Delving into the Latest Updates on Clevidipine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Clevelox, Clevidipine, Clevidipine (USAN/INN)

+ [5]

Target

L-type calcium channel

Mechanism

L-type calcium channel blockers(Voltage-gated L-type calcium channel blockers)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

HypertensionPerioperative hypertensionHypotension

Inactive Indication

Acute decompensated heart failureAneurysm, Intracranial Berry, 1Cerebral Hemorrhage+ [2]

Originator Organization

The Medicines Company (Spain) SL

Active Organization

Beijing Tide Pharmaceutical Co., Ltd.

Sichuan Kelun Pharmaceutical Co., Ltd.

Qilu Pharmaceutica Hainanco Ltd.

+ [4]

Inactive Organization

SPH No. 1 Biochemical & Pharmaceutical Co., Ltd.

The Medicines Co.

Chengdu Huide Pharmaceutical Technology Co Ltd

Drug Highest PhaseApproved

First Approval Date

US (01 Aug 2008),

Hypotension

Regulation-

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Structure/Sequence

Molecular FormulaC21H23Cl2NO6

InChIKeyKPBZROQVTHLCDU-UHFFFAOYSA-N

CAS Registry167221-71-8

The purpose of this study is to determine if treatment of pre-induction hypertension with an intravenous short acting calcium channel antagonist will (1) reduce the magnitude and duration of blood pressure excursions outside of a pre-established normal range and (2) decrease the requirement for vasoactive medications during the period from induction of anesthesia until just prior to surgical incision.

Start Date01 Jan 2025

Sponsor / Collaborator

University of California San Diego

NCT06402968

/ Not yet recruitingNot ApplicableIIT

Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage

The aim is to compare the rate of hypertensive subjects with ICH who reach SBP target with stability within 60 minutes of enrollment, among patients treated with IV clevidipine with those treated with alternate IV antihypertensive regimen.

Start Date01 Jun 2024

Sponsor / Collaborator-

CTR20231630

/ CompletedPhase 3

评估丁酸氯维地平注射用乳剂（QLG2071）对比原研丁酸氯维地平注射用乳剂（Cleviprex®）治疗高血压急症和亚急症的有效性和安全性的多中心、随机、双盲、阳性药物对照、平行设计Ⅲ期研究

[Translation] A multicenter, randomized, double-blind, active drug-controlled, parallel-design phase III study to evaluate the efficacy and safety of clevidipine butyrate injection emulsion (QLG2071) versus the original clevidipine butyrate injection emulsion (Cleviprex®) in the treatment of hypertensive emergencies and sub-urgent conditions

主要研究目的:评估丁酸氯维地平注射用乳剂（QLG2071）对比原研丁酸氯维地平注射用乳剂（Cleviprex®）治疗高血压急症和亚急症的疗效相似性。

[Translation]

Main study objective: To evaluate the similarity of the efficacy of clevidipine butyrate injection emulsion (QLG2071) versus the original clevidipine butyrate injection emulsion (Cleviprex®) in the treatment of hypertensive emergencies and sub-emergencies.

Start Date23 Jul 2023

Sponsor / Collaborator

Qilu Pharmaceutica Hainanco Ltd.

100 Clinical Results associated with Clevidipine

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100 Translational Medicine associated with Clevidipine

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100 Patents (Medical) associated with Clevidipine

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182

Literatures (Medical) associated with Clevidipine

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 Mar 2025·International Journal of Cardiology Cardiovascular Risk and Prevention

Effects of antihypertensives with and without IL-6 lowering properties on long-term blood pressure control: The prospective HELIUS cohort

Article

Author: Galenkamp, Henrike ; Batuo, Hillman ; van der Linden, Eva ; Born, Bert-Jan van der ; Chilunga, Felix P ; Moll van Charante, Eric

BackgroundChronic inflammation is a well-recognized contributor to hypertension pathogenesis. However, the role of targeting inflammation in hypertension treatment, particularly through modulation of inflammatory markers like interleukin-6 (IL-6), remains less understood. We investigated the effects of antihypertensive medications with and without IL-6-lowering properties on long-term blood pressure (BP) control in a multi-ethnic cohort in the Netherlands.MethodsParticipants from HELIUS cohort receiving hypertension treatment were followed over six years. BP control at follow-up was determined using WHO criteria. Due to unavailability of IL-6 data, a literature review was conducted to classify antihypertensives based on their IL-6-lowering properties - a proxy approach. Logistic regression models were used to assess associations between the IL-6-lowering potential of antihypertensives and BP control, both within and between antihypertensive classes. Effect modification by ethnicity was explored.ResultsA total of 1510 participants were included (mean age 57 years, 62 % women). Within the calcium channel blocker (CCB) class, medications with IL-6-lowering properties (amlodipine and barnidipine) were associated with superior BP control (aOR 1.41, 95 % confidence interval 1.05-1.90) compared to other CCBs (lercanidipine, nifedipine, verapamil, clevidipine, diltiazem). No significant associations were observed within angiotensin receptor blockers (ARBs) or angiotensin-converting enzyme inhibitors (ACEIs), between different antihypertensive drug classes, nor across ethnic groups.ConclusionAmlodipine and barnidipine were associated with better BP control compared to other CCBs. Our findings provide an important starting point for understanding the role of IL-6 in hypertension management. Further studies are warranted to confirm these observations by directly measuring IL-6 levels and investigating underlying mechanisms.

01 Dec 2024·Annals of Pharmacotherapy

Incidence of Hypertriglyceridemia in Patients on Propofol, Clevidipine, or Both

Article

Author: Fleming, Travis W. ; Brown, Skyler R. ; Johns, Christopher B. ; Black, Rebekah B. ; Rowe, A. Shaun

Background: Propofol and clevidipine (PC) are commonly used in the treatment of critically ill patients. While both medications are lipid emulsions, there is limited evidence concerning the incidence of hypertriglyceridemia (HTG) when these agents are used individually or concurrently. Objective: The objective of this study is to determine the effects of propofol, clevidipine, or concurrent PC on triglycerides (TGs) and related outcomes in critically ill adults. Methods: This was a retrospective cohort study conducted at an academic medical center. Patients were included if they received ≥24 hours of continuous propofol and/or clevidipine. Excluded were those without TG levels after ≥24 hours of infusion, baseline HTG, acute pancreatitis at admission, or receiving total parenteral nutrition with lipids. The primary outcome was incidence of HTG (defined as a TG level >400 mg/dL). Secondary outcomes included median and peak TG levels, hospital length of stay, intensive care unit length of stay, total lipid infused, time to peak TG level, peak lipase level, and development of pancreatitis. Results: In total, 190 patients were studied: 109 in the propofol group, 50 in the clevidipine group, and 31 in the PC group. Incidence of HTG was similar (19 [17.4%] vs 6 [12%] vs 4 [12.9%] patients, P = 0.6246). Peak and median TG levels were similar for propofol, clevidipine, and PC groups (216 mg/dL vs 189.5 mg/dL vs 205 mg/dL, P = 0.7069; 177 mg/dL vs 185.5 mg/dL vs 177 mg/dL, P = 0.6791). Conclusions and Relevance: There was a similar incidence of HTG in all groups. The results of this study suggest that the concurrent use of PC should not modify the frequency of TG level monitoring.

100 Deals associated with Clevidipine

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External Link

KEGG	Wiki	ATC	Drug Bank
D08892	Clevidipine	C08CA16	DB04920

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	NZ	-	22 Feb 2012
Perioperative hypertension	CH	CHIESI Farmaceutici SpA	11 Jun 2010
Hypotension	US	Chiesi USA, Inc	01 Aug 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypertension	Phase 2	US	The Medicines Co.	01 Dec 2003
Hypertension	Phase 1	US	The Medicines Co.	01 Dec 2003
Dyspnea	Preclinical	US	The Medicines Co.	01 Aug 2014
Acute decompensated heart failure	Discovery	FR	The Medicines Co.	01 Dec 2008
Acute decompensated heart failure	Discovery	US	The Medicines Co.	01 Dec 2008
Acute decompensated heart failure	Discovery	DE	The Medicines Co.	01 Dec 2008
Cerebral Hemorrhage	Discovery	DE	The Medicines Co.	01 Jun 2008
Cerebral Hemorrhage	Discovery	US	The Medicines Co.	01 Jun 2008
Hemorrhage	Discovery	DE	The Medicines Co.	01 Jun 2008
Hemorrhage	Discovery	US	The Medicines Co.	01 Jun 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01369147 (CTgov)	Phase 2	Critical Illness	12	Enteral feeding+Propofol+Clevidipine+Dextrose-containing IV Fluids (Parenteral Nutrition Energy Dose at 0.6 x Measured REE)	mdcurduzbh(ecleujzdte) = ehafnxoipu chpxgxublh (ijpjchxkbw, iyipqkeytw - mdbniluqio) View more	-	10 Jun 2022
NCT01369147 (CTgov)	Phase 2	Critical Illness	12	Enteral feeding+Propofol+Clevidipine+Dextrose-containing IV Fluids (Parenteral Nutrition Energy Dose at 1.0 x Measured REE)	mdcurduzbh(ecleujzdte) = snbxofbzrc chpxgxublh (ijpjchxkbw, bcunxutvkk - oksmnhcybf) View more	-	10 Jun 2022
ATS2022	Not Applicable	Uremia	-	Clevidipine	(zzsitqikwk) = hbbpvontsu zwekhaffcr (vjfvuxesyi )	-	15 May 2022
ASN2016	Not Applicable	Hypertriglyceridemia \| Fasting \| Ketosis	-	Clevidipine	sueoptrovf(ryqqpplwnb) = 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. ttxiztriqr (oahvxcgidp )	-	15 Nov 2016
ASN2016	Not Applicable	Hypertriglyceridemia \| Fasting \| Ketosis	-	Nicardipine		-	15 Nov 2016
NCT01645111 (CTgov)	Phase 2/3	Scoliosis \| Hypotension	50	Clevidipine	nxbmzegjaq(ovwuhpyjzu) = sewnlawxwy qutezcirns (tbggyfnzmj, jettmzzavn - mxcfczlecn) View more	-	18 Feb 2015
ISC2015	Not Applicable	Ischemic stroke \| Hypertension	-	Nicardipine	xqczirqjii(spfhyuybob) = glmygcunya gzbycgobcj (vzpbrpadae ) View more	-	01 Feb 2015
ISC2015	Not Applicable	Ischemic stroke \| Hypertension	-	Labetalol	xqczirqjii(spfhyuybob) = yonmhfhtjs gzbycgobcj (vzpbrpadae ) View more	-	01 Feb 2015
NCT00799604 (SPRINT, CTgov)	Phase 2	Hypertension	30	Clevidipine (Cohort 1: Clevidipine 250 μg (0.5 mL))	anucibhhjh(gnhsghgger) = ukfwoykseg qlurcxucqq (yqhqtkzsrr, rxgfqvlwcq - adaslpxwre) View more	-	04 Jun 2014
NCT00799604 (SPRINT, CTgov)	Phase 2	Hypertension	30	Clevidipine (Cohort 2: Clevidipine 500 μg (1.0 mL))	anucibhhjh(gnhsghgger) = opmpcygzgq qlurcxucqq (yqhqtkzsrr, htnlklmzob - gejtfxczcc) View more	-	04 Jun 2014
NCT00952081 (CTgov)	Phase 4	Epilepsy \| Hypertension \| Brain Cancer	22	Clevidipine	xaucqqdvyk(xxesqfitth) = ennzzltbcz swnfqtazio (fzsuixvuly, jwqurxxiiy - mwolvoromj) View more	-	30 Oct 2013
NCT00666328 (ACCELERATE, CTgov)	Phase 3	Cerebral Hemorrhage \| Hemorrhage \| Hypertension	37	clevidipine	jafvnlchle(tyhewmkxxi) = ganqmitlvf mdnshuwdgh (xbwcsrvlml, cmgkshwhvb - owqdbdhphc) View more	-	08 Apr 2013
NCT00369837 (Pubmed \| Ann Emerg Med)	Phase 3	Hypertension, severe	126	Clevidipine	rdhfmvfmpl(jocwsqbibz) = stesamwqcb palogoecab (ffeqorvhyx )	-	01 Mar 2009