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)

+ [31]

Target

Cav2.1

Action

inhibitors

Mechanism

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

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesOther Diseases

Active Indication

Heart FailureIntraoperative hypertensionAngina Pectoris+ [2]

Inactive Indication

Angina, Stable

Originator Organization

CHIESI Farmaceutici SpA

Active Organization

LTL Pharma Co., Ltd.

Pendopharm, Inc.Hikma International Pharmaceuticals LLC

+ [1]

Inactive Organization

Chiesi USA, Inc

License Organization

Daiichi Sankyo Co., Ltd.

Astellas Pharma, 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

NCT07044232

/ Not yet recruitingPhase 4IIT

NICardipine for Fast Achievement of Systolic BP Targets in ICH - a Quasi-randomized, Implementation Trial With Stepwise Rollout of Nicardipin Based Treatment of Hypertension.

Quality improvement study with a quasi-randomized design. The study monitors the effect of a gradually implemented treatment algorithm prioritizing intravenous antihypertensives (e.g., nicardipine) over long-acting nitrate patches. It aims to increase the proportion of patients reaching target systolic BP <140 mmHg within 1 hour of hospital admission while monitoring safety, clinical outcomes, and healthcare resource utilization.

Start Date01 Oct 2025

Sponsor / Collaborator

Århus Universitetshospital

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

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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4,879

Literatures (Medical) associated with Nicardipine Hydrochloride

01 Dec 2025·CHILDS NERVOUS SYSTEM

Intrathecal nicardipine for symptomatic, refractory vasospasm treatment in pediatric patients: a case series

Review

Author: Scoville, Jonathan ; Villalba, Nicole Dayanara ; Plonsker, Jillian ; Chiu, Lucinda ; Alden, Tord ; Lam, Sandi ; DeCuypere, Michael

Abstract:

Purpose:

Vasospasm is a potentially devastating condition that can develop in pediatric patients secondary to traumatic, inflammatory, infectious, and neoplastic etiologies and carries a high risk of morbidity and mortality (Isola et al. 2022, Krishna et al. 2005). Management is often adapted from adult to pediatric care given its relative rarity in children. There is level 3 evidence for the use of intrathecal (IT) calcium channel blocker (nicardipine) administration to treat refractory vasospasm in the adult subarachnoid hemorrhage (SAH) population. Its use has yet to be investigated in children (Krishna et al. 2005). We aim to review the safety profile and efficacy of IT nicardipine for non-traumatic SAH with refractory vasospasm at our institution.

Methods:

We present a single institution retrospective series of pediatric patients treated with IT nicardipine for symptomatic vasospasm refractory to standard therapies including oral nimodipine, hyperdynamic augmentation therapies, and targeted intra-arterial therapy.

Results:

Pediatric patients (n = 3), ages 16–17 years old, admitted with non-traumatic SAH who developed severe, symptomatic, and refractory vasospasm were included. All patients presented with SAH from ruptured aneurysms. A 5-day course of IT nicardipine was initiated using a protocol adapted from our adult cerebrovascular/neurocritical care service. Decreases in peak middle cerebral artery velocity (range 61–290 cm/s) and Lindegaard ratios (range 0.3–4.2) were observed from initiation to completion of treatment.

Conclusions:

IT nicardipine for pediatric non-traumatic SAH with vasospasm refractory to standard treatments was used in our small series with no complications and no new ischemic events. Clinical and radiographic effects were encouraging. Further study is warranted.

01 Dec 2025·Toxicology reports

The protective role of nicardipine in dextran sulfate sodium-induced colitis in mice: Modulating inflammation and apoptosis

Article

Author: Al-Joda, Ali M ; Zalzala, Munaf H

Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with persistent inflammation, oxidative stress, and epithelial apoptosis. Nicardipine, a dihydropyridine calcium channel blocker, exhibits anti-inflammatory and anti-apoptotic properties, but its therapeutic potential in UC remains unclear. This study evaluated the effects of nicardipine on dextran sulfate sodium (DSS)-induced colitis in mice, focusing on inflammatory, oxidative, and apoptotic pathways. Fifty BALB/c mice were assigned to five groups (n = 10): control, DSS, nicardipine 12 mg/kg, nicardipine 24 mg/kg, and 5-aminosalicylate (ASA) 75 mg/kg. Treatments were administered for 3 days before and 10 days during DSS exposure. Disease severity was assessed by body weight, disease activity index (DAI), and colon length. Colonic mRNA levels of Nlrp3, TNF-α, IL-17, and TNFSF10 were quantified by RT-PCR; protein expression of caspase-3, caspase-8, BAX, and BCL-2 was analyzed by Western blot. Serum malondialdehyde (MDA), myeloperoxidase (MPO), glutathione peroxidase-1 (GPX-1), occludin, and prostaglandin E₂ (PGE-2) were measured by ELISA. Histological scoring assessed epithelial integrity and inflammation. Nicardipine dose-dependently reduced DSS-induced weight loss, DAI, and colon shortening. Both doses significantly downregulated Nlrp3, TNF-α, IL-17, and TNFSF10 (p < 0.05), decreased caspase-3 and BAX, and increased BCL-2. Nicardipine restored GPX-1, lowered MDA and MPO, preserved occludin, and reduced PGE-2. Histology confirmed reduced mucosal injury and preserved epithelial architecture. Nicardipine attenuates DSS-induced colitis by suppressing pro-inflammatory cytokines, reducing oxidative stress, and inhibiting apoptosis, supporting its potential as a therapeutic candidate for UC. Further studies are warranted to clarify its molecular mechanisms and clinical relevance.

01 Nov 2025·JOURNAL OF CLINICAL NEUROSCIENCE

Post-craniotomy emergence hypertension: A scoping review

Review

Author: Kelly, Patrick D ; Kamal, Naveed ; Gauhar, Fatima

INTRODUCTION:

Post-craniotomy emergence hypertension (PCEH) is a phenomenon of transient increase in blood pressure during and after emergence from anesthesia for a craniotomy. It is frequently encountered in neurosurgical and neuroanesthesia practice. Clinical definitions and reported prevalence of PCEH vary significantly, so this review aims to characterize existing literature on the diagnosis and management of this clinical entity.

METHODS:

A scoping review of the literature was conducted using six electronic databases: PubMed, Embase, CINAHL, Web of Science, Cochrane, and Scopus. Title and abstract screening and subsequent full-text screening were conducted by two reviewers, and twenty-one relevant articles were identified. The quality of all studies was assessed using the appropriate version of the Joanna Briggs Institute (JBI) Critical Appraisal Checklists.

RESULTS:

The definitions of PCEH were heterogeneous among the studies included. The predominant method of reporting blood pressure diagnostic criteria was mean arterial blood pressure (42.9 %), followed by systolic blood pressure alone (33.3 %), or systolic and diastolic blood pressure together (14.3 %). Management of PCEH begins with early detection, often including arterial line blood pressure monitoring. Treatment mostly includes anti-hypertensives, including beta-blockers and calcium-channel blockers, where nicardipine seems superior to beta-blocker therapy. PCEH is believed to increase the risk of postoperative bleeding, and management of PCEH may also increase ICU length of stay.

CONCLUSIONS:

Current literature reveals widespread variability in the definition, monitoring approach, and management of PCEH. This review highlights the need to establish a consensus definition for PCEH to allow for more robust investigation of its clinical consequences.

3

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

15 Oct 2019

·www.daiichisankyo.com

Daiichi Sankyo Announces Transfer from Astellas Pharma of Three Products in Asia

PDF (112KB)PDF For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Sunao Manabe, Representative Director, President and CEO (Code no.: 4568, First Section, Tokyo Stock Exchange) Please address inquiries to Junichi Onuma, Vice President, Corporate Communications Department Telephone: +81-3-6225-1126 https://www.daiichisankyo.com Tokyo, Japan (October 15, 2019) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it agreed with Astellas Pharma Inc. (hereafter, Astellas Pharma) that Astellas Pharma local subsidiaries companies in six Asian countries will transfer three products to Daiichi Sankyo. The products to be transferred and the countries where they are sold are as follows. Product [generic name (brand name)] Korea China Taiwan Thailand Philippines Indonesia Ramosetron (Nasea) Antiemetic ○ ○ ○ ○ Nicardipine (Perdipine) Anti-hypertensive ○ ○ ○ Barnidipine (Oldeca) Anti-hypertensive ○ Product [generic name (brand name)] Korea China Taiwan Thailand Philippines Indonesia Ramosetron (Nasea) Antiemetic ○ ○ ○ ○ Nicardipine (Perdipine) Anti-hypertensive ○ ○ ○ Barnidipine (Oldeca) Anti-hypertensive ○ ○ indicate the countries where the products are sold The antiemetics are expected to have synergistic effects with mirogabalin and the cancer drugs that Daiichi Sankyo is currently developing in Asia, and the two antihypertensives are expected to effectively utilize Daiichi Sankyo’s current infrastructures in combination with its cardiovascular products, such as olmesartan and edoxaban. The total net sales of Astellas Pharma's three products in fiscal year 2018 were approximately 5.0 billion yen. Daiichi Sankyo will take over the rights and obligations, including manufacturing and marketing approvals, for each of the products, and from December 2019 onwards, the manufacturer, LTL Pharma Co., Ltd., will supply them for sale in Asia by Daiichi Sankyo’s local subsidiaries and other companies. Daiichi Sankyo will pay 9.6 billion yen to Astellas Pharma for the products to be taken over; moreover, in order to ensure continuous supplies of the products to patients, both companies will cooperate to smoothly transfer manufacturing and marketing approvals in the targeted countries. Daiichi Sankyo is strengthening its presence in each region by providing a rich range of regional value products in line with the market characteristics in each region, and the company strengthens its presence in Asia and plans to further contribute to healthcare in the region by acquiring these products. About Daiichi Sankyo Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.

Drug ApprovalBiosimilar

05 Apr 2011

·www.astellas.com

Astellas Assesses the Impact of the Eastern Japan Earthquake (3rd Notice)

Tokyo, April 5, 2011 - Astellas Pharma Inc. (“Astellas”, TSE: 4503) expresses its deepest sympathy for those who have lost their lives and been displaced by the Eastern Japan Earthquake, which devastated the region on Friday, March 11, 2011. Astellas looks forward to a quick recovery from this natural calamity and offers its support in the relief efforts. Astellas reports on the most recent conditions of its facilities which Astellas has confirmed until today in the wake of the Eantern Japan Earthquake below. 1. Nishine Plant* (Astellas Pharma Tech Co., Ltd. (former Astellas Tokai Co., Ltd), Hachimantai-shi, Iwate prefecture, ”Nishine Plant”） In the 2nd notice released on March 23, Astellas announced that the shipments of some products began at the Nishine Plant. Because Astellas has confirmed that its manufacturing facilities will function normally, it has decided to resume full operations of both manufacturing and shipments of products from tomorrow. *Nishine Plant is the formulating and packaging plant to produce the products including Harnal, Lipitor and Perdipine. 2. Impact Upon Earnings Astellas is currently assessing the impact of the earthquake upon its earnings and will quickly disclose pertinent information should it discover that its earnings are likely to be significantly impacted. Except for the above there is no update from the 2nd notice released on March 23. ######

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
Heart Failure	Japan	LTL Pharma Co., Ltd.	01 Jan 1998
Angina, Stable	United States	Chiesi USA, Inc	21 Dec 1988
Intraoperative hypertension	Japan	LTL Pharma Co., Ltd.	20 Sep 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


NCT01996436 (iVAST, CTgov)	Phase 4	Vasospasm \| Vasospasm, Intracranial	92	Nicardipine (Nicardipine)	xegiokmvnu(pfrzowzktf) = gsvtkuypke wviqmuvzwn (qhwhcfritx, 1.771) View more	-	11 May 2025
				Verapamil (Verapamil)	xegiokmvnu(pfrzowzktf) = xddnjwtrhu wviqmuvzwn (qhwhcfritx, 1.455) View more
NCT04269408 (Pubmed \| JAMA Neurol) Manual	Phase 3	Aneurysm, Intracranial Berry, 1	41	Nicardipine release implants + standard of care	xgvdvhiftf(sdajqmdmfx) = ogesefbcxk qmhmzqqpgp (cqxrmmfhph ) View more	Positive	19 Aug 2024
				Nicardipine (Standard of care)	xgvdvhiftf(sdajqmdmfx) = lptmkozhxl qmhmzqqpgp (cqxrmmfhph ) View more
NCT04116112 (BEST-II, CTgov)	Phase 2	Thrombosis \| Stroke	120	Labetalol+Nicardipine+Hydralazine (Higher Systolic Blood Pressure (SBP) Target)	kijzqryfkd(rzokgqjafl) = ybtqcndpiu eecbrwryxq (yziljuerls, fnyyemynwd - zjbwjmnscz) View more	-	12 Oct 2023
				Labetalol+Nicardipine+Hydralazine (Lower SBP (<160 mmHg) Target)	kijzqryfkd(rzokgqjafl) = fygiicmesz eecbrwryxq (yziljuerls, nxgmszjuzp - qqwvfmcyog) View more
NCT01176565 (ATACH-2 \| ATACH-II, CTgov)	Phase 3	Cerebral Hemorrhage \| Hypertension	1,000	Intravenous nicardipine hydrochloride (Standard SBP Reduction Arm)	iyllycwdwq = qqlvvsrqiw klnxpkelpd (jqbfhhgqjp, qlzoyueysx - psadbsopcw) View more	-	25 Apr 2017
				Intravenous nicardipine hydrochloride (Intensive SBP Reduction Arm)	iyllycwdwq = rmyeumsxri klnxpkelpd (jqbfhhgqjp, fowrwdhbma - mtdsejnxtm) View more
NCT00415610 (ATACH, CTgov)	Phase 1	Cerebral Hemorrhage \| Stroke \| Hypertension	60	nicardipine (Tier 1)	wgwjbecvni = bxeufdgvdm slvyraxgbw (qhmtohkkcl, yijifwatpy - fkaefsarim) View more	-	07 Sep 2015
				nicardipine (Tier 2)	wgwjbecvni = btczcaiehs slvyraxgbw (qhmtohkkcl, lfuxxgljgv - hjaizycqib) View more
NCT00765648 (CLUE, CTgov)	Phase 4	Hypertension	226	Nicardipine (Nicardipine)	bnlgblehej = lglmvjqjoc mlggygrhga (sznbijwfbu, jfediprhqd - erieysoopf) View more	-	11 Dec 2014
				Labetalol (Labetalol)	bnlgblehej = yokdxmsafq mlggygrhga (sznbijwfbu, jjbiltijhj - jdtmpyvfts) View more
NCT01810302 (CTgov)	Phase 2	Vasospasm, Intracranial	2	Nicardipine hydrochloride (Nicardipine Hydrochloride)	vamjlsyhka(clekjulvxd) = rocdmwxzwr ebrnkozsvr (jqjxelfmok, ixrafvixaj - ryhwnlojdt) View more	-	29 Aug 2014
				Preservative-free normal saline (Preservative-free Normal Saline)	vamjlsyhka(clekjulvxd) = jpjmtrnvsj ebrnkozsvr (jqjxelfmok, plhzxilrxo - ktntfyyhgv) View more
NCT01951950 (CTgov)	Phase 1	Hypertension \| Brain Cancer	40	Nicardipine (Nicardipine)	kenrezkpqt = oxktjvmkxm dnpwieafez (mlgwgubyvl, rdqixsvekt - seecuvofaw) View more	-	29 Aug 2014
				Esmolol (Esmolol)	kenrezkpqt = rzltdnbrzd dnpwieafez (mlgwgubyvl, qqfvzwemig - yjhlfoexwc) View more
NCT00508118 (NICNACS, CTgov)	Phase 2	Aortic Aneurysm, Thoracic	7	NICARDIPINE (NICARDIPINE GROUP)	obamdyjbwr(bwsqzlvixj) = jhjeyeuvpo lidoifedek (uliwgmzseu, dbctqxsczh - blbqphhbql)	-	08 Mar 2013
				Nicardipine (Nicardipine)	vntfbpjqsl(imgwojnlsu) = fvgmgonuhd xovjynsuec (wcycoclwko, umgmriwgoa - skcfjqtzmy) View more
ISC2013	Not Applicable	Aneurysm, Intracranial Berry, 1	1,357	Intravenous Nicardipine	cbaxavmhrc(mkwxhjildx) = ucscxxhjue iubiumqjho (ogdratlwkr )	-	01 Feb 2013