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, 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/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 Jan 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

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

9,162

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 Jan 2025·Asian Pacific Journal of Allergy and ImmunologyQ4 · MEDICINE

Skin necrosis following local anesthetic: Same presentation for two different diagnoses

Q4 · MEDICINE

Article

Author: Mankouri, Farid ; Burlet, Gilles ; Demoly, Pascal ; Chiriac, Anca Mirela ; Bourrain, Jean Luc ; Gauthier, Amélie ; Berbain, Thomas

BACKGROUNDLocal anesthetics (LA) are widely used in medicine and are generally well tolerated. Although most adverse reactions are nonallergic, LA are a frequent reason for allergy consultation.OBJECTIVEWe want to expand the differential diagnosis of adverse reactions to LA by presenting rare diagnoses.METHODSWe present here two patients with similar clinical presentations, namely skin necrosis after local anesthesia with lidocaine, but with two different final diagnoses.RESULTSFor Patient 1, skin necrosis was imputed to the vasoconstrictor effect of epinephrine in a patient with vascular background aggravated by heavy consumption of tobacco and cannabis. Patient 2 final diagnosis was Nicolau syndrome (embolia cutis medicamentosa), a cutaneous necrosis at the site of injection.CONCLUSIONSThe allergist should be aware of these diagnoses and include them in the differential diagnosis of local anesthetic hypersensitivity.

01 Jan 2025·The Journal of Clinical Pharmacology

Reply to: Comment: Cerebrospinal Fluid Pharmacokinetics of Nicardipine Following Intrathecal Administration in Subarachnoid Hemorrhage Patients

Letter

Author: Kandiah, Prem A. ; Buckley, Erin M. ; Grossberg, Jonathan A. ; Asbury, William ; Jeong, Yoo‐Seong ; Sathialingam, Eashani ; Samuels, Owen B. ; Jusko, William J. ; Cohen‐Sadan, Shany ; Sadan, Ofer

First, with regard to sample storage, the hourly cerebrospinal fluid (CSF) (or plasma) samples were collected and initially stored on ice while protected from light.The purpose of our study was to determinethe pharmacokinetics of nicardipine in the CSF of alimited number of patients with subarachnoid hemorrhage.As noted in our manuscript, we agree that larger and more rigorously designed studies are needed in the future to develop an optimal dosing strategy for IT nicardipine based on integrative pharmacokinetic/pharmacodynamic (PK/PD) assessment of patient outcome data.

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 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	pakwiexnwd(bhjhnzancp) = vtqsfkfdel rkuhsjxihp (ytmhwxipmk, 62.1)	-	31 Aug 2024
				Intracoronary Papaverine	pakwiexnwd(bhjhnzancp) = usykkemvzm rkuhsjxihp (ytmhwxipmk, 14.3)
NCT04269408 (Pubmed \| JAMA Neurol) Manual	Phase 3	Aneurysm, Intracranial Berry, 1	41	Nicardipine release implants + standard of care	uyvgnikouh(izigcxbknf) = jxltqptgxk mqywyprmkf (inklgwwjiy ) View more	Positive	19 Aug 2024
				Nicardipine (Standard of care)	uyvgnikouh(izigcxbknf) = sgcpxytkti mqywyprmkf (inklgwwjiy ) View more
NCT04116112 (BEST-II, CTgov)	Phase 2	Thrombosis \| Stroke	120	Labetalol+Nicardipine+Hydralazine (Higher Systolic Blood Pressure (SBP) Target)	dtmmhdjgdv(eawsssxuvz) = szhhewkbly myqaflaprk (xwwhbcozzj, onfxnppfmo - mybfgxkkld) View more	-	12 Oct 2023
				Labetalol+Nicardipine+Hydralazine (Lower SBP (<160 mmHg) Target)	dtmmhdjgdv(eawsssxuvz) = aheyzyedbf myqaflaprk (xwwhbcozzj, wyebyrqpzp - lemmfusruw) View more
P13-7.005 (AAN2023)	Not Applicable	Vasospasm, Intracranial	7	Intrathecal Nicardipine	rnjrtnihsh(eatomtbbqe) = one patient had brief, elevated intracranial pressure spikes with ITn ntihwfcuaw (yqpifvebow ) View more	-	25 Apr 2023
ISC2023	Not Applicable	Cerebral Hemorrhage	370	Intravenous Nicardipine	qpmpseegsp(wtgvpfwlny) = rsrwokfynq ehgxryzymh (kimzmpnesf )	-	01 Feb 2023
SAT-460 (ENDO2020)	Not Applicable	Myxedema coma	1	Levothyroxine	macnnoozhw(qpoapgxkrg) = qkowahcshz uxkluarmbl (msqzgmoazm ) View more	Positive	08 May 2020
				Dopamine	(anfavrupcb) = vjgvhactob pqwivubdxt (gusaszghet )
ISC2020	Not Applicable	Subarachnoid Hemorrhage	-	IT Nicardipine	rhqzdmhqiu(mdwlgnyykt) = ljvalsjnxq cckfdyezrb (khpmdjnvpz )	-	01 Feb 2020
ESC2018	Not Applicable	-	-	Nicardipine	vdgvlwmenf(qwvjvaubfj) = fkhxppxuib lfnwurrobo (neucjwpzhy ) View more	-	20 Apr 2018
ISC2018	Not Applicable	Cerebral Hemorrhage	59	i.v. Nicardipine only	(fqrthyzqlb) = bradycardia occurred in three patients of combination treatment group awzilhojlg (bkiqsqxzhm )	-	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)	nipiowehve(easvzmrwgu) = bgjcxeqjxj nmsalnuksc (uuuhklqaqz, xbcjugkucy - bsgcorxpmh) View more	-	25 Apr 2017
				Intravenous nicardipine hydrochloride (Intensive SBP Reduction Arm)	nipiowehve(easvzmrwgu) = kwqwveahcx nmsalnuksc (uuuhklqaqz, viiwyiovok - eadgfqgbrm) View more