Delving into the Latest Updates on Nicardipine Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Nicardipine, Nicardipine hydrochloride (JP17/USAN), Nicardipine Hydrochloride and Glucose

+ [29]

Target

Cav2.1

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

JP (01 May 1981),

Essential Hypertension

RegulationOrphan Drug (EU)

Login to view timeline

Structure

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 / 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 Jan 2025

Sponsor / Collaborator

Boston Medical Center

NCT06677970 / Not yet 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

Login to view more data

100 Translational Medicine associated with Nicardipine Hydrochloride

Login to view more data

100 Patents (Medical) associated with Nicardipine Hydrochloride

Login to view more data

8,895

Literatures (Medical) associated with Nicardipine Hydrochloride

31 Dec 2024·PHARMACEUTICAL BIOLOGY

Optimization of a sensitive and reliable UPLC-MS/MS method to simultaneously quantify almonertinib and HAS-719 and its application to study the interaction with nicardipine

Article

Author: Shen, Yuxin ; Chen, Dongxin ; Chen, Xiaohai ; Liu, Ya-nan ; Xia, Hailun ; Chen, Jie ; Xu, Ren-ai

CONTEXT:

Almonertinib is primarily metabolized by CYP3A4, so it could interact with a variety of drugs metabolized by CYP3A4, leading to the changes of systemic exposure.

OBJECTIVE:

For the purpose of this experiment, an ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) assay with accuracy and simplicity was optimized and fully validated for the simultaneous quantitative determination of almonertinib and its metabolite HAS-719, and drug-drug interactions (DDI) between almonertinib and nicardipine in vivo and in vitro was researched.

MATERIALS AND METHODS:

Detection of analytes was achieved by UPLC-MS/MS coupled with multiple reaction monitoring (MRM) in the positive ion mode with ion transitions of m/z 526.01 → 72.04 for almonertinib, m/z 512.18 → 455.08 for HAS-719 and m/z 447.16 → 128.11 for IS, respectively.

RESULTS:

There was favourable linearity in the 0.5-200 ng/mL calibration range for almonertinib and 0.5-100 ng/mL for HAS-719. The lower limit of quantification (LLOQ) for both analytes was 0.5 ng/mL. The precision, accuracy, stability, matrix effect and extraction recovery required for methodological validation were consistent with the requirements of FDA guideline. Then, the UPLC-MS/MS assay was employed successfully on the interactions of almonertinib and nicardipine in vivo and in vitro. The half-maximal inhibitory concentration (IC₅₀) was 1.19 μM in rat liver microsomes (RLM), where nicardipine inhibited the metabolism of almonertinib with a mixed inhibitory mechanism. In pharmacokinetic experiments of rats, it was observed that nicardipine could significantly alter the pharmacokinetic profiles of almonertinib, including AUC_(0-∞), AUC_(0-t) and C_max, but had no effect on the metabolism of HAS-719.

CONCLUSION:

According to the findings, it was indicated that nicardipine could inhibit the metabolism of almonertinib in vitro and in vivo.

31 Dec 2024·Hypertension in pregnancy

Anti-hypertensive therapy for preeclampsia: a network meta-analysis and systematic review

Review

Author: Jiang, Ruoan ; Li, Na ; Wang, Ting ; Yao, Yingsha ; Xu, Ting

BACKGROUND:

Preeclampsia (PE) is a pregnancy disorder that represents a major cause of maternal and perinatal morbidity and mortality.

METHODS:

This network meta-analysis was registered with PROSPERO. We searched the PubMed, ClinicalTrials.gov. and Embase databases for studies published from inception to the 31^st of March 2023. RevMan5.3 software provided by the Cochrane Collaboration was used for direct meta-analysis (DMA) statistical analysis. Funnel maps, network meta-analysis (NMA), the surface under the cumulative ranking curve (SUCRA) to rank the different interventions and publication bias were generated by STATA 17.0 software.

RESULTS:

We included eight randomized controlled trials (RCTs) involving a total of 1192 women with PE; two studies were of high quality and six were of moderate quality. Eight interventions were addressed in the NMA. In the DMA, we found that blood pressure in the Ketanserin group were significantly higher than those in the Nicardipine group. NMA showed that blood pressure in the Dihydralazine group was significantly higher than that in the Methyldopa, Labetalol, Nicardipine and Diltiazem groups. And the blood pressure in the Labetalol group was significantly lower than that in the Nicardipine group. SUCRA values showed that Diltiazem was more effective in lowering blood pressure than other drugs looked at in this study.

CONCLUSION:

According to the eight RCTs included in this study, Diltiazem was the most effective in reducing blood pressure in PE patients; Labetalol and Nicardipine also had good effects. Diltiazem is preferred for the treatment of patients with severe PE and high blood pressure.

05 Dec 2024·AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY

Use of dual intraventricular vasodilators for refractory cerebral vasospasm in a pediatric patient with traumatic subarachnoid hemorrhage: A case report

Article

Author: Francois, Yvonne ; Asbury, William H ; Cawley, C Michael ; Javellana, Marion ; Samuels, Owen B ; Howard, Brian M ; Pimentel, Cederic ; Kandiah, Prem ; Kinariwala, Jay P

Abstract:

Purpose:

Subarachnoid hemorrhage (SAH) is a rare but life-threatening clinical event for pediatric patients. Cerebral vasospasm is a common complication of SAH that often leads to poor outcomes. This case report describes the use of dual intraventricular (IVT) vasodilators in a pediatric patient.

Summary:

An 11-year-old male presented with traumatic diffuse SAH and cerebral vasospasm. Despite treatment with IVT nicardipine, intravenous (IV) milrinone by continuous infusion, enteral nimodipine, and intraarterial verapamil and milrinone given during digital subtraction angiography, transcranial Doppler (TCD) mean velocities continued to rise. IVT milrinone was then added to IVT nicardipine and IV milrinone. The combination of IVT nicardipine, IV milrinone, and rescue therapy with IVT milrinone was continued for a total of 7 days. TCD mean velocities decreased into the mild to moderate range within 2 days of the patient receiving this combined regimen and remained globally low thereafter.

Conclusion:

This case illustrates the potential benefit of using dual IVT vasodilators to improve outcomes for pediatric patients with refractory cerebral vasospasm.

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

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D00617	Nicardipine Hydrochloride	C08CA04	DB00622

R&D Status

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Angina, Stable	US	Chiesi USA, Inc	21 Dec 1988
Angina Pectoris	CN	Jiangsu Desano Pharmaceutical Co. Ltd.	01 Jan 1988
Hypertension	CN	Jiangsu Desano Pharmaceutical Co. Ltd.	01 Jan 1988
Essential Hypertension	JP	LTL Pharma Co., Ltd.	01 May 1981

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2024	Not Applicable	-	-	Intracoronary Nicardipine	ulyyjicmkf(mlvxjqbwmy) = kyubpzbnma bqhrguffvz (weqvjxycqz, 62.1)	-	31 Aug 2024
				Intracoronary Papaverine	ulyyjicmkf(mlvxjqbwmy) = fjhdzelpld bqhrguffvz (weqvjxycqz, 14.3)
NCT04269408 (Pubmed \| JAMA Neurol) Manual	Phase 3	Aneurysm, Intracranial Berry, 1	41	Nicardipine release implants + standard of care	ckohqttxah(titsznnmfe) = iivevojlwt rzkkqwwedi (kqlrjgjjwd ) View more	Positive	19 Aug 2024
				Nicardipine (Standard of care)	ckohqttxah(titsznnmfe) = kchaafnkwa rzkkqwwedi (kqlrjgjjwd ) View more
NCT04116112 (BEST-II, CTgov)	Phase 2	Thrombosis \| Stroke	120	Labetalol+Nicardipine+Hydralazine (Higher Systolic Blood Pressure (SBP) Target)	msnwiuncnl(kumxgjftfj) = zwlbdvbsfz orqirtdaqm (ifwmyrzkri, udlmdsvllv - tnjtesmlrz) View more	-	12 Oct 2023
				Labetalol+Nicardipine+Hydralazine (Lower SBP (<160 mmHg) Target)	msnwiuncnl(kumxgjftfj) = nyvsvaayup orqirtdaqm (ifwmyrzkri, kkjbhvxxxd - lczambmwfw) View more
P13-7.005 (AAN2023)	Not Applicable	Vasospasm, Intracranial	7	Intrathecal Nicardipine	zdjprceetk(prmrjavkvr) = one patient had brief, elevated intracranial pressure spikes with ITn iphapqiibj (fxgbpzvawm ) View more	-	25 Apr 2023
ISC2023	Not Applicable	Cerebral Hemorrhage	370	Intravenous Nicardipine	omnhtxrqeu(zucgvjfajy) = jicfsfhclw loclhvbsop (pnchzfaztn )	-	01 Feb 2023
ISC2020	Not Applicable	Subarachnoid Hemorrhage	-	IT Nicardipine	ajrgztmknt(ezdhbilila) = thlrpaeyig ielpnybtvs (qjhvyphogq )	-	01 Feb 2020
ESC2018	Not Applicable	-	-	Nicardipine	rwcfyllijw(bzuooxksiu) = ybrrvcongu ivvjldupbc (mlipajwxzr ) View more	-	20 Apr 2018
ISC2018	Not Applicable	Cerebral Hemorrhage	59	i.v. Nicardipine only	yeresjlxtp(cnglbajcup) = bradycardia occurred in three patients of combination treatment group rsxqmdnpbm (andthxgyop )	-	22 Jan 2018
				Bisoprolol transdermal patch and i.v. Nicardipine
NCT01176565 (ATACH-2 \| ATACH-II, CTgov)	Phase 3	Cerebral Hemorrhage \| Hypertension	1,000	Intravenous nicardipine hydrochloride (Standard SBP Reduction Arm)	pawurpxuur(aekcbwxlbz) = merxaytiho wjndtggahf (cixhgwjhai, yuxexgomcp - olnzaunksr) View more	-	25 Apr 2017
				Intravenous nicardipine hydrochloride (Intensive SBP Reduction Arm)	pawurpxuur(aekcbwxlbz) = cazcqyiijj wjndtggahf (cixhgwjhai, dlghcryjhg - tfbhxieqsr) View more
NCT00415610 (ATACH, CTgov)	Phase 1	Cerebral Hemorrhage \| Stroke \| Hypertension	60	nicardipine (Tier 1)	nvpmbhlopj(jhjbflyhdb) = wgywkrlcsm lmwoqzcraf (gbibtvrnni, bqntxvrmkw - xxhbnkwmyr) View more	-	07 Sep 2015
				nicardipine (Tier 2)	nvpmbhlopj(jhjbflyhdb) = rnnvewvwhh lmwoqzcraf (gbibtvrnni, igxxtwzuod - bpubjpwbbn) View more