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

Pendopharm, Inc.

Beijing Wehand-Bio Pharmaceutical Co., Ltd.

LTL Pharma Co., Ltd.

+ [2]

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

Pediatric prescribers are very often faced with a lack of suitable therapies, particularly oral ones. This represents a major public health problem and necessitates adjustments to dosage or pharmaceutical form using medications marketed for adults, some of which contain excipients that may be harmful to children. This creates risks of dilution errors, administration errors, and the occurrence of adverse effects. Hospital pharmacy technicians are called upon daily to provide appropriate treatment for children. However, although this activity is authorized (Public Health Code, Good Preparation Practices), pharmacokinetic/pharmacodynamic studies on these preparations are only exceptionally carried out. Indeed, only stability studies are required to determine the expiration date of the preparation. Thus, prescribers are left without the necessary information to choose the dosage and administration schedule. Pediatric dosages are extrapolated from those for adults without any certainty of the treatment's effectiveness.

Start Date01 Mar 2026

Sponsor / Collaborator-

NCT03184155

/ WithdrawnEarly Phase 1IIT

Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

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

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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4,496

Literatures (Medical) associated with Nicardipine Hydrochloride

01 Mar 2026·AMERICAN JOURNAL OF EMERGENCY MEDICINE

Outcomes of a blood pressure control protocol for intracerebral hemorrhage in the emergency department

Article

Author: Koch, Sebastian ; Ancheta, Selina ; Fee, Taylor ; Mckinley, Kelly ; Krenz, James

BACKGROUND:

Spontaneous intracerebral hemorrhage is a neurologic emergency associated with high morbidity and mortality. Acute blood pressure management is a modifiable factor shown to influence clinical outcomes. To address this outcome, a standardized blood pressure algorithm was integrated into an institutional ICH alert protocol to optimize timely antihypertensive therapy in the emergency department.

METHODS:

This single-center, retrospective observational study evaluated adult emergency department patients diagnosed with spontaneous intracerebral hemorrhage between August 2023 and March 2025. Outcomes compared pre-and post-protocol implementation and a per protocol group, with a primary objective of time from ICH alert activation to achievement of goal blood pressure. Secondary outcomes included medication administration times, protocol adherence, safety outcomes, and the impact of clinical pharmacist involvement.

RESULTS:

Seventy-seven patients met inclusion criteria (35 pre-protocol, 42 post-protocol), with 32 managed per protocol. Median time from ICH alert to systolic blood pressure goal decreased from 88 to 78 min (absolute reduction 10 min) post-protocol and to 55 min (absolute reduction 33 min) in the per-protocol subgroup (p = 0.012). Labetalol-nicardipine combination therapy was significantly faster in achieving blood pressure goals compared to nicardipine monotherapy (p < 0.001). Protocol deviations occurred in 55 % of post-protocol cases. Safety outcomes, including hypotension and bradycardia, were infrequent.

CONCLUSION:

In this single-center study, implementation of a standardized blood pressure management protocol for an ICH alert improved time to systolic blood pressure control when fully adhered to. Use of labetalol first, followed by nicardipine, was associated with faster intervention. These findings support protocolized, multidisciplinary approaches for improving acute ICH care.

01 Jan 2026·JOURNAL OF HYPERTENSION

Efficacy and safety of clevidipine emulsion injection compared with nicardipine in patients with hypertensive emergencies: a randomized, single-blind, positive-parallel-controlled, phase III clinical trial

Article

Author: Liu, Min ; Li, Na ; Ma, Changsheng ; Zhang, Gaoxing ; Ouyang, Yanhong ; Wu, Yanqing ; Xu, Tie ; Wang, Xifu ; Sun, Liming ; Wang, Zhifang ; Chen, Junhong ; Yang, Ping ; Wang, Hengliang ; Zhang, Hongwei ; Zhang, Xiwen ; Zhu, Tianyi ; Liang, Zijing ; Ma, Jinxia ; Zhao, Zhichen ; Zhu, Jiaying ; Chen, Chen ; Liu, Xianxia ; Guo, Shubin ; Sun, Lei ; Du, Bo ; Lv, Qiang ; Zhao, Min ; He, Ruili ; Chen, Dexiong ; Chen, Xiaoliang ; Cao, Zhanwei ; Lin, Ling ; Gao, Feng ; Chai, Yanfen ; Zhao, Xianming ; Zhong, Yiming ; Wu, Lidong ; Li, Lipeng

Background::

Clevidipine emulsion injection is an ultra-short-acting, intravenous calcium-channel blocker that produces a rapid and transient antihypertensive effect.

Methods::

This is a multicenter, randomized, single-blind, parallel, positive-controlled, noninferiority phase III clinical trial comparing the efficacy and safety of clevidipine and nicardipine in hypertensive emergencies. Participants were randomly assigned in a 1 : 1 ratio to the experimental group (clevidipine emulsion injection) or the positive-control group (nicardipine), and standard safety data were collected.

Results::

In the per-protocol set (PPS), the primary endpoint showed that 100.0% of patients in the clevidipine group achieved a 15–25% reduction in systolic blood pressure from baseline within 30 min after dosing, compared with 95.9% in the nicardipine group. The absolute difference between the two proportions was 4.1% [95% confidence interval (CI): 0.58, 7.62], with the lower bound exceeding the noninferiority margin of –10%. Secondary endpoints revealed that the median time to reach the target systolic blood pressure (defined as a 15–25% reduction from baseline) was 9.0 (9.0, 12.0) minutes for clevidipine versus 12.0 (12.0, 15.0) minutes for nicardipine, and the between-group difference was statistically significant ( P < 0.0001). The proportions of patients who successfully transitioned to oral antihypertensive therapy within 6 h after study drug discontinuation were 96.83% for clevidipine and 95.90% for nicardipine, with no statistically significant difference ( P = 0.7459). In the safety set (SS), the safety endpoint showed that the proportion of patients whose systolic blood pressure fell by >25% from baseline within 3 min after dosing was 0.00% for clevidipine and 0.79% for nicardipine, with no statistically significant difference ( P = 0.4980). The overall incidence of adverse events was similar between clevidipine and nicardipine.

Conclusions::

Clevidipine has similar therapeutic effects and safety compared with the nicardipine.

Registration::

URL: https://www.clinicaltrials.gov; Unique identifier: NCT04670809.

01 Jan 2026·RADIOLOGY

Article

Author: Mazzola, Maria A. ; Sposato, Anthony ; Kunst, Mara M.

History:

A 66-year-old man with a history of hypertension presented with left-sided jaw jerking, repetitive movements, aphasia, and dysarthria. He was afebrile and in no acute distress, with mild hypertension (153/81 mm Hg). Routine laboratory studies were unremarkable. Brain MRI showed multiple nonenhancing supratentorial, cortical, and subcortical hyperintensities on T2-weighted fluid-attenuated inversion recovery images, which were nonspecific for infectious, inflammatory, vascular, or neoplastic etiologies. CT of the chest, abdomen, and pelvis and MRI of the cervical and thoracic spine were unremarkable. CT angiography of the head and neck showed no areas of stenosis or occlusion. Extensive infectious, autoimmune, and paraneoplastic serologic tests were negative, including serum acetylcholinesterase, antinuclear antibody, erythrocyte sedimentation rate, C-reactive protein, aquaporin 4 and myelin oligodendrocyte glycoprotein (MOG) antibodies, treponemal testing, Tropheryma whipplei, human immunodeficiency virus, tick-borne disease panel, and COVID-19. Lumbar puncture showed 2% neutrophils (reference range, <6%), with normal protein and glucose levels. Cerebral spinal fluid studies, including protein electrophoresis, JC virus, herpes simplex virus polymerase chain reaction, MOG antibodies, cytologic examination, and a paraneoplastic panel ( Table ), were negative. The patient was treated with nicardipine and levetiracetam, with clinical improvement. A presumptive clinical diagnosis of posterior reversible encephalopathy syndrome was made, with plans for short-interval surveillance imaging and possibly brain biopsy, which the patient initially declined. He was subsequently lost to follow-up. Three years later, he experienced several months of progressive mood alterations followed by the development of psychosis and two generalized tonic-clonic seizures. At readmittance, he was again afebrile and in no acute distress, with mild hypertension (150/70 mm Hg). His neurologic examination was remarkable only for symmetric hyperreflexia. Repeat laboratory testing, including human immunodeficiency virus and hepatitis serologic tests, remained negative. Lumbar puncture showed 1% neutrophils, with normal protein and glucose levels and absent oligoclonal bands. MOG antibodies and an autoimmune encephalitis panel ( Table ) were negative. Repeat brain MRI was performed ( Figs 1 – 3 ).

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)	dpbhywymbl(ghenpmbnnt) = buipllumff fbzjgsahcx (hwdcuznrsn, 1.771) View more	-	11 May 2025
				Verapamil (Verapamil)	dpbhywymbl(ghenpmbnnt) = avdcqkiuhj fbzjgsahcx (hwdcuznrsn, 1.455) View more
NCT04269408 (Pubmed \| JAMA Neurol) Manual	Phase 3	Aneurysm, Intracranial Berry, 1	41	Nicardipine release implants + standard of care	drvppynemk(bgpjdzqxqr) = aejttpcnno vrewiqyizf (exgntonsag ) View more	Positive	19 Aug 2024
				Nicardipine (Standard of care)	drvppynemk(bgpjdzqxqr) = ajliemczjq vrewiqyizf (exgntonsag ) View more
NCT04116112 (BEST-II, CTgov)	Phase 2	Thrombosis \| Stroke	120	Labetalol+Nicardipine+Hydralazine (Higher Systolic Blood Pressure (SBP) Target)	sunuhmppec(rysjwsecqb) = hjxswzxtnz tobvjnxxdy (mypxkzxwgr, qgxecglccr - gjisewqibf) View more	-	12 Oct 2023
				Labetalol+Nicardipine+Hydralazine (Lower SBP (<160 mmHg) Target)	sunuhmppec(rysjwsecqb) = zgisobccnc tobvjnxxdy (mypxkzxwgr, gtbocexknz - xhviajogrn) View more
NCT01176565 (ATACH-2 \| ATACH-II, CTgov)	Phase 3	Cerebral Hemorrhage \| Hypertension	1,000	Intravenous nicardipine hydrochloride (Standard SBP Reduction Arm)	fsuygzuqqj = qiwucxxxav pkgfpvulxa (lbgqqalpgr, msxjjnawxk - ohuyvqzdup) View more	-	25 Apr 2017
				Intravenous nicardipine hydrochloride (Intensive SBP Reduction Arm)	fsuygzuqqj = gtrrvrozhx pkgfpvulxa (lbgqqalpgr, oijrrnsxgp - cpjowoudbp) View more
NCT00415610 (ATACH, CTgov)	Phase 1	Cerebral Hemorrhage \| Stroke \| Hypertension	60	nicardipine (Tier 1)	jhyhchkwql = duzxggtzsg utjfqaijve (guljmznjnu, pwgeuxxxjq - huzdlsebcy) View more	-	07 Sep 2015
				nicardipine (Tier 2)	jhyhchkwql = zzsgyrofbw utjfqaijve (guljmznjnu, rvmuroxufg - tcpehtzsxj) View more
NCT00765648 (CLUE trial \| CLUE, CTgov)	Phase 4	Hypertension	226	Nicardipine (Nicardipine)	dpzzpmqzfr = dqzsvlbont twdziqjagy (fnwbvjbjzq, bbmlusraan - xexqhftjhv) View more	-	11 Dec 2014
				Labetalol (Labetalol)	dpzzpmqzfr = vvyyzhzsro twdziqjagy (fnwbvjbjzq, eawcqbdqjf - jjvjzxkiyj) View more
NCT01951950 (CTgov)	Phase 1	Hypertension \| Brain Cancer	40	Nicardipine (Nicardipine)	jhduzfzpwf = sculijevtc bqcpbapgln (tacvfdyjqu, syqgatxbav - pffuqegksw) View more	-	29 Aug 2014
				Esmolol (Esmolol)	jhduzfzpwf = dcufcamgji bqcpbapgln (tacvfdyjqu, mggkscbfxr - oxmmlwppxd) View more
NCT01810302 (CTgov)	Phase 2	Vasospasm, Intracranial	2	Nicardipine hydrochloride (Nicardipine Hydrochloride)	rbculqmhjb(ptltrqpcma) = xawlnfjmrw nhvdzfuide (ntufdbcelk, edcjrfsrpf - aijxarpryl) View more	-	29 Aug 2014
				Preservative-free normal saline (Preservative-free Normal Saline)	rbculqmhjb(ptltrqpcma) = oryiumqmmk nhvdzfuide (ntufdbcelk, kdzrlhidku - wbyygvypyp) View more
NCT00508118 (NICNACS, CTgov)	Phase 2	Aortic Aneurysm, Thoracic	7	NICARDIPINE (NICARDIPINE GROUP)	lmrpskjtha(otmaodfbzv) = utcsavsmoc sscxhvaxgp (uxtztvzhbt, ilbkhlckkp - pxxqrcordk)	-	08 Mar 2013
				Nicardipine (Nicardipine)	evqobzrues(idiyvfdant) = edxuokozaj czbcaddugw (dswteohyzz, wqbwesmhjt - hvebhwwhwc) View more
ISC2013	Not Applicable	Aneurysm, Intracranial Berry, 1	1,357	Intravenous Nicardipine	zctqutsnxs(kmwxjumfuj) = xptzshuwqq sguadtnlhz (hzdcvudrns )	-	01 Feb 2013