Delving into the Latest Updates on Nicardipine Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Nicardipine, Nicardipine Hydrochloride QR Microgranules, Nicardipine Hydrochloride SR Microgranules

+ [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, StableSubarachnoid Hemorrhage

Originator Organization

CHIESI Farmaceutici SpA

Active Organization

LTL Pharma Co., Ltd.

Pendopharm, Inc.

Jiangsu Desano Pharmaceutical Co. Ltd.

+ [1]

Inactive Organization

BIT Pharma GmbH

Chiesi USA, Inc

Drug Highest PhaseApproved

First Approval Date

JP (01 May 1981),

Essential Hypertension

RegulationOrphan Drug (EU)

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Structure

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

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

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 Nov 2024

Sponsor / Collaborator

Boston Medical Center

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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9,098

Literatures (Medical) associated with Nicardipine Hydrochloride

31 Dec 2024·Hypertension in Pregnancy

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

Review

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

BACKGROUNDPreeclampsia (PE) is a pregnancy disorder that represents a major cause of maternal and perinatal morbidity and mortality.METHODSThis 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.RESULTSWe 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.CONCLUSIONAccording 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.

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

CONTEXTAlmonertinib is primarily metabolized by CYP3A4, so it could interact with a variety of drugs metabolized by CYP3A4, leading to the changes of systemic exposure.OBJECTIVEFor 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 METHODSDetection 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.RESULTSThere 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.CONCLUSIONAccording to the findings, it was indicated that nicardipine could inhibit the metabolism of almonertinib in vitro and in vivo.

01 Dec 2024·Pregnancy Hypertension

Optimal treatment for women with acute hypertension in pregnancy; a randomized trial comparing intravenous labetalol versus nicardipine

Article

Author: Gravesteijn, Benjamin Y ; de Groot, Christianne J.M. ; de Boer, Marjon A. ; Gravesteijn, Benjamin Y. ; van Bel, Frank ; Ganzevoort, Wessel ; de Boer, Marjon A ; Willem Mol, Ben ; de Groot, Christianne J M ; Hermes, Wietske ; Bij de Weg, Jeske M ; bij de Weg, Jeske M.

OBJECTIVESBlood pressure control in severe hypertension of pregnancy is crucial for mother and neonate. In absence of evidence, guidelines recommend either intravenous labetalol or nicardipine. We compared the effectiveness and safety of these two drugs in women with severe hypertension in pregnancy.STUDY DESIGNWe performed an open label randomized controlled trial. Women with a singleton pregnancy complicated by severe hypertension (systolic ≥ 160 mmHg and/or diastolic ≥ 110 mmHg) requiring intravenous antihypertensive treatment were randomized to intravenous labetalol or intravenous nicardipine. The primary outcome was a composite adverse neonatal outcome defined as severe Respiratory Distress Syndrome (RDS), Broncho Pulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH) IIB or worse, Necrotizing Enterocolitis (NEC), or perinatal death defined as fetal death or neonatal death before discharge from the neonatal intensive care unit (NICU). Based on a power analysis, we estimated that 472 women (236 per group) needed to be included to detect a difference of 15% in the primary outcome with 90% power. The study was halted prematurely at 30 inclusions because of slow recruitment and trial fatigue.RESULTSBetween August 2018 and April 2022, we randomized 30 women of which 16 were allocated to intravenous nicardipine and 14 to intravenous labetalol. The composite adverse neonatal outcome was not significantly different between the two groups (25 % versus 43 % OR 0.28 (95 % CI 0.05-1.43), p = 0.12)). Respiratory distress syndrome occurred more often in the labetalol group than in the nicardipine group (42.9 % versus 12.5 %). Neonatal hypoglycemia occurred more often in the nicardipine group than in the labetalol group (31 % versus 7 %). Time until blood pressure control was faster in women treated with nicardipine than in women treated with labetalol (45 (15-150 min vs. 120 (60-127,5) min).CONCLUSIONIn our prematurely halted small RCT, we were unable to provide evidence for the optimal choice of treatment for severe hypertension to improve neonatal outcome and/or to obtain faster blood pressure control. Differences in Respiratory distress syndrome and neonatal hypoglycemia between the groups might be the result of coincidental finding due to the small groups included in the study. A larger randomized trial would be needed to determine the safest and most efficacious (intravenous) therapy for severe hypertension in pregnancy. This study emphasizes the challenges of conducting a RCT for the optimal treatment for these women.

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

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Subarachnoid Hemorrhage	Discovery	DE	BIT Pharma GmbH	05 Apr 2020
Subarachnoid Hemorrhage	Discovery	AT	BIT Pharma GmbH	05 Apr 2020

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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	ibnrvasbpa(jxbmsfofjy) = mhmoegngjh uawuntxiha (zffdgvamrn, 62.1)	-	31 Aug 2024
				Intracoronary Papaverine	ibnrvasbpa(jxbmsfofjy) = dasauynzqq uawuntxiha (zffdgvamrn, 14.3)
NCT04269408 (Pubmed \| JAMA Neurol) Manual	Phase 3	Aneurysm, Intracranial Berry, 1	41	Nicardipine release implants + standard of care	vrsqxdmyox(rfoykztrjt) = eafysutrlr csrctdqqvk (mfxvrhyidk ) View more	Positive	19 Aug 2024
				Standard of care	vrsqxdmyox(rfoykztrjt) = eanwjevulg csrctdqqvk (mfxvrhyidk ) View more
NCT04116112 (BEST-II, CTgov)	Phase 2	Thrombosis \| Stroke	120	Labetalol+Nicardipine+Hydralazine (Higher Systolic Blood Pressure (SBP) Target)	jwdpouzoed(itlsmozcaz) = yxjgomyiqo xzsjetuxeh (rtwtnegpix, bcqdjxpvvn - twmsvxbpqz) View more	-	12 Oct 2023
				Labetalol+Nicardipine+Hydralazine (Lower SBP (<160 mmHg) Target)	jwdpouzoed(itlsmozcaz) = ikyjsoeojs xzsjetuxeh (rtwtnegpix, jvmkjlvluu - njhsspkcff) View more
P13-7.005 (AAN2023)	Not Applicable	Vasospasm, Intracranial	7	Intrathecal Nicardipine	kfncokosuc(kxfcgvgsyr) = one patient had brief, elevated intracranial pressure spikes with ITn kmvsgtppoj (kzhttablqa ) View more	-	25 Apr 2023
ISC2023	Not Applicable	Cerebral Hemorrhage	370	Intravenous Nicardipine	ameaqhxvvi(xsqvudpogc) = rgdmuyurln lmgrxvztqy (dqutsdvnbp )	-	01 Feb 2023
ISC2020	Not Applicable	Subarachnoid Hemorrhage	-	IT Nicardipine	loyypwlcuv(fqqwuudojb) = xljtdftwob bfqvowqiiy (hhxurssgzh )	-	01 Feb 2020
ESC2018	Not Applicable	-	-	Nicardipine	lceekadfdx(foetwojhwf) = lgyggqdsfu yngjrmucyg (sdmdjrfxzl ) View more	-	20 Apr 2018
ISC2018	Not Applicable	Cerebral Hemorrhage	59	i.v. Nicardipine only	(yaodduntyg) = bradycardia occurred in three patients of combination treatment group ttezughflb (fuyarwkrqw )	-	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)	tksnfxpmac(dgmjxezzkg) = zrgbmxjijq gvbgvweiwd (vvpicavxun, etjgndhhkl - covvpfabet) View more	-	25 Apr 2017
				Intravenous nicardipine hydrochloride (Intensive SBP Reduction Arm)	tksnfxpmac(dgmjxezzkg) = dcomhxmajt gvbgvweiwd (vvpicavxun, vqnzhrrogn - ewgigswndo) View more
ASN2016	Not Applicable	Hypertriglyceridemia \| Fasting \| Ketosis	-	Clevidipine	cfpymvlhuq(afxyupoawc) = To our knowledge this is the first reported case of severe hypertriglyceridemia and fasting ketoacidosis associated with intravenous CLV. For fasting patients receiving CLV, close monitoring of triglycerides and administration of glucose with insulin should be considered. ofxkozdmhy (xyrwvpbanl )	-	15 Nov 2016
				Nicardipine