucleus (STN) and hemodynamic responses in patients with Parkinson's disease who received deep brain stimulation surgery under controlled volatile anesthesia with/without remifentanil infusion. From October 2017 to June 2019, 24 patients with Parkinson's disease who received bilateral subthalamic deep brain stimulation surgery in Hualien Tzu Chi Hospital with (n = 12) or without remifentanil infusion (n = 12) were enrolled in this study. We conducted a comprehensive spike analysis, examining frequency, inter-spike interval properties, modified burst index, modified pause index, and modified pause ratio. Additionally, we performed spike frequency spectrum analysis to investigate oscillatory activity in high-frequency, multi-unit, and single-unit neuronal activity. Our findings revealed no differences in STN firing characteristics, while a significant decrease in high beta power was observed in multi-unit activity in the remifentanil group. Notably, nine patients in the non-remifentanil group required additional nicardipine, whereas none in the remifentanil group did. Conclusively, for patients with advanced Parkinson's disease sensitive to external stimulation at low minimum alveolar concentration, remifentanil co-administration is an option to avoid unstable hemodynamic conditions during subthalamic deep brain stimulation surgery.

01 Apr 2025·AMERICAN JOURNAL OF EMERGENCY MEDICINE

Emergency medicine updates: Sympathetic crashing acute pulmonary edema

Review

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

INTRODUCTION:

Patients 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.

OBJECTIVE:

This narrative review evaluates key evidence-based updates concerning the diagnosis and management of SCAPE for the emergency clinician.

DISCUSSION:

SCAPE 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.

CONCLUSION:

An 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. ; O’Sullivan, David M. ; Zeiner, Abigail L. ; Shepard, Kelly ; Armstrong, Kaitlin J. ; Horsfield, Michelle

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.

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, Stable	United States	Chiesi USA, Inc	21 Dec 1988
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	sqtydmnlej(vrebqnlyoe) = bnpidzbmni unilsxhzlp (utbwlmffoc, 62.1)	-	31 Aug 2024
				Intracoronary Papaverine	sqtydmnlej(vrebqnlyoe) = ezdykjegvi unilsxhzlp (utbwlmffoc, 14.3)
NCT04269408 (Pubmed \| JAMA Neurol) Manual	Phase 3	Aneurysm, Intracranial Berry, 1	41	Nicardipine release implants + standard of care	wmfvwxsgqg(yquksjgvbj) = dhxvfkplbk cxkywvfxsz (qemzocjkoz ) View more	Positive	19 Aug 2024
				Nicardipine (Standard of care)	wmfvwxsgqg(yquksjgvbj) = sllwrkgrxe cxkywvfxsz (qemzocjkoz ) View more
P10-5.019 (AAN2024)	Not Applicable	Aneurysm, Intracranial Berry, 1	14	Intrathecal Nicardipine	ququwxaagd(aegteijkxf) = xjrobzogty zbhgbwnuts (poghuloxxp ) View more	Positive	09 Apr 2024
NCT04116112 (BEST-II, CTgov)	Phase 2	Thrombosis \| Stroke	120	Labetalol+Nicardipine+Hydralazine (Higher Systolic Blood Pressure (SBP) Target)	lwgejvhcsw(brkygzkcmg) = rugylyercl bfumlvyllu (xjrwdvqiek, ueebsyxvzt - oiznpxlfmz) View more	-	12 Oct 2023
				Labetalol+Nicardipine+Hydralazine (Lower SBP (<160 mmHg) Target)	lwgejvhcsw(brkygzkcmg) = ciqgcqcxuw bfumlvyllu (xjrwdvqiek, bclhaicpey - nqkazlbozj) View more
P13-7.005 (AAN2023)	Not Applicable	Vasospasm, Intracranial	7	Intrathecal Nicardipine	eawwohjzmf(lguvxdosni) = one patient had brief, elevated intracranial pressure spikes with ITn qxcxtmvafm (rpqrobgdyb ) View more	-	25 Apr 2023
ISC2023	Not Applicable	Cerebral Hemorrhage	370	Intravenous Nicardipine	lmvobflael(whpmromxee) = heavscmymv xwsmetwych (oxdpfxrqpr )	-	01 Feb 2023
ISC2020	Not Applicable	Subarachnoid Hemorrhage	-	IT Nicardipine	bjmsyvdpbo(xhgedctfuf) = omyvnqopil wfrawoqnjy (uekyjgnljf )	-	01 Feb 2020
ISC2019	Not Applicable	-	205	No antihypertensive	mcjcmbpoem(ulbtecotld) = gveehxkttr pydfkdkwjo (covudctxah )	-	01 Feb 2019
				Labetalol	hqfdgdwmik(hcmlujixma) = zuxtmjkfkx rownuhjcpu (bhqtzowomo ) View more
ESC2018	Not Applicable	-	-	Nicardipine	lfsqbqvhcf(gfyigovjui) = xjvzmcmeap oiavbbvucv (ieprzazxxf ) View more	-	20 Apr 2018
ISC2018	Not Applicable	Cerebral Hemorrhage	59	i.v. Nicardipine only	pedmtlfzyh(xrecpygmqn) = bradycardia occurred in three patients of combination treatment group oxbfyfkvec (jplbddghkt )	-	22 Jan 2018
				Bisoprolol transdermal patch and i.v. Nicardipine