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.

Jiangsu Desano Pharmaceutical Co. Ltd.

LTL Pharma Co., Ltd.

+ [3]

Inactive Organization-

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)

Login to view timeline

Structure/Sequence

Molecular FormulaC26H30ClN3O6

InChIKeyAIKVCUNQWYTVTO-UHFFFAOYSA-N

CAS Registry54527-84-3

his prospective, single-center interventional study aims to evaluate the effect of two commonly used intravenous antihypertensive agents - nicardipine and sodium nitroprusside - on lung ventilation-perfusion (V/Q) distribution in patients with acute respiratory failure complicated by hypertension. Electrical Impedance Tomography (EIT) will be used for noninvasive monitoring of pulmonary ventilation and perfusion distribution before and after drug administration.
The study will compare the changes in V/Q ratio, oxygenation index, and hemodynamic variables after administration of the two drugs. The findings are expected to provide evidence for the optimal antihypertensive strategy in critically ill patients with respiratory failure and to clarify whether specific vasodilators exacerbate or improve ventilation-perfusion mismatch.

Start Date30 Jun 2026

Sponsor / Collaborator

Wannan Medical College

NCT07246629

/ Not yet recruitingPhase 4IIT

Prophylactic Use of Intrathecal Calcium Channel Antagonist Through Lumbar Drain in Patients With Subarachnoid Hemorrhage Due to Aneurysmal Rupture

The purpose of this study is to determine the effectiveness of prophylactic administration of intra-thecal nicardipine though lumbar cerebrospinal fluid drain in prevention of symptomatic vasospasm in patients with subarachnoid hemorrhage due to rupture of cerebral aneurysms.

Start Date01 Jun 2026

Sponsor / Collaborator

Wake Forest School of Medicine

NCT07372560

/ Not yet recruitingNot ApplicableIIT

Pharmacometric Modeling of a Hospital Preparation of Nicardipine Hydrochloride Oral Solution at 2 mg/mL in Hypertensive Patients in Pediatric Hematology-oncology

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-

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

3,802

Literatures (Medical) associated with Nicardipine Hydrochloride

01 Dec 2026·MOLECULAR BIOLOGY REPORTS

Mechanistic insights into nicardipine’s anti-colitic action: inhibition of pro-inflammatory cytokines, attenuation of oxidative stress, and protection of the mucosal barrier

Article

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

BACKGROUND:

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by excessive immune activation and oxidative stress. UC is characterized by elevated inflammatory cytokine levels. Nicardipine is primarily used for the management of hypertension and angina. Beyond its cardiovascular applications, nicardipine has demonstrated anti-inflammatory properties in various experimental disease models. This study investigates the therapeutic role of nicardipine in a murine model of dextran sulfate sodium (DSS)-induced colitis.

METHOD:

Fifty mice were divided into control, DSS-induced, and two treatment groups (12 and 24 mg/kg nicardipine). Quantitative real-time PCR (RT-PCR) was performed to assess the mRNA expression levels of NF-κB, IL-6, and IL-1β in colon tissues. Protein expression levels of TNF-α, COX-2, and MPO were evaluated using western blot analysis. ELISA was utilized to examine serum levels of Claudin-1, 8-OHdG, and superoxide dismutase. Additionally, histological examination of colon tissues was conducted to assess morphological changes and inflammation.

RESULTS:

Nicardipine treatment (12 and 24 mg/kg; the higher dose was more effective) ameliorated DSS-induced colitis in mice by reducing weight loss, DAI scores, and histological damage. It suppressed NF-κB mRNA expression and reduced the expression of IL-6, IL-1β, TNF-α, and COX-2. Moreover, nicardipine decreased MPO and 8-OHdG levels, restored claudin-1 expression, and enhanced SOD activity.

CONCLUSION:

Nicardipine plays a protective role in DSS-induced colitis. This effect appears to be achieved by regulating mechanisms involved in inflammation and oxidative stress.

01 Aug 2026·CLINICAL NEUROLOGY AND NEUROSURGERY

Anticipatory initiation of intrathecal nicardipine reduces delayed cerebral ischemia in subarachnoid hemorrhage: An exploratory study

Article

Author: Mattingly, Thomas K ; Roberts, Debra E ; Cotroneo, Matthew J ; McHugh, Daryl C ; Ellens, Nathaniel R ; Akkipeddi, Sajal Medha K ; Kohli, Gurkirat S ; Bender, Matthew T ; Nguyen, Vincent N ; George, Benjamin P ; Barrera, Pablo Valdes ; Bhalla, Tarun

OBJECTIVE:

Intrathecal nicardipine (ITN) is one treatment for vasospasm in subarachnoid hemorrhage (SAH), however, its efficacy is unclear. We sought to evaluate outcomes when ITN is utilized.

METHODS:

We performed retrospective chart review of all patients with aSAH requiring placement of an extra-ventricular drain at our institution from 2013 to 2023. We identified patients who received ITN (cases). Patients who received EVDs but no intrathecal nicardipine served as controls. We collected admission Hunt-Hess (HH) and Modified Fisher (mF), and trans-cranial doppler Lindegaard ratios. Delayed cerebral ischemia (DCI) was defined as the onset of infarcts on imaging or acute focal neurologic deficits (≥1 h) consistent with vasospasm. The circumstances in which ITN was initiated was defined as reactionary if it followed the onset of DCI and anticipatory otherwise. The incidence of DCI infarcts on imaging was our primary outcome.

RESULTS:

We identified 44 cases and 87 controls. Controls had higher mF (median=4) than cases (median=3, p = 0.038), but there was no significant difference in HH (p = 0.16). Overall, there was no difference in the incidence of DCI infarct between cases and controls (56.2% versus 55.2%, p = 0.86), yet cases were less likely to attain functional independence than controls (31.8% versus 54%, p = 0.016). Of the 44 cases, 16 received anticipatory ITN. Controls and anticipatory cases had no difference in mF and a trend toward increased HH among anticipatory cases. Anticipatory cases were significantly less likely to develop DCI infarct than controls (31.3% versus 55.2%, p = 0.042). Controls and anticipatory cases had similar incidences of 90-day mRS≤ 2 (54% and 38%, p = 0.13).

CONCLUSION:

Anticipatory ITN was associated with reduced rates of parenchymal infarcts and recalcitrant vasospasm. Among patients already experiencing DCI, reactionary ITN was not associated with reduced rates of additional infarcts or recalcitrant vasospasm. This offers rationale for further study of earlier initiation of ITN among SAH patients at high risk of DCI.

01 Aug 2026·JOURNAL OF SURGICAL RESEARCH

Adherence of Impulse Control in Primary Management of Grade I and II Blunt Thoracic Aortic Injury

Article

Author: Byerly, Saskya ; Kerwin, Andrew J ; DePhillips, Peter B ; Lenart, Emily K ; Mitchell, Erica L ; Tran, Jessica N ; Gross, Megan ; Dong, Caroline T ; Filiberto, Dina M

INTRODUCTION:

Recent studies have demonstrated no increased risk for mortality and excellent to intermediate outcomes with nonoperative management of grade I and II injuries. We aimed to evaluate the adherence of impulse control therapy for patients presenting with grade I-II blunt thoracic aortic injury (BTAI).

MATERIAL AND METHODS:

A retrospective chart review of patients who sustained BTAI at a level 1 trauma center from 2019 to 2023 was performed. Demographics, medical therapy, and management strategies were extracted.

RESULTS:

One hundred fifteen patients with BTAI were identified, of whom 65 were included in the study (42 grade I and 23 grade II injuries). Fifty patients (41 grade III and 9 grade IV injuries) were excluded. Heart rate (HR) and systolic blood pressure (SBP) targets were achieved with esmolol infusion (74%), nicardipine infusion (25%), vasopressor infusion (15%), intravenous antihypertensives as needed (25%), and oral antihypertensive therapy (42%). Median nonadherence time at target HR was 1 h (interquartile range [IQR]: 0-6), 2 h (IQR: 0-14), and 1 h (IQR: 0-6) in the first, second, and third 24-h intervals after admission, respectively. Median nonadherence time at target SBP was 4 h (IQR: 3-9), 7 h (IQR: 2-13), and 6 h (IQR: 1-16) in the first, second, and third 24-h intervals after admission, respectively. Percentage of time adherent to HR and SBP targets ranged from 88 to 98 and 64 to 94%, respectively. All patients with grade I BTAI tolerated initial medical management. Five patients (7%) with grade II BTAI, initially managed nonoperatively, subsequently underwent thoracic endovascular aortic repair.

CONCLUSIONS:

Adherence to anti-impulse control therapy ranged from moderate to excellent in this cohort of patients and was associated with favorable outcomes in low-grade BTAI.

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

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
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

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01996436 (iVAST, CTgov)	Phase 4	Vasospasm \| Vasospasm, Intracranial	92	Nicardipine (Nicardipine)	emhspaoodi(gjxxthtrpu) = recbrryqkr jpwcxsmltp (ttdnpmtmij, 1.771) View more	-	11 May 2025
				Verapamil (Verapamil)	emhspaoodi(gjxxthtrpu) = ddlkumnlpx jpwcxsmltp (ttdnpmtmij, 1.455) View more
NCT05625503 (Pubmed \| Cardiovasc Revasc Med)	Early Phase 1	Spasm	55	Nicardipine	ccgcfcbohq(vhtenoazwt) = gneundkzdm ktnpsucihl (mshrfdibia ) View more	Positive	01 May 2025
				Verapamil	ccgcfcbohq(vhtenoazwt) = rcbpdtrwne ktnpsucihl (mshrfdibia ) View more
NCT04269408 (Pubmed \| JAMA Neurol) Manual	Phase 3	Aneurysm, Intracranial Berry, 1	41	Nicardipine release implants + standard of care	mipgaopuhq(eyypmpnbcg) = itdnwdcair vxgwmzdulx (dhdzmgzndx ) View more	Positive	19 Aug 2024
				Nicardipine (Standard of care)	mipgaopuhq(eyypmpnbcg) = kjyygnncps vxgwmzdulx (dhdzmgzndx ) View more
NCT04116112 (BEST-II, CTgov)	Phase 2	Thrombosis \| Stroke	120	Labetalol+Nicardipine+Hydralazine (Higher Systolic Blood Pressure (SBP) Target)	mbyrgntcdr(usrjatfxqg) = cavqpsrrsw ewcylwguyp (axjyaitxkk, evkftzdhoq - ozlskyjoqd) View more	-	12 Oct 2023
				Labetalol+Nicardipine+Hydralazine (Lower SBP (<160 mmHg) Target)	mbyrgntcdr(usrjatfxqg) = efkdwbtxuk ewcylwguyp (axjyaitxkk, aqvurgpqis - rkcbqwjgsb) View more
NCT01176565 (ATACH-2 \| ATACH-II, CTgov)	Phase 3	Cerebral Hemorrhage \| Hypertension	1,000	Intravenous nicardipine hydrochloride (Standard SBP Reduction Arm)	ahnstzpcjv = lcwaycsoks kxcbravryr (uyjvlhtsgi, taowxytrdz - bjmlademui) View more	-	25 Apr 2017
				Intravenous nicardipine hydrochloride (Intensive SBP Reduction Arm)	ahnstzpcjv = wbhofltotv kxcbravryr (uyjvlhtsgi, jwtbbedwlj - ffyjegquej) View more
NCT00415610 (ATACH, CTgov)	Phase 1	Cerebral Hemorrhage \| Stroke \| Hypertension	60	nicardipine (Tier 1)	naloyhqshj = kkszyfrapj iioufdwszw (oiejedelib, kyibvjegyx - aqudjvsotg) View more	-	07 Sep 2015
				nicardipine (Tier 2)	naloyhqshj = vdwpjlokzi iioufdwszw (oiejedelib, gikgeeiitr - cknmpnyepe) View more
NCT00765648 (CLUE trial \| CLUE, CTgov)	Phase 4	Hypertension	226	Nicardipine (Nicardipine)	fhfgpfdwyw = xjzijkvbgk wfoatsfdjv (mheftcrimw, zeeprtcbzm - rbxpiouwdz) View more	-	11 Dec 2014
				Labetalol (Labetalol)	fhfgpfdwyw = vnxxolkonr wfoatsfdjv (mheftcrimw, nphmarhcgr - wjpqvbyngy) View more
NCT01810302 (CTgov)	Phase 2	Vasospasm, Intracranial	2	Nicardipine hydrochloride (Nicardipine Hydrochloride)	dofdjnswiy(lhajfclpwe) = oknijevvhl lbcilurvfo (dmhswbvigi, crgeigzlef - kvrfqnojwc) View more	-	29 Aug 2014
				Preservative-free normal saline (Preservative-free Normal Saline)	dofdjnswiy(lhajfclpwe) = ksmvzxqlye lbcilurvfo (dmhswbvigi, mrawsskdzd - khunqaebst) View more
NCT01951950 (CTgov)	Phase 1	Hypertension \| Brain Cancer	40	Nicardipine (Nicardipine)	pmfypuqtkt = xbqllglarg xzuyuznqwb (ejekgvegua, qstcwxowod - qpzfdqdchw) View more	-	29 Aug 2014
				Esmolol (Esmolol)	pmfypuqtkt = igjaswhnkd xzuyuznqwb (ejekgvegua, nxzgjeykcp - grrvgynhqg) View more
NCT00508118 (NICNACS, CTgov)	Phase 2	Aortic Aneurysm, Thoracic	7	NICARDIPINE (NICARDIPINE GROUP)	rgvytxaddv(eeyivshtdj) = swfqiwvnid cfekdrmmls (ddhfshtqug, vlvpknhhus - hdxkfwmhng)	-	08 Mar 2013
				Nicardipine (Nicardipine)	tgzwzanjeu(wfwtdzvpgb) = ikkzohqkzo ulyrcfviad (hxtukxlleo, nxqvuxqjnj - iiwacdncsh) View more