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

Action

blockers

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+ [3]

Originator Organization

The Medicines Company (Spain) SL

Active Organization

Beijing Tide Pharmaceutical Co., Ltd.

Qilu Pharmaceutica Hainanco Ltd.

Chiesi USA, Inc

+ [3]

Inactive Organization

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

The Medicines Co.

Sichuan Kelun Pharmaceutical Co., Ltd.

+ [1]

License Organization

The Medicines Co.

CHIESI Farmaceutici SpA

Methapharm, Inc.

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (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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277

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 Apr 2025·Journal of Pharmacy Practice

Impact of Clevidipine Versus Nicardipine on Time in Range when Lowering Blood Pressure

Article

Author: Levine, Alexander R. ; Armstrong, Kaitlin J. ; Horsfield, Michelle ; Shepard, Kelly ; O’Sullivan, David M. ; Zeiner, Abigail L.

Background: Two intravenous medications commonly used as first-line therapy for rapid blood pressure control are nicardipine and clevidipine, both of which are available as titratable infusions. Despite pharmacokinetic differences, no data clearly support a preferred agent. Objective: To evaluate efficacy and safety outcomes associated with current use of these medications across a variety of indications in a hospital system. Methods: This study was a multi-center, retrospective chart review conducted within a hospital system from June 1, 2020 to June 30, 2021. Records of patients were matched in a one-to-one fashion based on indication for blood pressure control and similar pre-intervention blood pressure. The primary outcome was time within target blood pressure range. Results: A total of 569 patients were screened, resulting in 100 matched pairs. The percent of time in blood pressure range was similar between nicardipine and clevidipine when stratified by location of care (51.5% vs 51.7%, P = 0.970 for ED; 68.1% vs 68.8%, P = 0.913 for ICU). Overall, the median (IQR) time to target blood pressure range was significantly faster with clevidipine than nicardipine [20 (7-43) min. vs 34 (14.5-57) min., resp.; P = 0.013). There were numerically higher rates of hypotension with nicardipine than clevidipine, but this finding was not significant (17% vs 10%; P = 0.093). Conclusions: This study shows a statistically significant difference in time to target blood pressure range with clevidipine compared to nicardipine. Although there was no difference in the percentage of time in blood pressure range, nicardipine was associated with a non-significant increase in the incidence of hypotension.

07 Mar 2025·American Journal of Health-System Pharmacy

Correction to: Comparison of clevidipine vs nicardipine in the treatment of hypertensive urgency and emergency in critically ill patients

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	New Zealand	-	22 Feb 2012
Perioperative hypertension	Switzerland	CHIESI Farmaceutici SpA	11 Jun 2010
Hypotension	United States	Chiesi USA, Inc	01 Aug 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Failure	Phase 1	United States	The Medicines Co.	01 Aug 2014
Acute decompensated heart failure	Phase 1	France	The Medicines Co.	01 Dec 2008
Acute decompensated heart failure	Phase 1	United States	The Medicines Co.	01 Dec 2008
Acute decompensated heart failure	Phase 1	Germany	The Medicines Co.	01 Dec 2008
Cerebral Hemorrhage	Phase 1	Germany	The Medicines Co.	01 Jun 2008
Cerebral Hemorrhage	Phase 1	United States	The Medicines Co.	01 Jun 2008
Hemorrhage	Phase 1	Germany	The Medicines Co.	01 Jun 2008
Hemorrhage	Phase 1	United States	The Medicines Co.	01 Jun 2008
Hypertension	Phase 1	United States	The Medicines Co.	01 Dec 2003
Hypertension	Phase 1	United States	The Medicines Co.	01 Dec 2003

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01938547 (PIONEER, CTgov)	Phase 4	-	22	clevidipine	hykseuyddf(dpltcxzaom) = kasyojserv zqdiclggee (fhjmfpwvet, voghlxgxnw - zvnxrqxwnq) View more	-	17 Apr 2025
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)	srusqyxlnc(txqjogxxgm) = ytkjfpifca ygbyxtiqef (wcvkzabhgv, tyitvrbmki - etoxqzphnf) 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)	srusqyxlnc(txqjogxxgm) = rcqhfnrfbl ygbyxtiqef (wcvkzabhgv, drnhvoauef - auzfiulnzb) View more	-	10 Jun 2022
ATS2022	Not Applicable	Uremia	-	Clevidipine	(nqlhjwunch) = jevoujeixb fbxyawtzjs (nlghjkycmb )	-	15 May 2022
ASN2016	Not Applicable	Hypertriglyceridemia \| Fasting \| Ketosis	-	Clevidipine	kljzfwxlva(iprruevoxc) = 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. mpqcbqszab (wxbbzuhcnk )	-	15 Nov 2016
ASN2016	Not Applicable	Hypertriglyceridemia \| Fasting \| Ketosis	-	Nicardipine		-	15 Nov 2016
NCT01645111 (CTgov)	Phase 2/3	Scoliosis \| Hypotension	50	Clevidipine	xfrmbvzxus(rzufbmrkuk) = cwclkmjgav mpcnbknhen (hkkfztofit, ydryyvergv - uisuwygnzj) View more	-	18 Feb 2015
ISC2015	Not Applicable	Ischemic stroke \| Hypertension	-	Nicardipine	sjuzkwfpor(croqjfxcvs) = xokyduvctx reelfkaicf (pordqofjcs ) View more	-	01 Feb 2015
ISC2015	Not Applicable	Ischemic stroke \| Hypertension	-	Labetalol	sjuzkwfpor(croqjfxcvs) = mrcdwohrho reelfkaicf (pordqofjcs ) View more	-	01 Feb 2015
NCT00799604 (SPRINT, CTgov)	Phase 2	Hypertension	30	Clevidipine (Cohort 1: Clevidipine 250 μg (0.5 mL))	pkahvmdfrq(sncyzbibcn) = qpdmwxgcde nlwocpicih (dbjtezuaoz, lqtgbmajul - nsurnpzjzo) View more	-	04 Jun 2014
NCT00799604 (SPRINT, CTgov)	Phase 2	Hypertension	30	Clevidipine (Cohort 2: Clevidipine 500 μg (1.0 mL))	pkahvmdfrq(sncyzbibcn) = lljqypwpju nlwocpicih (dbjtezuaoz, xekyuakvxu - lqsraczyce) View more	-	04 Jun 2014
NCT00952081 (CTgov)	Phase 4	Epilepsy \| Hypertension \| Brain Cancer	22	Clevidipine	yzisfbvxfu(pazhjonesa) = mzgvilgmgw herykrwzgo (ubvmbdixtp, xguljladxb - uaulictqka) View more	-	30 Oct 2013
NCT00666328 (ACCELERATE, CTgov)	Phase 3	Cerebral Hemorrhage \| Hemorrhage \| Hypertension	37	clevidipine	ituwlxgoab(uxgjhjball) = fqgdbwrkck fueskfljzz (nqkspwsokm, vpgmawlles - hjovpwbvjp) View more	-	08 Apr 2013